Has held senior positions at leading global companies. Most recently, he was CFO of the global biomedical research organization, Novartis Biomedical Research, a subsidiary of Novartis AG. He also brings a deep understanding of market dynamics as well as the efficient use of resources. Mr. Zapata has joined us today, and I would like to briefly pass the floor to him.
Thank you for the introduction, Helmut. As you can hear, my German is a little rusty, but it was important to me to speak personally to you. I'm very pleased to become part of BioNTech and would like to thank you all for your trust. See you soon. Thank you very much.
Dear Ramón, thank you very much. Before we move on to the agenda, I would first like to draw your attention to a few formalities. In accordance with Article 16, Paragraph 5 of our Articles of Association, the Executive Board has decided that today's AGM will be held as a virtual AGM without the physical presence of shareholders or their proxies at the venue of the AGM. The requirements for holding a virtual AGM will be met. I will go into further detail later, in particular regarding the granting of certain rights. The entire AGM will be broadcast live in sound and vision via our company's website. The broadcast via our investor portal is exclusively for our shareholders and their proxies. Please note that neither audio nor video recordings will be made of this meeting.
Kindly note that you are also not permitted to make any image or sound recordings of this broadcast. The speech by the Chairman of the Executive Board and the presentation by the Executive Board will be made available on the company's website after the end of this AGM. We have carefully checked the technical requirements for the live broadcast so that we can conduct the virtual AGM from here in a technically proper manner. The notary has had that technology explained to her and has been able to see the technical arrangements for herself. However, the quality of the image and sound transmission of the virtual AGM and availability of the investor portal may be subject to fluctuations, over which the company has no influence. If the transmission is disrupted from our end, we will inform you via our website.
The invitation to today's virtual AGM, including the agenda and the management's proposals for resolutions, was published on April 4th of 2025 with the legally required content in the Federal Gazette. It was also made available on the company's website, where you could and can still find the other documents and information to be made available for the AGM. A copy of each of these documents, as well as a confirmation of the Federal Gazette regarding the publication of convening of the AGM, has been submitted to the notary. The company has also notified the persons and institutions specified in Section 125 of the German Stock Market Stock Corporation Act of the convening of the AGM in due time. I hereby declare that today's AGM has been duly convened in compliance with the formal and deadline requirements in accordance with the law and the Articles of Association of BioNTech SE.
Within the statutory period, the company did not receive any application for amendments to the agenda requiring publication. Furthermore, no counter motions or election proposals from shareholders that ought to be made available have been received in advance of this AGM. The list of attendees is currently being compiled. In addition to the votes represented by proxies, this also includes shareholders and their proxies connected electronically. That means those persons who are currently logged into our investor portal. I will announce attendance at the latest before the first vote. The list of attendees will be available for inspection after the announcement of attendance in the investor portal in the list of attendees section. A copy of the list of attendees will be made available to the notary. Any subsequent changes will be added to the list of attendees as addenda, which will also be made available to the notary.
If you have received multiple sets of login details for the investor portal, please note that you must log in separately with each set of login details in order to exercise your voting rights for all your shares. Up to five days prior to the AGM, all shareholders and their proxies had the opportunity to submit statements to the company regarding today's AGM. However, no statements were submitted to the company within the specified period. The shareholders' right to information pursuant to Section 131, Paragraph 1 of the German Stock Corporation Act may only be exercised at today's annual general meeting and, as I hereby expressly determine, exclusively by means of video communication.
In advance of this AGM, we again gave our ADS holders the opportunity on a voluntary basis to submit questions on the items on the agenda by email until May 14th, 2025, at midnight Central European Summer Time. The Executive Board will address some of the points raised in the questions during its speeches in order to address the key issues that are of concern to our ADS holders. Following the reports of the Supervisory Board and the Executive Board, a general discussion of all items on the agenda will take place at today's AGM. During the general discussion, our shareholders and their proxies will have the opportunity to exercise their right to submit motions and election proposals, as well as their right to information and to speak via video communication through the investor portal.
Our shareholders and their proxies can use the investor portal to register, exercise their rights to information and to speak, as well as to submit motions and election proposals in order to register to exercise the corresponding rights via video communication. After you have registered, we will contact you and explain the further procedure in detail. Please understand that this process will take a few minutes and that we will first carry out a technical check as to the connection and functionality of the video communication. If functionality cannot be guaranteed, we reserve the right to reject the speech request for information or application or election proposal. If everything is working properly, you will be added to the list of speakers and will remain in a virtual waiting room until I call on you.
You will, of course, still be able to follow the AGM live in this virtual waiting room. Shareholders or their proxies who wish to speak on the items on the agenda of today's annual general meeting and have not yet indicated this accordingly are kindly requested to announce their intention to speak using the corresponding button in the investor portal. If you have any motions regarding the rules of procedure or the agenda, please also announce them in the investor portal using the corresponding button. This will facilitate the handling of your motions and thus contribute to the smooth running of the AGM. Of course, you can also speak during the debate in the manner just explained. I would like to begin briefly explaining the voting procedure.
As the chair of the meeting, I'm responsible for determining the order of the items on the agenda and the type and form of voting in accordance with Section 15, Paragraph 3 of the Articles of Association of BioNTech SE. Our shareholders and their proxies may exercise their voting rights via the investor portal by means of electronic postal voting or by issuing a proxy with instructions to the company's proxy holders. Postal votes may be cast, revoked, or changed via the investor portal until I close the vote at today's AGM. Proxies and instructions to proxy holders may be issued, changed, or revoked via the investor portal until the start of the voting at today's AGM. Proxies with instructions to proxy holders could be issued, changed, or revoked by email or email until the end of yesterday. The voting result will be determined by means of an additional procedure.
That means the yes votes and the no votes will be counted. The total number of valid votes cast and the share capital represented at the time of the resolution will be determined by adding the valid yes votes cast and the valid no votes cast. I will remind you again to vote at the appropriate time, but would like to ask you now to cast your votes in good time. If you wish to vote yes or no on one or more proposed resolutions, abstentions are not counted when calculating the required majorities and therefore have no influence on the voting results. Attendance is also irrelevant for determining the voting results by means of the addition procedure. The votes on the items on the agenda will take place after the general debate has been concluded. The votes will be counted by a data processing system.
Shareholders or their proxies participating in the AGM electronically will also be granted the right to object to a resolution of the AGM by means of electronic communication at today's virtual AGM. By clicking on the report unanswered questions button in the investor portal, shareholders and their proxies can also request that questions which they believe have been refused and the reason for the refusal be included in the notarized minutes. Any request for information pursuant to Section 131, Paragraph 4 of the German Stock Corporation Act can also be submitted via a corresponding button in the investor portal. In addition, shareholders can also authorize third parties to exercise shareholder rights on their behalf in the investor portal and revoke any powers of attorney granted. The use of the investor portal by an authorized representative requires that the authorized representative receives the relevant access data.
Ladies and gentlemen, now that the formalities have been completed, we will move on to the agenda, which was published in the Federal Gazette along with the management's proposed resolutions and made available on the company's website. I therefore assume that everyone is familiar with the agenda items and will not read them out. I will now move on to agenda item one, presentation of the approved annual financial statements, the approved consolidated financial statements, and the combined management reports for the company and the group, as well as the report of the Supervisory Board, each for the fiscal year of 2024 or as of December 31 of 2024. The documents relating to agenda item one were made available on the company's website when the Annual General Meeting was convened. They can also be accessed there during today's AGM.
With regard to agenda item one, I would like to state the following. The Supervisory Board has already approved the annual financial statements prepared by the Executive Board and audited with an unqualified audit opinion by the auditor as of December 31, 2024 and the consolidated financial statements. The annual financial statements are therefore adopted in accordance with Section 172, Paragraph 1 of the German Stock Corporation Act. The documents listed under agenda item one are therefore only to be made available to today's AGM without requiring any further resolution. Ladies and gentlemen, we now come to the Supervisory Board's report for the 2024 fiscal year.
The year 2024 was a year of progress for BioNTech, both in clinical development and in organizational development, a strategic decision by the Executive Board to acquire the biotechnology company Biotheus, thereby gaining, among other things, the full global rights to the antibody candidate BNT327 was a key driver of accelerated company development. We view the acquisition, which was completed in February, as an important contribution to creating value for patients and shareholders alike. The Supervisory Board also recognizes and supports the Executive Board's decision to continue to develop the company consistently in 2025 and beyond so that the strategic focus is reflected in capital allocation, pipeline prioritization, company-wide processes, and research and manufacturing capacities. Ladies and gentlemen, I would now like to give you an insight into some of the key points of the Supervisory Board's work in the past fiscal year.
For more formal explanations and further details, particularly regarding the specific activities of the Supervisory Board and its committees, please refer to the written report of the Supervisory Board on pages 12 to 21 of the annual report for the 2024 fiscal year, which is available on the company's website. Throughout the 2024 fiscal year, the Supervisory Board performed its duties and obligations in accordance with the law, the articles of association, and the rules of procedure. The Supervisory Board continuously monitored the Executive Board in its management of the company, advised it on a regular basis, and dealt with the strategic development of the company. The cooperation with the Executive Board was characterized in every respect by responsible and goal-oriented action. The Executive Board fulfilled its reporting obligations to the Supervisory Board in full.
