Morning. Welcome to the 2026 annual meeting of stockholders of OPKO Health, Inc. I'm Phillip Frost, Chairman of the Board of Directors and Chief Executive Officer of the company. I want to warmly welcome all of you virtually and express our appreciation for your support as we continue to build OPKO Health into a leading pharmaceutical and diagnostics company. I'm joined here by Dr. Elias Zerhouni, Vice Chairman of the Board and President. Dr. Jane Hsiao, who serves as Vice Chairman of the Board and Chief Technical Officer. Steven Rubin, Director and Executive Vice President. Adam Logal, Senior Vice President and Chief Financial Officer. Dr. Charles Bishop, CEO of our renal division. Dr. Gary Nabel, Chief Innovation Officer and a Director, and President and Chief Executive Officer of our ModeX Therapeutics subsidiary.
Ms. Camielle Green, who will act as secretary for today's meeting, and Mr. Rulfo Hernandez has been appointed the inspector of elections. I'd also like to acknowledge our board members who are here in person or joining us virtually today. Dr. Prem Lachman, Dr. Roger Medel, Mr. John Paganelli, Mr. Richard Pfenniger, Dr. Rao Uppaluri , and Dr. Alice Yu. All of these individuals have distinguished backgrounds in business and science. Our company is fortunate to have the benefit of their experience. We'll conduct the business portion of the meeting first. Then there will be a company update and designated question and comment period immediately following the formal portion of the meeting. Stockholders who have logged into the meeting may pose questions in the designated field on the meeting site. Please limit yourself to one question.
We'll do our best to respond to questions that pertain to the business of the meeting. Our executive officers and representatives from our registered public accounting firm, Ernst & Young, are also attending today's meeting. They'll be able to assist with questions during the Q&A portion of the meeting. This meeting is being recorded. However, no one attending the meeting via webcast is permitted to use any audio recording device. With that, I'll turn the meeting over to Ms. Green to make cautionary statements.
Thank you, Dr. Frost, and good morning. I would like to remind you that any statements made during this call by management, other than statements of historical fact, will be considered forward-looking, and as such, will be subject to risks and uncertainties that could materially affect the company's expected results. Those forward-looking statements include, without limitation, the various risks described in the company's SEC filings, including the annual report on Form 10-K for the year ended December 31st, 2025, and in subsequently filed SEC reports. This meeting may also contain time-sensitive information that is accurate only as of the date of the meeting, June 18th, 2026. Except as required by law, OPKO undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this meeting.
On behalf of OPKO's Board of Directors, I'd like to thank our employees for their outstanding effort and commitment, and our investors for their continued support. Now, I'd like to turn the meeting over to Ms. Green to begin the proceedings.
Thank you again, Dr. Frost, good morning again to our stockholders. There are three requirements for today's meeting, all of which have been met. First, the board of directors has adopted resolutions authorizing this meeting to be held today and establishing April 20th, 2026, as the record date for determining stockholders entitled to notice of and to vote at this meeting. Second, we have received the mailing agent affidavit of distribution certifying that notice of this meeting, together with the company's proxy statement, proxy card, and 2025 annual report were mailed on or about April 30th, 2026, to each stockholder of record on the record date. Third, consistent with the company's bylaws, no advance notice has been given to the company regarding any other business to be conducted at this annual meeting.
We have available for inspection online a certified list showing the stockholders of the company at the close of business on April 20th, 2026, the record date. The stockholder list shows that there were a total of 755,092,256 shares of common stock outstanding and entitled to notice of and to vote at this meeting. This list has also been available at the offices of the company for examination by stockholders for at least 10 days prior to this meeting. We are informed by the Inspector of Election that a total of 543,906,808 shares of common stock are present in person or represented by proxy at this meeting. This represents approximately 72% of the outstanding shares of common stock as of the record date.
