Q1 2026 OPKO Health Inc Earnings Call

April 28, 2026

Operator 2: Good day, and welcome to the OPKO Health Q1 2026 Financial Results Conference Call. I would now like to turn the conference over to Yvonne Briggs. Please go ahead.

Operator: Good day, and welcome to the OPKO Health Q1 2026 Financial Results Conference Call. All participants will be in a only listen mode. Should you need assistance please signal our conference list by pressing the star key followed by zero. After today's presentation there will be an opportunity to ask questions. To ask a question you may press star then one on your touchphone phone. To withdraw your question please press star two. Please note that this conference isbeing recorded. Would now like to turn the conference over to Yvonne Briggs. Please go ahead.

Speaker #2: After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press * then 1 on your touchstone phone.

Speaker #2: To withdraw your Thank you, today's call, excuse me, Dr. Phillip Frost, chairman and chief executive officer, will provide opening remarks. Dr. Elias Zerhouni, vice chairman and president, will then provide an overview of OPKO's therapeutic segment, as well as bioreference health.

Speaker #2: question, please press * then 2. Please note this event is being recorded. I would now like to turn the conference over to Yvonne Briggs, please go ahead.

Yvonne Briggs: Thank you, operator, and good afternoon. This is Yvonne Briggs with Alliance Advisors IR. Thank you all for joining today's call to discuss OPKO Health financial results for Q1 2026. I'd 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, are subject to risks and uncertainties that can materially affect the company's 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 31 December 2025. Furthermore, this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, 28 April 2026.

Yvonne Briggs: 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 call. Regarding the format of today's call, excuse me. Dr. Phillip Frost, Chairman and Chief Executive Officer, will provide opening remarks. Dr. Elias Zerhouni, Vice Chairman and President, will then provide an overview of OPKO's therapeutics segment as well as BioReference Health. After that, Adam Logal, OPKO's CFO, will review the company's Q1 financial results and discuss OPKO's financial outlook, and then we'll open the call to questions. Now I'd like to turn the call over to Dr. Frost.

Speaker #2: After that, Adam Logal, OPKO's CFO, will review the company's first quarter financial results and discuss OPKO's financial outlook, and then will open the call to questions.

Speaker #2: Now I'd like to turn the call over to Dr. Frost.

Speaker #3: Thank you for joining us today. During the first quarter, we made meaningful progress with our strategic initiatives with particular emphasis on advancing our MODEX product development pipeline.

Phillip Frost: Thank you for joining us today. During Q1, we made meaningful progress with our strategic initiatives, with particular emphasis on advancing our ModeX product development pipeline. ModeX now has five programs in the clinic spanning vaccines, oncology, and immunology, all with the potential to be first and best in class in their therapeutic areas. Days after the close of Q1, we dosed our first subjects in the phase I clinical trial of MDX2301, our BARDA-funded multispecific antibody for the prevention of COVID in high-risk populations. Shortly thereafter, we announced the dosing of the first patient in a phase I trial to evaluate MDX2003, a tetraspecific T-cell engager in patients with relapsed or refractory B-cell lymphoma. We also continue to advance our other oncology candidates in clinical development.

Speaker #3: MODEX now has five programs in the clinic spanning vaccines, oncology, and immunology, all with the potential to be first- and best-in-class in their therapeutic areas.

Speaker #3: Days after the close of the first quarter, we dosed our first subjects in the Phase I clinical trial of MDX2301, our BARDA-funded multi-specific antibody, for the prevention of COVID in high-risk populations.

Speaker #3: Shortly thereafter, we announced the dosing of the first patient in a Phase I trial to evaluate MDX2003 at Tetra specific T-cell engager in patients with relapsed or refractory B-cell lymphoma.

Speaker #3: We also continued to advance our other oncology candidates in clinical development, MDX2001 at Tetra specific T-cell engager targeting solid tumors, and MDX2004, a multi-specific immune rejuvenator.

Phillip Frost: MDX2001, a tetraspecific T-cell engager targeting solid tumors, and MDX2004, a multispecific immune rejuvenator. Over the course of this year, we expect ModeX to achieve a number of clinical and partnership milestones as these programs progress and, in the case of our EBV vaccine, approach later-stage development with our partner, Merck. Our collaboration with Regeneron is progressing well as we align their extensive antibody binder libraries with our multispecific engineering platform across various indications in metabolism, oncology, and immunology. This collaboration is another example of strategic partnerships that are a good source of non-dilutive capital to support our R&D efforts. The potential total value of the Regeneron collaboration exceeds $1 billion in milestones plus future royalties. In our diagnostics business, Q1 reflects our second full quarter with the new BioReference footprint following our oncology divestiture.

Speaker #3: Over the course of this year, we expect MODEX to achieve a number of clinical and partnership milestones, as these programs progress and, in the case of our EBV vaccine, approach later stage development with our partner, Merck.

Speaker #3: Our collaboration with Regeneron is progressing well, as we align their extensive antibody binder libraries with our multi-specific engineering platform across various indications in metabolism, oncology, and immunology.

Speaker #3: This collaboration is another example of strategic partnerships that are a good source of non-dilutive capital to support our R&D efforts. The potential total value of the Regeneron collaboration exceeds $1 billion in milestones, plus future royalties.

Speaker #3: In our diagnostics business, Q1 reflects our second full quarter with the new bioreference footprint, following our oncology divestiture. We're now centered on our core regional clinical laboratory operations in New York and New Jersey, our correctional health business, and our national specialty franchise anchored by the 4K score test.

Phillip Frost: We're now centered on our core regional clinical laboratory operations in New York and New Jersey, our correctional health business, and our national specialty urology testing franchise, anchored by the 4Kscore test. We continue to streamline our infrastructure and cost base to achieve profitable growth from this segment. We closed the quarter with a solid cash balance. This reflects past asset sales, continued R&D support from our partners, and contributions from our international pharmaceutical operations. This financial strength enables us to fund our R&D portfolio at a meaningful level and to return capital to shareholders through our stock repurchase program. With that overview, I'll turn the call over to Elias.

Speaker #3: We continue to streamline our infrastructure and cost base to achieve profitable growth from this segment. We close the quarter with a solid cash balance.

Speaker #3: This reflects past asset sales, continued R&D support from our partners, and contributions from our international pharmaceutical operations. This financial strength enables us to fund our R&D portfolio at a meaningful level, and to return capital to shareholders through our stock repurchase program.

Speaker #3: With that overview, I'll turn the call over to Elias.

Speaker #4: Well, thank you, Phil, and good afternoon, everyone. Let me start with the biopharma side of our business, because that's where we're making tremendous progress advancing our pipeline right now.

Elias Zerhouni: Well, thank you, Phil, and good afternoon, everyone. Let me start with the biopharma side of our business because that's where we're making tremendous progress advancing our pipeline right now. As Dr. Frost said, we now have 5 assets in the clinic and expect an additional program for our in vivo CAR T-cell platform to commence first in human clinical trials this year. Let me review our programs and provide the updates on each of them. Our collaboration with Merck is focused on the vaccine against Epstein-Barr virus that combines 4 EBV antigens developed by ModeX with Merck's adjuvants. In the phase I trial, Merck enrolled over 200 subjects to evaluate safety, tolerability, and immunogenicity.

Speaker #4: As Dr. Frost said, we now have five assets in the clinic, and expect an additional program for our in vivo CAR T-cell platform to commence first in human clinical trials this year.

Speaker #4: So let me review our programs and provide the updates on each of them. Our collaboration with Merck is focused on the vaccine against Epstein-Barr virus, that combines four EBV antigens developed by MODEX with Merck's adjuvants.

Speaker #4: In the Phase I trial, Merck enrolled over 200 subjects to evaluate safety, tolerability, and immunogenicity and various subgroup studies and analysis are underway to understand the responses in EBV naive subjects and patients as young as 12 years of age, which will be important for future studies.

Elias Zerhouni: Various subgroup studies and analysis are underway to understand the responses in EBV-naive subjects and patients as young as 12 years of age, which will be important for future studies. We expect Merck to have the data needed to inform a Phase II design by the end of this year, with initiation of a Phase II clinical study anticipated next year, subject to Merck's decisions and announcements. Now for MDX-2001, which is our lead immuno-oncology candidate for solid tumors, including head and neck, esophageal, pancreatic, lung, and prostate cancers. MDX-2001, as you know, is a tetraspecific T-cell engager directed at two tumor antigens, c-Met and Trop-2, and two T-cell activators, CD3 and CD28.

Speaker #4: So, we expect Merck to have the data needed to inform a Phase II design by the end of this year, with initiation of a Phase II clinical study anticipated next year, subject to Merck's decisions and announcements.

Speaker #4: Now, for MDX2001, which is our lead immuno-oncology candidate for solid tumors including head and neck, esophageal, pancreatic, lung, and prostate cancers, MDX2001, as you know, is a Tetra specific T-cell engager directed at two tumor antigens, CMET and TRP2, and two T-cell activators, CD3 and CD28.

Speaker #4: The goal is to drive a deeper and more durable response by simultaneously recognizing heterogeneous tumor antigen expression and providing both CD3 and CD28 activators and enhancers to T-cells.

Elias Zerhouni: The goal is to drive a deeper and more durable response by simultaneously recognizing heterogeneous tumor antigen expression and providing both CD3 and CD28 activators and enhancers to T-cells, thereby enhancing activation and T-cell survival. Enrollment of phase I study is continuing into two parallel cohorts to support dose escalation and optimize the dosing regimen. We have dosed more than 30 patients so far across multiple tumor types and have reached dose levels approximately 10-fold higher than the starting dose, all with acceptable safety. We plan to present phase Ia data at a conference in H2 of this year. In addition, phase Ib is expected to start later this year, focusing on the tumor types most likely to show signs of efficacy. We are also commencing work to enable subcutaneous formulations.

Speaker #4: Thereby enhancing activation and T-cell survival. Enrollment in our Phase I studies is continuing into two parallel cohorts to support dose escalation and optimize the dosing regimen.

Speaker #4: We have dosed more than 30 patients so far, across multiple tumor types, and have reached dose levels approximately tenfold higher than the starting dose.

Speaker #4: All with acceptable safety. We plan to present Phase IA data at a conference in the second half of this year. In addition, Phase IB is expected to start later this year, focusing on the tumor types most likely to show signs of efficacy.

Speaker #4: We're also commencing work to enable subcutaneous formulations. For our next program, MDX2004, which is our first in-class multi-specific immune rejuvenator that simultaneously engages CD3, CD28, and 41BB to not only activate but also expand and sustain stem-like and memory T-cells in the immune system, preclinical data has demonstrated that MDX2004 expands stem T-cells increases T-cell activation and stimulates proliferation of CD8 and CD4 memory subsets.

