Vivoryon Therapeutics N.V. (VVY) Earnings Call Transcript & Summary

[ Welcome to the Annual General Meeting of Vivoryon ] Therapeutics N.V. On behalf of the Board of Directors, I welcome all participants to this meeting, which is also broadcast through a webcast via Vivoryon's website. In accordance with Article 32.3 of Vivoryon's articles of association, the language of this meeting will be English. In view of the COVID-19 outbreak, Vivoryon has decided to use this opportunity to organize this meeting as a hybrid meeting in order to limit the health risks for anyone involved. The meeting has been designed in such a way that the interests of our shareholders are safeguarded and facilitated. The shareholders have been offered the opportunity to either attend the meeting in person or to attend the meeting remotely via a live webcast and to submit questions on the agenda items upfront via e-mail until Sunday, June 19, 2022, 1 p.m. Central European Daylight Saving Time. We did not receive any questions in advance of this meeting. There are no shareholders or their authorized representatives attending this meeting in person. Let me now introduce to you the people who are joining me. Joining the meeting are Mr. Dinnies von der Osten, Mr. Jörg Neermann and Ms. Charlotte Lohmann, all nonexecutive members of the Board of Directors; Mr. Ulrich Dauer, Chief Executive Officer; Mr. Florian Schmid, Chief Financial Officer; and Mr. Michael Schaeffer, Chief Business Officer, respectively, and all of these are executive members of the Board of Directors. Ms. Claudia Riedl and Mr. Samir Shah are nominated to be appointed as nonexecutive members of the Board of Directors. Mr. Samir Shah joins us via online means because he cannot travel right now. Herman van Meel, a partner at KPMG, and we also have Bastian Kardol who is the Relationship Manager at Computershare in Rotterdam. And let me also introduce and welcome Mr. Jan Hein Siemerink, civil law notary at KB notarissen in Amsterdam, who is present in person for the voting results. Voting for this meeting was also possible by written proxy, including voting instructions granted to the notary's independent party. Ms. Manuela Bader, Director, Investor Relations and Communications at Vivoryon is designated to keep the minutes of this meeting, and I formally appoint her secretary of the meeting. Audio recordings will be made of this meeting for reporting purposes. Let me come to the formalities. Convocation and record date. Before I move on to the next agenda item, let me point out that there was an opportunity to consult the agenda and explanatory notes published on Wednesday, May 11, 2022, on Vivoryon's website and, as of that date, also available at the Vivoryon offices in line with the statutory term of at least 40 days prior to the day of this meeting. The record date for the meeting was Wednesday, May 25, 2022, in line with the statutory term of exactly 28 days prior to the day of this meeting. Therefore, I determine that the notice to convene this meeting has been given the due observance of all legal and statutory requirements and that, therefore, this meeting is qualified to take legally binding decisions. As set out in the convocation documents as posted on the Vivoryon's website, shareholders or their authorized representatives who wish to attend the general meeting virtually or in person had to apply for registration as from the record date and no later than Wednesday, June 15, 2022, 6 p.m. CEST. The relevant holders of the validly registered shares have the right to virtually or in person, as the case may be, attend this meeting. For that purpose, the relevant holders of the validly registered shares wishing to attend virtually were provided by e-mail with log-in details for the webcast. Today represented a total of 7,020,878 shares, representing 31.84% of the Vivoryon's issued capital. I note that as explained in the convocation documents and as posted on the Vivoryon's website, shareholders who have been duly registered and to have logged in for virtual admission to the meeting can virtually attend and vote in real time at the meeting on all resolutions of the general meeting via the Internet by means of the online platform with their own smartphone, tablet or personal computer. Shareholders or their authorized representatives attending the meeting in person can exercise the voting rights in the meeting. At registration, you have received your personal log-in credentials and already have logged into this meeting. If you are logged in properly, you will see a welcome screen. Please raise your hand if that is not yet the case for you or if you are encountering any technical problems with this procedure. As also explained in the convocation documents, voting instructions on relevant agenda items may have been given by shareholders prior to this meeting by the granting of written proxies with voting instructions to the notary prior to this meeting. The notary received proxies with voting instructions for a total of 6,977,268 shares, representing 31.64% of the issued capital eligible to vote. Every share is entitled to one vote. Voting will be open for all agenda items for those shareholders who are logged in on time and have not granted a written proxy with voting instructions to the notary prior to the meeting. Please select the option of your choice. Select for if you would like to vote in favor of any of the proposals, select against if you would like to vote against the proposal or select abstain if you would like to abstain from voting. Voting remains open during the entire meeting and will be closed after the last voting item. I hereby open the voting on all agenda items. As announced in the convocation documents, in connection with the orderly conduct of this meeting, for each specific agenda item, only questions that have been submitted in writing by shareholders prior to this meeting and no later than on Sunday, June 19, 2022 at 1:00 p.m. CEST and questions of shareholders or their authorized representatives attending this meeting in person will be answered by Vivoryon. Furthermore, as also announced in the convocation documents, in addition to shareholders attending this meeting in person, only shareholders who have timely submitted a question prior to this meeting are allowed to ask a follow-up question during this meeting. We have not received any questions prior to this meeting. We come to the agenda item 2, report of the Board for the financial year 2021. This next item on the agenda for this meeting is the discussion of the report of the Board of Directors for the financial year 2021, including the report of the nonexecutive members of the Board of Directors. I will now give Dr. Ulrich Dauer, Chief Executive Officer of Vivoryon, the opportunity to present the report of the Board of Directors for the financial year '21. Uli, please?