Since this represents more than a majority of the voting power of all issued and outstanding stock entitled to vote on the record date, a quorum is present for purposes of transacting business. There are four proposals to be acted on at this meeting. Proposal one is the election of the following individuals to serve as directors of the company for a term ending at the 2027 annual meeting of stockholders. Or until such time that their respective successors are duly elected and qualified. Dr. Phillip Frost, Dr. Jane Hsiao , Dr. Elias Zerhouni, Mr. Steven Rubin, Dr. Gary Nabel, Dr. Prem Lachman, Dr. Roger Medel, Mr. John Paganelli, Mr. Richard Pfenniger, Dr. Subbarao Uppaluri, and Dr. Alice Yu. Proposal two is the approval of the company's 2026 equity incentive plan.
Proposal three is a non-binding advisory vote to approve the compensation paid to the company's named executive officers, as disclosed in our 2026 proxy statement. Proposal four is the ratification of the appointment of Ernst & Young LLP as the company's independent registered public accounting firm for the fiscal year ending December 31st, 2026. At this time, the polls are open. We will conduct voting on all matters to be presented. Each share of common stock is entitled to one vote. Any stockholder who hasn't yet voted or wishes to change their vote, please select Vote Here on the meeting portal. Stockholders who have sent in proxies or voted via telephone or internet and who do not wish to change their vote do not need to take any further action.
Now that everyone has had an opportunity to vote, I declare the polls are now closed for voting. I will now ask that Ms. Green please share the preliminary voting results.
I am pleased to report that proposals one, two, three, and four have been duly approved by the requisite vote of the company's stockholders. Each of the company's director nominees has been elected to serve as a director until the 2027 annual meeting of stockholders, or until such time as their respective successors are duly elected. The proposal to approve the company's 2026 equity incentive plan, the non-binding advisory vote on the proposal to approve the compensation of the company's named executive officers, and the proposal to ratify the appointment of Ernst & Young LLP as the company's independent registered public accounting firm have also been approved. A full tally of the votes will be published in an appropriate filing with the Securities and Exchange Commission.
Thank you. There being no further business to come before the meeting, the 2026 annual meeting of stockholders of OPKO Health is now adjourned. Before we begin the question and answer part of today's virtual meeting, I'd like to say a few words about our company's performance over the past year. The OPKO team is in high gear, working to achieve the results we all look forward to for your company. The ModeX unit, BioReference Labs, OPKO Biologics, OPKO Latin America, our Irish high potency development and manufacturing unit, EirGen, our oxyntomodulin project for obesity and MASH, and Rayaldee, our vitamin D product which achieves adequate blood levels even in overweight or obese people, have all made progress since last year's meeting. We feel the best is yet to come. Dr. Zerhouni will provide a bit more detail.
Thank you, Dr. Frost, and good morning, everyone, and thank you for joining us at this meeting. Let me take this opportunity to highlight our pipeline development as we progress programs targeting important unmet medical needs across large markets. Building on Dr. Frost's comments, let me start with ModeX, which is a key component of our long-term growth strategy. Operating now as a clinical stage platform across vaccines, oncology, and immunology, with multiple programs now in human studies. This includes five clinical programs that continue to advance and a sixth one beginning later this year or early 2027, with important milestones expected in 2026 and 2027. First, our Merck-partnered EBV vaccine program, fully funded by Merck, is in the late stages of data analyses of its completed phase I trial to inform design and potential progression to phase II.
Meanwhile, our MDX2001 program on solid tumors continues to advance in phase I and is expected to conclude dose escalation and regimen optimization by Q3 or early Q4 2026, with early data expected to be presented at a medical conference in late 2026 or early 2027. Similarly, our MDX2003 for the treatment of B-cell lymphomas has entered its phase I clinical trial and is enrolling patients. MDX2004, a first-in-class trispecific immune modulator antibody fusion molecules designed to rejuvenate exhausted T-cells and other immune cells, primarily in heavily pretreated cancer patients, is now enrolling patients in phase I, and we expect to announce preliminary data in 2027.
Finally, our MDX2301, a multispecific COVID-19 antibody that has been shown to be active against all prior and current circulating variants of the virus, is aimed at the prevention of COVID-19, primarily in high-risk immunocompromised patients, and should complete the enrollment of its phase I clinical trials in the third quarter of this year. Early results to be presented at medical meetings later this year or early 2027. This program, I remind you, is fully funded by the federal government agency, BARDA. Let me turn to our in vivo CAR-T program, which leverages multispecific antibody-targeted lipid nanoparticles to deliver DNA mRNA to specific cell types, which has completed all preclinical studies and is planned to enter the clinic later this year or in early 2027, potentially in cancer and autoimmunity indications.
