Hello. Welcome to the annual meeting of shareholders of Coya Therapeutics, Inc. Please note that today's meeting is being recorded. During the meeting, we'll have a question-and-answer session. You can submit questions or comments at any time by clicking on the message icon. It is now my pleasure to turn today's meeting over to Coya's Chief Executive Officer, Arun Swaminathan, PhD.
Good morning. I'm Arun Swaminathan, Chief Executive Officer of Coya Therapeutics, Inc. I would like to welcome each of you to our annual meeting of stockholders. I would also like to take a moment to thank each employee and each of our directors for their continued hard work during the past year. We also have with us members of our board in attendance today. We also have present Michael Termine, a representative from Computershare, who will act as the independent inspector of elections, Carey Savio, representative from Weaver and Tidwell, L.L.P., our independent registered public accounting firm, and David Snyder, the Chief Financial Officer and Chief Operating Officer. Daniel C. Porco, a representative from our outside corporate counsel, Lowenstein Sandler LLP, is also present. After the formal portion of the meeting has been completed, we will provide time for general questions.
Out of consideration for others, please limit yourself to one question. Please note, we will attempt to answer as many questions as time allows, but only questions that are germane to the meeting will be addressed. I would ask David Snyder, our Chief Financial Officer and Chief Operating Officer, to make certain preliminary announcements.
Thank you, Arun. First, please note that the company's bylaws provide that any business brought before the annual meeting by a stockholder, which is not specified in the notice of meeting, must be submitted in writing in advance to the secretary of the company, and that the notice meet certain requirements. The company did not receive any such notice, and voting will therefore only be to the two proposals outlined in the proxy statement. Secondly, any non-historical statements that the company will make today will constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. Actual results could differ materially from these statements as a result of a number of risks and uncertainties, including risks that the company has cited in its most recent 10-K and 10-Q filings with the Securities and Exchange Commission, and that Coya typically cites in its press releases.
I would like to remind everyone that this meeting is not a public forum for the purposes of the SEC's Regulation FD. As a result, while the company would be happy to provide you with general background information about the company, we will not be able to provide you with material, non-public information at this meeting. Dr. Swaminathan asked me to include with the minutes of the meeting a copy of the affidavit of distribution, a certified list of stockholders, a notice of meeting, and the proxy statement, which we refer to as the proxy materials. The notice of meeting and proxy statement were filed with the Securities and Exchange Commission on May 13th, 2026. The proxy statement describes the record date for this meeting and the number of eligible votes of common stock outstanding on that date.
Prior to the meeting, Dr. Swaminathan appointed Michael Termine as the inspector of elections, and he has taken the appropriate oath.
At this point, I will call the formal portion of our meeting to order. Will the Inspector of Elections please report on the existence of a quorum?
The board of directors selected May 1st, 2026, as the record date for the annual meeting. On the record date, there were 23,457,183 shares of common stock outstanding. A total of 16,572,461 shares are present in person or by proxy at this meeting, representing at least one-third of the voting power. Accordingly, a quorum is present.
Since a quorum is present, we may now proceed to the business of the meeting. I will first review the proposals to be presented at today's meeting. I will then entertain questions and comments from any stockholder wishing to ask questions or make comments. We will respond to questions to the extent that they do not require the disclosure of material non-public information. At an appropriate point, I will end the question and comment period. At that time, we will give stockholders an opportunity to vote or, if they have previously voted, to change their votes. I will then declare the polls closed and ask the Inspector of Elections to provide a preliminary voting tally. The final votes will be reported by the company in an 8-K filing with the SEC. I now declare the polls for voting on all matters to be open.
All stockholders entitled to vote at this meeting have the ability to do so through the virtual platform. Please remember that if you have already submitted a proxy to vote your shares, your shares will be voted in accordance with your instructions, and it is not necessary to vote at the meeting. If you choose to vote at the meeting, doing so will revoke any proxy that you previously granted. After voting has been completed on all matters, we will close the polls, and the Inspector of Elections will provide its preliminary report. We will now proceed to the voting portion of the annual meeting.