Based on the Executive Board's reports, we discussed the business development and events of importance to the company in detail. The Supervisory Board was directly involved at an early stage in all decisions of fundamental importance to the company. A total of nine regular meetings were held in fiscal year 2024 to discuss the strategic development of the company. Of these nine regular meetings, three were held in person, two were held in hybrid form, and the remaining four were held as virtual meetings. The regular meetings focused on the consistent further development of the corporate strategy, including the prioritization of selected business areas, and on discussions regarding the further development of the company's business activities in connection with the clinical development of its oncology candidates.
We also addressed the company's ongoing investments in the further development of the COVID-19 vaccine and the associated strategic decisions regarding its adaptation to the Omicron variant and its sub-lineages, the clinical development of next-generation COVID-19 vaccines, and the development of a combination vaccine against influenza and COVID-19 in collaboration with Pfizer. In addition, the Supervisory Board reviewed the further development of the diversified portfolio of oncology product candidates and the achievement of milestones in clinical trials, as well as the development of IT processes to support clinical development. The Supervisory Board also reviewed the company's global growth, developed a product-specific commercialization strategy, and established a commercial organization for the distribution of the company's future product candidates, and discussed commercial activities and necessary next steps for our product candidates in advanced clinical trials.
In addition, the Supervisory Board was involved in the conclusion of new strategic collaborations, including the acquisition of our partner Biotheus. The Supervisory Board has formed four committees to carry out its monitoring and advisory functions: an Audit Committee, a Compensation Nomination and Corporate Governance Committee, a Capital Markets Committee, and a Product Committee. The committees prepare the Supervisory Board's agenda items for discussion in the full Supervisory Board meeting. The Audit Committee met seven times in fiscal year 2024, the Compensation Committee and the Capital Markets Committee each met four times, and the Product Committee met five times in the last fiscal year. The annual financial statements prepared by the Executive Board, the dependency report, the consolidated financial statements, and the report on the situation of the group and the company have been issued with an unqualified audit opinion by the auditor Ernst & Young GmbH & Co. KG.
The auditor's report was discussed in the audit committee with the Executive Board and the auditors. For our part, we have audited the annual financial statements, the dependency report, the consolidated financial statements, and the report on the situation of the group and the company for the 2024 fiscal year. Based on the final results of our audit, we have no objections to raise and consider the auditor's assessment of the annual financial statements to be accurate. We have approved them. We have approved the annual financial statements prepared by the Executive Board and the consolidated financial statements prepared by the Executive Board. The former are hereby adopted. The Supervisory Board also agrees with the report on the situation of the group and the company, including the non-financial report, based on the final results of its audit.
The Supervisory Board also has no objections to the Executive Board's statement on related party transactions in the dependency report. After its own intensive review and discussion, the Supervisory Board had also endorsed the Executive Board's proposal for the appropriation of profits to be presented to today's AGM. With regard to the appropriation of net income for the 2024 fiscal year, the Executive Board and Supervisory Board proposed under agenda item two that the net income of BioNTech for the 2024 fiscal year in the amount of EUR 8,232,460.14 be carried forward in full to new account. In the short and medium term, it will be important to deploy resources in a disciplined manner in strategic growth areas, optimize costs through efficiency improvements, and prepare the first potential regulatory submission for a possible market launch in oncology in 2026.
The Supervisory Board believes that these measures, together with an increased focus on prioritized programs in oncology and ongoing investment in the further development of the COVID-19 vaccine, put the company in a good position to achieve or maintain a leading market position. Our goal is to successfully guide BioNTech through the next phase of its transformation into a leading global biopharmaceutical company with approvals in multiple indications. I would like to thank all employees who contributed to the successful planning and implementation, and I would also like to thank all shareholders for your trust. Ladies and gentlemen, we now come to the report of the Executive Board. I now give the floor to the Chairman of the Executive Board, Professor Uğur.
Dear ladies and gentlemen, dear shareholders and shareholder representatives, I would like to welcome you on behalf of myself and my colleagues on the Executive Board.
I would like to extend a very warm welcome to BioNTech's annual general meeting today. Before we begin with our report, we would like to point out that we will be making forward-looking statements in this annual general meeting. As described on this slide of the presentation, these statements are subject to the risks and uncertainties specified in our documents submitted to the U.S. Securities and Exchange Commission, including our most recent annual report on Form 20F. These statements relate to, among other things, our COVID-19 vaccine revenue, as these figures are derived from preliminary partner estimates, our estimated financial forecast 2025, the continued global demand for our COVID-19 vaccine, and the planned next steps in our pipeline program. Actual results may differ materially from those projected in these statements. All information in this presentation is up to date as of the date of this presentation.
Except as required by law, BioNTech disclaims any intention or obligation to update or revise any forward-looking statements contained in this presentation, whether as a result of new information, future developments, or otherwise. We would like to thank our employees and our cooperation partners for their dedicated and outstanding work last year and this year. I would also like to thank the patients who have taken part in our clinical trials and the healthcare professionals who have been instrumental in implementing our therapeutic approaches in clinical trials. Our vision is clear. We want to become a global leader in immune therapies using science to develop new immune therapies to improve people's health. In 2024, we further developed our clinical portfolio and advanced the evaluation of our focus programs in numerous phase two and phase three studies.
In parallel to our focus program, with our expertise and core competencies in immunogen, we used deep genomics and AI. We are convinced that we are excellently positioned in transforming cancer medicine into personalized medicine up to the operative excellence. Our position in immunology and mRNA-positioned platforms and such medicine focuses on the fact to define the therapy anew and to make them focused on an individual patient. Oncology is in a transformation process. The diagnostics become more predictive, therapies more focused, and translational research shortens the way from the laboratory to the patient. We do not only want to benefit from those technologies, but the medical revolution needs to be shaped by us. It is not the future we are talking about. It is the strategy we live.
We are sure that the era of the customized cancer medicine starts today, and BioNTech is going to make a major contribution at this point. Let's go back to the financial year of 2024. The successful development of the vaccine against COVID-19 sped up our development and increased our field of activities. We can see that COVID-19 and the vaccine business is a major part of our business. Together with our strong financial position, it enables us to make strategic financial investments into our research and development. We invest in clinical focus programs, which I'm going to explain in a moment. We are sure that our investments are going to lead to a sustainable value creation. In 2025, we have selected first clinical data in oncology in the late clinical treatment phase, and we do expect further data updates in a number of clinical programs.
Before the authorities will come to a conclusion and by the fulfillment of all requirements for authorization, we wish to achieve to release authorizations for tumor therapy with a lot of agreements. A first authorization may come in early 2026. During the years of 2022 and 2025, we were shaped by the development of the COVID vaccine together with Pfizer. In 2023 and 2025, we started to focus on our original goal, the further development. Before I explain our various therapeutic approaches in more detail, I would like to briefly address one of the fundamental problems in the treatment of cancer. These basic problems mean that many established therapeutic approaches are only effective for a limited time, especially if cancer has been diagnosed at a late stage. Cancer is a very individual disease that is caused by a series of changes in the genetic material of healthy cells.
These genetic changes are called mutations. They are random and vary in number and type from patient to patient. Even the cancer cells within the tumor differ from one another. Here we come to the basic problem. Every tumor is unique, and even the cells in a tumor are different. It changes over time. This means that not only the cells change, but they are different within a patient. This leads to the fact that a therapy is initially effective and eliminates a visible part of the cancer cells, but often not all of them. The cells that remain have often developed resistance to current therapies. They remain behind, cannot be treated with current therapies, and continue to grow uncontrollably. In such cases, tumors develop after a few months or years, which is then often so aggressive that the cancer can no longer be controlled.
We want to address this basic problem and improve the standard of care for many of these patients. Our product candidates are divided into three different therapeutic approaches, which I would like to discuss in more detail in the next slide. Our unique oncology portfolio consists of three complementary therapeutic modalities. First, there are our immune modulators. These kinds of therapies activate immune responses against specific targets on the cancer cells that are either patient-specific and work with. This blockage is a key obstacle in the fight against cancer. Our focus candidate, BNT327, neutralizes two of these mechanisms and is used in several clinical tests right now. The second class of therapies are the mRNA cancer immunotherapies. Here, we create patient-specific therapies. One program that is patient-specific on our FixVac program, which is tumor-type specific. They focus on a precise selection of structures of patients and tumors.
The third category are so-called targeted therapies. This includes drug-acquiring antibodies, the so-called ADCs. These antibodies specifically recognize surface features of cancer cells and dock onto them, and then they unload their toxic cargo, for example, chemotherapy agents, and they work against cancer in advanced stages. We believe that each of these modalities has the potential to provide precise mechanisms to fight cancer cells, and we want to achieve even more through the synergistic combination of different mechanisms. By not only providing innovative monotherapies with a suitable active agent partner, but also enhancing their individual effects in combination, thereby taking them to a new level. Ultimately, we want to help pave the way for curative approaches in cancer medicine and as many patients as possible.