Finally, our preclinical research, in collaboration with and fully supported by Regeneron, continues to advance as planned across initial programs in metabolism, oncology, and immunology, with full reimbursement of research costs at ModeX from Regeneron and by Regeneron, and potential milestone payments tied to program success exceeding $1 billion in addition to prospective royalty revenues. Let's move to our parathyroid hormone program, which is progressing in collaboration with Entera Bio as a first-in-class oral long-acting PTH tablet for hypoparathyroidism, structured under a 50/50 economic arrangement. Excellent preclinical results were reported at the recent ENDO conference, showing that the tablet was well-tolerated with no safety concerns identified and calcemic effects consistent with those reported for clinically validated injectable PTH replacement therapies for hypoparathyroidism. Ongoing studies are advancing this program towards first-in-human clinical evaluation with an intention to file an IND later this year.
Our long-acting adult human growth hormone antagonist program, which is designed to treat patients with acromegaly, known as OPK-8801001, is to advance to clinical trials at the end of 2026 based on excellent results presented recently at the ENDO conference, envisioning a once-a-week injection as opposed to the current standard of care of daily injections. Our metabolic and endocrine program, OPK-88006, a dual GLP-1 glucagon long-acting oxyntomodulin analog being developed for obesity, metabolic and fibrotic disorder, including MASH, is advancing toward first in human development in both injectable and once filed and cleared. Preparations are underway to initiate phase I clinical studies on the injectable formulation in mid 2026. Mazdutide, a GLP-1 glucagon dual agonist approved for chronic weight management and commercialized in China, for which we are entitled to royalties, continues to generate revenues, contributing meaningfully to cash flow.
NGENLA, our long-acting human growth hormone commercialized by our partner, Pfizer, continues to progress commercially according to plan and clinically for label expansion through ongoing pediatric studies building on pediatric growth hormone deficiency to further expand both market access and geographic reach. I should note that currently approved and commercialized in over 50 markets, the NGENLA long-acting pediatric growth hormone deficiency product is contributing meaningfully to recurrent cash flow. Our Iberoamerica pharmaceutical business continues to grow with sustainable profitability as we focus on accelerating top-line growth and driving further operating efficiencies. As mentioned by Dr. Frost, Rayaldee, our innovative vitamin D commercialized product, continues to perform to plans commercially. Finally, let me update you on our clinical diagnostics business.
As previously announced, following the sale of select oncology and oncology-related clinical testing assets to Labcorp in 2025, we received $192.5 million payment at closing, along with an additional $18.4 million earn-out payment received during the second quarter of 2026. In addition, BioReference, now focused on its core testing operations and operating efficiency measures, is progressing towards achieving break even, measured on an earnings-before-non-cash-expenses basis to position it for sustainable profitability in line with expectations. Now, along with Dr. Frost, let me take a moment to thank all the teams who have worked diligently this year to improve our portfolio across the board in research and development across the company and enhance our commercialized products portfolio, as well as improve our clinical diagnostics operation. We are encouraged by this portfolio advancements while generating non-dilutive revenues, more profitable growth, and cash flow from our global pharmaceutical business and BioReference Health.
We thank you for your continuing interest and support. Dr. Frost.
I'll now open the meeting for stockholder questions and comments. If you have a question pertinent to the business of today's meeting, please submit your question via the Ask a Question box located on the left side of the meeting portal now. Please be reminded that we will attempt to answer questions as time allows, but only questions that are related to the business of the meeting will be addressed. Please limit yourself to one question. How much cash remains authorized for the share repurchases?
Yeah, as of recently, it's approximately $98 million under the original $200 million authorization.
Thank you. Any other questions? That concludes our 2026 annual meeting of stockholders. I want to sincerely thank all of you for attending this year's meeting and for the interest and support you have shown in the affairs of OPKO Health.