Elias Zerhouni: For our next program, MDX2004, which is our first-in-class multispecific immune rejuvenator that simultaneously engages CD3, CD28, and 4-1BB to not only activate but also expand and sustain stem-like and memory T-cells in the immune system. Preclinical data has demonstrated that MDX2004 expands stem T-cells, increases T-cell activation, and stimulates proliferation of CD8 and CD4 memory subsets. These data support its potential as a pipeline and a product across cancers and chronic infections among the elderly and immune-impaired subjects. MDX2004 entered phase I in Q3 of last year, and we're currently in the dose escalation stage in heavily pre-treated cancer patients. The trial includes both PD-1-naïve patients and patients previously treated with PD-1 inhibitors, with the goal of determining whether immune rejuvenation can restore or prolong responses.

Speaker #4: And so these data support is product across cancers and chronic infections among the elderly and immune-impaired subjects. MDX2004 entered Phase I in the third quarter of late last year, and we're currently in the dose escalation stage in heavily pre-treated cancer patients.

Speaker #4: The trial includes both PD-1 naive patients and patients previously treated with PD-1 inhibitors. With the goal of determining whether immune rejuvenation can restore or prolong responses.

Speaker #4: Our objective this year is to complete Phase IA, define an appropriate dosing schedule, and prepare for expansion into select tumor types and longer-term into broader immune impairment indications.

Elias Zerhouni: Our objective this year is to complete Phase 1A, define an appropriate dosing schedule, and prepare for expansion into select tumor types and longer term into broader immune impairment indications. Our newest molecule in the clinic is MDX2003. It's our tetraspecific T-cell engager and expander targeting both CD19 and CD20 on B-cells and CD3 and CD28 on T-cells. The intent is to address tumor antigen heterogeneity and escape mechanisms, which we see with CD19 only or CD20 only approaches by maintaining activity even when one B-cell marker is lost. While CD28 co-stimulation supports sustained T-cell function. We recently initiated a Phase 1 trial in B-cell lymphomas and leukemias in Australia and Israel with additional sites to follow.

Speaker #4: Now, our newest molecule in the clinic is MDX2003. It's our tetraspecific T-cell engager and expander, targeting both CD19 and CD20 on B-cells, and CD3 and CD28 on T-cells.

Speaker #4: The intent is to address tumor antigen heterogeneity and escape mechanisms, which we see with CD19 only or CD20 only approaches by maintaining activity even when one B-cell marker is lost.

Speaker #4: While CD28 co-stimulation supports sustained T-cell function, we recently initiated a Phase I trial in B-cell lymphomas and leukemias in Australia and Israel, with additional sites to follow.

Speaker #4: In parallel, we're evaluating the optimal path to explore autoimmune indications for MDX2003, which has the potential to play a role in autoimmunity. In March, MODEX presented two posters at the ESMO Targeted Anti-Cancer Therapies Congress 2026 in Paris, further highlighting the breadth of our oncology portfolio.

Elias Zerhouni: In parallel, we're evaluating the optimal path to explore autoimmune indications for MDX2003, which has a potential to play a role in autoimmunity. In March, ModeX presented two posters at the ESMO Targeted Anticancer Therapies Congress 2026 in Paris, further highlighting the breadth of our oncology portfolio. One presentation profiled MDX2004, describing the ongoing first in human trial in patients with advanced tumors and introducing the concept of immune rejuvenation as a differentiated approach to restoring antitumor immunity. The second was focused on MDX2003 and showcased its potent preclinical activity across multiple B-cell malignancy models and its potential relevance in autoimmunity.

Speaker #4: One presentation profiled MDX2004, describing the ongoing first in human trial in patients with advanced tumors, and introducing the concept of immune rejuvenation as a differentiated approach to restoring anti-tumor immunity.

Speaker #4: The second was focused on MDX2003 and showcased its potent preclinical activity across multiple B-cell malignancy models and its potential relevance in autoimmunity. In addition to our own research, we're very pleased with the progress under our collaboration with Regeneron.

Elias Zerhouni: In addition to our own research, we're very pleased with the progress under our collaboration with Regeneron, which, as Dr. Frost mentioned, combines their extensive library of clinically validated monoclonal antibody binders with our modular multispecific architecture across immunology, oncology, and metabolic diseases. Together, the teams are focused on advancing four initial discovery programs using the ModeX platform to rapidly generate and optimize multispecific antibody candidates with the potential to expand into additional targets over time. Regeneron is responsible for funding preclinical, clinical, and commercial development of the selected assets, while OPKO is eligible for research, development, regulatory, and commercial milestones that could exceed $1 billion, as well as tiered royalties on global sales up to the low double digits. Moving to infectious diseases, MDX2301 is the first ModeX multispecific antibody program to enter the clinic under our collaboration with BARDA.

Speaker #4: Which, as Dr. Frost mentioned, combines their extensive library of clinically validated monoclonal antibody binders with our modular multi-specific architecture across immunology, oncology, and metabolic diseases.

Speaker #4: Together, the teams are focused on advancing four initial discovery programs using the MODEX platform to rapidly generate and optimize multi-specific antibody candidates with the potential to expand into additional targets over time.

Speaker #4: Regeneron is responsible for funding preclinical, clinical, and commercial development of the selected assets, while OPKO is eligible for research, development, regulatory, and commercial milestones that could exceed $1 billion as well as tiered royalties on global sales up to the low double digits.

Speaker #4: Now, moving to infectious diseases, MDX2301 is the first MODEX multi-specific antibody program to enter the clinic under our collaboration with BARDA. MDX2301 is a tetravalent, bispecific antibody that targets distinct and conserved regions of the SARS-CoV-2 spike receptor binding domain.

Elias Zerhouni: MDX2301 is a tetravalent bispecific antibody that targets distinct and conserved regions of the SARS-CoV-2 spike receptor binding domain. It is designed for broad coverage and long duration of protection because it really attacks two separate regions of the virus, which prevents escape of the virus through mutations. The initial indications are prophylaxis in high-risk immunocompromised populations that, who cannot be protected by immunization, vaccination, and used in post-exposure outbreak settings with potential expansion into acute treatment of COVID and the treatment of long COVID. To date, remarkably, this multi-specific antibody has demonstrated high potency against all known variants of SARS-CoV-2 and continues to be effective against all circulating variants of the virus.

Speaker #4: And by it is designed for broad coverage and long duration of protection because it's really attacks two separate regions of the virus which prevents escape of the virus through mutations.

Speaker #4: The initial indications are prophylaxis in high-risk immunocompromised populations who cannot be protected by immunization, vaccination, and use in post-exposure outbreak settings with potential expansion into acute treatment of COVID and the treatment of long COVID.

Speaker #4: To date, remarkably, this multi-specific antibody has demonstrated high potency against all known variants of SARS-CoV-2 and continues to be effective against all circulating variants of the virus.

Speaker #4: We initiated the Phase I trial of MDX2301, which is evaluating safety and tolerability across different routes of administration and dosing regimens in healthy volunteers and in adults at high risk for severe COVID.

Elias Zerhouni: We initiated the phase one trial of MDX2301, which is evaluating safety and tolerability across different routes of administration and dosing regimens in healthy volunteers and in adults at high risk for severe COVID. The first dose cohort is completed, and BARDA is funding the program, including the clinical trial costs. BARDA is also supporting our multispecific influenza program, which targets conserved regions of hemagglutinin to enable broad coverage across influenza A and B strains. We're currently conducting pre-IND work using challenge models to select the lead clinical candidate, and we expect this program to move closer to the commencement of clinical trials with the potential for additional financial support from BARDA. To date, BARDA has committed over $100 million since the inception of these two programs.

Speaker #4: And the first dose cohort is completed, and BARDA is funding the program, including the clinical trial costs. BARDA is also supporting our multi-specific influenza program, which targets conserved regions of hemagglutinin to enable broad coverage across influenza A and B strains.

Speaker #4: We're currently conducting pre-IND work using challenge models to select the lead clinical candidate and we expect this program to move closer to the commencement of clinical trials with the potential for additional financial support from BARDA.

Speaker #4: To date, BARDA has committed over $100 million since the inception of these two programs. Now, over the past several years, MODEX has also built a multimodal in vivo CAR-T and gene delivery platform that we believe is highly differentiated versus traditional ex vivo CAR-T approaches.

Elias Zerhouni: Over the past several years, ModeX has also built a multimodal in vivo CAR T and gene delivery platform that we believe is highly differentiated versus traditional ex vivo CAR T approaches because it combines our unique multi-specific technology with proprietary in vivo CAR technologies. Using lipid nanoparticles conjugated with cell-specific multi-specific antibodies on the surface, we can deliver mRNA or DNA payloads encoding CARs directly to specific immune cell subset, not only just T cells, but also B cells or NK cells to generate functional CAR T cells in vivo at lower effective doses. Preclinical data has been obtained in humanized mice and non-human primates, and a presentation of this work will be made at the ASGCT meeting in Boston next month. We believe this technology offers several potential advantages.

Speaker #4: Because it combines our unique multi-specific technology with proprietary in vivo CAR technologies, using lipid nanoparticles conjugated with cell-specific multi-specific antibodies on the surface, we can deliver mRNA or DNA payloads, including CARs.

Speaker #4: Directly to specific immune cell subsets, not only just T cells, but also B cells or NK cells, to generate functional CAR T cells in vivo at lower effective doses.

Speaker #4: Preclinical data has been obtained in humanized mice and non-human primates and a presentation of this work will be made at the ASGCT meeting in Boston next month.

Speaker #4: And we believe this technology offers several potential advantages at its it is off the shelf, can be redosed, and leverages our multi-specific antibodies for cell-specific targeting and built-in activation via CD3/CD28.

Elias Zerhouni: That is, it is off the shelf, can be redosed, and leverages our multispecific antibodies for cell-specific targeting and built-in activation via CD3/CD28. It also uses site-specific antibody conjugation and proprietary lipids to support manufacturability at scale and reduce off-target delivery to the liver. In non-human primate studies, we have shown proof of concept for in vivo CAR-T generation, deep B-cell depletion in blood and tissues, and a favorable tolerability profile. These effects were achieved at doses that were a fraction of those reported for completing platforms for competing platforms, sorry. We're now in IND-enabling studies for our lead CD19-targeted in vivo CAR-T program and expect entry into the clinic by the end of this year or early 2027. Now, turning to our endocrine and metabolic programs, we continue to advance our subcutaneous injection formulation of OPK-88006 for the treatment of MASH.

Speaker #4: It also uses site-specific antibody conjugation and proprietary lipids to support manufacturability at scale and reduce off-target delivery to the liver. In non-human primate studies, we have shown proof of concept for in vivo CAR T generation, deep B cell depletion in blood and tissues, and a favorable tolerability profile.

Speaker #4: These effects were achieved at doses that were a fraction of those reported for completing platforms. For completing platforms, sorry. We're now in IND enabling studies for our lead CD19 targeted in vivo CAR T program and expect entry into the clinic by the end of this year or early 2027.