Thank you, Erich. Ladies and gentlemen, shareholders and shareholder representatives, a warm welcome also from me and on behalf of my colleagues from the executive management team, Michael Schaeffer and Florian Schmid. We thank you for joining us today here in Amsterdam or virtually. Today's executive directors' report will comprise an overview of the key developments in the 2021 business year combined with a corporate update. I will continue with a brief summary of our upcoming clinical milestones and our portfolio of programs in development, followed by an overview of the key 2021 financials. Subsequently, I'd like to welcome Herman van Meel, representing our external auditor, KPMG, for his presentation. This will be followed by the report of the nonexecutive directors of the Board presented by Erich. Before we start, please be advised that during this presentation, we will be making certain forward-looking statements concerning the development of Vivoryon Therapeutics' core technologies, the progress of its current research and development programs and the initiation of additional programs. Should actual results differ from the company's assumptions, ensuing actions may differ from those anticipated. You are, therefore, cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date hereof. Now to contextualize the key 2021 corporate developments, I'd like to start off by highlighting Vivoryon's approach and how it differentiates from all others in the field. 2021 was an important year for all those people around the world whose lives are affected by the devastating reality of Alzheimer's disease and dementia, currently without a chance of being cured. 2021 saw the U.S. approval of aducanumab as the first, potentially disease-modifying, treatment for Alzheimer's disease. While aducanumab is currently not broadly available to patients outside of the clinical study setting, this approval, after nearly 20 years of disappointment in the space, was an important signal to the community and the markets. Nevertheless, uncertainties remain around the potential regulatory path to approval for other Abeta antibody-based approaches, and an extremely high unmet medical need remains for safe, effective and widely available treatment options. At Vivoryon, we are fully committed to making a real difference to all of the people affected by this merciless disease. Our approach to treat Alzheimer's disease is very different from antibody-based approaches and from those that focus solely on the amyloid aspect of the disease. I'd like to briefly share with you why this is the case and why we believe that this will allow us to become an important part of the solution to end the Alzheimer's crisis. At Vivoryon, we've specialized in developing medicines to block the misguided activity of certain enzymes that either cause the disease or allow them to progress. Our most advanced medicine in development, varoglutamstat, is a differentiated small molecule designed to overcome the challenges of Alzheimer's disease drug development. Varoglutamstat is in clinical Phase IIb development, and it has a unique dual mode of action that is truly differentiated from other approaches in clinical development, which is shown in the graphic on the right-hand side. Firstly, as you can see in pink on the left, varoglutamstat blocks the enzyme glutaminyl cyclase, or QPCT for short. And this prevents formation of neurotoxic N3pE amyloid, a toxic variant shown to play a pivotal role in the development and progression of Alzheimer's disease. Importantly, this happens way upstream of other approaches, which means that varoglutamstat can also have an impact on other downstream pathologies such as the Tau pathology, neuroinflammation and synaptic impairment. There's a second important pathway on which varoglutamstat acts, which is shown here on the right-hand side in dark purple. Here, the isoform or variation of glutaminyl cyclase, called QPCTL, up-regulates or boosts the pro-inflammatory signaling molecule, CCL2, by turning it into the more stable pE-CCL2. So by blocking QPCTL, we are able to reduce neuroinflammation. And moreover, CCL2 is also a promoter of the Tau pathology, so meaning that we can also address this pathology via both elements of varoglutamstat mode of action. So varoglutamstat is modulating all important pathological hallmarks of Alzheimer's disease: Abeta pathology, neuroinflammation, Tau pathology and, therefore, can protect synaptic function. What I want to stress here is that varoglutamstat is the first small molecule and, to our knowledge, the only project in clinical development selectively targeting the de novo production of neurotoxic N3pE amyloid. We've carefully designed our development program with a clear regulatory path in mind towards bringing it to patients in need as soon as possible. With antibody-based therapies in Alzheimer's disease, safety of the patients is one of the main concerns. We've already characterized varoglutamstat broadly, and our development strategy is rooted in promising Phase I and Phase IIa results where varoglutamstat was well tolerated and showed statistically significant changes in working memory after only 3 months of treatment in patients suffering from Alzheimer's disease. Another important benefit of our approach is that while many drugs in development in Alzheimer's disease are antibodies that have to be injected or infused, we focus on small molecule medicines. So varoglutamstat can be very conveniently administered as an oral pill. Our research and development efforts are protected by a strong IP estate with potential market exclusivity beyond 2035. 2021 was a truly outstanding year for Vivoryon marked by a number of hugely important achievements in the clinical development of varoglutamstat. Despite the pandemic-related challenges, we have met the recruitment objectives for our European Phase IIb VIVIAD study and initiated our Phase IIa/b study VIVA-MIND in the U.S. as planned. Clinical development in the U.S. is further supported by the Fast Track designation the FDA has granted for varoglutamstat last December. In addition, the regulatory achievements of our Chinese partner, Simcere, enabling near-term clinical development in China, broadens the tremendous opportunity we have to make varoglutamstat available to as many patients as possible. It's, of course, crucial that we have enough varoglutamstat for these activities. So in 2021, we've expanded our manufacturing capabilities for API production to ensure sustainable study drug supply for ongoing and future studies. This also increases our flexibility to react to global challenges such as the ongoing pandemic. Further substantiating the rationale for evaluating varoglutamstat in combination with monoclonal antibodies to treat Alzheimer's disease, in October 2021, our team, together with our collaboration partners published data providing strong preclinical evidence that treatment with a combination of varoglutamstat and our N3pE amyloid specific antibody, PBD-C06, has an additive effect on reducing brain Abeta pathology in transgenic mice. The data published in the International Journal of Molecular Science support the hypothesis of a potential benefit of a combination therapy that simultaneously targets 2 different and independent molecular pathways, namely reducing N3pE amyloid production by QPCT and QPCTL inhibition and clearing existing Abeta deposits through anti-N3pE immunotherapy. While we are currently focusing on developing varoglutamstat as a monotherapy, we see great potential in further investigating this approach in the future. In terms of additional opportunities for clinically investigating varoglutamstat, I'd also like to briefly point to our regional strategic licensing deal in China with Simcere, which is one of the corporate development highlights last year. Simcere has acquired a license to develop and commercialize varoglutamstat in China and an option to do the same for our antibody, PBD-C06. We're excited about this because we believe that Simcere is the ideal partner for us towards as many Alzheimer's disease patients in China as possible being able to benefit from our medications as soon as they are successfully developed. Commercially, we've agreed on combined upfront and future milestone-based payments of up to USD 565 million plus double-digit royalties on sales. On the management side, I'd like to highlight that we have strengthened our team with the addition of Florian Schmid as Chief Financial Officer as of April 2021. Through 2021, we have significantly expanded our patent portfolio with a total of 55 additional patents granted for our small molecule inhibitors and antibody-based medicines in development to treat Alzheimer's disease and other diseases with exceptionally high medical need. Building on the process we made in 2021, despite the current market conditions, in April 2022, we were able to successfully raise EUR 21 million in a private placement. This will enable us to reach a number of key milestones and inflection points we are looking towards in the remainder of this year, which we believe will further substantiate the potential of varoglutamstat in Alzheimer's disease. In the context of our capital raise, supported by a number of highly qualified institutional investors from Europe and the U.S. as well as executive and nonexecutive members of our own Board, we are extremely grateful to these investors and to all of you, our valued shareholders, for your continued support. Before we move to the financials, I want to provide an overview of the upcoming clinical milestones for the remainder of 2022 and first half of 2023. We are following a diligently designed development strategy without cutting corners. We're building on our solid preclinical data and the extremely encouraging results from our completed Phase I study, showing that varoglutamstat is well tolerated, and our completed Phase IIa study, our first trial for patients with Alzheimer's disease. This study met not only the primary objective of obtaining important safety information, but we were also able to show first evidence of these disease-modifying activity of varoglutamstat, most importantly, with statistically significant changes from baseline in working memory as an important cognitive ability after only 12 weeks of treatment. These Phase IIa results guided the design of our ongoing European Phase IIb study, VIVIAD. And we are enrolling patients in our U.S. Phase IIa/b study, VIVA-MIND, which is intended to complement the results of VIVIAD. Both trials are designed to align with the draft FDA guideline which, supported by the more frequent interactions we can benefit from due to our Fast Track designation, may provide further regulatory opportunities such as breakthrough designation and accelerated approval. This is, of course, contingent on the outcome of our studies, and all further relevant criteria in this context have to be fulfilled. For VIVIAD, we are on track for a very important data point which is the interim safety analysis planned for mid-2022 where we will obtain key safety and tolerability data. And based on at least 90 patients treated with varoglutamstat for 24 weeks or more, the independent Data and Safety Monitoring Board will select the final dose. We can then move forward with the remainder of the study, gearing up to final readout in the second half of 2023. VIVIAD is well on track with 22 active sites in 5 countries, and I'm truly grateful to everyone involved in this study for their outstanding efforts to meet the challenges all clinical studies around the world have faced over the past 2 years. And the same goes for VIVA-MIND, the U.S. study we initiated in September last year, which is run by the ADCS and supported by an NIH grant. Despite the pandemic and also weather-related challenges in the U.S. during the winter, the study is open with 11 active sites randomizing and treating patients in the ongoing Phase IIa part of the study. VIVA-MIND is on track for the interim futility analysis in the first half of 2023. If predefined criteria are fulfilled in this analysis, the trial will pass a stage gate into the Phase IIb part. And our partner Simcere is currently preparing Phase I and subsequent Phase II clinical development for varoglutamstat in Greater China, which is planned to add important data to the profile of varoglutamstat. So in summary, we are looking at several key milestones in 2022 and '23, and our overall data set is intended to support a clear path to approval for varoglutamstat. With our team's expertise, our technology platform and our compounds in development, we have really strong assets that have great potential beyond Alzheimer's disease, including in oncology, inflammation and fibrosis. While both in-house and through preclinical partnerships and licensings we have generated very encouraging data as a lean organization, it is crucial for us to allocate our resources in the most efficient way possible. And for the time being, this is clearly the clinical development of our lead candidate, varoglutamstat, in Alzheimer's disease. With what has happened in the space over the last 12 months, it is clear that the time is now to leverage the full potential here, which is why we are currently dedicating all our efforts to this space. We will continue to opportunistically evaluate opportunities for oncology and other indications in which our approach has great potential. And with that, I will move on to the financials. And I'll start with a condensed statement of P&L. We reported a gross profit for 2021 of EUR 9.2 million compared to 0 in 2020 due to our regional licensing partnership with Simcere for Greater China which was signed on June 29 in 2021. In 2021, research and development expense increased by EUR 4.2 million compared to the year-end December 31, 2020, to EUR 17.5 million. This increase is primarily attributed to higher expenses for our clinical trial VIVIAD and the related production of PQ912, or varoglutamstat. General and administrative expenses were EUR 4.5 million in 2021 compared to EUR 2.8 million in 2020. The increase of EUR 1.7 million was largely attributable to higher expenses for share-based payments as well as higher expenses for legal and consulting services in connections with preparations of a potential U.S. listing. Finance results in 2021 predominantly result from FX valuation of cash held in U.S. dollars and the valuation of receivables in U.S. dollars, interest income results from the company's U.S. dollar term deposits and distributions from our own money market funds. So in total, we had a net loss for the year 2021 of EUR 12.7 million or EUR 0.63 per common share compared to a loss of EUR 16.5 million or EUR 0.83 per common share in 2020. The key financial figures. The company held EUR 14.7 million in cash and cash equivalents as of December 31, 2021, compared to EUR 26.3 million as of December 31, 2020. On December 31, 2021, total assets amounted to EUR 24.5 million. Total equity is at EUR 16.6 million. Negative cash flows from operating activities was EUR 11.3 million in 2021 compared to EUR 14 million in the year 2020. The decrease in negative cash flows by EUR 2.8 million was mainly due to the EUR 10.8 million revenues shown in connection with the regional licensing partnership with Simcere, partially offset by the increase of research and development expenditures in connection with our clinical trial VIVIAD and the related production of PQ912, or varoglutamstat. Net cash used for investing activities decreased by EUR 0.6 million in the year ended December 31, 2021, mainly due to lower investments in intangible assets. Cash flows from financing activities were EUR 0.8 million for the year 2021 compared to cash used in financing activities of EUR 0.1 million in 2020. The change mainly relates to exercise of share options with EUR 1.1 million in 2021, fully offset by a capitalization of capital raising costs of EUR 1.9 million. The activities described above led to our cash and cash equivalents position of EUR 14.7 million at the end of 2021. So this concludes our analysis of the key financials. And with this, I'd like to hand over to Herman for the auditor's reports. Herman, the floor is yours.

