Thank you for standing by, and welcome to the Spruce Biosciences, Inc. annual meeting. I will now turn the meeting over to Mike Grey, Executive Chairman of the Board of Spruce Biosciences, Inc. Please go ahead.
Good morning, and welcome to the 2026 annual meeting of stockholders of Spruce Biosciences, Inc. My name is Mike Grey, and I serve as Executive Chairman of the Board of Directors. I will be chairing today's meeting. It is now 10:00 AM Pacific Time on Thursday, May 21, 2026, and I hereby call this meeting to order. On behalf of the Board of Directors and the entire Spruce team, thank you for joining us today. Before we begin the formal business of the meeting, I would like to introduce the members of our Board of Directors and our Executive Officers who are joining today. From our Board, Javier Szwarcberg, our Chief Executive Officer and a Director, Camilla Simpson, Percival Barretto-Ko, Daniel Spiegelman, Keli Walbert, Kirk Ways, who also serves as our Interim Chief Medical Officer.
From our executive team, in addition to Javier Szwarcberg, we are joined by Samir Gharib, our President and CFO, and Dale Hooks, Chief Commercial Officer. I'd also like to acknowledge representatives of BDO USA, P.C., our independent registered public accounting firm, who are available to respond to appropriate questions today. Serving as corporate secretary and inspector of the election for today's meeting is Samir Gharib, who will receive and tabulate the votes cast. I'll now turn the meeting over briefly to Samir to address procedural matters, including notice of the meeting and the presence of a quorum.
Thank you, Mike. The record date for this meeting was the close of business on March 24th, 2026. As of the record date, there were 1,372,278 shares of common stock outstanding and entitled to vote at this meeting. Each share is entitled to one vote on each matter to be acted upon. Notice of this meeting and the proxy materials, including the proxy statement and the company's 2025 annual report, were distributed and made available to stockholders of record beginning on or about April 9, 2026, in accordance with the rules of the Securities and Exchange Commission and the company's bylaws.
An affidavit of mailing has been filed with the records of this meeting. Under the company's bylaws, the holders of a majority of the outstanding shares entitled to vote or 686,140 shares must be present virtually or by proxy to constitute a quorum.
I confirm that the number of shares present, virtually or by proxy, exceeds that threshold. Accordingly, a quorum is present and the meeting may proceed to business.
Thank you. The secretary's report confirms that this meeting has been duly called and noticed, and a quorum is present. The meeting is therefore properly constituted to transact business. Before we proceed with the proposals, let me briefly review the rules of conduct for today's virtual meeting. First, this meeting is being conducted virtually through a live webcast. Stockholders may submit questions and vote during the meeting through the virtual meeting website.
Second, polls for each proposal will be open together at the start of the voting portion and will remain open until I declare the polls closed at the end of the voting portion. If you have already voted by proxy and do not wish to change your vote, you do not need to take any further action. Third, the Q&A portion of the meeting will follow the formal business.
Questions may be submitted at any time through the virtual meeting platform. We will address as many appropriate questions as time permits in accordance with the rules of conduct posted on the meeting website. Fourth, this meeting is not a forum for general economic, political, or personal commentary. Questions should be limited to matters relevant to the operation of the company and to the business of the meeting.
I retain the discretion to defer or decline questions as not appropriate. With those rules in mind, we will now proceed to the formal business of the meeting. The first item of business is the election of three Class III directors, each to serve until the company's 2029 annual meeting of stockholders and until his or her successor has been duly elected and qualified or until his or her earlier death, resignation, or removal.
The board has nominated the following three individuals for election as Class III directors: myself, Camilla Simpson, and Javier Szwarcberg. Biographical information for each nominee is set forth in the proxy statement. Directors will be elected by a plurality of the votes cast. That is, the three nominees receiving the greatest number of four votes will be elected. Stockholders may vote for each nominee or withhold their vote with respect to any nominee. Withheld votes and broken non-votes will have no effect on the outcome of this proposal.
