Opko Health (OPK) Q4 2024 Earnings Call Transcript

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Opko Health (NASDAQ: OPK)
Q4 2024 Earnings Call
Feb 27, 2025, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good day, and welcome to the OPKO Health fourth quarter 2024 financial results conference call. All participants will be in a listen-only mode. [Operator instructions] After today's presentation, there will be an opportunity to ask questions. [Operator instructions] Please note this event is being recorded.

I would now like to turn the conference over to Yvonne Briggs. Please go ahead.

Yvonne Briggs -- Investor Relations

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's financial results for the fourth quarter of 2024. I'd like to remind you that any statements made during this call by management other than statements of historical facts will be considered forward-looking and as such will be subject to risks and uncertainties that could materially affect the company's expected results.

These forward-looking statements include, without limitation, the various risks described in the company's SEC filings, including the soon-to-be filed Annual Report on Form 10-K for the year ended December 31, 2024, and in subsequently filed SEC reports. Furthermore, this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, February 27, 2025. 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. Before we begin, let me review the format for today's call.

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Dr. Phillip Frost, chairman and chief executive officer, will open the call. Dr. Elias Zerhouni, vice chairman and president, will then provide an overview of OPKO's Pharmaceuticals business and BioReference Health, as well as discuss progress with the ModeX pipeline.

After that, Adam Logal, OPKO's CFO, will review the company's fourth-quarter financial results and discuss this year's financial outlook. And then we'll open up the call for questions. Now, I'd like to turn the call over to Dr. Frost.

Phillip Frost -- Chairman and Chief Executive Officer

Good afternoon, and thank you for joining us today. 2024 was a transformative year for OPKO, and I'm confident about our prospects for the year ahead. ModeX made great strides to advance its pipeline as two programs entered Phase 1 clinical trials. We believe ModeX's proprietary technology platforms hold tremendous promise and we look forward to continued progress with its multispecific antibody technology and its nanoparticle vaccine platform.

Elias will provide more detail on the specific programs in a moment. Our product development pipeline also includes our once-weekly injectable dual-GLP-1 glucagon agonist, OPKO-88006, which continues to show encouraging clinical pharmacology data in diabetic and metabolic mice models. A promising orally bioavailable once-daily form has been an animal test by our partner Entera Bio. We expect both subcu and orally delivered forms to be IND-ready by the end of the year.

Pfizer continues to make progress on its global commercialization of NGENLA with sales presently growing in 42 countries. Elias and Adam will address in more detail. For Rayaldee, our partner in China, Nicoya, is anticipating a strong launch during 2025. From a financial point of view, we realigned our OPKO's capital structure to be in a strong position.

With the infusion of cash from various transactions, we are adequately funded to advance our pharmaceutical pipeline and to return capital to our shareholders through common stock and convertible note repurchases. We're executing our strategy and achieving significant milestones. As I mentioned last quarter, we are managing segments of our business to drive value for OPKO through additional partnerships, business development initiatives, and asset sales. We're confident that our current business prospects and strategy will continue to add value as we execute on this strategy.

We expect 2025 to be a year of progress in all aspects of our business and all a good year. With that overview, I'll turn the call over to Elias.

Elias Zerhouni -- Vice Chairman and President

Well, thank you, Phil, and good afternoon, everyone. As Phil mentioned, it was -- it has been a transformative year for OPKO. And starting with our Pharmaceuticals segment, last month, we announced that in collaboration with Merck, our Epstein-Barr Virus multivalent nanoparticle vaccine entered the clinic. And this investigational vaccine based on MDX-2201 is being evaluated with selected adjuvants for safety and tolerability in up to 200 healthy adults.

And so, with the start of this Phase 1 study going forward, Merck will assume all development activities of the EBV vaccine candidate through commercialization. For this development milestone, we achieved one of our milestone payments. And this is in addition to an upfront payment of $50 million we received upon the signing of the collaboration. We're also eligible for additional milestone payments of up to $860 million associated with progress in the development and commercialization of the EBV virus vaccine as well as royalties on global sales.