Thank you very much Mr. Dauer. As a short introduction, I'm Herman van Meel. I'm part of the KPMG Accountants in Amstelveen and the standing auditor for Vivoryon. In the Netherlands, it's a good corporate governance stipulation that the auditor address the AGM as I'm more than happy to do in this presentation. The first slide that's here, and it's on the annual report 2021 of Vivoryon Therapeutics, that contains the financial statements, company only, because it's not consolidated. They are prepared in accordance with EU IFRS, which is stipulated for a public company listed on Euronext. It also contains the Management Board report, and that's prepared in accordance with Dutch Civil Code. Management is responsible for the preparation and the fair presentation of the financial statements. The financial statements have been signed by the Management Board and the Board of nonexecutive directors, and the financial statement has been audited by KPMG. So the audit by KPMG, what procedures did we perform? Well, we've done an audit of the financial statements in accordance with Dutch law, including the Dutch standards on auditing. We have assessed if the Management Board report has been prepared in accordance with Title 9, Book 2 of the Dutch Civil Code. We have assessed the consistency of the Management Board report with the financial statements. We have assessed whether the communication required by the governance code have been included in the new report, and we have assessed the consistency of management's disclosure in relation to the system of internal controls and in control statements with the result of our audit procedures. The outcome of our audit is that our opinion is unqualified, and the financial statements give, in our opinion, a true and fair view. A few words on our audit approach. As you well know, an audit is not a 100% coverage, so we work with a concept of materiality. And materiality, the effects of nature, the timing and extent of procedures performed, and the materiality which was set for the 2021 audit of Vivoryon was EUR 400,000. That is also aligned with the auditor's PCAOB financial statements of 2021. The materiality is nearly 4% of the loss before tax. And loss before tax is the benchmark, and that's in line with the biotech industry, and we consider that an appropriate benchmark. Furthermore, we agreed with the Board that auditor statements above EUR 20,000 have been reported to the Board of nonexecutive directors and to the Board. The outcome of our audit. First, key audit matters. So a key audit matter is an area where the assessed risk of material misstatement is higher. It often deals about estimates and it often deals about significant transactions. For more details, I would like to refer you to our long-form audit report, which has been attached to the financial statements. And key audit matters change per year. You may recall that in 2020 audit, we had the conversion from AG to N.V. as a key audit matter. And in 2021, the key audit matter for us was the variable consideration of the Simcere contract. There's a fixed consideration where there's no future events dependable, but the company also recorded for its variable consideration revenues in 2021 as it was highly probable based on the development milestones in the contract with Simcere. Other relevant topics, going concerns. As Mr. Dauer already said, this is a typical area of interest. And given the fact that the company raised additional capital in 2022 before the issuance of the financial statements, we did not have to flag any going concern issue. Another relevant topic is fraud and noncompliance with laws and regulations. And it's good to confirm that our audit procedures did not reveal indications and/or reasonable suspicion of fraud or noncompliance that's considered material for our audit. Climate. As you may know, ESG is the new kid on the block. In a few years, companies have to report on this. And also, Vivoryon did an assessment of its strategy in relation to climate change risk, and they have reported that in the MD&A. And we have considered the impact of the climate-related risk on our investigation and assessment of the risk of material misstatements, and we concluded that it's in line with the regulations. And then that brings me to the end of my presentation. I would like to give it back to you, Mr. Chairman.