Speaker #4: Now, turning to our endocrine and metabolic programs, we continue to advance our subcutaneous injection formulation of OPKO AD8006 for the treatment of MASH. AD8006 is an analog of the natural GLP-1 glucagon hormone oxyntomodulin.

Elias Zerhouni: OPK-88006 is an analog of the natural GLP-1 glucagon hormone oxyntomodulin. We're planning a first-in-human, single ascending dose and multiple ascending dose Phase 1/2A clinical study with data expected by H2 2027. The findings will be used to guide the further development of our oral oxyntomodulin in partnership with Entera Bio. We also recently expanded our relationship with Entera to include a third joint program for a first-in-class long-acting PTH tablets for patients with hypoparathyroidism. This program combines OPKO's proprietary long-acting PTH variants with Entera's N-Tab technology. We and Entera each hold a 50% ownership interest in this program, and we will share development costs equally. Presuming favorable PK/PD data, we're targeting an IND filing later this year. Now, our international pharmaceutical operations continued to experience solid growth during Q1 with healthy contributions to the overall business.

Speaker #4: And we're planning a first-in-human single ascending dose and multiple ascending dose Phase I/2A clinical study, with data expected by the second half of 2027.

Speaker #4: The findings will be used to guide the further development of our oral oxyntomodulin in partnership with Antera Bio. We also recently expanded our relationship with Antera to include a third joint program for a first-in-class long-acting PTH tablets for patients with hypoparathyroidism.

Speaker #4: And this program combines OPKO's proprietary long-acting PTH technology. And we in Antera each hold a 50% ownership interest in this program, and we will share development costs equally.

Speaker #4: Presuming favorable PKPD data, we're targeting an IND filing later this year. Now, our international pharmaceutical operations continue to experience solid growth during Q1 with healthy contributions to the overall business.

Speaker #4: For the quarter, global pharmaceutical product sales grew about 9% versus the prior year due to favorable demand trends as well as foreign currency tailwinds.

Elias Zerhouni: For the quarter, global pharmaceutical product sales grew about 9% versus the prior year due to favorable demand trends as well as foreign currency tailwinds. Our partner, Pfizer, continues its global commercial expansion of our long-acting growth hormone product, NGENLA. Now, as a final topic for today, I'd like to turn attention to our diagnostics business. Following the sale of BioReference's oncology assets to Labcorp in 2025, BioReference is now a regionally focused clinical laboratory with a national specialty testing franchise highlighting our proprietary 4Kscore test. We operate with a more efficient footprint with an expanding menu of higher-margin services. In Q1 2026, BioReference's streamlined business showed a volume increase of more than 3% in the number of accessions per day compared to the previous quarter.

Speaker #4: Our partner Pfizer continues its global commercial expansion of our long-acting growth hormone product Agenda. Now, as a final topic for today, I'd like to turn attention to our diagnostics business.

Speaker #4: Following the sale of BioReference's oncology assets to Labcorp in 2025, BioReference is now a regionally focused clinical laboratory with a national specialty testing franchise highlighting a proprietary 4Kscore test.

Elias Zerhouni: Following the sale of BioReference's oncology assets to Labcorp in 2025, BioReference is now a regionally focused clinical laboratory with a national specialty testing franchise highlighting our proprietary 4Kscore test. We operate with a more efficient footprint with an expanding menu of higher-margin services. In Q1 2026, BioReference's streamlined business showed a volume increase of more than 3% in the number of accessions per day compared to the previous quarter.

Speaker #4: We operate with a more efficient footprint, with an expanding menu of higher margin services. In the first quarter of 2026, bioreferences streamlined business showed a volume increase of more than 3% in the number of accessions per day compared to the previous quarter.

Speaker #4: This performance was reflected in particularly strong volume in our FQHC and corrections business lines, plus momentum in our higher margin services. Margins also saw improvement versus Q4.

Elias Zerhouni: This performance was reflected in particularly strong volume in our FQHC and corrections business lines, plus momentum in our higher-margin services. Margins also saw improvement versus Q4, primarily driven by the aforementioned volume increase and continued efficiency gains, including an additional 4% reduction in headcount. Within diagnostics, 4Kscore continues to be an important part of our test offering, and the recent label update, which removes the digital rectal examination requirement, positions us to broaden adoption beyond urologists and gradually build a presence in primary care. We see 4Kscore as a unique, high-value asset with the potential to deliver significant revenue and profitability as we broaden payer coverage and continue educating both urologists and primary care physicians about its clinical utility.

Speaker #4: Primarily driven by the aforementioned volume increase and continued efficiency gains, including an additional 4% reduction in headcount. Within Diagnostics, 4Kscore continues to be an important part of our test offering, and the recent label update—which removes the digital rectal examination requirement—positions us to broaden adoption beyond urologists.

Elias Zerhouni: Within diagnostics, 4Kscore continues to be an important part of our test offering, and the recent label update, which removes the digital rectal examination requirement, positions us to broaden adoption beyond urologists and gradually build a presence in primary care. We see 4Kscore as a unique, high-value asset with the potential to deliver significant revenue and profitability as we broaden payer coverage and continue educating both urologists and primary care physicians about its clinical utility.

Speaker #4: And gradually build a presence in primary care. And we see 4Kscore as a unique, high-value asset with the potential to deliver significant revenue and profitability as we broaden payer coverage and continue educating both urologists and primary care physicians about its clinical utility.

Speaker #4: Without geographically focused footprint, right-sized workforce, expanding menu, and proprietary 4K score test, we are seeing a nice performance improvement at bioreference, and we believe that these continued efforts achieve break-even in the business will help achieve break-even in the business by the middle of the year.

Elias Zerhouni: With our geographically focused footprint, right-sized workforce, expanding menu, and proprietary 4Kscore test, we are seeing a nice performance improvements at BioReference, and we believe that these continued efforts will help achieve breakeven in the business by the middle of the year. In summary, our progress with the ModeX pipeline, along with our partnerships and collaborations, international pharmaceutical portfolio, and restructured diagnostics business, have really transformed OPKO into a more targeted innovation-led organization with multiple key catalysts coming up later this year. With that, I'll turn the call over to Adam to review our financial results and outlook. Adam?

Speaker #4: In summary, our progress with the MODX pipeline, along with our partnerships and collaborations, international pharmaceutical portfolio, and restructured diagnostics business, have really transformed OPKO into a more targeted innovation-led organization with multiple key catalysts coming up later this year.

Elias Zerhouni: In summary, our progress with the ModeX pipeline, along with our partnerships and collaborations, international pharmaceutical portfolio, and restructured diagnostics business, have really transformed OPKO into a more targeted innovation-led organization with multiple key catalysts coming up later this year. With that, I'll turn the call over to Adam to review our financial results and outlook. Adam?

Speaker #4: So with that, I'll turn the call over to Adam to review our financial results and outlook. Adam?

Speaker #2: Thank you, Elias. We ended the quarter with a strong cash position with over $341 million in cash, cash equivalents, and restricted cash. Which is more than sufficient to fund our ongoing operating needs and development plans while we also are returning capital to our shareholders.

Adam Logal: Thank you, Elliot. We ended the quarter with a strong cash position with over $341 million in cash equivalents, and restricted cash, which is more than sufficient to fund our ongoing operating needs and development plans while we also are returning capital to our shareholders. Let's start with the financial performance of our diagnostics business. The financial results for Q1 met our expectations, and we are encouraged by the progress the team has made, sequentially improving the operating loss by $5.3 million and by $11 million over the Q1 of last year. We have restructured this business and remain on track to achieve breakeven as measured by results from operations before non-cash expenses by the middle of the year. Revenue for Q1 2026 was $72.2 million, including $6.5 million from our 4Kscore test.

Adam Logal: Thank you, Elias. We ended the quarter with a strong cash position with over $341 million in cash equivalents, and restricted cash, which is more than sufficient to fund our ongoing operating needs and development plans while we also are returning capital to our shareholders. Let's start with the financial performance of our diagnostics business. The financial results for Q1 met our expectations, and we are encouraged by the progress the team has made, sequentially improving the operating loss by $5.3 million and by $11 million over the Q1 of last year. We have restructured this business and remain on track to achieve breakeven as measured by results from operations before non-cash expenses by the middle of the year. Revenue for Q1 2026 was $72.2 million, including $6.5 million from our 4Kscore test.

Speaker #2: Let's start with the financial performance of our diagnostics business. The financial results for the first quarter met our expectations, and we are encouraged by the progress the team has made.

Speaker #2: Sequentially improving the operating loss by 5.3 million and by 11 million over the Q1 of last year. We have restructured this business and remain on track to achieve break-even as measured by results from operations before non-cash expenses by the middle of the year.

Speaker #2: Revenue for Q1 2026 was $72.2 million, including $6.5 million from our 4K score test. Revenue in Q1 2025 was $102.8 million, with the year-over-year decline expected due to the oncology customer accounts included in the Labcorp transaction that closed in September of 2025.

Adam Logal: Revenue in Q1 2025 was $102.8 million, with the year-over-year decline expected due to the oncology customer accounts included in the Labcorp transaction that closed in September 2025. Revenue from our retained business slightly declined versus the prior year, principally due to test mix changes as we shifted some unprofitable but higher-priced esoteric testing to our strategic partners, along with snowstorms that impacted the New York-New Jersey markets, which we mentioned in our February call. Total costs and expenses were $85.1 million, down from $126.8 million last year, reflecting the September 2025 transaction closing, as well as the continued efforts to rationalize our cost structure to align with our focused geographic footprint and testing offerings.

Speaker #2: Revenue from our retained business slightly declined versus the prior year, principally due to test mix changes as we shifted some unprofitable but higher-priced esoteric testing to our strategic partners, along with Snowstorms that impacted the New York-New Jersey markets, which we mentioned in our February call.

Speaker #2: Total costs and expenses were $85.1 million, down from $126.8 million last year reflecting the September 2025 transaction closing as well as the continued efforts to rationalize our cost structure to align with our focused geographic footprint and testing offerings.

Speaker #2: Our diagnostic operating loss was $13 million, compared to $23.9 million in Q1 2025. Depreciation in the amortization for this segment came in at $3.9 million, down from $5.7 million in 2025.

Adam Logal: Our diagnostic operating loss was $13 million compared to $23.9 million in Q1 2025. Depreciation and amortization for this segment came in at $3.9 million, down from $5.7 million in 2025. Turning to our Pharmaceutical Business, revenue was $52 million in Q1 compared to $47.1 million in the prior year. Revenue from product sales increased to $38 million, up from $34.8 million, reflecting higher sales volume in our international operations and foreign exchange tailwinds during the quarter. As we continue to focus on the profitability of Rayaldee, the growth to net improvements we began to realize last year have resulted in meaningful positive cash flow from operations in 2026 while maintaining overall revenue levels.

Speaker #2: Turning to our pharmaceutical business, revenue was $52 million in Q1 compared to $47.1 million in the prior year. Revenue from product sales increased to $38 million up from $34.8 million, reflecting higher sales volume in our international operations and foreign exchange tailwinds during the quarter.