The Phase 1 trial with our tetraspecific antibody MDX-2001 continues to enroll patients at increasing doses. This open-label trial at four sites is expected to enroll 45 patients with a variety of solid tumors, including lung, breast, prostate, pancreatic, and others. The Phase 1 portion -- Phase 1a portion of this study is primarily designed to evaluate the safety and immunogenicity of ascending doses of MDX-2001 and to establish a biologically active dose in humans. The trial is progressing well with safety and tolerability data, hopefully, available in the second half of this year, and early efficacy data toward the later part of 2025 or early 2026.

This program utilizes a next-generation enhanced T-cell engager that stimulates dual signaling through CD3 and CD28. And this tetraspecific antibody engages T-cells through CD3, and to activate the T-cells, and promotes their extension -- expansion, and survival by binding to CD28, a very unique combination. The other two arms bind to two tumor antigens TROP2 and c-MET, both of which are validated targets found on a variety of solid tumors. We have two other immunology programs including MDX-2003, a tetraspecific antibody for hematology tumors and autoimmune diseases and this molecule is in the pre-IND stage, expected to enter the clinic late this year or early next year.

In addition, we're developing the immune modulator MDX-2004 to rejuvenate and strengthen the immune system in patients who are immune impaired or in patients who are aged by stimulating the proliferation of T-stem cells to rejuvenate and improve the immune function of these patients. And this program is also in the pre-IND stage, aiming for IND finalization and perhaps Phase 1 entry in the fourth quarter of this year. Now, switching gears to our antiviral programs. We were awarded $51 million of additional funding by BARDA including a $35 million supplement to accelerate our development of the COVID multispecific antibody and $16 million into our existing contract to develop broadly neutralizing influenza multispecific antibodies using our proprietary MSTAR antibody platform.

And to date, $110 million of non-dilutive funding have been committed by BARDA with a potential total of $205 million if all options and milestones are executed. So, if granted, this additional funding will be used to accelerate the COVID and flu programs to develop novel manufacturing methods, to target other biodefense threats as well as to develop a platform with gene-based delivery methods for use against future pandemics. Our lead anti-COVID multispecific antibody, MDX-2301 is progressing to IND and Phase 1 entry plan also for the fourth quarter of this year. So, we continue to be active on the business development front as we explore significant interest in our various platforms with external pharma collaborations, and we believe these partnerships will assist in advancing our pipeline in an accelerated and cost-efficient manner with the opportunity to further expand our programs.

And so, we're actively pursuing these conversations and interactions with hopefully some results to, in fact, further validate our platforms. As for our commercialized products, NGENLA is performing well with Pfizer's global commercialization ongoing. Pfizer's work involves converting existing patients from daily administration to our once-weekly drug and securing new patients for treatment with our pediatric long-acting growth hormone drug, and we continue to advance our additional pediatric and adult indications associated with up to $100 million in potential milestones. Within our long-acting biologics portfolio, we have several other molecules in development, including a GLP-2 for short bowel syndrome and as mentioned by Phil, a dual agonist GLP-1 glucagon, which is an analog of oxyntomodulin.

Now, GLP-1 agonists have been successful in treating diabetic and obese patients and several clinical-stage dual GLP-1 glucagon agonists have also reported efficacy in the treatment of non-alcoholic fatty liver disease with improvement in liver fibrosis score. In parallel, we have a collaboration underway with Entera Bio, as mentioned by Phil, to develop an oral formulation of this molecule using their N-Tab technology. In-vivo proof of concept studies in rodent and pig models have shown that a single oral dose resulted in a desirable pharmacokinetic profile and bioavailability. So, we're actively working to reach the IND stage as soon as possible for both the injectable and oral forms of oxyntomodulin analog that we have developed.

As discussed briefly in our last quarterly conference, let me cover BioReference Health for you. We completed the sale of BioReference Health lab testing businesses focused on clinical diagnostics and women's health nationwide but retain operations in New York and New Jersey as well as oncology and the corrections business nationwide. This was a significant part of the restructuring we are undertaking to improve BioReference's financial and operational performance, including reducing expenses along with headcount. We rightsized the workforce down to 2,000 from 3,300 previously.