As indicated in the first proposal of the proxy statement, the board of directors has nominated each of Secretary Wilbur Ross and Dieter Weinand for election as a director until the 2029 annual meeting of stockholders, and until their respective successors have been duly elected and qualified. The board of director recommends a vote for Secretary Ross and a vote for Mr. Weinand. The second proposal relates to the ratification of the appointment of Weaver and Tidwell, L.L.P. as the company's independent registered public accounting firm for the fiscal year ending December 31st, 2026. The board of directors recommends a vote for this proposal. I will now spend a few moments reviewing the past year before we open the floor for questions. I'll draw your attention to our forward-looking statements. At Coya Therapeutics, we are focused on advancing potential therapies to combat neurodegenerative diseases.
These are diseases like ALS, Frontotemporal Dementia, Alzheimer's disease, that have a high unmet need, and today these patients have very limited options. Our scientific approach is to target neuroinflammation by restoring and maintaining the function of regulatory T cells, or Tregs, using combination therapies. Our lead asset is COYA 302. We are in phase IIb trial in patients with ALS, called the ALSTARS trial, and also intend to initiate a phase IIa trial in Frontotemporal Dementia later this year. Both these diseases have significant multibillion-dollar market potential. We also entered into a strategic partnership with Dr. Reddy's Laboratories in 2023, where they acquired the commercial rights for one indication, ALS, in major global markets, excluding Japan and Latin America. This partnership has provided us non-dilutive capital, and we continue to have line of sight to non-dilutive capital as we achieve future milestones leading to the commercial launch.
Upon commercialization, we are eligible to receive mid-teen royalties and up to $650 million in sales milestones. On March 31st of this year, we reported a cash balance of $50.7 million and have guided that the cash will take us into the second half of 2027, which is past our projected guidance for the top-line results of the ALSTARS trial. For our investors, some of the milestones you can look forward to in the upcoming months, one of the key ones is the complete enrollment of our ongoing ALSTARS trial. We anticipate the completion of enrollment in the second half of 2026, followed by a top-line data readout in the first quarter of 2027. We also anticipate initiating a phase IIa study in patients with frontotemporal dementia in the second half of 2026.
In addition to that, we will have, throughout the year, communications around translational data sets, including biomarker, proteomics, and single-cell data in these neurodegenerative diseases like ALS, Alzheimer's, and FTD, which we believe will further strengthen our mechanistic rationale and our confidence in the mechanism and its approach to stopping the progression of these devastating neurodegenerative diseases. Our three strategic pillars that give us confidence in our approach are, one, the scientific validation to date, including the Nobel Prize for Discovery and the role of Treg biology. Two, a differentiated combination-based approach that increases the probability of clinical and technical success. Last, the evidence to date from the small investigator-initiated studies and biomarker data that suggests strong potential for the combination approach to stabilize disease progression in both ALS and FTD. COYA 302 is our proprietary combination of low-dose interleukin-2 and CTLA4-Ig, and it is our lead asset.
As I mentioned before, COYA 302 is currently in a phase IIb trial for patients with ALS and is about to enter phase IIa for patients with frontotemporal dementia. We have very strong IP covering this combination. In addition to our partnership with Dr. Reddy's for ALS, we also have an investment from the Alzheimer's Drug Discovery Foundation to support our FTD program, adding to the strong external validation of our approach. COYA 302 is differentiated in the approach of how we keep Tregs functional in a sustained manner. Simply put, the low-dose interleukin-2 increases the number and the suppressive function of Tregs. However, in a highly inflammatory disease like ALS, frontotemporal dementia, when the macro environment remains inflammatory, these functional Tregs tend to revert back to becoming dysfunctional, and that is the differentiating aspect of our combination strategy.
The IL-2 low dose helps get the Treg numbers up and the suppressive function up, while the CTLA-4, by acting on a different aspect of the immune system, quietens the activated myeloid cells and keeps down the inflammation at the macro level. By doing so, we are able to keep the functional Tregs durable for a sustained period of time, which then should translate to sustained efficacy. ALS is a disease with a relentless decline, and the average patient today, despite the existing therapies, declines at about one point a month on the score called ALSFRS. Essentially, the lower the score, the worse the patient is doing. As an example, a six-point decline can be the difference between mild symptoms like an arm feeling weak versus the inability to use these arms.