The board recommends a vote for each of the named nominees. I now declare Proposal 1 properly before the meeting. The second item of business is the ratification of the selection by the Audit Committee of the Board of Directors of BDO USA, P.C. as the company's independent registered public accounting firm for the fiscal year ending December 31, 2026.
Approval of this proposal requires the affirmative vote of the majority of the shares present, virtually or by proxy at the meeting and entitled to vote on the subject matter. Abstentions will have the same effect as a vote against. This proposal is considered a routine matter. We do not expect broker non-votes for this proposal. The board recommends a vote for Proposal 2. I now declare Proposal 2 properly before the meeting.
The third item of business is an advisory vote to approve the compensation of the company's named executive officers as disclosed in the proxy statement, commonly referred to as the say on pay vote. Approval of this proposal requires the affirmative vote of a majority of the shares present, virtually or by proxy at the meeting, and entitled to vote on the subject matter. Abstentions will have the same effect as a vote against.
Broker non-votes will have no effect on the outcome. Because this vote is advisory, it will not be binding on the company or the board. However, the board and the Compensation Committee value the views of our stockholders and will consider the outcome of the vote when making future decisions regarding executive compensation. The board recommends a vote for Proposal 3. I now declare Proposal 3 properly before the meeting.
The fourth and final item of business is an advisory vote on the preferred frequency of future stockholder advisory votes on the compensation of the company's named executive officers. Stockholders may indicate whether they prefer that the advisory vote on executive compensation occurs every one year, two years, or three years, or may abstain from voting. Abstentions will have the same effect as a vote against each of the proposed frequencies. Broker non-votes will have no effect on the outcome.
If none of the three options receives the affirmative vote of a majority of the shares present and entitled to vote, the company will consider the option receiving the highest number of for votes to be the frequency preferred by our stockholders. Because this vote is advisory, it will not be binding on the company or the board. The board values the views of our stockholders and will take the outcome into account in determining the frequency of future say on pay votes. The board recommends a vote for of one year as the preferred frequency. I now declare Proposal 4 properly before the meeting. All four proposals are now properly before the meeting. The polls are now open for voting on Proposals 1, 2, 3, and 4.
If you have already voted by proxy and do not wish to change your vote, you do not need to take any further action. Your vote has been received. If you are attending the meeting through the virtual meeting platform and have not yet voted, or if you wish to change your previously submitted vote, please cast your vote now by following the instructions on the meeting website. You'll need the 16-digit control number from your notice of internet availability, proxy card, or voting instruction form. If there is anyone present who has not yet voted and would like to do so, please cast your vote now. Hearing no further requests to vote, the polls are now closed. An inspector of election has tabulated the preliminary voting results. Samir, please go ahead.
Thank you, Mike. Based on the preliminary report of the inspector of election, with respect to Proposal 1, each of the three nominees, Mike Grey, Camilla Simpson, and Javier Szwarcberg, have received a plurality of the votes cast. With respect to Proposal 2, the ratification of BDO USA, P.C. as the company's independent registered public accounting firm has been approved. With respect to Proposal 3, the advisory vote on executive compensation has been approved on an advisory basis. With respect to Proposal 4, one year received the highest number of votes as the preferred frequency for future advisory votes on executive compensation. Final voting results certified by me will be filed with the Securities and Exchange Commission on a current report on Form 8-K within four business days of this meeting.
Thank you, Samir. This concludes the formal business of the meeting. We will now turn to the question and answer portion of today's meeting. We have allotted approximately 10 minutes for questions from stockholders. Questions should relate to matters of interest to stockholders generally and to the operation of the company. Consistent with the rules of conduct posted on the meeting website, we may group questions or similar topics, or we may decline to address questions that are not appropriate for this forum. Do we have any questions at this time?
