OPK

It has been about a month since the last earnings report for OPKO Health (OPK). Shares have lost about 9.7% in that time frame, underperforming the S&P 500. Will the recent negative trend continue leading up to its next earnings release, or is OPKO Health due for a breakout? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the latest earnings report in order to get a better handle on the important drivers. OPKO Health Q2 Earnings & Revenues Beat Estimates OPKO Health, Inc. reported a second-quarter 2026 loss of 1 cent per share, narrower than the year-ago quarter's loss of 19 cents. The figure beat the Zacks Consensus Estimate of a loss of 8 cents by 87.5%. Revenues rose 4.3% year over year to $163.6 million, driven by strong growth in the Pharmaceuticals segment. The top line also surpassed the Zacks Consensus Estimate by 24.7%. The better-than-expected performance reflected higher pharmaceutical revenues, including income related to the amended Nicoya licensing agreement, partially offset by lower Diagnostics revenues following last year's oncology asset divestiture. Q2 Segment Details Total pharmaceutical revenues increased 59.8% year over year to $89 million. The upside was primarily driven by higher product sales and a significant increase in revenues from intellectual property transfers and other sources. Diagnostics service revenues declined 26.3% year over year to $74.5 million. The comparison was affected by the sale of OPK's oncology assets to Labcorp in September 2025, which contributed $24.9 million to revenues in the prior-year quarter. Excluding the divested oncology business, core diagnostics revenues declined modestly to $68.2 million from $69.3 million a year ago. Revenues from the 4Kscore prostate cancer test fell to $6.3 million from $6.9 million. Management attributed the decline primarily to changes in test mix following the transfer of certain lower-margin esoteric tests to strategic partners. OPK’s Product Sales Improve Product revenues increased 5.4% year over year to $42.9 million. Growth was supported by higher sales volumes in the company's Spanish and Mexican operations, along with a favorable foreign exchange impact of $1.8 million. These gains were partially offset by approximately $1.7 million of lower revenues across other international markets. RAYALDEE revenues increased to $8.1 million from $7.2 million in the prior-year quarter, mainly driven by favorable gross-to-net adjustments. Management stated that international pharmaceutical operations continued to perform well, while RAYALDEE sales remained ahead of internal expectations. OPK’s Margin Expands as Costs Decline For the second quarter, gross profit increased to $80 million from $49.4 million a year ago, while gross margin expanded to 48.9% from 31.5%. The improvement reflected lower service costs following the Diagnostics asset sale and a higher contribution from intellectual property and other revenues, including income tied to the amended Nicoya agreement. Total costs and expenses declined 21.3% year over year to $170.6 million. Cost of service revenues fell 29% year over year to $58.5 million, while selling, general and administrative expenses declined 11.2% to $52.9 million. Research and development expenses increased 9.3% year over year to $33.2 million, reflecting continued investment in early-stage clinical programs. Consolidated operating loss narrowed to $7 million from $60 million, aided by higher pharmaceutical revenues, lower Diagnostics costs and an $18.1 million Labcorp earnout gain. The Diagnostics segment posted an operating income of $4.8 million against an operating loss of $18.2 million a year ago. Cash Position OPKO Health exited the second quarter with cash, cash equivalents, marketable securities and restricted cash of $314.4 million compared with $341.9 million at the first-quarter end. During the quarter, the company repurchased $13.2 million worth of common stock. As of June 30, 2026, cumulative share repurchases under the existing authorization totaled approximately $105.3 million, with $94.7 million still available for future buybacks. Cumulative net cash used in operating activities at the end of second-quarter 2026 was $62.8 million compared with $117.9 million a year ago. OPK’s Q3 & FY26 Guidance For the third quarter of 2026, OPKO Health expects total revenues in the range of $131-$142 million. The outlook includes service revenues of $73-$78 million, product revenues of $40-$44 million and intellectual property and other revenues of $16-$20 million. Management raised its full-year 2026 revenue guidance to $560-$585 million from the previous range of $530-$560 million. The company lowered its full-year cost and expense outlook to $710-$740 million from the earlier projection of $725-$750 million. Expected research and development spending remains unchanged at $125-$135 million. In the past month, investors have witnessed a upward trend in estimates revision. The consensus estimate has shifted 21.62% due to these changes. Currently, OPKO Health has a average Growth Score of C, however its Momentum Score is doing a bit better with a B. However, the stock was allocated a score of F on the value side, putting it in the bottom 20% quintile for this investment strategy. Overall, the stock has an aggregate VGM Score of D. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending upward for the stock, and the magnitude of these revisions looks promising. Notably, OPKO Health has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. OPKO Health is part of the Zacks Medical - Instruments industry. Over the past month, Intuitive Surgical, Inc. (ISRG), a stock from the same industry, has gained 2.8%. The company reported its results for the quarter ended June 2026 more than a month ago. Intuitive Surgical reported revenues of $2.89 billion in the last reported quarter, representing a year-over-year change of +18.5%. EPS of $2.80 for the same period compares with $2.19 a year ago. Intuitive Surgical is expected to post earnings of $2.61 per share for the current quarter, representing a year-over-year change of +8.8%. Over the last 30 days, the Zacks Consensus Estimate remained unchanged. The overall direction and magnitude of estimate revisions translate into a Zacks Rank #3 (Hold) for Intuitive Surgical. Also, the stock has a VGM Score of C. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report OPKO Health, Inc. (OPK) : Free Stock Analysis Report Intuitive Surgical, Inc. (ISRG) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

OPKO Health, Inc. OPK reported a second-quarter 2026 loss of 1 cent per share, narrower than the year-ago quarter's loss of 19 cents. The figure beat the Zacks Consensus Estimate of a loss of 8 cents by 87.5%. Revenues rose 4.3% year over year to $163.5 million, driven by strong growth in the Pharmaceuticals segment. The top line also surpassed the Zacks Consensus Estimate by 24.7%. The better-than-expected performance reflected higher pharmaceutical revenues, including income related to the amended Nicoya licensing agreement, partially offset by lower Diagnostics revenues following last year's oncology asset divestiture. OPK shares gained 11.3% in today’s pre-market session. Total pharmaceutical revenues increased 59.8% year over year to $89 million. The upside was primarily driven by higher product sales and a significant increase in revenues from intellectual property transfers and other sources. Diagnostics service revenues declined 26.3% year over year to $74.5 million. The comparison was affected by the sale of OPKO's oncology assets to Labcorp in September 2025, which contributed $24.9 million to revenues in the prior-year quarter. Excluding the divested oncology business, core diagnostics revenues declined modestly to $68.2 million from $69.3 million a year ago. Revenues from the 4Kscore prostate cancer test fell to $6.3 million from $6.9 million. Management attributed the decline primarily to changes in test mix following the transfer of certain lower-margin esoteric tests to strategic partners. Product revenues increased 5.4% year over year to $42.9 million. Growth was supported by higher sales volumes in the company's Spanish and Mexican operations, along with a favorable foreign exchange impact of $1.8 million. These gains were partially offset by approximately $1.7 million of lower revenues across other international markets. RAYALDEE revenues increased to $8.1 million from $7.2 million in the prior-year quarter, mainly due to favorable gross-to-net adjustments. Management stated that international pharmaceutical operations continued to perform well, while RAYALDEE sales remained ahead of internal expectations. For the second quarter, gross profit increased to $80 million from $49.4 million a year ago, while gross margin expanded to 48.9% from 31.5%. The improvement reflected lower service costs following the Diagnostics asset sale and a higher contribution from intellectual property and other revenues, including income tied to the amended Nicoya agreement. Total costs and expenses declined 21.4% year over year to $170.5 million. Cost of service revenues fell 29.1% year over year to $58.4 million, while selling, general and administrative expenses declined 11.2% to $52.9 million. Research and development expenses increased 9.6% year over year to $33.2 million, reflecting continued investment in early-stage