Speaker #2: As we continue to focus on the profitability of Royalties, the gross-to-net improvements we began to realize last year have resulted in meaningful positive cash flow from operations in 2026 while maintaining overall revenue levels.

Speaker #2: Royalties contributed $6.3 million during Q1 of both 2026 and 2025, reflecting slightly improved gross-to-net offset by a slight decline in volume. Our Pfizer profit share was $6.4 million for the quarter, reflecting a 42% increase to $2,025's 4.5 million.

Adam Logal: Rayaldee contributed $6.3 million during Q1 of both 2026 and 2025, reflecting slightly improved growth to net, offset by a slight decline in volume. Our Pfizer profit share was $6.4 million for the quarter, reflecting a 42% increase to 2025's $4.5 million. Pfizer's progress in the global commercialization of NGENLA continues to show consistent growth. The 2025 profit share was negatively impacted by certain growth to net and inventory revaluations that did not recur in 2026. In addition, BARDA funding was $4 million in Q1 of 2026 compared to $7 million a year ago, reflecting the start of our COVID clinical program under this collaboration, while the 2025 period included higher levels of CMC activities for our infectious disease programs.

Speaker #2: Pfizer's progress on the global commercialization of Ingenla continues to show consistent growth. The 2025 profit share was negatively impacted by certain gross-to-net and inventory revaluations that did not recur in 2026.

Speaker #2: In addition, BARDA funding was $4 million in the first quarter of 2026, compared to $7 million a year ago, reflecting the start of our COVID clinical program under this collaboration.

Speaker #2: While the 2025 period included higher levels of CMC activities, for our infectious disease programs. As a result, IP transfer and other revenue was $14 million, compared to 2025's $12.3 million.

Adam Logal: As a result, IP transfer and other revenue was $14 million compared to 2025's $12.3 million. Costs and expenses for our pharmaceutical business were $81.7 million, similar to 2025's $81.9 million, reflecting a favorable sales mix of higher-margin products while we continued to meaningfully invest in our R&D programs. R&D for Q1 2026 totaled $28.8 million, down slightly from $30.2 million in the 2025 quarter due to lower CMC-related activities, partially offset by increased levels of our early-stage clinical trials. As a result, our pharmaceutical operating loss was $30 million in Q1 2026 compared to last year's operating loss of $34.8 million.

Speaker #2: Costs and expenses for our pharmaceutical business were $81.7 million, similar to 2025's $81.9 million. Reflecting a favorable sales mix of higher margin products while we continue to meaningfully invest in our R&D programs.

Speaker #2: R&D for Q1 2026 totaled $28.8 million, down slightly from $30.2 million in the 2025 quarter. Due to lower CMC-related activities, partially offset by increased levels of our early-stage clinical trials.

Speaker #2: As a result, our pharmaceutical operating loss was $30 million in Q1 2026, compared to last year's operating loss of $34.8 million. Depreciation in amortization expense was $18.3 million, which was slightly higher than $17.8 million from last year.

Adam Logal: Depreciation and amortization expense was $18.3 million, which was slightly higher than $17.8 million from last year. For our consolidated financial results, total revenues for Q1 2026 were $124.2 million compared to $149.9 million in Q1 2025. Consolidated operating loss for Q1 2026 was $51 million, improved from 2025's $67.2 million loss. Our net loss for Q1 2026 was $54.8 million or $0.07 per share, which improved from 2025's net loss of $67.6 million or $0.10 per share.

Speaker #2: For our consolidated financial results, total revenues for Q1 2026 were $124.4 million, compared to $149.9 million in the first quarter of 2025. Consolidated operating loss for Q1 2026 was $51.0 million, improved from 2025's $67.2 million loss.

Speaker #2: Our net loss for Q1 2026 was $54.8 million or $0.07 per share, which improved from 2025's net loss of $67.6 million or $0.10 per share.

Speaker #2: Looking forward to the outlook for our second quarter of 2026, we expect total revenue to be between $127 to $132 million, with revenue of services from $72 to $76 million, with the range reflecting several assumptions around testing volumes and reimbursement pricing.

Adam Logal: Looking forward to the outlook for our Q2 2026, we expect total revenue to be between $127 to $132 million, with revenue of services from $72 to $76 million, with the range reflecting several assumptions around testing volumes and reimbursement pricing. We expect pharmaceutical product revenue of $38 to $42 million, and we expect IP and other revenue to be between $15 to $19 million, including the Pfizer profit share of $6 to $8 million. Total costs and expenses for Q2 are expected to come in between $180 and $190 million, excluding the earn-out anticipated from LabCorp related to the closing of our second transaction, as well as any one-time restructuring costs.

Speaker #2: We expect pharmaceutical product revenue of $38 to $42 million, and we expect IP and other revenue to be between $15 to $19 million, including the Pfizer profit share of $6 to $8 million.

Speaker #2: Total costs and expenses for Q2 are expected to come in between $180 and $190 million, excluding the earnout anticipated from Labcorp related to the closing of our second transaction.

Speaker #2: As well as any one-time returning one-time restructuring costs. With our expanding investments in R&D, we expect R&D to become between $32 and $38 million, partially offset by $5 to $7 million in BARDA funding.

Adam Logal: With our expanding investments in R&D, we expect R&D to become between $32 million and $38 million, partially offset by $5 million to $7 million in BARDA funding. We expect depreciation in amortization expense of approximately $24 million. We're affirming our full year guidance that we introduced when we reported our Q4 results, which are included in our earnings release. As of the end of Q1, we had approximately $108 million authorized to repurchase shares of our common stock. With that, we have concluded our prepared remarks, and we'll open the call for questions.

Speaker #2: And we expect depreciation in amortization expense of approximately $24 million. We're affirming our full-year guidance that we introduce when we reported our Q4 results, ts, which are included in our earnings release.

Speaker #2: And as of the end of Q1, we add approximately $108 million authorized to repurchase shares of our common stock. With that, we have concluded our prepared remarks.

Speaker #2: And we'll open the call for questions.

Speaker #1: Thank you. We will now begin the question and answer session. To ask a question, you may press star then 1 on your touchstone phone.

Operator 2: Thank you. We will now begin the question and answer session. To ask a question, you may press star then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time a question has been addressed and you would like to withdraw your question, please press star then two. Analysts are requested to limit to one question and one follow-up. At this time, we will pause momentarily to assemble our roster. The first question comes from Maury Raycroft with Jefferies. Please go ahead. Maury Raycroft, your line has been unmuted. Please go ahead with your question.

Operator: Thank you. We will now begin the question and answer session. To ask a question, you may press star then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time a question has been addressed and you would like to withdraw your question, please press star then two. Analysts are requested to limit to one question and one follow-up. At this time, we will pause momentarily to assemble our roster. The first question comes from Maury Raycroft with Jefferies. Please go ahead. Maury Raycroft, your line has been unmuted. Please go ahead with your question.

Speaker #1: If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time a question has been addressed and you would like to withdraw your question, please press star then 2.

Speaker #1: Analysts are requested to limit one question and one follow-up. At this time, we will pause momentarily to assemble our roster. The first question comes from Mauri Raycroft, with Jefferies.

Speaker #1: Please go ahead. Mauri Raycroft, your line has been unmuted. Please go ahead with your question.

Speaker #3: Can you hear me now?

Maury Raycroft: Can you hear me now?

Speaker #4: Yeah. Hello. Go ahead. I'm sorry about that. So thanks for taking my questions. Starting off, I was going to ask one on 4K score and wondering if you can comment on the proportion of payer policies that have been updated to reflect your new FDA label and what else needs to be done on this front.

Adam Logal: Yeah.

Operator 2: Yes.

Operator: Yes.

Adam Logal: We can hear you, Maury. Go ahead.

Maury Raycroft: Sorry about that. Thanks for taking my questions. Starting off, I was gonna ask one on 4Kscore. Wondering if you can comment on the proportion of payer policies that have been updated to reflect your new FDA label, and what else needs to be done on this front. Can you talk about what you're doing to get more primary care docs on board with the diagnostic, and are there education efforts underway there?

Speaker #4: And can you talk about what you're doing to get more primary care docs on board with the diagnostic? And are there education efforts underway there?

Speaker #3: Yeah. So I'll start off, Mayor, Mauri. So on the payer policies, we are continuing to work across the board, starting with Medicare to update their coverage determination or more accurately reflect the FDA label.

Adam Logal: Yeah. I'll start off there, Maury. On, on the payer policies, you know, we are continuing to work across the board, starting with Medicare to update their coverage determination or more accurately reflect the FDA label. Beyond that, you know, we are engaging with payers. I'll say there's not many payers that had a requirement for GRE on the commercial setting or outside of Medicare. We are continuing to look at that from an overall perspective. As it relates to going into the primary care market, we are, we are waiting for that LCD to get updated before we more aggressively go into the primary care market. You know, we would expect that to happen, you know, in the middle of this year.

Speaker #3: But beyond that, we are engaging with payers I'll say there's not many payers that had a requirement for DRE on the commercial setting or outside of Medicare.

Speaker #3: So we are continuing to look at that from an overall perspective. So as it relates to going into the primary care market, we are waiting for that LCD to get updated before we more aggressively go into the primary care market.

Speaker #3: And we would expect that to happen in the middle of this year.

Speaker #4: Got it. Okay. And anything more you can say on how would you think about growth expectations for the base business and what 4K score how 4K score will contribute to that growth over the course of the year?

Maury Raycroft: Got it. Okay. Anything more you can say on how we should think about growth expectations for the base business and what 4Kscore, how 4Kscore will contribute to that growth over the course of the year?

Speaker #3: Yeah. So I think you'll see in the applied way that the math works between the first half and second half, you'll see some growth coming in the back half of the year driven by some of the expectations we have around 4K and just generally a more focused footprint on bioreferences New York, New Jersey businesses.

Adam Logal: Yeah. I think you'll see in the applied way that the math works between H1 and H2. You'll see some growth coming in H2 of the year, driven by some of the expectations we have around 4Kscore and just generally a more focused footprint on BioReference New York, New Jersey businesses. You know, 4Kscore grew significantly last year. You know, the comps this year were a little bit more challenging, so we didn't see the same level of growth that we saw last year.

Speaker #3: So 4K grew significantly last year. The comps this year were a little bit more challenging. So we didn't see the same level of growth that we saw last year.

Speaker #3: But we would have an expectation that we should achieve double-digit growth on 4K volumes this year, which will lead to us getting into that range of $300 to $312 million for the total business of bioreference.

Adam Logal: We would have an expectation that we should achieve double-digit growth on 4Kscore volumes this year, which will lead to us, you know, getting into that range of $300 to 312 million for the total business of BioReference.