A 12-point difference can be the difference between the arm feeling weak versus the patient potentially being on a wheelchair. Every point decline in the score has a significant impact on the quality of life of these patients. The average ALS patient dies within three to five years from diagnosis. What we saw in a small investigator-initiated study that studied this combination of low-dose IL-2 and CTLA4-Ig, is that we were able to ameliorate the progression of ALS. In all of these patients over a 24-week period, there was no progression of disease. The mean stayed the same. The mean ALSFRS score stayed the same at 24 weeks from the beginning. As you may recall, you would anticipate the score to have dropped by approximately six points in this time period.
Also, at 48 weeks, there was very little decline in the ALSFRS score of these patients. This data, when you compare it to historical data, was remarkable and gave us the confidence to move forward with a phase IIb study in patients with ALS. The ALSTARS trial is a double-blind, randomized, placebo-controlled trial in 120 patients and is currently actively enrolling across 25 centers in the U.S. and Canada, and we anticipate completing enrollment in 2026. We have also received a Fast Track designation from the FDA for ALS. As I previously mentioned, we anticipate the top-line results from the study in the first quarter of 2027. Moving a little bit to our next indication, frontotemporal dementia.
What we have seen in a small investigator-initiated trial with this combination is very similar to what we observed in ALS, which increases our confidence that this mechanism of restoring and maintaining functional Tregs is translating potentially into meaningful difference in clinical efficacy. What we have seen in the study is that Treg functions and Treg numbers are sustained, which is what we would expect with our mechanism. What we saw in the cognitive scales, as measured by CDR-FTLD and MoCA, which is the Montreal Cognitive Assessment scale, is a stabilization of the cognitive function.
This study gave us the confidence to move forward with a bigger study where we intend to initiate a phase IIa study in patients with frontotemporal dementia, a double-blind, placebo-controlled trial, looking at a specific subtype of frontotemporal dementia patients, the non-fluent, primary progressive aphasia subtype, and we intend to start this later this year. In summary, we're making very good progress on COYA 302 in our clinical programs in both ALS and FTD, and we will keep the market appraised as we make progress in these programs. In addition to that, we have the preclinical program, COYA 303, which is a combination of low-dose interleukin-2 with the GLP-1 agonist. We have previously reported that preclinical studies, both in in vitro model and in an inflammatory rodent model, have shown the potential synergistic effects of this combination in reducing neuroinflammatory markers.
We will keep the market updated as we make progress in all of these other programs as well. With that, I wanted to stop here and say thank you to everyone. I will be happy now to entertain any questions that stockholders wish to raise and any comments that stockholders wish to make regarding the proposal submitted at this meeting or regarding Coya Therapeutics in general. Please note that representatives from our independent registered public accounting firm are also present and available to answer appropriate questions from stockholders.
This is David. We can wait just a second here, I don't see any questions at the moment.
All right. All right. Since we don't have questions at this point, I will end the question and comment period. Stockholders should feel free to write to me, care of the company, if they have questions or comments that they wish to address to me. I assume that everyone present has voted by means of proxy or voted via telephone or on the internet. If there is anyone present at the meeting that would like to vote, either because they have not voted or because they wish to change their vote, please vote via the virtual meeting platform now. Stockholders who have sent in proxies or voted via telephone or internet and do not want to change their vote do not need to take any further action. It is now 10:24 A.M. Pacific Time, 1:24 P.M. Eastern Time, I declare the polls closed.
The Inspector of Elections will now report on the results of the proposal.
Each of Secretary Wilbur Ross and Dieter Weinand was elected by a plurality of the voting power. The proposal to ratify Weaver and Tidwell, L.L.P. as the company's independent registered public accounting firm for fiscal year 2026 was approved by a majority of the votes cast by holders of outstanding shares of the company's capital stock, present or represented by proxy at this annual meeting. Precise number of votes will be sent forth in my written report.
The certificate of the Inspector of Election with the final tabulation will be filed with the minutes of this meeting. The proxies and the ballots will be filed with the corporate records. The final results of each proposal will be disclosed in the company's current report on Form 8-K, announcing the results of this annual meeting to be filed within four business days of today's date. At this point, the meeting is adjourned. Thank you all for attending.
This concludes the meeting. You may now disconnect.