Thank you, Mike. We have two questions. The first question is as follows. Given access to the Avenue loan and the availability of the at-the-market issuing of smaller batches of shares, what cash flow considerations led to the bulk of issuance of 1.3 million shares versus these two routes? I would be happy to address that question. Prior to our recent financing, our cash runway extended through the end of this year. While importantly, that allowed the company to finance its operations through its anticipated BLA submission of TA-ERT, which remains on track for the fourth quarter of this year, it did not allow us to finance the company to and through the anticipated PDUFA date for the submission and the program.
Given the scale of capital needed, we deemed that a follow-on offering be the most appropriate mechanism to achieve that additional financing, importantly, to and through the PDUFA date. From a use of proceeds standpoint, these additional proceeds will allow us to finance pre-launch and launch activities. It'll allow us to fund the confirmatory study for TA-ERT, as well as the planned expanded access program that will be conducted in the U.S. It'll finance PPQ manufacturing and other BLA-enabling activities. It'll fund working capital, which effectively for the company is personnel expenses for the company. Lastly, a milestone payment that is owed to the upstream licensor, BioMarin. Thank you for that question. Our second question reads as follows.
Can management provide an update on the PPQ manufacturing effort, including whether production is domestic or international, the manufacturing partner's experience with biologic and enzyme replacement therapies, the current PPQ status and timeline, and the capital budget amount to complete the PPQ batch manufacturing for the BLA submission? I will direct that question to our CEO, Javier Szwarcberg. Javier, please go ahead.
Sure. Happy to do that, Samir. Thank you for the question. We're in the process of making the first PPQ batch. We've already completed and executed two of the DF batches that will go into the PPQ. We will put four DF batches into the first, second, and third PPQ batches, DP batches, which will be submitted to the FDA in the following sequence. The first PPQ batch with the BLA and prior to the submission of the BLA will be included in the BLA documents. The second PPQ DP batch will be submitted to the BLA around the time of the mid-cycle meeting. The third PPQ batch will be a post-approval submission, will be submitted as a PMR.
We already discussed the timing of the submission and aligned with the FDA on this at a Type B meeting that we conducted in January of 2026, but seek to confirm this with the FDA at an upcoming pre-BLA meeting. Samir, I'll pass on to you the financials of the cost of a PPQ batch, if you're ready to address that.
Thank you, Javier. Yes. Along the lines of the response to my first question, the proceeds from the recent raise will allow us to fully fund the anticipated costs of the three PPQ batches that Javier has alluded to that'll be part of the BLA submission and the post-approval requirement. Thank you for that question.
There was one other piece to that question, which is where is the drug product substance in the context of PPQ being made? We're manufacturing them in South Korea. The vendor we're utilizing is very versed, has done a ton of submissions, and has participated in a number of BLAs. Their expertise is actually on biologics, including peptides and monoclonal antibodies.
Great. Thank you, Javier. Our last question of the day, which I will also direct to Javier, reads as follows. Can you advise on the progress of phase III enrollment?
Sure. The 301 trial, which is the confirmatory trial that we expect to initiate while the product is under review by the FDA, has not initiated enrollment just yet. We've completed the study protocol, SAP, and feasibility assessment, which all three we've submitted to the FDA in final format. We have alignment from the FDA that it's all right to initiate the trial while the product is under review and initiate is defined as enrolling the first patient, have the study underway. We expect to do that in the latter part of the year when the drug is under review by the FDA.
Thank you, Javier. Well, this concludes our Q&A session for today's meeting. Mike, at this point, we don't have any further questions at this time.
Thank you, Samir. Before we close, on behalf of the board of directors and the management team, I'd like to thank our stockholders for your continued support of Spruce Biosciences and to thank our employees for their commitment and hard work throughout the past year. There being no further business to come before the meeting, this 2026 annual meeting of stockholders, Spruce Biosciences, is hereby adjourned. A replay of this meeting will be made available on our investor relations website at investors.sprucebio.com and will remain accessible for at least 90 days. Thank you and have a good day.
This concludes today's meeting. You may now disconnect.