Speaker #4: Got it. Okay. That's helpful. And maybe one other question on the in general genotropin profit share. Wondering if you can comment more on just your latest communications with Pfizer related to forecasts here and can you clarify whether you're observing commercial impact from the deer doctor letter that Pfizer sent to prescribers over the course of summer last year?

Maury Raycroft: Got it. Okay. That's helpful. Maybe one other question on the NGENLA Genotropin profit share. Wondering if you can comment more on just your latest communications with Pfizer related to forecasts here. Can you clarify whether you are observing commercial impact from the Dear Doctor letter that Pfizer sent to prescribers over the course of summer last year? If Pfizer is doing more on that front to increase switching from Genotropin to NGENLA.

Speaker #4: And if Pfizer is doing more on that front to increase switching from genotropin to in general.

Speaker #3: Yeah. So we have continued to see pretty good growth for in general is part of the total franchise between genotropin and in general. So we think Pfizer's been quite aggressive in seeing that conversion pull through and continuing to maintain their share or grow their share beyond some of the other long-actings in the growth hormone space, both here in the US, but also globally.

Adam Logal: Yeah. We have continued to see, you know, pretty good growth for NGENLA as part of the total franchise between Genotropin and NGENLA. We think Pfizer's been quite aggressive in seeing that conversion pull through and continuing to maintain their share or grow their share beyond some of the other long-actings in the growth hormone space, both here in the US, but also globally. We've seen pretty significant growth, you know, quarter over quarter and year over year for the NGENLA share. We still think that Pfizer owns, you know, around a third of the global long-acting market. The conversions are happening, you know, at a consistent pace, not as aggressively as we previously had expected. Certainly ramping upwards.

Speaker #3: We've seen pretty significant growth quarter over quarter and year over year. In general, for share, we still think that Pfizer owns around a third of the global long-acting market.

Speaker #3: The conversions are happening at a consistent pace, not as aggressively as we previously had expected. But certainly, ramping upwards. And as it relates to Pfizer sharing their outlooks or forecasts, they don't necessarily give us anything forward-looking.

Adam Logal: As it relates to Pfizer sharing their outlooks or forecasts, they don't necessarily give us anything forward-looking, as it relates to how we should expect the entire franchise to grow. I think I covered all the questions, Maureen.

Speaker #3: As it relates to how we should expect the entire franchise to grow. I think I covered all the questions, Mauri.

Speaker #4: Yep. Yeah. That was helpful. Thanks for taking my questions.

Maury Raycroft: Yep. Yeah, that was helpful. Thanks for taking my questions.

Speaker #3: Thank you.

Adam Logal: Thank you.

Speaker #1: The next question comes from Brian Chang. With JP Morgan.

David Brown: The next question comes from Ryan Chang with JP Morgan.

Operator: The next question comes from Ryan Chang with JP Morgan.

Speaker #5: Hi, guys. Thanks for taking my question this afternoon. Maybe just first, I want to know a little bit more about your expectations for your tetravalent TCE B-cell lymphoma trial.

Ryan Chang: Hey, guys. Thanks for taking our question this afternoon. Maybe just first, wanna know a little bit more about your expectations for your tetravalent TCE B-cell lymphoma trial. Can you walk through, you know, what you'll be looking for from that study? What will be good response data to see early on? Do you have a sense of what would be a good line of setting for this specific mechanism? We have a follow-up. Thank you.

Speaker #5: Can you walk through what you'll be looking for from that study? What will be good response data to see early on? And do you have a sense of what will be a good line of setting for this specific mechanism?

Speaker #5: And we have a follow-up. Thank you.

Speaker #3: I think Gary, who's leading the MODX, can answer that because that's a great question, actually. That's good to talk about. Gary?

Elias Zerhouni: I think Gary, who's leading the ModeX, can answer that because that's a great question, actually. That's, you know, good to talk about. Gary?

Speaker #6: Yeah. Thanks, Elias. Well, obviously, the first order of business is to show acceptable toxicity. And that's where the early phase one data becomes important.

Gary: Yeah. Thanks, Elias. Well, you know, obviously the first order of business is to show acceptable toxicity, and that's where the early phase 1 data becomes important. We don't expect to see anything different from other candidates that have gone forward, but we need to get through that first. Once we go into therapeutic efficacy, what we're particularly interested in is looking at the failures to the CD20 multi-specifics or bispecifics, for example, molecules like glofitamab, for which resistance becomes evident quite frequently. We think as a starting indication, this will be a population where we can, you know, essentially salvage a therapeutic response.

[Company Representative] (OPKO Health): Yeah. Thanks, Elias. Well, you know, obviously the first order of business is to show acceptable toxicity, and that's where the early phase 1 data becomes important. We don't expect to see anything different from other candidates that have gone forward, but we need to get through that first. Once we go into therapeutic efficacy, what we're particularly interested in is looking at the failures to the CD20 multi-specifics or bispecifics, for example, molecules like glofitamab, for which resistance becomes evident quite frequently. We think as a starting indication, this will be a population where we can, you know, essentially salvage a therapeutic response.

Speaker #6: We don't expect to see anything different from other candidates that have gone forward, but we need to get through that first. Once we go into a therapeutic efficacy, we're particularly interested in looking at the failures to the CD20 multi-specifics or bispecifics.

Speaker #6: And for example, molecules like lefitamab, for which resistance becomes evident quite frequently. And so we think as a starting indication, this will be a population where we can essentially salvage a therapeutic response.

Gary: Eventually that gives us the opportunity to move up in terms of the actual order of and priority of treatment. The other indication that we shouldn't forget is that by depleting B cells with CD19 and CD20, this molecule has an opportunity to be used in autoimmunity. There are opportunities, for example, in lupus and other autoimmune B cell diseases, where we will look for its ability to reduce the inflammatory reaction. Those will come after we get the initial safety data, but not much delayed after that. There are multiple indications that we think we can pursue.

Speaker #6: I should also and then eventually, that gives us the opportunity to move up in terms of the actual order of and priority of treatment.

[Company Representative] (OPKO Health): Eventually that gives us the opportunity to move up in terms of the actual order of and priority of treatment. The other indication that we shouldn't forget is that by depleting B cells with CD19 and CD20, this molecule has an opportunity to be used in autoimmunity. There are opportunities, for example, in lupus and other autoimmune B cell diseases, where we will look for its ability to reduce the inflammatory reaction. Those will come after we get the initial safety data, but not much delayed after that. There are multiple indications that we think we can pursue.

Speaker #6: The other indication that we shouldn't forget is that by depleting B cells with CD19 and CD20, this molecule has an opportunity to be used in autoimmunity there.

Speaker #6: There are opportunities. For example, in lupus and other autoimmune B-cell diseases, where we will look for its ability to reduce the inflammatory reaction, and those will come after we get the initial safety data, but not much delayed after that.

Speaker #6: So there are multiple indications that we think we can pursue.

Speaker #1: Got it. That's very helpful. And then maybe just one more on the Merck partnership on the EBV vaccine. Any updates in terms of data disclosure, perhaps later this year, and also can you give us a better sense about the next step for that program?

Ryan Chang: Got it. That's very helpful. Then maybe just one more on the Merck partnership on the EBV vaccine. Any updates in terms of data disclosure perhaps later this year? Also, can you give us a better sense about the next step for that program? Thank you.

Speaker #1: Thank you.

Speaker #3: Gary?

Elias Zerhouni: Gary?

Gary: Sure. yeah, Elias, you want me to cover that as well?

[Company Representative] (OPKO Health): Sure. yeah, Elias, you want me to cover that as well?

Speaker #6: Sure. Yeah. Elias, you want me to cover that as well?

Speaker #3: Yes, please.

Elias Zerhouni: Yes, please.

Gary: As you know, we began the phase 1 study a while ago with two different adjuvants that where we compared their efficacy one to another, both in naive individuals and also in virally infected or formerly virally infected individuals. The reason we're looking at both populations is that ultimately the vaccine's intended for patients who are EBV naive. Another consideration we have to watch out for is that the vaccine doesn't have any untoward effects on the people who are EBV positive. The vaccine trial has gone smoothly. Enrollment has been very, you know, facile and no surprises. We are not disappointed at all in terms of the immunogenicity that we're seeing.

Speaker #6: Yeah. Yeah. So as you know, we began the phase one study a while ago with two different adjuvants, i.e., that where we compared their efficacy one to another, both in naive individuals but also in virally infected or formerly virally infected individuals.

[Company Representative] (OPKO Health): As you know, we began the phase 1 study a while ago with two different adjuvants that where we compared their efficacy one to another, both in naive individuals and also in virally infected or formerly virally infected individuals. The reason we're looking at both populations is that ultimately the vaccine's intended for patients who are EBV naive. Another consideration we have to watch out for is that the vaccine doesn't have any untoward effects on the people who are EBV positive. The vaccine trial has gone smoothly. Enrollment has been very, you know, facile and no surprises. We are not disappointed at all in terms of the immunogenicity that we're seeing.

Speaker #6: The reason we're looking at both populations is that ultimately, the vaccine's intended for patients who are EBV naive. But another consideration we have to watch out for is that the vaccine doesn't have any untoward effects on the people who are EBV positive.

Speaker #6: The vaccine trial has gone smoothly. Enrollment has been very facile, and there have been no surprises. We are not disappointed at all in terms of the immunogenicity that we're seeing.

Speaker #6: But what we are trying to do in anticipation of phase two is to get a better read on the EBV-negative patients, who are a much smaller proportion of the overall population.

Gary: What we are trying to do in anticipation of phase 2 is to get a better read on the EBV negative patients who are a much smaller proportion of the overall population. We have been filling in those blanks with the idea that we will then down-select one of the two adjuvants and simplify the formulations for phase 2. I do think that information will be available certainly by the end of the year. We won't disclose any trial results, obviously, until all the data are in. I think you will hear about the evolving plans for phase 2 and then what the rationale and what the data is behind that.

[Company Representative] (OPKO Health): What we are trying to do in anticipation of phase 2 is to get a better read on the EBV negative patients who are a much smaller proportion of the overall population. We have been filling in those blanks with the idea that we will then down-select one of the two adjuvants and simplify the formulations for phase 2. I do think that information will be available certainly by the end of the year. We won't disclose any trial results, obviously, until all the data are in. I think you will hear about the evolving plans for phase 2 and then what the rationale and what the data is behind that.

Speaker #6: So, we have been filling in those blanks with the idea that we will then down-select one of the two adjuvants and simplify the formulations for phase two.

Speaker #6: So I do think that information will be available. Certainly, by the end of the year. And we won't disclose any trial results, obviously, until all the data are in.

Speaker #6: But I think you will hear about the evolving plans for phase two and then what the rationale and what the data is behind that.

Gary: I just don't wanna get too far in front of it because these are really decisions that Merck will make. We don't want to do anything that steps outside of the guidelines they normally use for advancing their products.

Speaker #6: And I just don't want to get too far in front of it, because these are really decisions that Merck will make. And so we don't want to do anything that steps outside of the guidelines they normally use for advancing their products.