Thank you Herman van Meel. I will now represent a report of the nonexecutive directors. As of the end of last year, the nonexecutive directors of Vivoryon were Charlotte Lohmann, Dinnies von der Osten, Jörg Neermann and myself, Erich Platzer. The size and composition of Vivoryon's Board of Directors, including the number and selection of nonexecutive directors, was established in conformity with the Board profile available on our website. The nonexecutive directors strive to ensure a diverse composition that meets the Board of Directors' diversity targets as laid out in the diversity policy and contributes to the proper functioning of the Board of Directors as a whole. I am the Chairman of the Board of Directors and Dinnies von der Osten is the Vice Chairman. As indicated in the nonexecutive report as well, all nonexecutive directors are independent within the meaning of the Dutch corporate governance code. The nonexecutive directors are entrusted with supervising the performance of the members of the Board of Directors. The Board of Directors acts as a collegial body and, as such, members discussed and budgeted for the upcoming financial year. Further, the Board of Directors monitored the operation of the internal risk management and control systems and carried out a systematic assessment of their design and effectiveness. The nonexecutive directors held one meeting independent from the executive directors to, number one, conduct a self-assessment regarding their own performance in 2021, including their interactions with the executive directors and the Board of Directors as a whole; and two, evaluate the functioning of the Audit Committee, the functioning and performance of the entire Board of Directors and the performance of the external auditor; and three, review the desired profile composition, competencies and expertise after nonexecutive directors. The Board of Directors has established an Audit Committee, a Compensation Committee and Nomination and Corporate Governance Committee. As of December 31, 2021, the members of the Audit Committee were Dinnies von der Osten as Chairman, Charlotte Lohmann and Jörg Neermann. As indicated in Chapter 1.8.4.1 of the annual report, the responsibilities of the Audit Committee include, but are not limited to, number one, recommending the appointment of the independent auditor; two, evaluating the independent auditor's qualifications, performance and independence; and three, assessing the effectiveness of the design and operation of the company's internal controls. As of December 31, 2021, members of the Compensation Committee were Jörg Neermann as Chairman; Charlotte Lohmann and myself, Erich Platzer. As indicated, in Chapter 1.8.4.2 of the annual report, the responsibilities of the Compensation Committee include, but are not limited to, preparing the decision-taking of the Board of Directors regarding Vivoryon's compensation policy and benefits policy generally and the compensation of Vivoryon's executive officers and the individual directors. As of December 31, 2021, the members of the Nomination and Corporate Governance Committee were Charlotte Lohmann as Chairwoman; Jörg Neermann and myself, Erich Platzer. As indicated in Chapter 1.8.4.3 of the annual report, responsibilities of the Nomination and Corporate Governance Committee include, but are not limited to, preparing the decision-taking of the Board of Directors regarding the selection and appointment procedure for Vivoryon's executive officers and individual directors as well as developing and monitoring the compliance of the Vivoryon's code of conduct. Lastly, I'd like to inform you that the attendance of nonexecutive directors at meetings of the Board of Directors was 89% and at Audit Committee meetings was 75%. This concludes the presentation of the nonexecutive report. And as there are no questions relating to the matter, this also concludes agenda item 2. We now come to agenda item 3, remuneration report. The next item on the agenda for this meeting is the advisory vote on the remuneration report for the financial year 2021 as is set out on pages 68 through 73 of Vivoryon's annual report 2021. This item is a voting item, and votes shall be cast under agenda item 3, remuneration report. The remuneration report gives an overview of the remuneration of the Board of Directors in 2021 and explains how this relates to the Vivoryon's remuneration policy. The Board of Directors proposes to cast a favorable vote. Agenda item #4, 2021 annual accounts. This agenda item for this meeting is the proposal to adopt the 2021 annual accounts as set out on pages 76 through 109 of the company's annual report 2021. This item is a voting item, and votes shall be cast on the agenda item 4, 2021 annual accounts. The next agenda item, #5, is on the reservation and dividend policy. In accordance with the Dutch corporate governance code and in due observance of the company's articles of association, the reservation and dividend policy is dealt with and explained as a separate agenda item. As indicated in the agenda, Vivoryon has not made any distributions of profits, interim distributions of profits and/or other distributions since its incorporation. Pursuant to Vivoryon's dividend policy as adopted by the Board of Directors on April 29, 2021, it is not foreseen that any distributions shall be made on shares in the capital of the company until the company generates profits for the first time and there are no legal restrictions on distributions by the laws of the Netherlands or by the company's articles of association. Within this framework, Vivoryon may, but will not be obliged to, at times consider returning capital to its shareholders by making distributions of profits, interim distributions of profits and/or distributions at the expense of any reserve of the company or by repurchasing shares if deemed appropriate on the basis of its strategy. Agenda item 6 is the release from liability of the company's executive directors. This item is a voting item, and votes shall be cast under agenda item 6, release from liability of company's executive directors. The Board of Directors proposes to release the company's executive directors from liability for the exercise of their duties in the financial year 2021, insofar as the exercise of those duties is reflected in the 2021 annual accounts or otherwise disclosed to the general meeting prior to the adoption of the 2021 annual accounts. Agenda item 7. The next item on the agenda for this meeting is the release from liability of the company's nonexecutive directors. This item is a voting item, and votes shall be cast under agenda item 7, release from liability of the company's nonexecutive directors. The Board of Directors proposes to release the company's nonexecutive directors from liability for the exercise of their duties in the financial year 2021, insofar as the exercise of those duties is reflected in the 2021 annual accounts or otherwise disclosed to the Annual General Meeting to the adoption of 2021 accounts. Agenda item 8, reappointment of Ms. Eva Charlotte Lohmann as a nonexecutive member of the Board. This item is a voting item, and votes shall be cast under the agenda item 8, reappointment of Ms. Eva Charlotte Lohmann as nonexecutive member of the Board. In accordance with Article 15.4 of the company's articles of association, the Board of Directors, by way of binding nomination, following a recommendation by the Nomination and Corporate Governance Committee, proposes to reappoint Ms. Lohmann as nonexecutive member of the Board of Directors with effect from the date of this Annual General Meeting and until immediately after the closing of the Annual General Meeting of the company to be held in 2025. The profile of Ms. Lohmann and the reasons for the nomination for her reappointment were published as part of the explanatory notes to this agenda item. I will hereby set out the reasons for the nomination of Ms. Lohmann's reappointment. As Ms. Lohmann is present at the meeting herself, I will, after that, give her the opportunity to speak to you and introduce herself. Charlotte Lohmann has been a nonexecutive member of the Board of Directors since the conversion of this company into a Dutch N.V. in 2020 and has been a Supervisory Board member of Vivoryon Therapeutics, previously named Probiodrug AG, since the 2015 Annual General Meeting. She qualifies as a corporate legal and financial expert due to many years of professional practice. Ms. Lohmann is also familiar with the sector in which the company operates. Due to Charlotte Lohmann's experience and valuable contributions to the company, the Board of Directors is of the opinion that Vivoryon will continue to benefit from is Ms. Lohmann's membership as a nonexecutive member of the Board. Now Ms. Lohmann will shortly introduce herself.