We closed underperforming facilities and streamline operations. Our restructuring efforts are ongoing as we optimize our performance. In addition, we are focusing on our areas of strength, which include our specialty testing in oncology and urology as well our comprehensive clinical diagnostic services in New York and New Jersey. On a comparable basis, meaning excluding the assets acquired by Labcorp, overall testing volume grew by 1% in Q4 2024 as compared to Q4 2023.

Our National Oncology Testing segment had another favorable quarter, finalizing nine new hospital reference account contracts, including a large academic center in New York, and finishing the quarter with a 5% growth in net revenues compared to Q4 2023. Additionally, we continue to expand our oncology testing menu focusing on cancer genomics and hereditary cancers. As for our Urology segment, the 4Kscore continued to see strong performance, growing 16% in test volume and revenue for 2024 as compared to 2023. Furthermore, our Latin America and Europe pharmaceutical divisions continued to perform well with 9% growth compared to 2023 and a positive EBITDA trend despite forex headwinds due to the strong dollar.

The Rayaldee sales continue at same levels with new evidence published this year that show that the use of Rayaldee for patients with secondary hyperparathyroidism may delay the need for dialysis. So, in conclusion, overall, we are encouraged by the performance of our Biopharmaceutical and Diagnostic business segments and are confident in our prospects for positive results across these two segments this year. And with that, I'll turn the call over to Adam to discuss our financial results. Adam?

Adam E. Logal -- Senior Vice President, Chief Financial Officer

Thank you, Elias. The fourth quarter of 2024 reflects meaningful progress in enhancing shareholder value. The team at BioReference continue to reduce costs and improve operating efficiency, and we have a clear path toward profitability excluding non-cash and nonrecurring charges as well as positive cash flow in 2025. While the work at BioReference continues, the improved focus geographically and on high-value, high-margin testing resulted in a meaningful improvement in operating results, particularly after considering the nonrecurring expenses that help reduce fixed costs.

Our Global Health business within our Pharmaceutical segment continued to deliver revenue growth and operating income expansion, while our R&D pipeline continued to make progress, as Phil and Elias have discussed. We advanced our efforts during the fourth quarter to realize the value of our assets and exited one of our liquid investments, and redeployed some of that capital to buying back common stock and convertible notes. Turning to our operating results and starting with our Diagnostics segment. Revenue was $103.1 million for Q4 2024 compared to $124.2 million for the 2023 period.

This decrease was primarily the result of the Labcorp transaction, which closed in September. During the fourth quarter of 2024, costs and expenses totaled $124.8 million compared to $166.4 million for the comparable period of 2023. The Q4 2024 figure included approximately $4.5 million of nonrecurring costs and expenses for severance and facility closures, all incurred as expenses as expected as we realign our business to ensure sustainable growth and profitability. During the fourth quarter of 2024, operating loss was $21.7 million compared to an operating loss of $42.3 million for the 2023 quarter.

Depreciation and amortization expense for the Diagnostics segment was $6 million and $8.1 million for the 2024 and 2023 periods, respectively. Moving to our Pharmaceuticals segment. Revenue was $80.5 million for the fourth quarter of 2024 compared to $57.7 million for the comparable period of 2023. Revenue from products, including our international Pharmaceuticals businesses, was $37.4 million compared to $43 million for the 2023 period.

Despite the challenging foreign currency environment that has impacted revenue, the profitability of the business continues to improve above our expectations. Product revenue includes revenue from Rayaldee of $9.1 million, which was similar to 2023's $9.3 million. Revenue from the transfer of IP was $43.1 million for the fourth quarter of 2024 compared to $14.7 million for the same quarter of 2023. This number includes a $12.5 million milestone payment earned for the initiation of our EBV clinical trial and $10.2 million of commercial milestones for our EirGen business.