[Company Representative] (OPKO Health): I just don't wanna get too far in front of it because these are really decisions that Merck will make. We don't want to do anything that steps outside of the guidelines they normally use for advancing their products.

Speaker #1: Got it. Thanks for the call in. Looking forward to it. Thank you.

Ryan Chang: Got it. Thanks for the color and looking forward to it. Thank you.

Speaker #6: Sure.

Gary: Sure.

[Company Representative] (OPKO Health): Sure.

Speaker #1: The next question comes from Yi Chen with HC Wainwright. Please go ahead.

Operator 2: The next question comes from Yi Chen with H.C. Wainwright. Please go ahead.

Operator: The next question comes from Yi Chen with H.C. Wainwright. Please go ahead.

Speaker #3: Thank you for taking my questions. My first question is the reported first-quarter revenue is just a little bit below your previous guidance. So can you talk about which segment in revenue sort of underperformed a little bit in the first quarter and how should we look at the second quarter revenue guidance?

Yi Chen: Thank you for taking my questions. My first question is the reported Q1 revenue is just a little bit below your previous guidance. Can you talk about which segment in revenue sort of underperformed a little bit in Q1, and how should we look at the Q2 revenue guidance?

Speaker #7: Yeah. Where the majority of that shortfall came was actually related to our other revenue, an IP revenue. So we had planned activities to do some additional CMC activities under our got delayed until later this year.

Adam Logal: Yeah. Where the majority of that shortfall came was actually related to our other revenue and IP revenue. We had planned activities to do some additional CMC activities under our BARDA contract, and those got delayed until later this year. That was about almost $6 million of the shortfall, which is, you know, what took us below where we had previously guided. From a net bottom line perspective, no impact because R&D came in lower than we had forecasted, along with the associated revenue that would have been recorded. Hopefully, that makes sense.

Speaker #7: So that was about almost $6 million of the shortfall, which is what took us below where we had previously got it. So from a net bottom line perspective, no impact because R&D came in lower than we had forecasted.

Speaker #7: Along with the associated revenue that would have been recorded. Hopefully, that makes sense.

Speaker #3: Got it. Got it. Thank you. And also, with respect to the commercial plan for MDX2301 for prevention of COVID-19, do you have any plan to commercialize it just by yourself in the future, or is it going to be a contract with the government?

Yi Chen: Got it. Got it. Thank you. Also, with respect to the commercial plan for MDX2301 for prevention of COVID-19, do you have any plan to commercialize it just by yourself in the future, or is it going to be a contract with the government?

Speaker #7: Well, I'll start and let Gary also comment. I mean, from our point of view, depending upon the results we observed, we have two markets that really need such a molecule, given its ability to resist mutations, or so far has been an antibody that has shown activity against all known variants.

Elias Zerhouni: Well, I'll start and let Gary also comment. I mean, from our point of view, I mean, depending upon the results we observe, I mean, we have two markers that really need such a molecule, given its ability to resist mutations or so far has been, you know, an antibody that has shown activity against all known variants. We think that the immune-impaired population, whether it be cancer patients or patients under therapies that are immunosuppressive or cannot really get vaccinated or mount an immune response, those would be the primary population that would really benefit from such a molecule, and that's about 30 million people in the US.

Speaker #7: So we think that the immune-impaired population will be cancer patients or patients under therapies that are immunosuppressive who cannot really get vaccinated or mount an immune response; those would be the primary population.

Speaker #7: That would really benefit from such a molecule. And that's about 30 million people in the U.S. In terms of developing it, we definitely are looking for a partner to co-develop or find a way because I think it's going to require that sort of expertise and experience in the marketplace around the immune-impaired populations.

Elias Zerhouni: In terms of developing it, we definitely are looking for a partner to co-develop or find a way, because I think it's going to require that sort of expertise and experience in the marketplace around the immune-impaired populations, whether it be cancer centers or other, you know, nursing homes and all that. Yes, the question is what population? Immune-impaired. Doing it on our own? No. Probably with a partner that can add to our, you know, clinical development process. Gary, am I missing anything?

Speaker #7: What would be cancer centers or other nursing homes and all that. So yes, the question is, what population immune-impaired? Do we get on our own?

Speaker #7: No, probably with a partner. That can add to our clinical development process. Gary, am I missing anything?

Speaker #6: Well, yes. Thanks, Elias. The only thing I would add is that, just to be clear, there can be two different partners or two different sources of revenue.

Gary: Well, yes. Thanks, Elias. The only thing I would add is that, just to be clear, there can be two different partners or two different sources of revenue. Clearly, as this gets to the point of being approved, this is a product that BARDA would want to stockpile. Yes, there would be some, assuming we get to that point, some kind of a contract with the government to provide materials to stockpile. I think both BARDA and we feel that the best way of addressing, you know, future threats from COVID is to also make sure it's out there and available for those who need it.

[Company Representative] (OPKO Health): Well, yes. Thanks, Elias. The only thing I would add is that, just to be clear, there can be two different partners or two different sources of revenue. Clearly, as this gets to the point of being approved, this is a product that BARDA would want to stockpile. Yes, there would be some, assuming we get to that point, some kind of a contract with the government to provide materials to stockpile. I think both BARDA and we feel that the best way of addressing, you know, future threats from COVID is to also make sure it's out there and available for those who need it.

Speaker #6: So clearly, if this gets to the point of being approved, this is a product that BARDA would want to stockpile and so yes, there would be some assuming we get to that point, some kind of a contract with the government to provide material to stockpile.

Speaker #6: I think both BARDA and we feel that the best way of addressing future threats from COVID is to also make sure it's out there and available for those who need it.

Speaker #6: And so that's why Elias is saying, we think there's a great unmet need in people who don't respond to vaccines—people who have underlying cancers or elderly who can't mount effective immune responses. And so yes, we one way or another want to address that market.

Gary: That's why Elias is saying, we think there's a great unmet need in people who don't respond to vaccines, people who have underlying cancers or elderly who can't mount effective immune responses. Yes, we, one way or another, want to address that market. I think that, at this point, it's probably just too early to say what commercial partner or what commercial, you know, infrastructure we might choose to pursue. I think our eye is mostly on the next steps of getting the approvals for and licensure from FDA. That's kind of the near-term target.

[Company Representative] (OPKO Health): That's why Elias is saying, we think there's a great unmet need in people who don't respond to vaccines, people who have underlying cancers or elderly who can't mount effective immune responses. Yes, we, one way or another, want to address that market. I think that, at this point, it's probably just too early to say what commercial partner or what commercial, you know, infrastructure we might choose to pursue. I think our eye is mostly on the next steps of getting the approvals for and licensure from FDA. That's kind of the near-term target.

Speaker #6: And I think that at this point, it's probably just too early to say. What commercial partner or what commercial infrastructure we might choose to pursue?

Speaker #6: I think our eye is mostly on the next steps of getting the approvals for, and licensure from, the FDA. That's kind of the near-term target.

Speaker #3: Got it. Thank you.

Yi Chen: Got it. Thank you.

Operator 2: The next question comes from Kevin DeGeeter with Ladenburg Thalmann. Please go ahead.

Operator: The next question comes from Kevin DeGeeter with Ladenburg Thalmann. Please go ahead.

Speaker #1: The next question comes from Kevin Dijida with Larman Thalman. Please go ahead.

Speaker #8: Hey, good afternoon. Thanks, everybody, for taking our questions. My question's first on the in vivo CAR-T program. We've seen a lot of continued to see a lot of activity on the M&A front in the space.

Kevin DeGeeter: Hey, good afternoon. Thanks, everybody, for taking our questions. My question's first on the in vivo CAR-T program. We've continued to see a lot of activity on the M&A front in the space. Can you just remind us maybe of two things? One, you know, how you see the differentiation of your in vivo CAR-T platform from some of the others that are just slightly more advanced in early-stage clinical development. Just two, you know, how you see, you know, key milestones that you need to execute against to bring that program into the clinic late in 2026, early in 2027.

Speaker #8: Can you just remind us maybe of two things? One, how you see the differentiation of your in vivo CAR-T platform from some of the others that are slightly more advanced in early-stage clinical development?

Speaker #8: And then just two, how you see key milestones that you need to execute against to bring that program into the clinic late in '26 or early in '27?

Elias Zerhouni: I'll start, and I, Gary, if, let me start, and then you can, you know, cover what, like, what I'm missing. Actually, the in vivo CAR T program is not a new program. This is something we have been doing for several years, thinking about it from, you know, the point of view of differentiation. What differentiation do we talk about? Number one, as you know, in the lipid nanoparticles by themselves, you know, do not target specific cells. We thought that the number one differentiation would be targeting of the lipid nanoparticle better than the competition does. In this case, we knew that we could use our multispecific platform to target different types of cells and in different ways by conjugating an antibody on top of the LNP, but conjugating in a covalent way.

Speaker #7: I'll start, and Gary, let me start, and then you can cover what I'm missing. So actually, the in vivo CAR-T program is not a new program.

Speaker #7: This is something we have been doing for several years, thinking about it from the point of view of differentiation. What differentiation do we talk about?

Speaker #7: Number one, as you know, in the lipid nanoparticles by themselves, do not target specific cells. And so we thought that the number one differentiation would be targeting.

Speaker #7: Of the lipid nanoparticle better than the competition does. And in this case, we knew that we could use our multi-specific platform to target different types of cells and in different ways by conjugating an antibody on top of the LNP, but conjugating in a covalent way.

Speaker #7: So it's attached. It doesn't fall away. And then when that's done, it goes to the proper target cells in a proportion that is favorable to the activity of the CAR-T technology.

Elias Zerhouni: It's attached, it doesn't fall away. When that's done, it goes to the proper target cells in a proportion that is favorable to the activity of the CAR T technology. That leads to, A, a differentiation, B, the ability to multiply the number of targets you can, and number of type of cells you can address. Also, it reduces the need for higher doses because you don't have a loss of LNPs in areas where there is no targeting. That's number 1. Differentiation 1 is unique technology combination of LNPs that we actually improved ourselves in a proprietary way with lipids that are really designed for what we do, plus chemical conjugation that is unique in the business. Having the multi-specifics pull the LNP gave us potential.

Speaker #7: So that leads to, A, a differentiation; B, the ability to multiply the number of targets you can and number of cells you can number a type of cells you can address, but also it reduces the need for higher doses because you don't have a loss.

Speaker #7: Of LNPs in areas where there is no targeting. So that's number one. So differentiation one is unique technology combination of LNPs that we actually improved ourselves and in a proprietary way with lipids that are really designed for what we do, plus chemical conjugation that is unique in the business.

Speaker #7: And so having the multi-specifics pull the LNP gave us potential. Second is we use what we know best, which is a targeting and activation which also leads us to actually have effects at 5 to 10 times lower doses than the competition, which obviously improves the therapeutic window.