Thank you, Erich. I'm very honored to have the opportunity to be reappointed as nonexecutive member of the Board of Directors. I have been working over 20 years in the biopharmaceutical industry where I, throughout the years, have been responsible for different areas. My core areas of expertise are corporate legal matters, corporate governance, licensing and M&A deals as well as financing transactions and capital measures, including public listings on the Frankfurt Stock Exchange and on NASDAQ. I'm currently a member of the Executive Committee of MorphoSys, a biopharmaceutical company that is focused on the development of cancer therapies. And I'm responsible for the legal, compliance and intellectual property departments. With this background, I believe I can support Vivoryon as a member of the nonexecutive Board of Directors to further grow as a company. On a personal note, my mother suffered from Alzheimer's disease for very many years. So I have experienced myself how severe and terrible this illness is and how it impacts the patient and the family members. So I truly believe that we can bring hope to patients with this severe disease with our clinical compound currently in Phase II clinical development. I would like to thank our shareholders for their trust and support. And with this, I'll give back the floor to Erich.

Thank you, Charlotte. We turn to agenda item 9. This item on the agenda for this meeting is the proposal for my reappointment as nonexecutive member of the Board of Directors of Vivoryon. As this agenda item relates to me I will now ask Charlotte Lohmann as she is the Chairwoman of the Nomination and Corporate Governance Committee to address this item. Charlotte?