Our gross profit share from Pfizer was $9.5 million during the fourth compared -- quarter compared to $12.2 million for the 2023 period, which included a catch-up payment related to the Q3 '23 launch of NGENLA in the United States. In addition, the fourth quarter of 2024 includes $11 million in R&D funding related to our BARDA agreement compared to $1.2 million for the 2023 period. Costs and expenses for our Pharmaceuticals segment were $82.6 million for the fourth quarter of 2024 compared to $73.8 million for the 2023 period. Return, search, and development expenses were $29.8 million compared to $18.7 million a year ago.

R&D expense increased as a result of the activities for ModeX development activities, including the Phase 1 clinical trial for our first oncology program as well as our BARDA supportive activities. The resulting operating loss for the quarter ended December 31, 2024, was $2.1 million compared with an operating loss of $16.1 million for the 2023 quarter. Depreciation and amortization expense for the fourth quarter of 2024 increased slightly to $18.1 million from $17.9 million for the 2023 quarter. Turning to our consolidated financial results.

Net income for the fourth quarter of 2024 was $14 million or $0.01 per diluted share compared to a net loss of $66.5 million or $0.09 per share for the 2023 period. Net income for the fourth quarter of 2024 included a realized gain of $54.1 million from the sales of GeneDx as well as non-cash other income of $21.4 million compared to non-cash other expense of $3.2 million in the comparable quarter related to the change in fair value of the GeneDx shares. We ended 2024 with approximately $495 million in cash, cash equivalents, liquid investments, and restricted cash. We are allocating up to $100 million for common stock repurchases under our previously announced buyback program as well as opportunistic convertible note purchases.

We may accelerate or increase repurchases as market conditions change. In addition, we anticipate utilizing up to $100 million of cash in operations, included -- including our anticipated research and development priorities that Elias discussed. After considering capital expenditures of approximately $15 million, we expect to end 2025 with at least $300 million in cash and cash equivalents before any potential non-dilutive financing transactions or third-party collaborations. As we look ahead, we are keenly focused on delivering on the key objectives that Elias laid out, and the following assumptions influence our financial guidance.

For our Pharmaceutical segment, we expect Pfizer to continue to grow sales of NGENLA and realize the benefits of the expanded gross margins due to the scale-up of its manufacturing processes. We also assume a stable foreign currency exchange rate for our ex-U.S. pharmaceutical businesses. R&D expenses will reflect higher activities related to our ModeX programs, including CMC and efforts related to our ongoing oncology clinical trial as well as furthering the development of our oxyntomodulin analog development program.

A portion of the increased ModeX activities will continue to be funded through our BARDA agreements. For our Diagnostics segment, we are continuing our multi-year, multi-phase program to reach and improve profitability. This program is focused on operational efficiencies and the reduction of fixed infrastructure costs. We expect to incur an additional $4 million to $8 million in nonrecurring costs during the first quarter, which is primarily seventh in facility closure costs.

We have established gross margin threshold targets that had laid out last quarter for the business to be above 27% and expect positive cash flow for the full year 2025. We have established an additional cost reduction program targeting a further $20 million of annualized cost savings throughout 2025. In addition, we expect to further rationalize our test offerings and client mix during the first half of 2025, which will allow us to further focus BioReference and realize a profitable and growing business. As a result, we expect the following for the full year 2025.

Total revenues between $675 million and $700 million, including revenue from services of $405 million to $425 million, revenue from products between $165 million and $175 million, and other revenue between $80 million and $95 million, inclusive of the Pfizer gross profit share estimate between $35 million and $45 million and BARDA revenue of $40 million to $48 million. We expect costs and expenses to be between $825 million and $875 million, excluding the nonrecurring expenses related to our restructuring of BioReference. R&D expense is expected to be between $120 million and $140 million depending on the enrollment rate of our clinical trial and the timing for certain CMC activities for our ModeX programs with $40 million to $48 million of that being offset by BARDA. We also expect depreciation and amortization expense to be approximately $90 million.

This concludes our prepared remarks. Thank you all for your attention. And now, operator, let's open the call for questions.