With this combination strategy, we aim to tackle the entire spectrum of solid cancers at various stages, starting with operable cancers that are in the so-called adjuvant phase. In this phase, patients often appear cancer-free after surgical removal of the tumor, but a significant proportion have a risk of recurrence dependent on the type of cancer. The other end of the spectrum includes early-stage metastatic cancers and also late-stage cancers that are resistant to various types of treatment. To this end, we are investing in so-called pan-tumor programs, which we believe can be applied to many different tumor types. It is also our goal that these programs will enable us to improve treatment outcomes for patients across the spectrum of cancers. We have two focus programs that we believe have great potential to do this.
Our mRNA cancer immunotherapy approaches, FixVac and iNeST, and our immunomodulator candidate BNT327, a bispecific anti-PD-L1 and anti-VEGF. We believe that our individualized mRNA cancer immunotherapy, also called iNeST, is particularly suitable for the treatment of early-stage or low-tumor burden cancers. We have our bispecific antibody candidate BNT327, which could become a next-generation immunomodulator. We believe it is suitable for a broad spectrum of cancers. In addition, we are convinced that each of these programs can also be used as a combination partner for our portfolio of product candidates with complementary mechanisms of effect. We believe that these two programs alone have groundbreaking innovation potential that is in line with our vision. If successfully developed and approved, these programs could establish a new standard of care in oncology. If we are successful in achieving this, we could improve treatment outcomes for patients in various cancer indications.
Our investment strategy follows these data-based observations. We are investing significantly in the clinical development of these programs. At the same time, we are establishing a sales organization for future marketing in key markets and expanding our production capacities to ensure both clinical trials and the commercial supply of these therapies. The data obtained so far from over 1,000 patients indicate that BNT327 has the potential to become an innovative key candidate. BNT327 binds to both PD-L1 and VEGF, synergistically effecting two validated cancer biological mechanisms. Based on those two validated mechanisms against cancer, BNT327 uses a synergistic way and focuses on one of the key obstacles by surpassing immune answers to cancer. The docking of BNT327 enables us to be worked there in the micro environment of the cancer. With our studies, we were able to come to findings that prove the effectiveness of this.
We are running more than 20 clinical studies with BNT327 or even being planned, be it in monotherapy or innovative combination with therapies. It could be in combination with other substances from our pipeline as well. The indications in focus are small cell and non-small cell lung cancer, and particularly difficult to treat types of cancer. Another form is the advanced breast cancer, the so-called triple negative breast cancer, TNBC. We are pushing ahead the clinical development of BNT327 and have already started two pivotal trials for these types of lung cancer just mentioned. The further approval trial with BNT327 for the treatment of the aforementioned breast cancer will also start in the course of this year. The generated clinical data of BNT327 as monotherapy or in combination with chemotherapy show a controllable safety profile and an encouraging clinical activity.
This appears to be independent of the PD-L1 status of the tumors, which could make BNT327 a key immuno-oncology therapeutic approach to a broad patient population. Our hypothesis is that BNT327 could be applicable for the checkpoint immunity systems, but also for cancer kinds that have no such medication available right now. The need is immense. In the United States alone and the European Union, 1.5 million patients every year are diagnosed with cancer types for which anti-PD-L1 therapy is approved. Despite the enormous progress made in this field over the last 10 years, patients with various advanced cancers have an average survival rate of less than 50% within five years of their diagnosis. In addition, it is estimated that more than 1.4 million newly diagnosed cancer patients in the United States and the European Union are not being treated with current immuno-oncology therapies.
We believe that BNT327 could help to close this gap. We want to further the use of BNT327 and the benefits for our patients. As part of our recommendation strategy, we are evaluating the combination of BNT327 with various other therapeutic modalities for the treatment of advanced solid tumors. We have already started to test BNT327 in clinical trials in combination with different antibody-drug conjugates to complement or even replace conventional chemotherapy with more targeted approaches. By the acquisition of Biotheus, we receive the global rights to BNT327 and it gives us full power over this trial and gives us complete freedom of choice and enables us to accelerate the development of BNT327 and rapidly expand the indication use. The acquisition of Biotheus was a significant strategic step for BioNTech, which I would like to discuss in more detail.
As already mentioned, BNT combines two complementary mechanisms in one molecule, PD-L1 and VEGF signaling pathways are affected. We believe that combining these complementary mechanisms of action in the core environment of the tumor, we can induce stronger immune responses against the cancer than the respective individual therapies. This is also shown by our data to date. We decided to acquire Biotheus for several reasons. The first reason is to speed up clinical trials, especially phase I and phase III studies. Secondly, the acquisition allows us to use the plants in China to use them for the production. Thirdly, is the increasement of the Biotheus pipeline, which includes other bispecific product candidates that have the potential to create long-term value. In summary, we see BNT327 as an innovative immunomodulator, which can improve standard therapy for many cancer patients, especially in the late stages of the disease.
A key aspect of our vision for the future of cancer treatment will be the fusion of artificial intelligence and biology. BioNTech is committed to harnessing the power of digitalization and automation to drive auto innovation and medical breakthroughs. With our AI subsidiary InstaDeep, we have direct access to extensive AI expertise and capabilities that support our work in genomics, immunology, and biopharmaceutical development. On the left side of the slide, you see the approach to developing personalized therapies. A particular focus here is on our iNeST program, an individualized mRNA cancer immunotherapy approach targeting neoantigens. Four clinical trials are currently underway, including over 450 patients treated to date, and we are continuously learning how to improve the identification of further neoantigens, for example. We have been using computer-assisted algorithms for many years to identify new targets for cancer immunotherapy and to establish semi-automated production for the vaccines.
On the right side of the slide, we refer to our innovative Deep Chain platform. Deep Chain can be seen as a basic AI model that could be used for any kind of lead candidate optimization. We have also introduced an automated tri-web lab process that forms the basis for using AI to continuously improve and identify targets and lead molecules. We have built world-class internal supercomputing capabilities, which we presented at our AI day in October last year. Ultimately, we want to use AI not only in research and development, but in all areas of the company and integrate this technology into processes along the value chain. In this way, we can create sustainable value at the interface between BioNTech and AI. Let us now move to our marketed COVID-19 vaccine.
When the COVID-19 pandemic broke out, we faced the challenge of making life-saving vaccines available worldwide at short notice. According to the journal Nature, the development of Comirnaty was the fastest vaccine development in the history of medicine, and to date, we have delivered over 4.9 billion doses of vaccine to over 180 countries. This success underlines not only the versatility of our mRNA technology, but also our ability as a company to translate research into innovation and to make it usable for society while creating value for our shareholders. With the help of our innovative strength and by utilizing the global infrastructure of our partner Pfizer, we intend to maintain our market-leading role in the fight against COVID-19. We believe that there will continue to be a need for seasonally adapted vaccines against COVID-19 in the future. The virus is constantly changing.
In addition, there are extensive results that prove the long-term health benefits and protection provided by repeated vaccinations. Statistics show that even with the current SARS-CoV-2 variants, the risk of severe disease progression remains high, especially in older and immunocompromised individuals. We believe that variant-adapted vaccines will continue to play an important role in protecting people from COVID-19 and severe disease progression in the future. We are currently preparing to adapt our COVID-19 vaccine so that it will be available in time for the upcoming 2025-2026 vaccination season. Let me conclude by summarizing what we achieved in 2024 and the first quarter of 2025. We have made significant progress with our two focus programs, BNT327 and our mRNA cancer immunotherapies. For our mRNA cancer immunotherapies, we have initiated a new phase two study to evaluate BNT122, also known as autogene servoumeran, for the treatment of surgically removed bladder cancer.
At the beginning of the year, we also published two manuscripts in renowned scientific journals describing our findings from two phase I studies with autogene servoumeran. We have also published for our FixVac program data, including the positive phase II data for our FixVac candidate BNT111 for the treatment of melanoma patients in whom the melanoma has either recurred or in whom the usual standard therapies have failed. We have presented important datasets for BNT327, initiated potentially pivotal phase III and phase II/III studies in small cell lung cancer and non-small cell lung cancer, respectively. We plan to start another pivotal trial with BNT327 in triple negative breast cancer this year. With the acquisition of our long-standing partner Biotheus, we have obtained the global rights for the development and marketing of BNT327 and further expanded our capabilities in the field of immunotherapy.
We were able to maintain our leading global market position for our COVID-19 vaccine together with Pfizer. We also continue to drive forward several other programs for infectious diseases with high medical need. We were able to achieve all of this while maintaining a strong financial position. We believe that we have laid a good foundation for our further growth in 2024 to date and are therefore well positioned for continued progress in 2025. I would now like to summarize our priorities for the year 2025. In doing so, I will focus on the most important expected clinical and regulatory milestones for our oncology pipeline. This year, we will continue to concentrate on the development of our two focus programs, BNT327 and our mRNA cancer immunotherapies. These programs are currently in phase two or phase three trials and are expected to deliver data later this year.
