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OPKO Health is shifting toward therapeutics by integrating ModeX Therapeutics and advancing programs in obesity, growth hormone disorders, targeted CAR-T, oncology and immunology, while streamlining its BioReference diagnostics business.

The company expects a data-rich 12 to 18 months, with potential catalysts including clinical updates for ModeX candidates, Merck's Epstein-Barr virus vaccine, and a BARDA-funded COVID antibody program.

OPKO has approximately $400 million to $450 million in cash, $125 million from monetizing a China GLP-1 royalty, and additional partner funding; it is also pursuing R&D investment and shareholder returns through a $200 million buyback authorization.

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OPKO Health (NASDAQ:OPK) outlined a strategy to shift its business mix toward therapeutics while continuing to streamline its diagnostics operations, with management highlighting a pipeline of early-stage clinical programs, external collaborations and capital available to fund development.

Speaking at the Wells Fargo Healthcare Conference, President and Vice Chairman Elias Zerhouni said the company is seeking to become "more of a therapeutics company, less of a diagnostics company." The transition includes the integration of ModeX Therapeutics, which OPKO acquired in 2022, as well as restructuring actions within its BioReference laboratory business.

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Zerhouni, a ModeX co-founder, described the company's technology as a platform for designing high-order multispecific molecules, including therapies with four or more targeting components. He said ModeX currently has five molecules in clinical development and is pursuing applications in solid tumors, hematology, immunology and vaccines.

Among the company's internal programs, OPKO is advancing:

OPK-88006, a GLP-1/glucagon candidate in Phase I development for obesity and metabolic dysfunction-associated steatohepatitis, or MASH. Zerhouni said the company is conducting dose escalation and plans a Phase Ib assessment, with development dependent on safety, immunogenicity and evidence of differentiation from competing approaches.

OPK-8801001, an anti-growth hormone product being developed for patients with excess growth hormone production. The company said it is at the investigational new drug stage and expects to enter clinical trials in the following month.

A targeted in vivo CAR-T program, for which the company is completing chemistry, manufacturing and controls work. Zerhouni said a first clinical trial is expected at the end of the year or early next year.

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Zerhouni said the targeted CAR-T approach uses the company's multispecific technology to target selected cells and activate immune cells. He said OPKO has completed preclinical work and non-human primate studies for the program.

The company also discussed several ModeX oncology and immunology candidates. MDX-2001, a T-cell engager for solid tumors, has completed or nearly completed dose escalation, according to Zerhouni. He said OPKO plans to concentrate further study on two or three tumor types that appeared to respond better in its Phase I trial, with potential results expected early next year.

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MDX-2003, a program for liquid tumors, is in Phase I and may have potential in cancer and autoimmune disease based on B-cell depletion, Zerhouni said. MDX-2004, described by management as an "immune rejuvenator," is also generating human data.

Management highlighted partnerships with Merck and Regeneron. Zerhouni said Merck is overseeing further development of a multivalent Epstein-Barr virus vaccine developed using ModeX technology. The vaccine is intended to target four viral antigens to reduce viral entry into B cells and epithelial cells.

According to Zerhouni, Merck has completed enrollment or work involving approximately 200 to 300 patients and is evaluating data across age groups while determining next steps. OPKO expects Merck to make a decision on how to proceed in the near term, he said.

The company also has a broad collaboration with Regeneron spanning metabolism, oncology and immunology. Zerhouni said the collaboration could ultimately involve approximately five products if development efforts are successful. He added that OPKO expects to pursue additional partnerships because it does not intend to independently fund every program through later stages.

Separately, Zerhouni said OPKO recently completed a Phase I study of a four-target COVID antibody funded by the U.S. government through BARDA. The company is working to demonstrate subcutaneous administration and continuous-flow manufacturing, he said.

Chief Financial Officer Adam Logal said BioReference Health has been restructured to focus more heavily on the New York and New Jersey clinical laboratory market, while retaining a national presence through a urology sales force promoting the company's 4Kscore test for aggressive prostate cancer.

Logal said OPKO has divested parts of the diagnostics business and is working toward BioReference reaching breakeven during the year. He said the company does not plan significant new capital investment in the unit, but expects it to preserve and potentially increase its value as it generates returns.

On financing, Logal said OPKO received $125 million in exchange for its 3% royalty on a GLP-1 compound commercialized in China by Innovent. He said the upfront payment represented roughly 10 years of royalties at the current run rate, while OPKO retained future upside after the royalty obligation is paid off.

Zerhouni said proceeds from asset sales and other activities had left the company with approximately $400 million to $450 million in cash. Management also cited non-dilutive funding from Merck, BARDA and Regeneron.

Logal said OPKO's capital allocation approach includes both investment in research and development and shareholder returns. The company has authorized a $200 million stock-repurchase program and has repurchased about $110 million under that authorization, leaving approximately $90 million available. He added that OPKO has deployed about $250 million over several years toward convertible debt repurchases and share repurchases.

Management characterized the coming 12 to 18 months as data-rich, with key potential catalysts including the EBV vaccine data, the COVID antibody program, and clinical updates across the ModeX oncology and immunology portfolio.

OPKO Health, Inc (NASDAQ:OPK) is a diversified, global healthcare company headquartered in Miami, Florida, with a focus on diagnostics, pharmaceuticals and biologics development. The company operates two main business segments—Laboratory Services and Pharma Services & Products—driven by its mission to advance patient care through innovation in testing and targeted therapies.

In its Laboratory Services segment, OPKO leverages BioReference Laboratories, one of the largest full-service commercial labs in the United States.

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The article "OPKO Health Pivots to Therapeutics, Eyes Data-Rich 12 to 18 Months" was originally published by MarketBeat.

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