Questions & Answers:

Operator

We will now begin the question-and-answer session. [Operator instructions] The first question comes from Maury Raycroft from Jefferies. Please go ahead.

Maury Raycroft -- Analyst

Hi. Thanks for taking my questions. I'll just start with BioReference. Just wondering if you can bookend timelines, provide any more granularity on the quarter you anticipate that you could reach profitability, and maybe talk a little bit more about how you're currently thinking about balancing spend while you continue to expand your testing menu for oncology?

Phillip Frost -- Chairman and Chief Executive Officer

Adam, do you want to take that?

Adam E. Logal -- Senior Vice President, Chief Financial Officer

Sure. So, Maury, I think we're -- we talked about the fourth quarter results showing meaningful improvement. When you think about this quarter -- the third quarter of the year, we were at about a $20 million EBITDA loss. Q4 cut that in a little bit more than in half.

So, we see a pretty good guide path into the first quarter to achieve breakeven during the quarter and then profitability thereafter. So, I think that's the best glide path for timing. We're going to have a few charges in the first quarter while we finish up that restructuring that we initiated last year, but see a pretty good pace to achieving that. And all signs say we'll get there.

As far as the spend, we're not -- there's not significant investment being made into the test menu. The team is doing a good job of being efficient in bringing up those new modalities that Elias laid out. And I think there's not a significant push there to spend dollars.

Maury Raycroft -- Analyst

Got it. OK. That's helpful. And for EBV, you mentioned the $12.5 million milestone for Merck.

Can you say what the Phase 2 milestone could look like if Merck decides to advance the program? And then, can you clarify if Merck would do a press release on a data update from this program and what timing could look like for that?

Phillip Frost -- Chairman and Chief Executive Officer

I can take that. So, timing-wise, Maury -- it's a study for 200 patients, right? And so -- I cannot speak for Merck, obviously, but estimates would be -- results will be in because you can recruit quite quickly with these trials, so maybe second quarter. And then the analysis will go through and then the decision will be to go not to Phase 2, which will probably be taken in the third quarter. And so, that does trigger a significant milestone.

I don't know if you can give the number right now, we have to ask Merck, but -- or Adam, if you know. And at that point, obviously, there will be -- obviously, an announcement of progression of the portfolio toward Phase 2, I mean the program.

Adam E. Logal -- Senior Vice President, Chief Financial Officer

Yeah. We're not able to disclose the milestones under our agreement until they're earned.

Maury Raycroft -- Analyst

Got it. OK. Well, thank you for taking my questions. I'll hop back in the queue.

Operator

The next question comes from Jeffrey Cohen from Ladenburg Thalmann. Please go ahead.

Jeffrey Cohen -- Analyst

Hello, and thank you for taking our questions. I wonder if you could first elaborate on some of the initial comments from Dr. Frost on the dual agonist with Entera Bio. Could you tell us a little bit more as far as what's being studied during this period? Is it oral or injectable? And is it weekly or daily? And are you aiming to go after Type 1 diabetics? Is that the intention?

Elias Zerhouni -- Vice Chairman and President

So, I'll start, and then Dr. Frost might complete my answers because, what we've done is, the dual agonist there are two forms. There's an injectable form and through our partner an oral form, we're pursuing both. And the injectable rate is about once a week.

It's a weekly injection. The Oral is a daily regimen, if you will. So, those are the two parameters, if you will, from the clinical point of view. Now, in terms of the physiology of a GLP-1/glucagon, there are a few like that already in the market in development, which have shown that when you add glucagon, you actually increase metabolism, which has some -- potentially very beneficial effects for patients with diabetics, obese and who may have also liver fat or what we call fatty liver disease or NASH or MASH.

So, those are the specific population is where this analog of oxyntomodulin that we have developed can actually get applied. We're still in the pre-IND phase, and the only thing I can say is, and I'll let Dr. Frost speak to it, is that the results are quite, let's say, promising. And I don't know, Phil, if you want to add to what I'm saying.

Phillip Frost -- Chairman and Chief Executive Officer

No, I think you've covered it.