clinical programs. Consolidated operating loss narrowed to $7 million from $60 million, aided by higher pharmaceutical revenues, lower Diagnostics costs and an $18.1-million Labcorp earnout gain. The Diagnostics segment posted an operating income of $4.8 million against an operating loss of $18.2 million a year ago. OPKO Health, Inc. price-consensus-eps-surprise-chart | OPKO Health, Inc. Quote OPKO exited the second quarter with cash, cash equivalents, marketable securities and restricted cash of $314.4 million compared with $341.9 million at the first-quarter end. During the quarter, the company repurchased $13.2 million worth of common stock. As of June 30, 2026, cumulative share repurchases under the existing authorization totaled approximately $105.3 million, with $94.7 million still available for future buybacks. Cumulative net cash used in operating activities at the end of second-quarter 2026 was $62.8 million compared with $117.9 million a year ago. For the third quarter of 2026, OPKO expects total revenues in the range of $131-$142 million. The outlook includes service revenues of $73-$78 million, product revenues of $40-$44 million and intellectual property and other revenues of $16-$20 million. Management raised its full-year 2026 revenue guidance to $560-$585 million from the previous range of $530-$560 million. The company lowered its full-year cost and expense outlook to $710-$740 million from the earlier projection of $725-$750 million. Expected research and development spending remains unchanged at $125-$135 million. OPK exited the second quarter with better-than-expected earnings and revenues, supported by higher pharmaceutical revenues, income tied to the amended Nicoya agreement and a leaner Diagnostics cost base. Operating loss narrowed sharply year over year, while the Diagnostics business generated operating income, aided by the Labcorp earnout. BioReference continues to focus on its regional New York and New Jersey laboratory operations, the correctional health business and the 4Kscore franchise. Management remains focused on improving reimbursement, broadening payer coverage and aligning the cost structure with the retained testing footprint as the unit works toward sustainable profitability. Within therapeutics, OPKO Health continued to advance a broad clinical pipeline. ModeX is enrolling patients in the Phase 1 studies of MDX2003 in relapsed or refractory B-cell lymphoma, MDX2001 in solid tumors and MDX2004 in heavily pretreated cancer patients. The BARDA-funded Phase 1 study of MDX2301 for COVID-19 prevention is expected to complete enrollment in the third quarter, with early data targeted for late 2026 or early 2027. The company also initiated a Phase 1/2a study of OPK-88006, its once-weekly dual GLP-1/glucagon agonist, in healthy volunteers and participants with presumed MASH. ModeX presented preclinical data on its antibody-targeted in vivo CAR-T platform at ASGCT and plans to move MDX3001 into clinical testing in late 2026 or early 2027, initially targeting autoimmune disease. OPKO Biologics also plans to advance long-acting growth hormone receptor antagonist OPK8801001 into clinical trials by year-end. On business development, OPKO amended its agreement with Nicoya to support RAYALDEE commercialization in Greater China, receiving a 15% equity stake while retaining eligibility for up to $115 million in development, regulatory and sales milestones. The Regeneron collaboration continues across four discovery programs, with potential milestones exceeding $1 billion and tiered royalties on future sales. OPKO and Entera Bio are also advancing oral peptide programs EB612 for hypoparathyroidism and EB618 for obesity and metabolic disorders toward first-in-human development. Meanwhile, NGENLA continues to expand commercially through Pfizer, with label-expansion studies underway, while OPKO’s active share repurchase program provides an additional avenue for capital deployment alongside continued investment in research and development. OPK currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the broader medical space are McKesson MCK, Phibro Animal Health PAHC and Cardinal Health CAH. McKesson carries a Zacks Rank #2 (Buy) at present and has an estimated long-term growth rate of 13.7%. GMED’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 3.09%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Globus Medical’s shares have gained 8.8% against the industry’s 12.7% decline in the year-to-date period. Phibro Animal Health, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 21.5%. PAHC’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 16.25%. Phibro Animal Health stock has climbed 44.2% against the industry’s 17.1% decline in the year-to-date period. Cardinal Health, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 17%. CAH’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 10.27%. Cardinal Health’s shares have lost 2.6% compared with the industry’s 3.1% decline in the year-to-date period. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report OPKO Health, Inc. (OPK) : Free Stock Analysis Report Cardinal Health, Inc. (CAH) : Free Stock Analysis Report McKesson Corporation (MCK) : Free Stock Analysis Report Phibro Animal Health Corporation (PAHC) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is pivoting the ModeX portfolio toward first-in-class multi-specific antibodies, now with five programs in clinical trials and a sixth in-vivo CAR-T asset expected to begin clinical studies by the end of 2026 or early 2027. The Diagnostics segment is undergoing a structural transformation following the Labcorp transaction, focusing on a leaner geographic footprint and higher-margin specialty testing like the 4Kscore test. Operational efficiency in the lab business was driven by a significant headcount reduction from 3,300 to approximately 1,400 and the strategic outsourcing of unprofitable esoteric testing. Pharmaceutical growth was supported by a 7% increase in international product sales and improved gross-to-net benefits for RAYALDEE, which is now contributing meaningful cash flow. The collaboration strategy emphasizes risk-sharing, with Merck and BARDA fully funding specific infectious disease programs while Regeneron supports discovery-stage multi-specific assets. Management attributed the improved consolidated operating loss to the $18.1 million Labcorp earn-out and the recognition of $29.4 million in preferred shares from the Nicoya partnership. Full-year 2026 revenue guidance was raised to $560 million–$585 million, reflecting stronger pharmaceutical product sales and partner collaboration revenue. Management expects the MDX2001 solid tumor program to conclude dose escalation by Q3 or early Q4 2026, with preliminary data presentations anticipated in late 2026 or early 2027. The in-vivo CAR-T program (MDX3001) is expected to begin clinical studies by the end of 2026 or early 2027, potentially for cancer and autoimmunity indications., initially focusing on B-cell depletion for autoimmune indications. Diagnostics profitability objectives assume achieving breakeven in 2026 through continued cost rationalization and a shift toward higher-margin services. The Pfizer NGENLA profit share is expected to accelerate in the second half of 2026 as the gross profit share percentage increases following the annual January 1 reset. The company received an $18.1 million gain from the final earn-out payment from Labcorp in Q2 2026, which served as a significant one-time offset to diagnostic operating expenses. Management flagged a slight downward adjustment in service revenue guidance due to slower-than-expected maturation of new revenue verticals and pending Medicare reimbursement decisions for 4Kscore. Operational headwinds in the second quarter included higher-than-anticipated employee benefit costs and professional fees within the diagnostics segment. The company continues to execute its share buyback program, repurchasing 9.7 million shares for approximately $13 million during the quarter, with approximately $94 million remaining in the authorization. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management plans to prioritize autoimmune diseases by depleting normal B-cells using a CD19 CAR encoded by mRNA. The company is actively seeking a large pharma partner with expertise in autoimmune regulatory pathways and commercialization to move the asset into the clinic. The Phase IIa portion will evaluate safety and effectiveness in presumed MASH patients over 16 weeks using a composite biomarker panel rather than initial biopsies. Management believes the molecule is differentiated because glucagon acts upstream of FGF21, potentially creating an internal synergy that enhances weight loss and liver health. After enrolling 39 'all-comer' patients to establish safety, the study is shifting to specific targets including non-small cell lung cancer and renal carcinomas. Management is also developing a subcutaneous formulation to allow for higher dosing and improved patient tolerability compared to IV administration. Broader primary care market penetration is being held back until definitive CMS approval regarding Medicare requirement changes is received. Management anticipates that the significant volume and reimbursement tailwinds for the 4Kscore test will likely be a 2027 and beyond impact, as the necessary CMS approvals have not yet been received.