Thank you. This item is a voting item, and votes shall be cast under agenda item 9, reappointment of Mr. Erich Maximilian Oswald Platzer as nonexecutive member of the Board. In accordance with Article 15.4 of the company's articles of association, the Board of Directors, by way of binding nomination, following a recommendation by the Nomination and Corporate Governance Committee, proposes to reappoint Mr. Platzer as nonexecutive member of the Board of Directors with effect from the date of this Annual General Meeting and until immediately after the closing of the Annual General Meeting of the company to be held in 2025. The profile of Mr. Platzer and the reasons for the nomination for his reappointment were published as part of the explanatory notes of the agenda for this item. I will hereby set out the reasons for the nomination of Mr. Platzer's reappointment. As Mr. Platzer is present at the meeting himself, I will, after that, give him the opportunity to speak to you and introduce himself. And after that, he will continue with the next agenda item. Erich Platzer has been a nonexecutive member of the Board of Directors since the conversion of the company into a Dutch N.V. in 2020 and has been a Supervisory Board member of Vivoryon Therapeutics AG, previously named Probiodrug AG, since the 2007 Annual General Meeting. He qualifies as a financial expert due to many years of professional practice. Mr. Platzer is also familiar with the sector in which the company operates. Due to Erich Platzer's experience and valuable contributions to the company, the Board of Directors is of the opinion that Vivoryon will continue to benefit from Mr. Platzer's membership as nonexecutive member of the Board of Directors. Mr. Platzer will now shortly introduce himself.

Thank you, Charlotte. I've had the honor to be on the Board of this company since 2007. I took a strong interest in the company also for personal reasons, both as a medical doctor by training, even though I'm an oncologist, I took deep interest in Alzheimer's disease since my father actually suffered from Alzheimer's, and he lived out the rest of his life in my home. So I have immediate and direct impression of the burden on families and the society that this disease causes. So I'm deeply motivated to help lead this company to success. My personal experience is that I've been in clinical medicine as an associate professor of medicine for in excess of 12 years. Then I joined pharmaceutical industry, F. Hoffmann-La Roche, in Basel. I headed up all of the oncology therapeutic area. And subsequently, in the year 1999, I actually left, became Chairman of several biotech companies, have taken some of them public. And subsequently, I have been helping financing companies for many years, since the year 2000. On top of that, I've also been the inventor of one major drug in oncology, which basically taught me what are the essential requirements for a company to become successful. With this, I'd like to finish my personal profile. As I said, I'm deeply motivated to help see this company through to success, which we expect is not too far off in the future with all the risks that are still involved and which you have heard Uli Dauer described in his introduction. I thank the shareholders for the trust they have extended to me in the past, and I hope to help leading this company into the future. Thank you very much. With this, we turn to general item #10. This is the proposal to reappoint Mr. Dinnies Johannes von der Osten as nonexecutive member of the Board of Directors of Vivoryon. This item is a voting item, and votes shall be cast under agenda item 10, reappointment of Mr. Dinnies Johannes von der Osten as nonexecutive member of the Board. In accordance with Article 15.4 of the company's articles of association, the Board of Directors, by way of binding nomination, following a recommendation by the Nomination and Corporate Governance Committee, proposes to reappoint Mr. von der Osten as nonexecutive member of the Board of Directors with effect from the date of this Annual General Meeting and until immediately after the closing of the Annual General Meeting of the company to be held in 2025. The profile of Mr. von der Osten and the reasons for the nomination for his appointment were published as part of the explanatory notes to this agenda item. I will hereby set out the reasons for the nomination for Mr. von der Osten's reappointment. As Mr. von der Osten is present at the meeting himself, I will, after that, give him the opportunity to speak to you and introduce himself. Dinnies von der Osten has been a nonexecutive member of the Board of Directors since the conversion of the company into a Dutch N.V. in 2020 and has been a Supervisory Board member of Vivoryon Therapeutics AG, previously named Probiodrug AG, since the 2007 Annual General Meeting. He qualifies as a financial expert due to many years of professional practice. Mr. von der Osten is also familiar with the sector in which the company operates. Due to Dinnies von der Osten's experience and valuable contributions to the company, the Board of Directors is of the opinion that Vivoryon will continue to benefit from Mr. von der Osten's membership as a nonexecutive member of the Board of Directors. And now Mr. von der Osten will introduce himself.

Thank you, Erich. So I'm honored actually for the proposal to reappoint myself as a member of the nonexecutive directors of the Board. I'm serving this Board previously as Probiodrug AG since 15 years and being Chairman of the Audit Committee since then. Currently, I'm co-owner of a family office based in Berlin. We are investing in technology, especially in renewable energy, software companies and biotech companies. So basically, before that, I have done 25 years in venture capital, financing technology-oriented companies. I will thank for the trust actually to reappoint me for the next 3 years and give back to Erich.

Thank you very much. Now we come to the agenda item 11. The next item on the agenda for this meeting is the proposal to reappoint Mr. Jörg Neermann as nonexecutive member of the Board of Directors of Vivoryon. This item is a voting item, and votes shall be cast under agenda item 11, reappointment of Mr. Jörg Neermann as nonexecutive member of the Board. In accordance with Article 15.4 of the company's articles of association, the Board of Directors, by way of binding nomination, following a recommendation by the Nomination and Corporate Governance Committee, proposes to reappoint Mr. Neermann as nonexecutive member of the Board of Directors with effect from the date of this Annual General Meeting and until immediately after the closing of the Annual General Meeting of the company to be held in 2025. The profile of Mr. Neermann and the reasons for the nomination for his appointment were published as part of the explanatory notes to this agenda item. I will hereby set out the reasons for the nomination of Mr. Neermann reappointment. As Mr. Neermann is present at the meeting himself, I will, after that, give him the opportunity to speak to you and introduce himself. Jörg Neermann has been a nonexecutive member of the Board of Directors since the conversion of the company into a Dutch N.V. in 2020 and has been a Supervisory Board member of Vivoryon Therapeutics AG, previously named Probiodrug AG, since the 2011 Annual General Meeting. He qualifies as a financial expert due to many years of professional service. Mr. Neermann is also familiar with the sector in which the company operates. Due to Mr. Neermann's experience and valuable contributions to the company, the Board of Directors is of the opinion that Vivoryon will continue to benefit from Mr. Neermann's membership as a nonexecutive member of the Board of Directors. And now Mr. Neermann will shortly introduce himself. Jörg?