We will continue to expand our commercial capacities in oncology. Our aim is to become a fully integrated biopharmaceutical company in oncology as well. We will continue to invest in vaccines for the prevention of infectious diseases this year to maintain our global leadership position in the COVID-19 vaccine market while advancing the next generation of COVID-19 vaccines and combination vaccines in the clinic. In addition, we plan to present data on our early infectious disease pipeline later this year. Finally, we are preparing for our first potential market launches in oncology. One potential candidate for this is our antibody-drug conjugate BNT323, which we are continuing to develop in the direction of a biologics license application. We are also continuing to expand our team for targeted AI-supported commercialization so that we are well equipped for the distribution of our future oncology products in key markets.
We expect several approvals for oncology products in a range of indications, particularly in the next few years. We believe that we are well on the way to establishing ourselves as one of the world's leading oncology companies. The year 2025 means a lot of change for BioNTech. As part of this great team, I look forward to supporting our product candidates on their path to market and making this value creation visible for the company and for society. We have a unique opportunity to make a difference in medicine, and I believe we have what it takes to establish BioNTech as one of the leading global immunotherapy companies. It is the commitment, passion, and highly professional work of our employees who continuously contribute to making BioNTech's vision a reality. Our thanks therefore go to you.
We would like to extend our thanks to our valued shareholders for your continued trust and support over the past few years. You are helping us to take the next steps together in implementing our strategy and realizing our vision. Finally, I would like to say a few personal words to Jens before handing the floor back to the Chair of the meeting. As mentioned, our esteemed CFO will be retiring in June of this year. Dear Jens, we thank you very much for your excellent financial leadership and your significant contributions to the successful development of BioNTech. We wish you continued success and fulfillment in all that you do in the future. I look forward to welcoming Ramón to our Executive Board team as Jens' successor from July. With his experience and expertise, we will continue to drive forward our strategic goals for the coming years together.
With that, I would like to thank everyone who has joined us for this annual general meeting today. I would now like to hand the floor back to the chair of the meeting.
Thank you very much, Uğur, for your comments. I would now like to give the floor to Mr. Jens Holstein, Chief Financial Officer of the company, to comment on the financial section of the executive board report and to explain the creation of authorized capital 2025 proposed under agenda item 7. He will also talk about the use of the ADS as of 2024 and the first quarter of 2025.
Thank you very much, Helmut. Dear shareholders, dear shareholder proxies, ladies and gentlemen, a warm welcome also from my side to our annual general meeting. When we look back to the financial year of 2024, we took important steps towards realizing our vision.
We have significantly developed our portfolio. More than 20 product candidates are now entering phase two and phase three clinical trials with a particular focus on our bispecific antibody BNT327. In addition to the pipeline, we have also strategically developed our organization and made targeted investments in it. We are working on future-proof structures. With these, we want to enable the planned market launch of our first oncology products. Without the commitment of our employees, the progress of last year would not have been possible. Here, I would like to thank all our employees for their dedication and hard work. Dear colleagues, thank you so much for your commitment. Before I now move on to the figures for the 2024 financial year, I would like to point out that in my report today, I always refer to BioNTech's group. This includes BioNTech and all its subsidiaries.
As the development of BioNTech is largely dependent on the development of the group, we refrain from commenting on its individual development. Let us now move on to our financial results for the 2024 financial year. Together with our partner Pfizer, we were once again able to build on the profitable COVID-19 vaccine business. With a market share of over 50%, we were able to maintain our leading global market position. On this basis, we generated total sales of around EUR 2.8 billion in the 2024 financial year. The decline compared to around EUR 3.8 billion in the previous year is mainly due to lower demand for the COVID-19 vaccine. In addition, amortization from our corporation partner Pfizer reduced our share of gross profit from sales. We continued to invest heavily in research and development in the 2024 financial year.
At more than 50%, expenditure on research and development accounts for a significant proportion for our overall cost structure. This underlines our ambition to breakthroughs in medicine and use them to become a leading global biotechnology company. The clear focus here is on our focus programs and late-stage clinical development. Our goal is to submit our first approval application for a cancer therapy by the end of 2025. Regulatory submissions for the treatment of a whole range of cancers are to follow. With our investments and intention for long-term value creation, we ended the 2024 financial year with a pre-tax loss of EUR 678 million. This corresponds to a basic and diluted loss per share of EUR 2.777. We were largely able to maintain our strong balance sheet and liquidity in the 2024 financial year.
At the end of the 2024 financial year, our cash and cash equivalents plus investments in securities amounted to EUR 17.4 billion compared to EUR 17.7 billion at the end of the 2023 financial year. We are in a good financial position to continue investing in a sustainable creation of value and implementation of our strategy in the interest of our shareholders. Next slide. Let's move on here. Here we can see the results for the 2024 financial year compared to our financial forecast from our third quarter reporting. Overall, we have successfully implemented our updated financial forecast for 2024, which we published in our third quarter 2024 conference call in November. As already mentioned, we recorded total sales of around EUR 2.8 billion in the 2024 financial year.
This meets our expectations and is roughly in the middle of our original sales forecast of EUR 2.5 billion-EUR 3.1 billion. Let us look now at the cost for research and development. In the 2024 financial year, we recorded research and development costs of around EUR 2.3 billion. This is slightly below the lower end of our financial forecast of EUR 2.4 billion-EUR 2.6 billion. This is partly due to our active portfolio management and the postponement of some costs for approval studies from 2024 to 2025. Sales and general administrative expenses and our investment expenditure for business operations were both at the lower end of our forecast range for 2024. We have focused on consistent cost management here. Let us now move on to capital transactions in the 2024 financial year and the first quarter of 2025.
We have summarized the transactions and measures in which capital shares were issued or used in the 2024 financial year and in the first quarter of 2025 in the two tables on the slide. The previously acquired 289,058 American Depositary Shares or ADS shown in the top line were used for the settlement of our employee stock option plans, the ESOP 2018 and LTI 2020. This means that we issued these ADSs to employees and members of the Executive Board who were involved in the program. These ADSs corresponded to around 2.12% of our share capital at the end of the 2024 financial year. We already reported in the AGM of last year. The ADSs transferred to the employees corresponded to 0.12% of our share capital at the end of the 2024 financial year.
When calculating the percentages, we had a look at the shares they were taking out and also the ADSs that are represented here. For the ADSs, they are only given out to those authorized in the program. The price that is transferred here, when buying shares and ADSs, that was only possible for authorized persons. Also, the authorization of the Executive Board made decisions on this. The AGM of 2024 and the authorization took place in January 2024. The acquisition took place in a combination of cash and also ADSs of 24,000 roundabout. This corresponded to a share of around 0.18% of the share capital at the end of the first quarter of the 2025 financial year. Here, that amounted to a price of roundabout EUR 16 per ADSs.
Also the use of the ADSs and the acquisition of Biotheus, it was possible to us to have an attractive counter performance for acquiring it. The committee of the subscription rights was responsible for this. Before I get to the key financial figures for the first quarter of 2025, I would like to briefly address agenda item 7. We would like to ask you for your approval today. The authorization of the Executive Board resolved by the AGM on June 22, 2021 under agenda item 5 allows the share capital of the company to be increased once or several times with approval of the Supervisory Board. The authorization runs until June 21, 2026, and may be increased once or several times by a total of up to EUR 123,155.40 by issuing up to 123,155.40 new value-registered shares against cash or non-cash contributions.
The authorization has been partially utilized and currently still exists in the amount of EUR 120,000. Under agenda item 7, the Executive Board, no, the Executive and Supervisory Board proposed that the existing authorization, insofar as it has not been used, be canceled and replaced by a new authorized capital 2025 in the amount of EUR 124,276.00. This corresponds to 50% of the current share capital. This proposal is intended to give the company the necessary flexibility with regard to its financing and to acquire attractive acquisition targets in the future. This may help to drive forward the transformation into a leading global biopharmaceutical company even in the short term. This applies in particular to the areas of oncology and infectious diseases.
The protection of shareholders against the dilution of their shareholdings is to be improved compared to the authorized capital 2021 by limiting the possibility of excluding subscription rights when issuing new shares from the authorized capital 2025 to a total of 10% of the share capital. The company will make use of the proposed authorization as soon as this is appropriate in the opinion of the Executive Board and the Supervisory Board. The utilization of the authorized capital 2025 is in the interest of the company. Let us now continue with selected key financial figures for the first quarter of 2025. In the first quarter of 2025, we realized sales revenue of around EUR 183 million. This is in line with our expectations and reflects the seasonality we had observed in the epidemic COVID-19 environment.
Revenues in the first quarter of 2025 were mainly driven by revenues from BioNTech's COVID-19 vaccine collaboration with Pfizer. Our operation expenses are in line with our internal planning. We continue to pursue active cost management and focus on clinical studies in advanced development phases. Research and development expenses amounted to around EUR 526 million. We closed the first quarter of 2025 with a pre-tax loss of around EUR 445 million. This corresponds to a basic and diluted loss per share of EUR 1.73. We continue to have a strong financial position and liquidity totaling EUR 15.9 billion in cash and cash equivalents plus securities held. The decrease compared to the end of the year is due, among other things, to the payment of around $800 million as part of the acquisition of BioSeas.