Elias Zerhouni: Second is we use what we know best, which is a targeting and activation, which also leads us to actually have effects at 5 to 10 times lower doses than the competition, which obviously improves the therapeutic window. That's the second one. The third one is the fact that we found ways of having cargos, you know, that are both RNA and DNA. That is very promising because others haven't been able to achieve that. Last but not least, because we have a multi-specific technology, we can create chimeric antigens that are also bispecific or trispecific themselves. That gives you a sense. Now, the other question, key milestones. We've already completed all the non-human primate studies.

Speaker #7: And so that's the second one. The third one is the fact that we found ways of having cargos that are both RNA and DNA.

Speaker #7: And that is very promising because others haven't been able to achieve that. And last but not least, because we have a multi-specific technology, we can create chimeric antigens that are also bispecific or tri-specific themselves.

Speaker #7: So that gives you a sense. Now, the other question key milestones, we've already completed all the non-human primate studies. We're in the middle of creating the CMC, essentially, which will be finished in terms of drug product within the next few months, three, four months, five months maybe.

Elias Zerhouni: We're in the middle of creating the CMC essentially, which will be finished in terms of drug product within the next few months, 3, 4, 5 months maybe. Then preparing, in fact, the launch of the first trial, human trial, you know, before the end of this year, we hope. Those are the milestones for us. Get into the clinic and show both safety and efficacy, what we believe is going to be a more effective way of truly deploying this very promising technology. I stop here, Gary. Did I miss anything that you wanna add color to?

Speaker #7: And then preparing, in fact, the launch of the first trial. Human trial. Before the end of this year, we hope. Those are the milestones for us.

Speaker #7: Get into the clinic and show both safety and efficacy. What we believe is going to be a more effective way of truly deploying this very promising technology.

Speaker #7: I stop here, Gary. Did I miss anything that you want to add color to?

Gary: Yeah, I think you covered it very well, Elias. I, the only minor things I would add are that we, while our lead program is targeted towards in vivo CAR T cells, we've also learned how to use other antibodies to target genes into other cell types so that we can target B cells, we can target NK cells. We see this really as the leading edge of a very exciting broad platform that builds on our knowledge of the multi-specific platforms. The one other application that Elias didn't mention is that obviously, it can be used for gene correction, using CRISPR recombinases, to modulate or make sure the DNA is permanently kept or in other cases, transiently expressed.

Speaker #5: Yeah, I think you covered it very well, Elias. The only minor things I would add are that we while our lead program is targeted towards in vivo CAR-T cells, we've also learned how to use other antibodies to target genes into other cell types so that we can target B cells.

[Company Representative] (OPKO Health): Yeah, I think you covered it very well, Elias. I, the only minor things I would add are that we, while our lead program is targeted towards in vivo CAR T cells, we've also learned how to use other antibodies to target genes into other cell types so that we can target B cells, we can target NK cells. We see this really as the leading edge of a very exciting broad platform that builds on our knowledge of the multi-specific platforms. The one other application that Elias didn't mention is that obviously, it can be used for gene correction, using CRISPR recombinases, to modulate or make sure the DNA is permanently kept or in other cases, transiently expressed.

Speaker #5: We can target NK cells. And so we see this really as the leading edge of a very exciting broad platform that builds on our knowledge of the multi-specific platforms.

Speaker #5: So and the one other application that Elias didn't mention is that obviously it can be used for gene correction. Using CRISPR, recombinations to modulate or make sure the DNA is permanently kept or in other cases, transiently expressed.

Speaker #5: So it's just a very fertile area and the only other thing I would emphasize because I think we implied it but didn't come out and say it is that we're planning to do the initial studies using the IIT mechanism in China.

Gary: It's just a very fertile area. The only other thing I would emphasize because I think we slide it but didn't come out and say it, is that we're planning to do the initial studies using the IIT mechanism in China, which allows us to go faster, allows us for us to be more efficient and for us to also do it with lower cost. It will accelerate our efforts there. That's where in, when Elias was talking about the preclinical package, we also have some safety data that we will be providing the investigators who will be conducting the studies.

[Company Representative] (OPKO Health): It's just a very fertile area. The only other thing I would emphasize because I think we slide it but didn't come out and say it, is that we're planning to do the initial studies using the IIT mechanism in China, which allows us to go faster, allows us for us to be more efficient and for us to also do it with lower cost. It will accelerate our efforts there. That's where in, when Elias was talking about the preclinical package, we also have some safety data that we will be providing the investigators who will be conducting the studies.

Speaker #5: Which allows us to go faster, allows us to be more efficient, and for us to also do it at a lower cost.

Speaker #5: So it will accelerate our efforts there. And that's where when Elias is talking about the preclinical package, we also have some safety data that we will be providing the investigators who will be conducting the studies.

Speaker #5: But everything is on track and we're very excited about it because it's a whole new world in terms of both antibodies and gene delivery.

Gary: Everything is on track, and we're very excited about it because it's, you know, a whole new world in terms of both antibodies and gene delivery.

[Company Representative] (OPKO Health): Everything is on track, and we're very excited about it because it's, you know, a whole new world in terms of both antibodies and gene delivery.

Kevin DeGeeter: Yeah. Thank you for all that feedback. That's all for our questions today. Thank you so much.

Speaker #7: No, thank you for all that feedback. That's all for our questions today. Thank you so much.

Operator 2: The next question comes from Yale Jen with Leerink Partners. Please go ahead.

Operator: The next question comes from Yale Jen with Leerink Partners. Please go ahead.

Speaker #1: The next question comes from Yale Jem with Laidlaw & Co. Please go ahead.

Speaker #8: Oh, good afternoon and thanks for taking the questions. We have two here. on the guidance for the 2026. We believe the diagnostic and the business seems having a continuous growth quarter over quarter in that pattern.

Elias Zerhouni: Good afternoon, thanks for taking the questions. Just we have two here. The first one is in terms based on the guidance for the 2026. We believe that diagnostic business seems to be having a continuous growth quarter-over-quarter in that pattern. You mentioned about the 4Kscore. Would there be any other aspect or factors also could drive the revenue growth on that on that operation? We have a follow-up.

Yale Jen: Good afternoon, thanks for taking the questions. Just we have two here. The first one is in terms based on the guidance for the 2026. We believe that diagnostic business seems to be having a continuous growth quarter-over-quarter in that pattern. You mentioned about the 4Kscore. Would there be any other aspect or factors also could drive the revenue growth on that on that operation? We have a follow-up.

Speaker #8: So, you mentioned the 4Kscore. Would there be any other aspects or factors that could drive the revenue growth on that operation? Then we have a follow-up.

Speaker #9: Yeah, so yeah, the main drivers beyond 4K is really the first full year of the focus on the New York, New Jersey market. So the commercial team has been very aggressive in identifying new opportunities and growth opportunities in those markets.

Adam Logal: Yeah. Yale Jen, the main drivers beyond 4K is really the first, you know, full year of the focus on the New York, New Jersey market. The commercial team has, you know, very aggressive in identifying new opportunities and growth opportunities in those markets. It's, it's all still within the typical clinical and women's health portions of the business. There are, you know, some adjacent lines that we continue to explore and work towards, but it is, you know, core accounts being one in the markets, and we have a very rich and deep pipeline the team's executing against.

Speaker #9: It's all still within the typical clinical and women's health portions of the business. There are some adjacent lines that we continue to explore and work towards, but it is core accounts being one.

Speaker #9: In the markets, and we have a very rich and deep pipeline the team's executing against.

Speaker #1: Okay, great. And maybe just one question for 2001. Given that top one is one of the targets, just curious, at this stage, is the triple negative breast cancer one of the targets or how should we think about the next stage in terms of the target selection?

Yale Jen: Okay, great. Maybe just one question for 2001. Given that Trop-2 is one of the targets, just curious at this stage, is the t-triple negative breast cancer one of the targets? How should we think about the next stage in terms of the target selection, tumor target, tumor type selection and, you know, development as well? Thanks.

Speaker #1: Tumor type selection and development as well. And thanks.

Elias Zerhouni: Yeah. As you know, we're doing trials in patients who are not responding to other tumors. Triple negative breast cancer also has high expression of Trop-2 and c-Met, so it is part of our, you know, list of 14 cancers that could be responsive. We're gonna focus on the ones that show, that have shown, promising responses. We haven't had a lot of triple negatives in our population so far. We hope to have them and eventually grow that population when we get into the phase 1B, the next phase. We're also trying to enrich the population right now that we are near or at the right regimen and dose.

Speaker #8: Yeah. So, as you know, we're doing trials in patients who haven't, or are not, responding to other tumors. Triple negative breast cancer also has high expression of TROP2 and c-MET.

Speaker #8: So it is part of our list of 14 cancers that could be responsive. But we're going to focus on the ones that show that have shown promising responses.

Speaker #8: But we haven't had a lot of triple negatives in our population so far. And so we hope to have them and eventually grow that population when we get into the phase 1B.

Speaker #8: The next phase. We're also trying to enrich the population right now that we are near or at the right regimen and dose. So that's certainly a tumor that we'd like to have more of in our samples.

Elias Zerhouni: That's certainly a tumor that we'd like to have more of in our samples, but it is theoretically possible to have an effect on triple-negative breast cancer.

Speaker #8: But it is theoretically possible to have an effect on triple negative breast cancer.

Speaker #1: And maybe just a refresh my memory. When we should anticipate the next data readout or 2001? And thanks.

Yale Jen: Maybe just refresh my memory, when we should anticipate the next data readout for MDX2001? Thanks.

Speaker #8: Well, like I said, we're finishing the dose escalation and the regimen and how do you do this? When you do immuno-oncologies, there's not a one-size-fits-all protocol.

Elias Zerhouni: Well, like I said, we're finishing the dose escalation and the regimen and, you know, how do you do this. When you do immuno-oncologies, you know there's not a one-size-fits-all protocol. There's step dosing, there's you use or you don't use steroids, and then at what level, you know, you really do the interval, one week. Also, we are developing, because we're very encouraged by what we see with our IV, we're now developing the liquid formulation so we can use subQ delivery, which would be easier on the patients. We're exploring all of that. Obviously, once we finish this towards Q3, beginning of Q4, we will have basically the plans for the phase 1B pretty much in place by then.

Speaker #8: There's step dosing. You use or you don't use steroids. And then at what level you really do the interval, one week, also we are developing because we're very encouraged by what we see with our IV.

Speaker #8: We're now developing the liquid formulation so we can use subcu delivery, which would be easier on the patients. And so we're exploring all of that.

Speaker #8: And obviously, once we finish this towards the third quarter, beginning of fourth quarter, we will have basically the plans for the phase 1B pretty much in place.

Speaker #8: But then, so at the end of the third quarter, beginning of the fourth quarter, we'll be able to complete this current phase.

Elias Zerhouni: At the end of Q3, beginning of Q4, we'll be able to complete this current phase.

Speaker #1: Okay, great. That's very helpful and congrats on all the progress.

