OPK

EX-99.1

2 opk-ex99_1.htm

EX-99.1

EX-99.1

OPKO Health Reports First Quarter 2026 Business Highlights and Financial Results

Conference call begins at 4:30 p.m. Eastern time today

MIAMI, April 28, 2026 – OPKO Health, Inc. (NASDAQ: OPK) (OPKO) reports business highlights and financial results for the three months ended March 31, 2026.

Highlights from the first quarter of 2026 and recent weeks included the following:

• Initiated and completed first dose cohort of MDX2301 Phase 1 clinical trial for the prevention of COVID-19.MDX2301 is a tetravalent bispecific antibody that neutralizes all known variants of SARS-CoV-2 and also has the potential to delay resistance by emerging variants. The Phase 1 clinical trial (NCT07445971) is evaluating the safety, pharmacokinetics and tolerability of MDX2301 administered via different routes in healthy volunteers and in immune impaired adults at high risk for severe COVID-19. By combining multiple antibody binding domains in a single molecule, MDX2301 is designed to provide high potency and greater breadth compared with conventional monoclonal antibodies. This trial is being funded by the Biomedical Advanced Research and Development Authority (BARDA).

• Initiated MDX2003 Phase 1 clinical trial in relapsed or refractory B-cell lymphoma. MDX2003 (CD19xCD20xCD3xCD28) is a novel tetraspecific T-cell engager-expander designed to optimize sustained T-cell function and address the two most common and validated targets in lymphomas and leukemias. The MDX2003 Phase 1 study (NCT07249905) is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of MDX2003 in adults with various types of B-cell lymphoma. The study includes dose-escalation and dose-expansion phases. B-cell lymphoma, a form of non-Hodgkin lymphoma arising from B lymphocytes, represents the most common lymphoma subtype, accounting for approximately 85% of cases.

• ModeX to present data on multispecific antibody targeted in vivo CAR T cell programs at the American Society of Gene + Cell Therapy (ASGCT) Annual Meeting with plans to enter Phase 1 studies later this year. Built on its multispecific technology, ModeX recently developed an in vivo CAR‑T and gene delivery platform that it believes is highly differentiated compared with ex vivo and other in vivo CAR‑T approaches. Using antibody‑targeted lipid nanoparticles, this platform can deliver genes encoding chimeric antigen receptors (CARs) directly to specific immune cell subsets that generate functional CAR‑T cells in vivo.

• Presented two posters highlighting MDX2003 and MDX2004 at the ESMO Targeted Anticancer Therapies Congress 2026. In March, an abstract titled “MDX2003, a First-in-Class CD19xCD20xCD3xCD28 Tetraspecific T-Cell Engager with Potent Preclinical Activity against B Cell Malignancies and Promise in Autoimmunity” was presented at the European Society for Medical

Oncology’s (ESMO) Targeted Anticancer Therapies Congress 2026 in Paris. An abstract titled “A phase 1/2a, multicenter, first-in-human, open-label clinical trial evaluating monotherapy with MDX2004, a trispecific antibody-fusion protein in patients with advanced tumors” was also presented at the Congress.

• Expanded partnership with Entera Bio to advance first-in-class oral long-acting PTH tablet for patients with hypoparathyroidism. This third program under the collaboration combines OPKO's proprietary long-acting PTH variants with Entera's proprietary N-Tab® technology. Following favorable pharmacodynamic and pharmacokinetic data reported in December 2025, the companies have jointly decided to accelerate development and expect to file an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) in late 2026. OPKO and Entera Bio each hold a 50% ownership interest in the long-acting PTH hypoparathyroidism program and each is responsible for 50% of the program's development costs.

First Quarter Financial Results

• Consolidated: Consolidated total revenues for the first quarter of 2026 were $124.2 million compared with $149.9 million for the 2025 period, with the decrease principally resulting from the sale of certain BioReference assets in 2025. Operating loss for the first quarter of 2026 improved to $51.0 million compared with operating loss of $67.2 million for the 2025 quarter. Net loss for the first quarter of 2026 was $54.8 million, or $0.07 per share, compared with net loss of $67.6 million, or $0.10 per share, for the 2025 quarter. The prior year results included a $3.9 million realized gain from the sale of shares of GeneDx Holdings Corp.

• Pharmaceuticals: Revenue from products in the first quarter of 2026 was $38.0 million compared with $34.8 million in the first quarter of 2025, driven by higher sales volumes from OPKO’s Spanish operations and by a positive net foreign exchange impact of $2.4 million. Revenue from Rayaldee remained consistent at $6.3 million in the first quarter of both 2026 and 202

8-K

false000094480900009448092026-02-262026-02-26

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 26, 2026

OPKO Health, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware

001-33528

75-2402409

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

4400 Biscayne Blvd.

Miami, Florida

33137

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: 305 575-4100

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock

OPK

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition. On February 26, 2026, OPKO Health, Inc. (the “Company”) issued a press release announcing operating and financial highlights for the quarter and year ended December 31, 2025. The press release also contains information on how to access the conference call the Company is hosting to discuss its financial and operating results for the fourth quarter and year ended December 31, 2025, as well as provide business updates and financial guidance. A copy of the press release is attached hereto as Exhibit 99.1.

The information included herein and in Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 as amended or the Exchange Act, except as expressly set forth by specific reference in such a filing. Item 9.01 Financial Statements and Exhibits.

(d)

Exhibits

Exhibit No.

Description

99.1

Press Release of the Company dated February 26, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

OPKO Health, Inc.

By:

/s/ Adam Logal

Date: February 26, 2026

Name:

Adam Logal

Title:

Senior Vice President, Chief Financial Officer

8-K

false000094480900009448092025-10-292025-10-29

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 29, 2025

OPKO Health, Inc. (Exact name of Registrant as Specified in Its Charter)

Delaware

001-33528

75-2402409

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

4400 Biscayne Blvd.

Miami, Florida

33137

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: 305 575-4100

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock

OPK

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition. On October 29, 2025, OPKO Health, Inc. (the “Company”) issued a press release announcing operating and financial highlights for the quarter ended September 30, 2025. The press release also contains information on how to access the conference call the Company is hosting to provide a business update and discuss its financial and operating results for the third quarter ended September 30, 2025, as well as provide financial guidance. A copy of the press release is attached hereto as Exhibit 99.1.

The information included herein and in Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 as amended or the Exchange Act, except as expressly set forth by specific reference in such a filing. Item 9.01 Financial Statements and Exhibits.

(d)

Exhibits

Exhibit No.

Description

99.1

Press Release of the Company dated October 29, 2025

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

OPKO Health, Inc.

By:

/s/ Adam Logal

Date: October 29, 2025

Name:

Adam Logal

Title:

Senior Vice President, Chief Financial Officer