The payment in connection with the settlement of a contractual dispute with the National Institutes of Health amounting to around $792 million is already included in the Q1 balance sheet item. In addition, we expect a further settlement payment of $400 million in connection with the settlement of a contract dispute with the University of Pennsylvania, and that will be reflected in our financial position for the second quarter of 2025. For both settlements, we expect a partial reimbursement from our collaboration partner Pfizer totaling around $535 million in the financial years 2025 and 2026. Our partner Pfizer made the first reimbursement payment as planned in the first quarter of 2025. Now, the forecast for the 2025 financial year.
We already explained this in the outlook for the 2025 financial year, the reporting for the 2024 financial year, and recently confirmed this in the Q1 2025. Total sales in the range of around EUR 1.7 billion-EUR 2.2 billion. Research and development costs of between EUR 2.6 billion and EUR 2.8 billion. Sales and general administrative expenses of around EUR 650 million and capital expenditure for business operations in the order of EUR 250 million-EUR 350 million. These forecast ranges are based on various assumptions, which are naturally subject to uncertainties. Our sales forecast assumes relatively stable vaccination rate prices and market shares compared to 2024. We also expect a similar seasonality of sales as last year, with the last three, two, four months of the year having a significant impact on sales. The sales distribution forecast is based on the assumption of seasonal COVID-19 vaccine demand.
Similar to influenza vaccinations, we expect most vaccinations in the core markets in the fall and winter season in the northern hemisphere. Please note that any changes in legislation or policy decisions, including tariffs and public health policies, as well as changing global public opinion on issues such as vaccinations, could further negatively impact our expected revenues and expenses. Also, it is premature at this stage to comment on the potential impact of U.S. tariffs on the pharmaceutical industry. We are actively monitoring the situation and evaluating potential risk mitigation strategies. Our sales forecast also takes into account a certain amount of potential inventory write-downs and other charges from our collaboration partner Pfizer. These have a negative impact on BioNTech's share of gross profit from the sale of COVID vaccines in Pfizer's sales territory.
Furthermore, we expect revenues related to our services business, as well as revenues from the pandemic preparedness contract with the German government, could contribute to our total revenues. The forecast excludes external risks that are not yet known and quantifiable. This includes, but is not limited to the fact that the forecast does not include the impact of ongoing or potential future litigation and related activities or certain potential one-off effects and charges in connection with portfolio optimization. The forecast reflects the expected impact of license agreements, collaborations, and transactions to the extent they are published and may be subject to updates. For 2025, we do not anticipate a net profit. The main reasons for this are rising research costs as investments in the development of innovative drugs and adjusted sales due to the endemic situation and seasonality.
Our investments in oncology, particularly in BNT327 and mRNA-based cancer immunotherapies, remain a top priority. Dear shareholders and proxies, ladies and gentlemen, people from all over the world and with different areas of expertise work in our company. What unites us is a shared vision. We want to achieve groundbreaking medical breakthroughs that make a tangible difference for people with cancer. We want to set new standards in oncology and leave the beaten track. With the acquisition of Biotheus, we have complemented our existing activities in this area, and we believe that to be well-positioned globally to take the next decisive steps towards achieving our vision. Together with you, ladies and gentlemen, we have already made history once and made a tangible difference for humanity. Today, more than ever, we are working to realize our mission to make a meaningful difference in oncology.
We would like to take you with us on our journey. On my last slide, I would like to draw your attention to our annual investor event, which we are planning this year. On November 11th, we will host our already established annual innovation series, which focuses on developments in our pipeline and the company's overall product development strategy. Details of this event will be announced shortly. Today, I would like to conclude my section with a personal note. The time is now right for me to hand over my responsibilities as CFO of BioNTech and leave the operational responsibility in order to focus on non-operational activities in the future. Consequently, today, this is my last annual general meeting as CFO of BioNTech.
I would like to take this opportunity to thank you, dear shareholders, as well as my colleagues on the Executive Board and Supervisory Board and my teams for their commitment and cooperation during this valuable time. It has been a privilege to have been part of BioNTech's development into one of the largest global biotechnology companies. I'm convinced that BioNTech is well-positioned to continue its success. I wish my successor, Ramón, all the best. He can look forward to a strong team of dedicated people who are committed to BioNTech's vision with heart and entrepreneurial spirit.
Ladies and gentlemen, this brings us to the Q&A part. Before we come to the Q&A session, I would like to say that the ADS holders have received the questions, and they had the opportunity to send their questions by email to BioNTech.
This is why we would like to now talk about those questions that have reached us. We thank the ADS holders and also would like to thank Mr. Schmidt, who submitted questions on behalf of the SDK, and Mr. Tüngler, who sent us questions on behalf of DSW. We would now like to respond to these questions. The SDK asked to what extent our subsidiary, InstaDeep, can also generate substantial income by offering solutions for other companies and thus diversifying its sales revenues.
That is true. InstaDeep is a leading company in the field of artificial intelligence and, as a subsidiary of BioNTech, already covers various sectors in the third-party business in addition to biotechnology. This includes technology, transportation, and logistics industry, and financial services. The strategic rationale behind the acquisition was to jointly develop core innovations at the intersection of AI and biology.
The next question relates to the possibility of paying milestone payments to collaboration partners with own shares. For us, capital-efficient measures are always a priority, but the contractual provisions usually set certain limits here and can, for example, provide for a cash payment at milestones. This question was asked by Mr. Tüngler as well as Mr. Schmidt. Both organizations would like an update on legal disputes with competitors and other third parties. As I mentioned in the speech, we announced the settlement of contractual disputes with the National Institutes of Health and the University of Pennsylvania at the end of 2024. Other cases refer to legal disputes regarding intellectual property. We described this in our foreign intersection based on our current analysis. They do not give the criteria for write-downs, but we cannot comment in further detail.
We are aware of the fact that it is not unusual that other companies in the pharmaceutical industry could infringe their intellectual property rights. We would like to underline that we also are going to protect our innovations against any attempts to infringe their property rights. Mr. Tüngler is asking whether a dividend is planned in the near future and which role the draft resolution on authorized capital on agenda item 7 will play in this. First, I will answer the part regarding the share buybacks and the dividend. Returning capital to our shareholders remains an important capital allocation consideration for us. Given our success in recent years, we had a dividend payment in 2022, but we considered it adequate to pay back a dividend to our shareholders who have supported us over this period of time.
We also consider and see ourselves as a growth company and are convinced that we will create value for our shareholders primarily through the further development of innovative therapies and the achievement of long-term sales growth. For this reason, our priority in the coming years will be to increase our expenditure in research and development in order to invest in the many attractive products and opportunities that we see. Now I will turn to the authorized capital that was addressed in the question. The authorized capital 2025 gives the company the necessary flexibility in its financing. Among other things, the proposed authorization for the so-called simplified exclusion of subscription rights makes it easier for the company to raise equity capital if necessary and opens up the opportunity to take advantage of favorable market conditions quickly and flexibly.
The proposed authorization will also enable us to take advantage of further emerging opportunities for strategically appropriate acquisitions in a flexible and liquidity-friendly manner. It also puts us in a position to act swiftly at short notice if the opportunity arises without burdening the company's liquidity. The proposed authorization can thus contribute to further advancing the transformation into a leading global biopharmaceutical company, even in the short term. The Executive Board will examine on a case-by-case basis whether the use of authorized capital 2025 is in the interest of the company and thus in its shareholders. We will, of course, inform you of any future developments in due course and in accordance with the applicable legal provisions. In addition, our ADS holders ask whether the Executive Board is planning to plan the holding money and invest in more long-term investments.
In the past years, as you know, were shaped by an inversive interest structure and short-term investments were more profitable than long-term investments. We are observing right now that the market, we are observing the market and with the change of the interest curve, we have started to invest on a long-term basis as well. In addition, there was an interest which kind of instruments we might use in order to optimize the revenue in the future. We are focusing our investments in shaping a balance between acquisitions and keeping our investments. We focus on an efficient disposition to keep our cash movements in interest-bearing securities. The next question focused on in how far our own shares might be used for reserves against takeovers. We have short-term capital that we can use for acquisitions.
In addition, on the 31st of March, we have about 8 million of our own shares of those ADS, of which partially use in case of acquisitions is always considered. Even in the past, we bought treasury stocks or used treasury stocks for our investments. Regarding the reporting regarding our Q1 figures, the question was why the figures of Pfizer differ to ours and whether the figures are audited regularly. First of all, the financial reporting cycles of Pfizer are different than ours. Pfizer is using for the international statements the month from December to February of 2025. Our reporting of the first quarter is from January till March 2025. Therefore, there are large differences in the reporting between the two parties. In addition, I would like to mention that both parties have a gross profit split contractually agreed.
We, as BioNTech, receive 50% of the gross margin, the external incomes minus production costs and possible amortization from Pfizer. This also causes differences. Apart from the sales revenues from Comirnaty, we are reporting income from our service business. This includes InstaDeep agreements with the Federal Republic of Germany. Second question regarding financial inference in Pfizer regarding Pfizer and us auditing through auditing companies. Those financial information are provided based on the contracts that we have and analyzed on both sides. Furthermore, the question was whether an extension for a real listing in the stock exchange would be a consideration. Whereby listed on the NASDAQ that we received this. Because of the free circulation, we are available to a large range of investors to be part in the development of our share.