Thank you, Erich. So it has been actually my pleasure to serve on the Board of this company in the last couple of years. And actually, I'm looking forward to continue to support the company in the very exciting times to come because now the company, as already Ulrich Dauer presented, is in a very crucial and very, very exciting phase and I believe looking towards a very bright future. So by training, I'm a biotechnologist. I studied biotechnology in Germany, in Brunswick, and at MIT in the United States; also studied economics in Germany and in the States; did my PhD in biotechnology, mammalian cell culture engineering; then worked actually for 25 years in the venture capital industry for companies like Atlas Venture, Deutsche Venture Capital and Life Sciences Partners; served actually on the Boards of numerous companies; saw actually all kinds of phases those biotech companies go through; private, public various financings, M&As, IPOs. And currently, I am the CEO of a very exciting, young, German start-up company active in the space of anti-aging using actually exosomes as therapeutic agents for age-related diseases. So I'm very interested in and try to promote the space, especially if there are new therapeutic modalities around as we also have here in Vivoryon. And I really would like to see this compound making it actually to the market helping millions and millions of people.

Thank you, Jörg. We now come to agenda item 12, which is the proposal to appoint Ms. Claudia Riedl as nonexecutive member of the Board of Directors of Vivoryon. This item is a voting item, and votes shall the cast under agenda item 12, appointment of Ms. Claudia Riedl as nonexecutive member of the Board. In accordance with Article 15.4 of the company's articles, the Board of Directors, by way of binding nomination, following a recommendation by the Nomination and Corporate Governance Committee, proposes to appoint Ms. Riedl as nonexecutive member of the Board of Directors with effect from the date of this Annual General Meeting and until immediately after the closing of the Annual General Meeting of the company to be held in 2025. The profile of Ms. Riedl and the reasons for the nomination for the appointment were published as part of the explanatory notes to this agenda item. I will hereby set out the reasons for the nomination of Ms. Riedl's appointment. As Ms. Riedl is present at the meeting herself, I will, after that, give her the opportunity to speak to you and introduce yourself. Dr. Riedl is a seasoned investor relations and communications professional in the biotech industry and bring senior executive, corporate communications and investor relations expertise to Vivoryon. Dr. Riedl's broad expertise also includes senior advisory roles in a number of IPOs and financings in various geographies. During her 15-year tenure, as Head of Corporate Communications and Investor Relations at the German biotech company, MorphoSys, until 2016, she supported the company's transformation and growth from a technology-focused antibody discovery and development enterprise into a fully integrated biopharmaceutical company. Subsequently, in a senior adviser capacity, she was instrumental in the company's successful secondary listing on NASDAQ in 2018. The Board of Directors is of the opinion that her professional track record will complement the current nonexecutive Board of Directors' expertise and will be beneficial for the company. Now Ms. Riedl will briefly introduce herself.

Hello, my name is Claudia Riedl, and it's my pleasure to be here today. And I'm very honored about the opportunity to support Vivoryon maybe as a nonexecutive member of the Board of Directors. I'm a biologist by training, and I have more than 20 years' experience in investor relations and corporate communications. As set out by Erich, my expertise spans all the areas of corporate communications and investor relations, including financial PR, media relations, leadership, internal and change communications as well as issues management, crisis communications and stakeholder relations. During my career, I worked for the German biotech company, MorphoSys, also set out by Erich already, and I was also involved in the very successful NASDAQ IPO in 2018 of MorphoSys. Currently, I'm active as a senior adviser at MC Services AG where I support various clients in the biotechnology industry in all aspects of investor relations and corporate communications. I would be very honored to support Vivoryon going forward here as a nonexecutive Board member. And I hope with my expertise, I can be part of the success of the company in the future. Thank you very much.

Thank you very much, Claudia. We come to agenda item 13. The next item on the agenda for this meeting is the proposal to appoint Mr. Samir Shah as nonexecutive member of the Board of Directors of Vivoryon. This item is a voting item, and votes shall be cast under agenda item 13, appointment of Mr. Samir Shah as nonexecutive member of the Board. In accordance with Article 15.4 of the company's articles of association, the Board of Directors, by way of binding nomination, following a recommendation by the Nomination and Corporate Governance Committee, proposes to appoint Mr. Shah as nonexecutive member of the Board of Directors with effect from the date of this Annual General Meeting and until immediately after the closing of the Annual General Meeting of the company to be held in 2025. The profile of Mr. Shah and the reasons for the nomination for his appointment were published as part of the explanatory notes to this agenda item. I will hereby set out the reasons for the nomination for Mr. Shah's appointment. As Mr. Shah is participating in this meeting online, as he was prevented from traveling today as originally intended, I will, after this, give him the opportunity to speak to you and introduce himself. Through his long-standing career in the pharmaceutical industry, Dr. Shah brings senior executive, business development, commercial, financial and investor relations expertise to Vivoryon. As a trained physician who has led the global neurology franchise of a large pharmaceutical company, he is an expert in a sector in which Vivoryon operates. The Board of Directors is of the opinion that his professional track record will complement the current nonexecutive Board members' expertise and will be beneficial for the company. Mr. Shah will now shortly introduce himself. Samir?

Thank you very much, and I hope you can hear me. My apologies, again, to everybody there as I couldn't travel today. If I am elected by you, the shareholders, I'll be humbled and honored that you have elected me. I just want to say right upfront that I appreciate and understand the responsibilities, if I am voted, that you'll bestow on me as in working with the rest of the Board and in working with the senior management. And one thing which I want to make very clear is that I will be representing the viewpoints of the shareholders and investors. It's as important to have their viewpoints first, along with making sure that this wonderful medicine actually makes it to the market for the patients. So it's almost like the shareholder/investor first, an equal first, with making sure the medicine gets into the marketplace. I have absolute confidence, having seen the data and everything which Uli and the team have done, with respect to getting varoglutamstat to where it is at the moment, a beautiful development program, really well-conducted studies, a good selection of investigators. For me personally, I think Erich has said just about everything, I was born in India, primary education in the U.K., a doctor of medicine where I practice in the U.K. I moved into the pharmaceutical industry 34 years ago. And I spent about 15, 20 years in development, the rest in commercial and business development. A lot of my experience is from the neuroscience area. So with that, all I want to say is I would be deeply honored if you bestow the trust in myself with a voting. And there's one final thing, which I want to say is I hope to learn an awful lot from the other senior managers within Vivoryon as well as the rest of the Board based on their experience and expertise. Thank you.