This article first appeared on GuruFocus. Cash Position: Over $300 million in cash, cash equivalents, and restricted cash. Share Repurchase: 9.7 million shares repurchased for approximately $13 million. Diagnostics Revenue: $74.5 million in Q2 2026, including $6.2 million from 4Kscore test. Pharmaceutical Revenue: $89 million in Q2 2026, up from $55.7 million in the prior year. Rayaldee Revenue: $8.1 million in Q2 2026, compared to $7.2 million last year. Pfizer Gross Profit Share: $6.4 million for the quarter. BARDA Funding: $5 million for Q2 2026. Consolidated Revenue: $163.6 million in Q2 2026, compared to $156.8 million in Q2 2025. Net Loss: $8.4 million or $0.01 per share in Q2 2026, improved from $148.4 million or $0.19 per share in Q2 2025. Q3 2026 Revenue Outlook: Expected to be $141 million to $142 million. Full Year 2026 Revenue Guidance: Adjusted to $560 million to $585 million. Warning! GuruFocus has detected 4 Warning Signs with OPK. Is OPK fairly valued? Test your thesis with our free DCF calculator. Release Date: July 27, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. OPKO Health Inc (NASDAQ:OPK) made significant progress in improving operating efficiency and profitability during the second quarter. The company has a strong cash position with over $300 million, sufficient to fund ongoing operations and development plans. ModeX is advancing with five clinical trial programs in oncology, immunology, and vaccines, with a sixth program expected to begin trials soon. Ngenla, partnered with Pfizer, continues to increase market penetration and contribute to cash flow. The company is actively advancing its pipeline, including a Phase I/IIa study of a GLP-1 Glucagon candidate and progress in OPKO Biologics' programs. Revenue for the Diagnostics business declined year-over-year due to the sale of Oncology customer accounts to LabCorp. The company faces operational headwinds resulting in slightly higher costs and expenses, particularly in employee benefits and professional fees. The 4Kscore test is slightly behind expectations due to pending confirmations from Medicare, affecting broader market opportunities. Some new revenue verticals in the Diagnostics business are taking longer to mature than anticipated. The company is cautious about primary care space expansion for the 4Kscore test until CMS approvals are confirmed. Q: How do you think about target and indication selection for your first in vivo CAR-T program in the clinic? What type of collaboration with Pharma will you be looking for? A: For the in vivo CAR-T program, we are initially targeting autoimmune diseases, focusing on B-cells. We have preclinical data showing effectiveness in depleting B-cells. We are looking for partnerships with big pharma that have expertise in autoimmune diseases and can help move the product into clinical trials. Q: What do you need to see to justify moving the 88-006 molecule into a larger MASH study? A: We need to demonstrate that the molecule has a competitive profile, showing improvements in weight loss and MASH status through biomarkers. If successful, we will consider moving to a full-fledged Phase II study to prove tolerability and efficacy. Q: Can you give us a sense of what's going on with enrollment for the MDX-2001 study? A: We have enrolled 39 patients in the MDX-2001 study, focusing initially on safety and pharmacokinetics. We are now targeting specific tumor types like non-small cell lung cancer and renal carcinomas, and exploring subcutaneous injection for better patient tolerability. Q: How are you prioritizing oncology versus autoimmune indications for the MDX-2003 program? A: We are initially focusing on B-cell lymphomas in oncology due to existing clinical proof of concept. Autoimmune indications will follow, using safety data from oncology studies to guide dosing and efficacy in autoimmune diseases. Q: What are your expectations for the 4Kscore test in terms of market opportunities and payer policy advancements? A: We are awaiting confirmations from Medicare before expanding into broader market opportunities. We expect double-digit growth opportunities once CMS approvals are confirmed, likely impacting 2027 and beyond. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Conference Call to Begin Today at 4:30 p.m. ET MIAMI, July 27, 2026 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (OPKO) (NASDAQ: OPK), a fully-integrated healthcare company focused on delivering next-generation solutions for serious diseases across established global markets, today reports business highlights and financial results for the second quarter ended June 30, 2026. Highlights from the second quarter of 2026 and recent weeks included the following: ModeX presented 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 or in early 2027. Leveraging its multispecific technology, ModeX’s in vivo CAR T platform uses antibody-targeted lipid nanoparticles to deliver CAR-encoding genes directly to selected immune cell subsets, generating functional CAR T cells in vivo and potentially overcoming limitations of ex vivo and other in vivo CAR T approaches. Efforts are currently underway to begin a company-sponsored phase 1 study in autoimmune disease in late 2026 or early 2027 at the same time that opportunities for collaboration with large pharma partners are being explored. Initiated and enrolling patients in MDX2003 Phase 1 clinical trial in relapsed or refractory B-cell lymphoma. MDX2003 (CD19 x CD20 x CD3 x CD28) 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 is evaluating safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity in adults with B-cell lymphomas through dose-escalation and dose-expansion cohorts. B-cell lymphoma, a form of non-Hodgkin lymphoma represents the most common lymphoma subtype, accounting for approximately 85% of cases. Initiated MDX2301 Phase 1 clinical trial for the prevention of COVID-19, with plans to complete enrollment in the third quarter 2026 and early data to be presented in late 2026 or early 2027. MDX2301 is a tetravalent bispecific antibody designed to neutralize known SARS-CoV-2 variants while maintaining breadth and reducing the potential for resistance. The Phase 1 trial is evaluating safety, tolerability, and pharmacokinetics across multiple routes of administration in healthy volunteers and immunocompromised adults at high risk for severe COVID-19. This trial is being funded by the Biomedical Advanced Research and Development Authority (BARDA). Continued progress across additional ModeX clinical trials. MDX2001, a tetraspecific T cell engager directed to solid tumors that express Trop2 and c-Met, is proceeding with Phase 1 enrollment as planned. MDX2004 a trispecific immune rejuvenator that stimulates through CD3, CD28 and 4-1BBL, also continues Phase 1 enrollment as planned at sites in Australia and Israel. We expect to report initial safety, tolerability, pharmacokinetic and immune data in the first half of 2027. Initiated the Phase 1/2a clinical study of OPK-88006 in healthy and presumed MASH participants. OPK-88006, a dual GLP-1/Glucagon agonist administered subcutaneously, has begun enrolling participants in the US. The objectives of this study are to assess the safety and pharmacokinetic of single ascending doses in healthy volunteers. Second part of the trial is to evaluate the clinical effects of OPK-88006 administered weekly for 16 weeks in presumed Metabolic Dysfunction Associated Steatohepatitis (MASH) subjects. OPKO Biologics presented preclinical data on long acting Growth Hormone Receptor Antagonist OPK8801001 at the Endocrine Society (ENDO) 2026 annual meeting, with plans to advance the program to clinical trials at the end of 2026. In animals, including non-human primates data showed that OPK8801001 achieved robust, dose-dependent, and sustained suppression of insulin-like growth factor-1 (IGF-1), a marker of disease activity in acromegaly, a rare endocrine disorder caused by excess growth hormone. The findings support its potential as a weekly alternative to current daily acromegaly treatments. In vitro, OPK8801001 showed ~20-fold greater growth hormone receptor antagonism than established Pegvisomant therapy. OPKO’s strategic partner, Entera Bio, presented preclinical data on the EB612 and EB618 pipeline programs at the Endocrine Society (ENDO) 2026 annual meeting, with ongoing studies advancing both programs toward first-in-human clinical evaluation. Both programs are being co-developed by OPKO and Entera. EB612 is a proprietary first-in-class long-acting PTH(1-34) analog formulated with Entera’s N-Tab® oral peptide platform. In preclinical models, EB612 achieved robust bioavailability and sustained increases in calcium, supporting its potential as an oral hormone replacement therapy for patients with hypoparathyroidism. EB618 is a first-in-class oral dual GLP-1/glucagon receptor agonist for obesity and metabolic disorders. In non-human primates, EB618 showed dose-proportional pharmacokinetics and a robust effect on blood glucose.We are pleased to congratulate our partner, Entera Bio, on its announcement today of its oversubscribed $275 million private placement, which underscores the strength of its scientific platform and provides substantial support for the continued advancement of its development programs. Expanded Nicoya Agreement