We evaluate on a regular basis in the framework of our capital market strategy the possibilities of a second stock market listing and consider important parameters such as making sure of the necessary liquidity in our shares that gives optimal access of our shareholders to the market and the necessary requirements to report. At the moment, we don't plan a second stock market listing, but we don't exclude this. ADS holders were interested in how far ADS holders can exercise their voting rights without having to switch their ADSs into core shares. We are always in contact with the Bank of America Merrill and have provided all necessary information in time. The Bank of New York has also provided and passed on the information to the Depot Banks in time, in time.
It is within the responsibility of the Depot Banks to pass on this information to the ADS holders. On this, we unfortunately have no influence. Any information regarding the voting rights can also be viewed on our homepage as well.
I would now thank you for the questions we have raised so far, Mr. Tüngler, Mr. Schmidt. For the next questions regarding the remuneration business, I will pass on to our Supervisory Board, Helmut. Again, the microphone.
Thank you very much, Jens. I will be happy to answer the question that were handed in. The question regards the remuneration system. It was interest in what amount could share-based payments be made in a best-case scenario and in what years. In addition, the question was, have you planned to compensate for this with cash, share buybacks, or from the authorized share capital, for example, via capital increases?
I would like to give you the following information. As part of our valid long-term remuneration system, the Executive Board receives annual share-based performance incentives as part of the long-term incentive program, or LTI. This consists of share options and performance share units, the so-called PSUs, and aims to promote sustainable and value-oriented corporate development. The instruments are subject to a four-year vesting period and can only be exercised if ambitious performance targets are achieved, specifically an annual increase in value of 20% and at least equivalent performance compared to the NASDAQ Biotechnology Index for the share options and the latter for the PSUs. If the targets are achieved in definition of the two definitions starting from the year 2029, a payment of the LTI at 1.54 times of the defined individual agreed agreement of the LTI would be paid.
If targets are achieved, the defined ATEI target remuneration can be paid out at the end of the waiting period. As ATIs are granted annually, a continuous annual payment is also made if performance is successful. To protect shareholders, upper remuneration limits are also set for exceptional outliers. To date, we have used an efficient combination of repurchased treasury shares and cash to service the programs and to settle wage tax obligations. This established practice supports a balanced capital strategy. However, we will continue and evaluate the best possible way to do this. With this, I'll hand over to Uğur to answer further questions about our strategic direction and pipeline.
Thank you, Helmut. Thank you also for your interest and the valuable questions. Both Mr. Tüngler and Mr. Schmidt have asked for an update on the status of our first potential market approval, which we have communicated for 2026.
I am happy to provide you with the latest status. We are currently preparing the submission of clinical data and preparing the BNT elements for the application. Those activities are part for handing in our first application for approval in the U.S. for in the field of oncology. Subject to a positive regulatory response, our ADC candidate BNT323 for the treatment of uterine cancer will be submitted. If approval is successful, we are ultimately aiming for a market launch in 2026. With this debut, our goal is to bring approvals in a number of different cancer indications to the market by 2030. Regarding the additional question of which requirements, such as a fast track designation, must be met for the 2026 launched work, I would be happy to provide some context.
To keep a certain status, such as the fast track status and the breakthrough therapy status, can expedite the development and regulatory review and allow for priority review if appropriate criteria are met. BNT323 has been granted both fast track and breakthrough therapy status. There are many factors to consider when launching an oncology product. We take all these factors into account and prepare accordingly. This also includes the development and expansion of our commercial infrastructure, including our sales organization and our production network. The next SDK question relates to BNT327, one of our two focus programs. The first question was about the reasons for our conviction for BNT327, which I already summarized, but I would like to say this. It is a molecule. It's a bispecific antibody which has two validated complementary mechanisms in oncology that are united in one molecule.
We have data of more than 1,000 patients in multiple indications with BNT327, where BNT327 was used in monotherapy or in combination with other drugs or product candidates. These data are very promising. I do believe, and I already mentioned that as well, that BNT327 is not only usable for one indication, but for several kinds of cancer. With taking over Biotheus, we have acquired the full rights for the strategic development of BNT327 so that with the good financial position that we have now, the further development of this molecule can be pushed. The next question concerns the data from Akeso in connection with the approval of its product, Ivonescimab, in China. The publication of the preliminary data a few weeks ago was associated with a fall in our share price. The SDK would like to understand how we assess this data.
First of all, to say anything about data of other companies is problematic. What we can do is collect a couple of facts here. Ivonescimab was authorized and received approval in China. A lot of experts see this as a confirmation of the potential of the bispecific antibodies that have one thing in common. The PD-L1 and VEGF signaling pathways are being used. In connection with the approval, data became public. This data was preliminary and has to be considered accordingly. The published surveillance data are immature, and interim analysis data statistically cannot give too much proof of information. In our conversations with specialized physicians, the feedback here was uniformly positive. Most physicians consider the data from the study as to be encouraging.
They interpret this data as supporting the assumption that this class of bispecific antibody has the potential to improve or replace the current standard treatment. Perhaps we do believe our antibody BNT327, in addition, is additionally differentiated by its mechanism of action by binding to the PD-L1 receptor on the surface of the tumor in the tumor microenvironment. We believe that this docking could help to further target the action of this molecule. Another question about BNT327 was what our plans are for partnering to realize the full potential of the product candidate. I have already said that regarding BNT327, we are currently focusing on further development on a lot of clinical studies. We do this together with colleagues who, at the beginning of the year, by the acquisition of Biotheus, became part of the BioNTech group. I mentioned the main indications.
The very important indication that they are very important regarding the number of patients as well as the market potential. Of course, we are also considering further indications in the medium term and in the past have already explained that successful partnerships could be entered. We are always interested in value-creating strategic partnerships. Therefore, we are also going to look into options whether partnerships might make sense in the future. If decisions are made, we would inform you as our shareholders in due time. The next question relates to our focus program of the mRNA-based cancer immunotherapies, FixVac and iNeST, also known as BNT122. Here, the SDK would like to know what the status of a possible market launch would be. It is our target that our cancer immunotherapies will be authorized before 2030. We are currently conducting several phase two studies.
The next important milestone for our individualized mRNA approach, that is the iNeST program, will be the first data from the first two studies for the treatment of colorectal cancer, which is expected in late 2025 or early 2026. This study is the first randomized phase two study from our iNeST program in the so-called adjuvant setting, a treatment in early stages of the disease with the aim of reducing the risk of relapse. At present, we see the possibility that our iNeST program will set a new standard of treatment, especially in the early stages of the disease. As part of our FixVac program, we announced first positive results for our BNT111 product candidate in advanced melanoma last year. We plan to present the results from the study at a medical conference and are evaluating the next steps.
We are convinced that mRNA cancer immunotherapies have transformative potential and will continue to focus on their clinical development.
Another question about our mRNA-based cancer immunotherapies comes from DSW. Mr. Tüngler asks to what extent our mRNA technology is differentiated from competitors and what is important in competition. The technologies for mRNA cancer immunotherapies differ at various levels. First, regarding the mRNA format, we use in the field of oncology the so-called uridine-based mRNA, which we have optimized for immunogenicity and make it an immune-activating enhancer. Secondly, in terms of drug formulation, we use our proprietary lipoplex formulation to deliver mRNA into dendritic cells in lymphoid tissues. Those cells are really important for optimal antigen presentation and activation of T-cell immune response. Thirdly, with regard to the target structures, I already mentioned that the selection and the number of selected target structures are important factors.
We use our proprietary computational approaches to select and artificial intelligence to select suitable tumor antigens. As you know, we have developed and optimized our technologies over decades and continue to work on them. Among that, this includes the selection and improvement of new antigens. The mRNA cancer immunotherapy is a potentially revolutionary technology. With our expertise in this field, we will be able to maintain our pioneering role with BioNTech.
Let's move on to the next question, which relates to our commercial readiness. The question is, how do we ensure that we create important conditions for the first launch with regard to sales and production?
When we only count on market launches in the U.S., but also in other markets, we are continuing to expand our commercial capacities in oncology in a targeted manner in order to establish ourselves as a fully integrated biopharmaceutical company and set the course for future market launches. This includes both the production capacities and the establishment of a sales organization, particularly in the United States as one of our targeted core markets. We have already recruited excellent managers who have many years of experience in the pharmaceutical industry and are therefore ideally placed to drive forward our transition to a commercial oncology company. These include our Managing Directors for sales in the U.S. and a high-caliber market access team. Regarding the questions on the focus markets, it is our target to become a global biopharmaceutical company.
Apart from the USA and EU, we focus on other markets as well as with other drugs as well. Certain facts and framework conditions have to be taken into consideration so that postponement in approvals in different countries can take place.