Jeffrey Cohen -- Analyst

OK. Got it. That's helpful. And then secondly, could you talk a little bit about the launch of Rayaldee in China with Nicoya? How large of the commercial organization are they anticipating? And what do we expect to hear out of the launch through 2025?

Phillip Frost -- Chairman and Chief Executive Officer

Yeah. So, the size of the commercial team, I don't have the particular details on -- from Nicoya. We would expect the initial launch to be fairly small that will -- as they begin some sales out of one of the small -- smaller territories of China. But throughout the year, once they achieve formal NDA approval, they'll go into a broader launch phase.

It's a rough milestone and royalty-driven transaction for us. So, we'll report those out in due course.

Jeffrey Cohen -- Analyst

OK. Got it. And then lastly for us, you did mention the $26.9 million from BARDA followed by the $24.1 million and indicated potential of $110 million. Could you give us an indication of what time period that might be?

Phillip Frost -- Chairman and Chief Executive Officer

Sure. I can try. I can -- yeah, go ahead, Adam. Go ahead.

Adam E. Logal -- Senior Vice President, Chief Financial Officer

Yeah. I was just going to say the dollars that we're expecting in 2025 is between $40 million and $48 million. Phil, if you could talk about some of the activities by all means?

Phillip Frost -- Chairman and Chief Executive Officer

Yeah. So, Jeff, if you recall, we received $59 million for COVID development and then we received an additional $35 million. And that is the COVID program at this time. And so, $59 million plus $35 million is $84 million and so that program is going to basically last the next two years, a year and a half, depending on how well we can recruit.

The goal this year is to bring the first molecule to the clinic toward Q3, Q4 of this year and enter the clinic with that as soon as we can because it seems like it's really important to show that there is safety in these antibodies for patients. So, we expect to have significant milestones passed this year. In the case where the milestones are passed and positive, like what BARDA has asked us to actually innovate in terms of manufacturing, which we have done, and they are quite positive on that. And if we can prove that we can produce at a much-reduced cost, if you will, and then we'll have an extension of our program.

On the other hand, we are also working on flu and we received $16 million as a contract -- a firm contract on flu. And if we can meet the milestones not only for Flu A and Flu B but also pandemic flu, then that would be also increased. The total envelope, a budgetary envelope for this program with BARDA is about $205 million, of which $110 million essentially have been committed, and about the rest $95 million will be committed subject to milestones.

Jeffrey Cohen -- Analyst

Perfect. Thanks for the clarification.

Phillip Frost -- Chairman and Chief Executive Officer

Next two years, next two and a half years, three years. Depends on how the milestones are met.

Jeffrey Cohen -- Analyst

Got it. Thanks for the clarification. Thank you for taking our questions.

Operator

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

Edward Tenthoff -- Analyst

Great. Thanks. And if I may, just a quick housekeeping question. Adam, can you please repeat the product sales guidance you mentioned? And then I have a follow-up question.

Adam E. Logal -- Senior Vice President, Chief Financial Officer

Sure. The product sales were $165 million to $175 million.

Edward Tenthoff -- Analyst

$165 million and $175 million. Great. Thank you. And then when it comes to ModeX data this year with respect to the Cancer program, what should we be expecting in terms of data this year? And what's the latest with respect to the hematologic cancer program? Thank you.

Elias Zerhouni -- Vice Chairman and President

So, in terms of the ModeX data, it's related to what we call MDX-2001, which is a multispecific antibody that has a target called TROP2 and a target called c-MET, which attaches to solid tumors, and then the CD3, CD28, which has a dual action activation and expansion of T-cells that can kill the tumor. This one is in the clinic already, and we're going to what we call the dose escalation. The primary purpose of that is to evaluate safety and tolerability of the molecule. We will get those results probably within this year toward the fourth quarter.

And then you really want to see signals of efficacy, but you don't get those until you really reach what we call therapeutic -- safe therapeutic doses, which will occur, and maybe we'll be lucky to have some this year, but primarily will occur in 2026, probably the first half of 2026. In terms of the CD19, CD20, which is what you're referring to, it is essentially going in the pre-IND phase of development right now. CMC is being finalized. Files are being put together to go to the FDA toward the end of the year.