Yale Jen: Okay, great. That's very helpful. Congrats on the progress.

Speaker #8: Thank you.

Elias Zerhouni: Thank you.

Speaker #1: The next question comes from Edward Tenthoff with Piper Sandler. Please go ahead.

Operator 2: The next question comes from Edward Tenthoff with Piper Sandler. Please go ahead.

Operator: The next question comes from Edward Tenthoff with Piper Sandler. Please go ahead.

Speaker #10: Great. Thank you so much. And excited about everything going on at OPKO. Looking forward to the in vivo data at ASTCT and Tuesdays are one data and second half.

Edward Tenthoff: Great. Thank you so much, excited about everything going on at OPKO. Looking forward to the in vivo data at ASGCT and MDX2001 data in the H2. One quick question. Did you say you would run the phase I study for in vivo in China? Is that with a partner, or are you partnering with a specific university there? Thanks.

Speaker #10: One quick question. Did you say you would run the phase one study for in vivo in China? And is that with a partner or are you partnering with a specific university there?

Speaker #10: Thanks.

Elias Zerhouni: I'm sorry, I couldn't hear. Which product are you talking about, Tim?

Speaker #8: I'm sorry, I couldn't hear. Which product are you talking about?

Edward Tenthoff: For in vivo.

Speaker #9: So for in vivo.

Elias Zerhouni: Oh, in the in vivo CAR T.

Speaker #8: Oh, the in vivo CAR-T.

Speaker #1: In vivo CAR-T, I think he's referring to.

Adam Logal: In vivo CAR T, I think he's referring to.

Speaker #8: Right. Yeah. So we're absolutely we have a team actually right now there interviewing the clinical sites. And with a partner, a local partner. And so I don't know at this point who will one or two sites actually there are two sites that are very interested in participating.

Elias Zerhouni: Right. Yeah. You know, we're absolutely, we have a team actually right now. They're interviewing the clinical sites and with a partner, a local partner. I don't know at this point who will, you know, one or two sites actually. There are two sites that are very interested in participating. We're basically doing due diligence on that right now. I can't tell you which site and when, but they're very anxious to really participate in this trial given the uniqueness of this particular platform.

Speaker #8: So we're basically doing due diligence on that right now. I can't tell you which site and when, but they're very, very anxious to really participate in this trial given the uniqueness of this particular platform.

Speaker #9: Very neat. And when it comes to the immune rejuvenator, I appreciate it's still early, but what do you see as the regulatory path here?

Edward Tenthoff: Very neat. When it comes to the immune rejuvenator, I appreciate it's still early, but what do you see as the regulatory path here? Is this something that you'd have to use in combination with other IO agents? If so, does it make sense to partner this?

Speaker #9: Is this something that you'd have to use in combination with other IO agents? And if so, does it make sense to partner this?

Speaker #8: Yeah, so this is a great question. As always, so we have actually two arms in our phase one. As we described, there's a PD-1 naive.

Elias Zerhouni: Yeah. This is a great question, as always. We have actually two arms in our phase one. As we described, there's a PD-1 naive population and a PD-1 exposed population or prior exposure to PD-1. Now, a lot of people, when they look at this molecule, they, you know, the most common question we say, Oh, you don't have a cancer target. Well, PD-1 also doesn't have a cancer target. It is a checkpoint inhibitor. The difference is that MDX2004 is an accelerator. It really enhances the response. It does not unblock the response. When you just unblock, obviously, you may be unblocking very exhausted T-cells. That's why we came up with this concept of rejuvenation.

Speaker #8: Population and a PD-1 exposed population, or prior exposure to PD-1. Now, a lot of people, when they look at this molecule, the most common question we hear is, "Oh, you don't have a cancer target." Well, PD-1 also doesn't have a cancer target.

Speaker #8: There's a checkpoint inhibitor. The difference is that 2004 is an accelerator—really enhances the response. It does not unblock the response. And when you just unblock, obviously, you may be unblocking very exhausted T cells.

Speaker #8: And so that's why we came up with this concept of rejuvenation. So think of it as basically a Keytruda or an Opdivo of a different kind, which will be combined, obviously, with other therapies at some point.

Elias Zerhouni: Think of it as basically, a Keytruda or an Opdivo of a different kind, which will be combined, obviously, with other therapies at some point. We have to show also to the FDA that a, you know, monotherapy also has an effect, and that's what we're doing right now. It's a monotherapy trial where for patients that are either naive to PD-1 or have been exposed to PD-1 but have progressed. I hope that helps you.

Speaker #8: But we have to show also to the FDA that a monotherapy also has an effect. And that's what we're doing right now. It's a monotherapy trial.

Speaker #8: For patients that are either naïve to PD-1 or have been exposed to PD-1 but have progressed. I hope that helps you.

Speaker #9: Very much. Thanks, Elias.

Edward Tenthoff: Very much so. Thanks, Elias.

Elias Zerhouni: Understood. Yeah.

Edward Tenthoff: Lastly, did I hear correctly that the plan was to advance subcu oxyntomodulin before advancing the oral formulation? In other words, sort of seeing what you learn from subq first and then taking the oral into the clinic with Entera technology? Thanks.

Speaker #8: And then lastly, did I hear correctly that the plan was to advance subcu accentamodulin before advancing the oral formulation? In other words, sort of seeing what you learn from subcu first and then taking the oral into the clinic with enterotechnology?

Speaker #8: Thanks. That is Dr. Shaw runs the program and that is exactly what is happening. We need to understand better with the phase one/2A the behavior of the drug in an injectable format.

Elias Zerhouni: That is, you know, Dr. Shah runs the program, and that is exactly what is happening. We need to understand better with the phase 1 and 2A, the behavior of the drug in an injectable format. Once we fix that range, then you can really do the implementation of the oral because then you know what to target in terms of PK, in terms of area under the curve, Cmax, and side effects and so on. We decide, and Dr. Shah decided it was better to get that information first instead of having many different approaches and dosing with the oral. We think it would simplify, in fact, the path to oral.

Speaker #8: So then, once we fix that range, then you can really do the implementation of the oral, because then you know what to target in terms of PK, in terms of area under the curve and Cmax, and side effects, and so on.

Speaker #8: So we decided—and Dr. Shaw decided—it was better to get that information first, instead of having many, many different approaches and dosing with the oral.

Speaker #8: So we think it would simplify, in fact, the path to oral.

Speaker #9: Great. That's super helpful. Thanks, guys.

Edward Tenthoff: Great. That's super helpful. Thanks, guys.

Speaker #8: Thank you.

Elias Zerhouni: Thank you.

Speaker #1: The next question comes from the line of Michael Petowsky with Barrington Research.

Operator 2: The next question comes from the line of Michael Petusky with Barrington Research.

Operator: The next question comes from the line of Michael Petusky with Barrington Research.

Speaker #11: Hey, good evening. So I think Adam, I think you referred to in terms of the diagnostic business, one of the drivers in the second half would be opportunities that that team is pursuing and sort of focus away in New York, New Jersey.

Michael Petusky: Hey, good evening. I think, Adam Logal, I think you referred to, in terms of the diagnostics business, one of the drivers in the H2 would be opportunities that that team is pursuing and, you know, sort of in a focused way in New York, New Jersey. Do you guys have line of sight of new business pieces that may be starting mid-year or like, are there data points that you guys have put together or is essentially, Hey, at this point these guys are, sort of getting after it? Thanks.

Speaker #11: Do you guys have line of sight of new business pieces that may be starting mid-year, or are there data points that you guys have put together, or is it essentially, 'Hey, at this point, these guys are sort of getting after it'?

Speaker #11: Thanks.

Adam Logal: Yeah. Thanks for the question, Mike. You're right. The team is, you know, pretty mature in a lot of the onboarding of the accounts that are required to hit the numbers, and we feel confident we didn't change our full year outlook. For the year, we showed quarter-over-quarter growth. You know, some of that growth is coming from 4Kscore, but a lot of it's coming from the traditional business that, you know, we have a very clear line of sight to.

Speaker #9: And so thanks for the question, Mike. So you're right. So the team is pretty mature in a lot of the onboarding of the accounts that are required to hit the numbers and we feel confident we didn't change outlook.

Speaker #9: For the quarter, we showed or for the year, we showed quarter over quarter growth. The sum of that growth is coming from 4K, but a lot of it's coming from the traditional business that we have a very clear line of sight to.

Speaker #11: Okay, great. And then, just sort of sticking with the same segment, I think you guys referred to—there was a little bit of a headcount reduction.

Michael Petusky: Okay. Great. Just sort of sticking, you know, with the same segment. I think you guys referred to that there was a little bit of a headcount reduction. I think you were talking about in Q1 in that business. As you sort of look out, are there other, you know, cost and expense reduction initiatives that you know, would anticipate throughout the remainder of the year? Thanks.

Speaker #11: I think you were talking about in Q1 in that business. As you sort of look out, are there other costs and expense reduction initiatives that you would anticipate throughout the remainder of the year?

Speaker #11: Thanks.

Speaker #8: Yeah, Elias mentioned the 4% headcount reduction that happened in the first quarter of this year. Unlike prior years where we had major cost-out initiatives that we executed against, a lot of this year is really turning into operating efficiencies.

Adam Logal: Yeah. Elias mentioned the 4% headcount reduction that happened in the Q1 of this year. We unlike prior years where we had, you know, major cost out initiatives that we executed again. A lot of this year is really turning into operating efficiency, ensuring that we've got the right, the right counts of people doing the right things. There's no significant cost out plan to achieve the results. It's continuing achieving the operating efficiency that we're targeting. I think the quarterly or sequential improvements will continue to show that.

Speaker #8: So, ensuring that we've got the right counts of people doing the right things. But there's no significant cost-out plan to achieve the results. It's continuing achieving the operating efficiency that we're targeting.

Speaker #8: And I think the quarterly or sequential improvements will continue to show that.

Speaker #11: Okay. All right. Great. Very good. Thank you.

Michael Petusky: Okay. All right. Great. Very good. Thank you.

Speaker #1: Thank you. This concludes our question and answer session. I would like to turn the conference back over to Dr. Frost for any closing remarks.

Operator 2: Thank you. This concludes our question and answer session. I would like to turn the conference back over to Dr. Frost for any closing remarks.

Operator: Thank you. This concludes our question and answer session. I would like to turn the conference back over to Dr. Frost for any closing remarks.

Speaker #9: I want to thank everybody for participating. And for the good questions that we've been trying to answer. We move forward to meeting with you again to discuss the results of the next quarter.

Phillip Frost: I want to thank everybody for participating and for the good questions that we've been able to answer. We look forward to meeting with you again to discuss the results of the next quarter. With that in mind, I wish you a good evening. Thank you.

Speaker #9: So wish you a good evening. Thank you.

Operator 2: Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect. Thank you.

Operator: Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect. Thank you.

Q1 2026 OPKO Health Inc Earnings Call

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