Now we come to the next question of Mr. Tüngler. He would like to know whether we see any new regulatory hurdles or reservations, for example, in connection with mRNA-based therapies or personalized oncology vaccines that have or could have an impact on our approval plans. The short answer is no. We do not see any specific new regulatory obstacles or reservations that could influence our mRNA-based therapies or vaccines, but we have to see the changes in regulations or governmental policy and could have an influence on the approval of such therapies. Mr. Schmidt of the SDK asks for innovations in the context of cancer diagnostics and our actions in these fields.
This is a very good point. Our current focus is on developing innovative cancer therapies and conducting clinical trials within our focus programs, BNT327 and our mRNA cancer immunotherapies. We believe that these focus programs can create great added value for our patients and shareholders. Innovative research and development is our driving force as a company, and we therefore remain open to complementary technologies and potential acquisitions provided that they synergistically complement our appointments. This could be diagnostics as well. I would now like to answer the question that comes from the Umbrella Association of Critical Shareholders and refer to our prophylactic vaccine candidates against infectious diseases. In the sense of a structured answering of the question, the questions were sorted and clustered by topic.
The first question is related to the start of the production in our modular production units, the BioTainers in Rwanda. The plant is planned in such a way and set up in such a way that mRNA vaccines can be produced for certain products or diseases. It is a multi-product plant, so to speak, for mRNA-based vaccines. It is an aspect with which we want to contribute to changing the African ecosystem. As the current status in Rwanda and Germany, currently, employees work on implementing the current measures in order to be able to apply for authorization by the authorities. Next question, we focus on which vaccines are produced there and how we make sure how those are distributed and what our measures are beyond that strategy. For our COVID-19 vaccines, the demand has been covered with the current capacities of production.
Together with Pfizer, we have enough capacity to fulfill the global demand in the future. We plan the validation of our plant in Kigali with our COVID-19 vaccine in Kigali. It has not been planned, however, to open that plant for the COVID-19 vaccine. Regarding our mRNA vaccine candidates, for example, against tuberculosis, malaria, mpox, and HIV, we want to increase our attempts to provide medical treatment in the Africa region. The mentioned diseases are the most current infectious diseases in Africa, endemic diseases that occur frequently with more than 2 million mortalities per year for malaria, HIV, and tuberculosis. Among malaria, there is high child mortality. We are convinced that our attempts can be a solution in order to build sustainable production capacities, especially with the vaccine production that we are working on right now.
We are also aware of the fact that the task of providing access to medication cannot be done by ourselves alone. We work together with partners such as international organizations, governments, non-governmental organizations worldwide. We all have the goal to create a sustainable long-term ecosystem. Regarding our vaccines against infectious diseases, there were questions regarding the timeline for approvals and registration potential and prices, especially for countries with low income. As was just communicated for countries with low income, there were a lot of vaccines in development against tuberculosis, mpox, and HIV. We will provide them at a not-for-profit price insofar as those vaccines were developed successfully and approved.
We want to mention at this point that our product candidates for tuberculosis and malaria are currently in early stage developments of clinical research, and we will inform you about the next steps and in the future over our quarterly reports. In addition, there were questions regarding our tuberculosis program that is funded by the Bill & Melinda Gates Foundation. I would also like to give you an overview about this. Our vision is that we can make the most of the full potential of our physical immune system in order to fight cancer and infectious diseases, especially tuberculosis, for which there is a high unmet need in this world. Our mRNA vaccine development against tuberculosis focuses on finding immune responses and antibodies as well as T-cells against several antigens of tuberculosis and other diseases.
Our work hypothesis is that such vaccines will work against the progress of tuberculosis of infected patients as well as being able to protect people from infection at all. I would like to repeat that fighting global infection requires many years of research and cooperation across the entire medical system. We are grateful that through our partnership with the Gates Foundation, we have access to a great network of people in this field. The final questions of the Umbrella Association of Critical Shareholders focus on our plans for the late-phase clinical development of our vaccine programs against infectious diseases. I can say that these kinds of development programs of infectious diseases based on scientific data and certain studies are being planned. At the moment, we cannot give you any timelines regarding the tuberculosis and malaria vaccine candidates.
We do assume, however, that this year several updates regarding our pipeline in the field of infectious diseases in three clinical stages will be published. Finally, I would like to answer the question whether our target of at least 10 ongoing potential approval-relevant studies until the end of 2024 was achieved. The answer is yes. We are already counting more than 20 studies in phase two and three in our oncology portfolio. Among that, three approval studies of our focus kind of BNT327. This year as well, we want to enter further approval-relevant phase three studies for BNT327 in combination with chemotherapy for patients with triple-negative breast cancer. We concentrate on the indications in this field with a high unmet medical need. We would like to thank our ADS holders, Mrs. Upsal, Mrs. Behrens of the Umbrella Association of Critical Shareholders, and Mr. Tüngler, Mr.
Schmidt, we thank you very much. We appreciate your continued support of the company, and we would also like to thank our ADS holders for your interest and our sympathy for our company. For the final question of our shareholders and their proxies, the Executive Board will give more information during the general debate later. I now hand the floor back to the Chair of the meeting. Thank you very much. Ladies and gentlemen, I think you will agree that it is appropriate at this moment for me to thank the Executive Board and the employees for their work and to ask that you pass on the thanks of the Annual General Meeting to the employees. Ladies and gentlemen, I have now received the list of attendees. I am pleased to announce the current attendance as follows.
Of the company's registered share capital totaling EUR 248,552,200 divided into 248,552,200 no-value shares, 50,234,641 no-value shares are represented with the same number of votes. This corresponds to 20.21% of the registered share value. In addition, postal votes were received for 186,509,773 no-value shares. This means that a total of 236,744,414 no-value shares are represented, which corresponds to 95.25% of the registered share capital. The list of attendees is available for inspection by our shareholders and their proxies in the investor portal under the corresponding heading list of attendance. Now let's enter the general debate. If you want to have a word or raise a question, then I would like to ask you to use the button in the investor portal to submit this. I would also ask those to speak that you will be guided through the technical process and placed in a virtual waiting room.
I will call you when it is your turn, and you will then be connected live to the annual meeting via video conference. Those of us here in the room, the participants via the investor portal and our other viewers via the internet will then be able to see and hear you. Please state your name and the organization, if applicable, you are representing at the beginning of your contribution. Questions on the agenda items will be collected unless a separate response is appropriate. After that, once all speakers have been heard or after a larger block of questions, the Executive Board will answer the questions addressed to it. While I, as Chairman of the Supervisory Board, will answer questions that fall within the remit of the Supervisory Board with the approval of the Executive Board.
Once all questions have been answered and there are no further comments, the general debate will be closed. The agenda items will then be put to the vote without further discussion. I will now move to the agenda items. I will now move on to agenda items 2 to 7 and open the discussion on all agenda items. I would like to ask those shareholders and proxies who have asked to speak to stand by so that they can speak via the investor portal once they have been called on and the video connection has been established. At the moment, I did not receive any requests to speak. At the moment, no speakers have requested the floor so far. If you wish to speak, please register in the investor portal as explained before. Still, I did not receive any requests to speak.
If there are any shareholders or proxies and if they want to speak, then please tell us via the investor portal. Via our investor portal, I know that no requests to speak have been received and that there were no requests to speak or questions even after I asked for them. I would ask the notary to note this in the minutes. I hereby close the debate. Agenda item one is concluded. Now we will proceed to vote on agenda items two to seven of today's annual general meeting. At today's virtual annual general meeting, votes may only be cast by electronic postal vote via the investor portal or by authorizing and instructing the proxies appointed by the company. Voting will be by cumulative voting.
This means that the yes votes and the no votes on all items of the agenda will be counted. If you still wish to vote yes or no on one or more of the agenda items or sub-items to be voted on, or if you wish to issue a corresponding instruction to the proxy holders, you must use the buttons provided for this purpose in the investor portal, either for electronic postal voting or for issuing a proxy and instructions to the proxy holders. If you wish to vote yes on an agenda item or sub-item, please click on the yes button. If you wish to vote no on an agenda item or sub-item, please click on the no button.
If you wish to abstain from voting on an agenda item or sub-item, you do not need to click on anything for the relevant agenda item or sub-item, or you can alternatively select an abstention using the corresponding button. Please note that your vote or proxy and instruction will only be recorded in the investor portal once you click on continue at the bottom right and then on save. Abstentions are not counted when calculating the required majorities and therefore have no influence on the voting results. Proxies and instructions to the company's proxy holders may be issued, amended, or revoked via the investor portal until the start of voting. The votes recorded by the data processing system will then be released during the vote. Postal votes may be cast, amended, or revoked via the investor portal. It is possible until the closing of the voting.
A simple majority of the votes cast is required for agenda items two to six. For agenda item seven, if at least half of the share capital is represented, a simple majority of the votes cast and a majority comprising at least three quarters of the share capital represented at the time of the resolution is required. Otherwise, a majority of at least two-thirds of the votes cast and three quarters of the share capital represented at the time of the resolution is required. According to our articles of association, each no-value share carries one vote. The number of your votes is recorded via the investor portal.