So, there will be no data -- there will be no data on that one until next year.

Edward Tenthoff -- Analyst

Yeah. Have you disclosed what the targets are for the hematologic?

Elias Zerhouni -- Vice Chairman and President

CD19, CD20. It's a dual. Yeah.

Edward Tenthoff -- Analyst

Yeah, nice detail. Are you considering that for autoimmune disease as well or --

Elias Zerhouni -- Vice Chairman and President

No, that's a good question. And I can tell you're on top of your toes, the subject, and yes, the answer is yes.

Edward Tenthoff -- Analyst

Thanks, guys.

Operator

The next question comes from Yale Jen from Laidlaw and Company. Please go ahead.

Yale Jen -- Analyst

Great. And thanks for taking the questions. Just a general sort of macro question, which is that with the recent government changes, do you guys worry about the vaccine -- so the prospect of the vaccine as well as maybe the other funding in the future, or that's probably not necessarily a concern?

Elias Zerhouni -- Vice Chairman and President

Yeah, that's a great question. And we don't know. So, far -- I mean, basically remember, we're -- if you're talking about the EBV vaccine, I mean, so far we haven't heard anything from our partner that would justify not progressing a major vaccine like this, which has a tremendous benefit to patients, especially that it relates to preventing not only mononucleosis but cancer, secondary cancers and maybe, maybe multiple sclerosis. So, that I don't think will be affected in terms of a clinical trial.

Now, you hear the things about vaccines in Washington and the potential controversy there. And so, some people feel maybe that there will be less support for early development of new vaccines. We're not in that field. We're in the antibody field.

We're in multispecifics. And we keep very close contact with our contracting officers. And so, far, we haven't had any indication given the importance of being prepared for pandemics and residual endemic phenomena like COVID returning every year now and flu that, in fact, there's still continuing interest in supporting this kind of progress of programs that we are leaders in. Let me just say, I don't have a crystal ball about what's happening in Washington right now.

So, we'll have to wait and see. But right now, no indication of -- no, we are not worried so far, let's say.

Yale Jen -- Analyst

That sounds good. And none of us have that as well. And thanks a lot. Appreciate it, and best of luck to you, guys.

Elias Zerhouni -- Vice Chairman and President

Thank you.

Operator

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

Unknown speaker -- H.C. Wainwright -- Analyst

This is Eduardo on for Yi. I guess related to that question about the impact of the Trump administration and government, specifically for the BARDA-sponsored programs, if anything were to happen, does current funding kind of, is it sufficient to progress the current kind of clinical trial that you want to conduct in 2025? Are you guys really counting on that $40 million to $48 million?

Phillip Frost -- Chairman and Chief Executive Officer

No, I mean, the money that has been committed to date with extra -- the supplemental $35 million can carry us through to developing a lead molecule and all the way through Phase 1 and at the edge of Phase 2. We could also within that, depending on how things go, develop a backup molecule, but not carried through Phase 1, OK? And the plan that BARDA has proposed to us and funded is that we would do the full development all the way through Phase 1 and the beginning of Phase 2, at which point they may be interested in continuing it or they will say, great, you continue on your own or get a partner to continue it, depending on the results that you get. So, at this point, I feel pretty secure that the $110 million that we have received from them are pretty safe and committed and can carry us through to an inflection point here. Now, the second part, the one that is not committed, I have no guess and no indication of that being taken away or continued, I don't know.

Unknown speaker -- H.C. Wainwright -- Analyst

Got it. That's really helpful. Good to know. And also, any update on the HIV monoclonal, or has focus kind of shifted more toward EBV, COVID, and flu because that's where the kind of incentives are right now?

Phillip Frost -- Chairman and Chief Executive Officer

Yeah. I'll let -- Gary Nabel is on the line, and he is the lead on that. So, I'll let Gary respond to you.