Thank you, Samir. We now come to agenda item #14, which is on the remuneration of nonexecutive members of the Board of Directors. This item, again, is a voting item, and votes shall be cast under the agenda item 14, remuneration of nonexecutive members of the Board. The Board proposes upon recommendation by the Compensation Committee of the Board of Directors to establish share-based remuneration in the form of share options for the nonexecutive members of the Board of Directors to be reappointed or appointed during this Annual General Meeting in such numbers and subject to such terms and conditions including, but not limited to, vesting periods as set out in annex A to the notice of this Annual General Meeting, all in accordance with the company's long-term incentive plan 2021 as approved by the general meeting on June 28, 2021. The Board of Directors proposes upon recommendation by the Compensation Committee of the Board of Directors to establish a fixed remuneration for the nonexecutive members of the Board of Directors to be appointed or reappointed during this Annual General Meeting in such amounts as set out in annex A to the notice of this Annual General Meeting, all in accordance with the company's remuneration policy. The next agenda item, #15, the reappointment of external auditor. This item is a voting item, and votes shall be cast on the agenda item 15, reappointment of external auditor. The Board of Directors proposes upon a recommendation to that effect by the Audit Committee of the Board of Directors, to reappoint KPMG Accountants N.V., Laan van Langerhuize 1, 1186 DS Amstelveen, the Netherlands, as external auditor to audit the annual accounts of the company for the financial year 2022. The next item 16 on the agenda for this meeting is the authorization to acquire own shares. This item is a voting item, and votes shall be cast under agenda item 16, authorization to acquire own shares. The Board of Directors proposes to authorize the Board of Directors for a period of 18 months, starting on Wednesday, June 22, 2022, to acquire shares in the capital of the company for a consideration. The number of shares that may be so acquired will not exceed 10% of the company's issued share capital. Shares may be acquired at the stock exchange or otherwise at a price for each share between par value and 110% of the opening price at Euronext Amsterdam N.V. at the date of the acquisition of such share. The purpose of this proposal is to give the Board of Directors the authorization to reduce the company's share capital in order to return capital to the company's shareholders and/or to cover obligations under share-based compensation plans or for other purposes. We now come to the voting results. This was the last voting item. Let's wait a few seconds to give all shareholders the opportunity to vote. Please let me remind you that you can vote on all agenda items if you haven't done so already. If you have locked in correctly, you should see the voting on your screen. If not, select voting in the upper right-hand corner. You can cast your votes on all agenda items. The voting will remain open for all agenda items until I close the voting in a few seconds. [Voting]

So I now close the vote. We wait a few seconds for the votes to be ready on the screen. I see it's already there. Let me first start out by saying that the total number of votes cast in all agenda items that were voting items was always 7,020,878 shares. On agenda item 3, the remuneration report. 5,815,569 votes were cast for and 818,988 were cast against. That means since the abstentions of 386,321 are not counted in the percent of votes, that we have 87.66% votes for agenda item #3. Agenda item #4, 2021 annual accounts. 6,990,066 votes were cast for and that represents 100% of the votes on that. Agenda item #6, release from liability of the company's executive directors. 6,984,250 votes have been cast for and 34,600 votes have been cast against release from liabilities of the Executive Directors. 2,022 votes abstained. That represents a 99.51% majority for a release from liability of company's executive directors. Agenda item 7, release from liability of the company's nonexecutive directors. The votes for were 6,979,794. The votes against were 34,600. Abstentions were 6,483, which means that 99.51% of votes were for release from liability of nonexecutive directors. Agenda item #8, reappointment of Ms. Eva Charlotte Lohmann as nonexecutive member of the Board. 100% of the votes cast except the abstentions, of course, were actually in favor of her reelection. Agenda item #9, that's my own reappointment as a nonexecutive member of the Board. A total of 6,938,432 or 99.27% of the votes were for; 51,334, against; and 31,112, abstentions. Agenda item #10, reappointment of Mr. Dinnies Johannes von der Osten. 6,824,208 votes were for, which equates 97.63% for. Against were 165,558 or 2.37% and abstentions were 31,112. Agenda item #11, that's the reappointment of Mr. Jörg Neermann as nonexecutive member of the Board of Directors. The votes for were 6,870,781. That equates 98.36% of votes were for; 1.64% were against, that's 114,224 shares; and abstentions were 35,873. Agenda item 12, appointment of Ms. Claudia Riedl as nonexecutive member of the Board. The votes for were actually 6,824,208, equating 97.63% for. Against were 165,558, that's 2.37% against; and 31,112 abstentions. Agenda item #13, the appointment of Mr. Samir Shah as nonexecutive member of the Board. The votes cast for were 6,823,908, that equates 97.63% for; and 165,558, that's 2.37% against; with abstentions of 31,412. Agenda item #14, remuneration of nonexecutive members of the Board. The votes for were actually 5,815,209 votes, that's 87.66% for; against were 818,538 votes, that's 12.34% against; and there were abstentions in total of 387,131. Agenda item #15, reappointment of external auditor. The votes for were 100% at 7,019,766 million. There were 1,112 abstentions. Agenda item #16. The votes for were 6,955,529, that's 99.93% for; against were 4,900 votes, that's 0.07%; and the total abstentions were 60,494. So with this, all of the agenda items were receiving their required majorities in each of the instances. We'd like to thank our shareholders for the votes. And the Board will happily take on the responsibility and do our best to bring this company to success. I'd also like to specifically welcome the 2 new members of the Board, Ms. Claudia Riedl and Mr. Samir Shah. We're looking forward to work together with you. Agenda item #17 is any other business. I note that in accordance with best practice provision 4.1.10 of the Dutch corporate governance code, a draft of the minutes of this meeting shall be made available on the request to the shareholders no later than 3 months after the end of this meeting. After which, shareholders are going to have the opportunity to react to the minutes in the following 3 months. The minutes shall then be adopted by the secretary of this meeting and myself and, as evidence thereof, shall be signed by both of us such in accordance with Article 32.4 of Vivoryon's articles of association. As there is no other business before this meeting, I conclude this agenda item. I hereby close the meeting at 14:23, and I'd like to thank all shareholders and other participants for participating via the audio webcast. I hope that we can meet in person at the next general meeting. Thank you very much.