The members of the Executive Board in office in the 2024 fiscal year may not vote or have their votes cast on their own behalf, on behalf of others, or through others when a resolution is passed on their own discharge under item three of today's agenda. The same applies to the members of the Supervisory Board in office in the 2024 financial year when resolving on their discharge under agenda item four. It is ensured that no votes can be cast for the shares concerned in the respective vote. I will now put on the agenda items two to seven to the vote. Agenda items two to seven, together with the respective proposal for resolutions by the management, will be put to the vote as published in the Federal Gazette on April 4th of 2025.
After all proposed resolutions have been called, you have a few minutes to exercise your voting rights in the investor portal by means of electronic postal voting or by authorizing and instructing the proxies appointed by the company or to change or revoke votes already cast or proxies already granted with instructions to the proxies. Now we get to the agenda item two, resolution on the appropriation of net income for the 2024 fiscal year. Executive Board and Supervisory Board propose that the net income of BioNTech for the past fiscal year of 2024 in the amount of EUR 8,232,460.14 be carried forward in full to a new account. We now come to agenda item three, resolution in the discharge of the Board of Directors.
The board of directors and Supervisory Board propose that the members of the board of directors serving in the fiscal year 2024 be discharged for this period. This brings us to agenda item four, resolution on the discharge of the Supervisory Board. Executive Board and Supervisory Board propose that the members of the Supervisory Board in office in the 2024 fiscal year be discharged for this period. We continue with agenda item five, resolution on the appointment of the auditor and the group auditor for the 2025 fiscal year and the auditor for any audit or review of interim reports. Election of the auditor for sustainability reporting for the 2025 fiscal year.
Under agenda item 5.1, a resolution will be passed on the appointment of the auditor and the group auditor for the 2025 financial year and the auditor for any audit or review of interim reports, namely half-year financial reports and quarterly reports for the 2025 financial year and for the first quarter of the 2026 financial year. Under agenda item 5.2, a resolution will be passed on the appointment of the auditor for sustainability reporting for the 2025 financial year. This is being done as a precautionary measure and exclusively for the event that if, as a result of the adoption of a German implementation law for directive EU 2022/2464, the company is required by law to prepare sustainability reports for the 2025 fiscal year and the appointment of the auditor for sustainability reporting by the annual general meeting is required.
The exact wording of the Supervisory Board's proposed resolutions on agenda items 5.1 and 5.2 was published in the Federal Gazette on April 4th of 2025. I assume that the wording is known to all and will refrain from reading it out and put the Supervisory Board's proposed resolutions on the agenda items 5.1 and 5.2 as published in the Federal Gazette on April 4th of 2025 to the vote. Now we get to agenda item six, resolution on the approval of the remuneration report. The Executive Board and the Supervisory Board propose that the remuneration report for the 2024 fiscal year prepared and audited in accordance with section 162 be approved.
This brings us to agenda item seven, resolution on the cancellation of the existing authorized capital 2021 and the creation of new authorized capital 2025 with the option of excluding subscription rights and the corresponding amendment to the articles of association. I assume that the exact wording of the resolution proposed by the Executive Board and Supervisory Board on agenda item seven, as published in the Federal Gazette, is known to all and will refrain from reading it out loud. It will be put. I will put the resolution proposed by the Executive Board and Supervisory Board on agenda item seven to a vote. Ladies and gentlemen, you now have five minutes. That means until 4:13 P.M. to authorize proxy holders via the investor portal to exercise your voting rights or to change or revoke instructions already given. You also have now the opportunity to cast your postal votes.
Postal votes can still be cast, changed, or revoked via the investor portal until I close the vote. However, I would like to point out that the actual voting process essentially consists of the release of the votes represented by the company's proxy holders, so it is expected to be very short. If you still wish to cast, change, or revoke postal votes, you should do so now. If you wish to vote yes or no on one or more of the agenda items or sub-items up for vote, please do so now via the investor portal. I will now pause the meeting for a moment. Ladies and gentlemen, I continue the meeting. We have the possibility to authorize proxy holders via the investor portal to exercise your voting rights in accordance with your instructions or to change or revoke instructions already given. We have closed this.
The postal votes took place according to the instructions and also those which are documented in the system. I will now open the agreement vote on the management's proposals for resolutions on the items two to seven that was published in the Federal Gazette on April 4, 2025, which I am putting to the vote unchanged. I ask the proxy holders to approve the votes previously recorded by a show of hands. Ladies and gentlemen, the proxies have indicated that all votes stored in the system have been released for voting. As announced, the option to cast postal votes via the investor portal is now closed. I hereby close the vote on agenda item two to seven. I will announce the results of the vote immediately after they have been counted. Until the voting results are available, we will now take a break, which should last about 15 minutes.
I would ask you to be patient and will now adjourn the AGM until the voting results are available. [Foreign language] . Ladies and gentlemen, I now have the results of the vote. We will continue with the annual general meeting. The attendance did not change; meanwhile, the list of attendance is available for you in the portal of Investor for Revision. I will now announce the voting results of item number two, and they will be available; the results will be available at the end of the day on the internet website of the company. I have now the result, the voting result as to item two. I hereby declare and announce valid votes were cast for 236,723,942 shares of valid votes, and that corresponds to 95.24% of the registered share capital.
So, the voting resulted in 236,705,725 yes votes and 18,270 no votes. The annual general meeting has thus approved the resolution proposed by the Management Board and the Supervisory Board under agenda item two, resolution on the appropriation of the net. Oh, they told me I can read out the percentages as well. All right. I will repeat and start with the result of the voting. I hereby declare and announce that valid votes were cast for 236,723,942 shares of valid votes. That corresponds to 95.24% of the registered share capital, and the voting resulted in 236,705,725 yes votes, and 18,000; those yes votes amount to 99.99%, and the no votes correspond to 18,217, corresponding to 0.01%. The AGM has approved the resolution proposed by the Executive Board and Supervisory Board under agenda item two.
The result of the agenda item three, I declare and announce that valid votes were cast for 192,500,067 and 348 shares. That amounts to 77.48%. The voting resulted in yes votes of 192,391,103, amounting to 99.91%, and no votes 176,245 no votes. Here we have the resolution on the discharge of the board of directors be voted on, and it is accepted with the required majority. Here we have the voting results of the agenda item four. I declare and announce that valid votes were cast for 234,724,994 shares. That corresponds to 94.44% of the registered share capital, and the voting resulted in 233,705,373 yes votes corresponding to 99.57%, and no votes 1,019,621 no votes. The AGM did agree on the resolution on the discharge of the supervisory board, and it was accepted by the required majority.
For the agenda item 5.1 for 236,679,086 shares, that amounts to 95.22%. The voting resulted in 236,231,202 yes votes, 99.81%, 447,884 no votes amounting to 0.19%, and that the AGM has thus approved the resolution proposed by the Executive Board and Supervisory Board as to the resolution of the appointment of an auditor and consolidated annual statement auditors for the fiscal year of 2025, as well as an auditor for review or audit review of interim reports and also as published by the federal gazette, and that was accepted with the required majority. The voting results as to agenda item 5.2, I declare and announce the voting results resulted of 236,679,377 shares corresponds to 95.22% of registered share value. The voting resulted in 236,362,084 yes votes and 316,536 no votes.
The AGM has thus approved the resolution proposed by the Executive Board and Supervisory Board under agenda item 5.2, the resolution to appoint an auditor and consolidated annual statement auditor for the fiscal year of 2025, and also for reviewing interim reports and also appointing an auditor for the sustainability report for the fiscal year of 2025 with the required majority. We have the voting results of agenda item six. I declare and announce the voting of 236,712,646 shares corresponding to 95.24% of the registered value resulted in 223,001,909 yes votes and 13,710,737 no votes. The AGM has thus approved the resolution proposed by the Executive Board and Supervisory Board as to the approval of the remuneration report published in the Federal Gazette with the required majority.
Agenda item seven, I declare and announce that in the voting 236,705,833 shares corresponding to 95.23% of the share capital resulted in a voting of 230,725,069 yes votes and 5,980,764 no votes corresponding to 2.53%. The AGM approved the resolution proposed by the Executive Board and Supervisory Board under agenda item seven, resolution on the cancellation of the existing authorized capital of 2021 and the creation of a new authorized capital 2025 with the option of the excluding subscription rights and the corresponding amendment to the articles of association with the corresponding required majority. I state finally that the resolutions of the management of the items two to seven were accepted and approved by the required majority correspondingly. Ladies and gentlemen, I stated and announced the results of the voting, so we are at the end of our agenda. We come to the end of our this year's AGM.
There is still the opportunity to pose an objection to one or more resolutions until I close the meeting. This will take place shortly. After that, it will no longer be possible to lodge an objection. The same applies to the option of using the complaint function on the investor portal to request that the question asked and the reason for refusing to provide information be included in the notarized minutes. Ladies and gentlemen, before closing the AGM, I would like to thank you very much for your contributions and demonstrating your interest in and commitment to our company by participating in the virtual AGM. I would also like to thank the members of the Executive Board and Supervisory Board as well as all employees who played an active role in preparing and concluding this Annual General Meeting, namely Nadesh, Natalie, Stephanie, and Yasmina. Thank you very much.
Also the rest of the back office supporting us. Ladies and gentlemen, I hereby close the annual general meeting and end the broadcast. Bye-bye and thank you.