Gary Nabel -- Co-Founder, President and Chief Executive Officer, ModeX Therapeutics

Thank you, Elias. Yeah, and thank you for the question. The short answer is, we have made good progress with that molecule. As you know, we had a first-generation HIV that went into multispecific antibody, that went into clinical trials and it was well-tolerated, low immunogenicity, and good half-life.

We've now made a second generation that has been optimized for potency. So, it's about ten-fold more potent than the first-generation, and it takes advantage of our proprietary MSTAR format. So, we're basically at the point where we have a -- we're about to declare a lead candidate. We have one that would be able to move forward, and we are in discussions with various partners about how to advance that program.

But the molecule itself looks good, and we've been able to leverage our experience from the BARDA programs, both in terms of the CMC and the yields and the scalability. So, we are optimistic about that molecule.

Unknown speaker -- H.C. Wainwright -- Analyst

OK, great. That's encouraging. And then one final one regarding MDX-2001, your tetravalent antibody in the solid tumor trial. I'm curious, you guys are selecting -- obviously, it's kind of a basket trial, it seems with the different indications.

What specific cutoff -- I know you guys are selecting for elevated expression of c-MET and TROP2. I'm curious what fraction of patients within -- I guess it's variable with each of the indications, but roughly meet that criteria for recruitment.

Phillip Frost -- Chairman and Chief Executive Officer

It's a large proportion. TROP2 and c-MET are quite widely distributed in multiple kind of tumors at very significant levels of expression. So, it doesn't seem to be a limiting factor, and we haven't even used actually a selection criterion based on biomarkers because it's very high -- a very high percentage of tumors. At least the tumors we picked have demonstrated a high level of c-MET, TROP2 expression, lung tumors, gastric tumors, breast cancer.

The most common solid tumors are really -- and we can provide you with more data if you want offline on the -- because we know what that is. But Gary, you want to add something to that question?

Gary Nabel -- Co-Founder, President and Chief Executive Officer, ModeX Therapeutics

Yeah, I can add a little bit. We have looked at the relative expressions, and I would say that we've debated using like a 45% cutoff for surface expression. And with that 45% expression, you pick up a vast majority of the tumors that -- of those types. As you know, there's close to 13 different solid tumors that have both c-MET and TROP2.

But that might be -- as Elias is implying, that might be maybe overly conservative because when we look at cells that have low expression, even 10% of the maximum levels that we see, you still get killing even when you have 10% expression. So, I think our presumption is that it should work against the vast majority, and it's likely in the trials that will take all comers. And then, once we look at the efficacy data, we'll be able to sort out what the threshold might be for efficacious responses.

Unknown speaker -- H.C. Wainwright -- Analyst

Got it. So, you are measuring expression levels, but you're not excluding based on those biomarkers, right?

Adam E. Logal -- Senior Vice President, Chief Financial Officer

Correct. Yeah. Go ahead, Gary.

Gary Nabel -- Co-Founder, President and Chief Executive Officer, ModeX Therapeutics

No, that's exactly right. At the moment, we're taking all comers.

Unknown speaker -- H.C. Wainwright -- Analyst

OK, that's really helpful. Thanks. Those are all my questions.

Operator

This concludes our question-and-answer session. I would like to turn the conference back over to Dr. Frost for closing remarks.

Phillip Frost -- Chairman and Chief Executive Officer

I want to thank you all for your participation and for your good questions. We look forward to meeting with you again next time.

Operator

[Operator signoff]

Duration: 0 minutes

Call participants:

Yvonne Briggs -- Investor Relations

Phillip Frost -- Chairman and Chief Executive Officer

Elias Zerhouni -- Vice Chairman and President

Adam E. Logal -- Senior Vice President, Chief Financial Officer

Maury Raycroft -- Analyst

Adam Logal -- Senior Vice President, Chief Financial Officer

Jeffrey Cohen -- Analyst

Edward Tenthoff -- Analyst

Yale Jen -- Analyst

Unknown speaker -- H.C. Wainwright -- Analyst

Gary Nabel -- Co-Founder, President and Chief Executive Officer, ModeX Therapeutics

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