to Support RAYALDEE® Commercialization in Greater China. Under the amended agreement, OPKO received a 15% equity stake in Nicoya in exchange for a revised tiered royalty and transfer price schedule. In connection with the amendment, OPKO received an initial tranche of Series A-2 Preferred Shares and expects to close on the second equity issuance of Series A-2 Preferred Shares in the third quarter of 2026. The amended arrangement also expands the field of use while reinforcing Nicoya’s commitment to commercialize RAYALDEE in Greater China. The milestone structure under the original agreement remains unchanged with OPKO eligible to receive up to $115 million upon the achievement of development, regulatory and sales-based milestones. Second Quarter Financial Results Consolidated: Consolidated total revenues for the second quarter of 2026 were $163.5 million compared with $156.8 million for the 2025 period, with the increase principally resulting from higher revenue from the transfer of intellectual property and other, partially offset by lower revenue from services following the September 2025 sale of our oncology assets to Labcorp. Operating loss for the second quarter of 2026 improved to $7.0 million compared with operating loss of $60.0 million for the corresponding 2025 quarter. Net loss for the second quarter of 2026 was $8.4 million, or $0.01 per share, compared with net loss of $148.4 million, or $0.19 per share, for the corresponding 2025 quarter. Pharmaceuticals: Revenue from products in the second quarter of 2026 was $42.9 million compared with $40.7 million in the second quarter of 2025, driven by higher sales volumes from OPKO’s Spanish and Mexican operations and by a positive net foreign exchange impact of $1.8 million. Revenue from Rayaldee increased to $8.1 million in the second quarter of 2026, compared to $7.2 million for the same period in 2025, primarily due to favorable gross-to-net adjustments. These positive drivers were partially offset by a decrease of approximately $1.7 million in product revenue from other international operations. Revenue from the transfer of intellectual property and other rose to $46.1 million, up from $15 million in 2025, primarily driven by $29.4 million in revenue recognized from shares received in connection with an amendment to our license agreement with Nicoya who is beginning to commercialize Rayaldee in China. Also contributing to the increases was higher partnership revenue, including NGENLA profit share of $6.4 million compared with $6.1 million in the corresponding 2025 quarter, as well as combined revenue from Eli Lilly and Regeneron of $4.3 million in the second quarter of 2026. The increase was partially offset by a decrease in revenue recognized under the BARDA contract, which totaled $5.0 million in the second quarter of 2026 compared with $6.5 million for the same period in 2025. Total costs and expenses were $88.2 million in the second quarter of 2026 compared with $84.4 million in the prior-year period. Operating income was $0.8 million in the second quarter of 2026, which included $18.5 million in depreciation and amortization expense, compared with operating loss of $28.7 million in the second quarter of 2025, which included $18.1 million of depreciation and amortization expense. Diagnostics: Revenue from services in the second quarter of 2026 was $74.5 million compared with $101.1 million in the prior-year period, which included $24.9 million of revenue related to the oncology assets sold to Labcorp in September 2025. Total costs and expenses were $69.8 million in the second quarter of 2026 compared with $119.3 million in the second quarter of 2025, which included $29.4 million of costs and expenses related to oncology assets that were sold to Labcorp. Operating expenses were offset by an earnout received of $18.1 million related to the assets sold to Labcorp in September 2025. Income from operations was $4.8 million in the second quarter of 2026, which included $3.9 million of depreciation and amortization expense, compared with operating loss of $18.2 million in the same 2025 period, which included $4.9 million of depreciation and amortization expense. Cash, cash equivalents, marketable securities and restricted cash: Cash, cash equivalents, marketable securities and restricted cash were $314.4 million as of June 30, 2026. As of June 30, 2026, approximately $105.3 million of OPKO’s common stock had been repurchased under the program authorized in July 2025, including $13.2 million in the second quarter of 2026. Approximately $94.7 million remained authorized and available for future repurchases. Financial Guidance The table below contains financial guidance for the 2026 third quarter and full year financial guidance (in millions): Conference Call and Webcast Information OPKO’s senior management will provide a business update, discuss second quarter financial results, provide financial guidance and answer questions during a conference call and live audio webcast today beginning at 4:30 p.m. ET. Participants are encouraged to pre-register for the conference call here. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing 833-630-0584 (U.S.) or 412-317-1815 (International). A webcast of the call can also be accessed through OPKO’s Investor Relations here. A telephone replay will be available until August 5, 2026, by dialing 855-669-9658 (U.S.) or 412-317-0088 (International) and providing the passcode 2140261. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here. About OPKO Health OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise, and novel and proprietary technologies. For more information, please visit www.opko.com. Cautionary Statement Regarding Forward Looking Statements This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected financial performance and expectations regarding the market for and sales of our products, including whether and when Phase 1 study for the multispecific targeted in vivo Car T cell programs will be initiated and whether data will be positive, whether and when we will complete the clinical studies initiated for each of MDX2301 and MDX2003, and whether final study data will be positive for one or both studies, whether data will support marketing approval, our ability to develop and commercialize each of MDX2301 and MDX2003, whether MDX2301 is capable of effectively preventing COVID-19, whether each of MDX2301 and MDX2003 will be safe and tolerable, or have any impact on the severity of disease, whether the studies for each of MDX2001 and MDX2004 will continue to progress, whether OPK-88006 data will show positive safety and pharmacokinetic outcomes, whether OPK8801001 will enter clinical trials and the data will be positive, whether EB612 and EB618 study results are reproducible in humans, expectations regarding the products, their efficacy and market potential, whether our expanded collaboration with Nicoya will be successful and Nicoya will be able to commercialize Rayaldee, whether our product development efforts will be successful and whether the expected benefits of our products will be realized, including whether preclinical data will be indicative of clinical data should any of our preclinical programs progress into clinical development, whether the relationship with our commercial and strategic partners will be successful, whether our commercial and strategic partners will be able to commercialize our products and successfully utilize our technologies, whether we will continue to successfully advance products in our pipeline and whether they can be commercialized, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and under the heading “Risk Factors” in our other filings with the Securities and Exchange Commission, as well as the continuation and success of our relationship with our commercial partners, liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA. Contacts:Alliance Advisors IRVivian Cervantes, [email protected] —Tables to Follow— OPKO Health, Inc. and SubsidiariesCondensed Consolidated Statements of Operations(in millions, except share and per share data)Unaudited

Interested in OPKO Health, Inc.? Here are five stocks we like better. OPKO Health narrowed its Q2 net loss to $8.4 million, or $0.01 per share, from $148.4 million a year earlier, while revenue rose to $163.6 million. The company ended the quarter with more than $300 million in cash and repurchased 9.7 million shares for approximately $13 million. Diagnostics profitability improved following the Labcorp transaction, with BioReference’s segment posting $4.8 million in operating income versus a $18.2 million loss a year earlier. Pharmaceutical revenue increased to $89 million, helped by a $29.4 million contribution from the China RAYALDEE commercialization agreement. OPKO raised its 2026 revenue outlook to $560 million–$585 million while lowering its total cost-and-expense forecast. The company is also advancing its pipeline, including a Phase I/IIa MASH study for OPKO-88006 and plans to begin first-in-human testing of its in vivo CAR-T candidate by late 2026 or early 2027. 3 Stocks That Wall Street Insiders Can’t Stop Buying OPKO Health (NASDAQ:OPK) reported a narrower second-quarter loss as gains tied to its diagnostics restructuring and a China commercialization agreement helped lift revenue, while the company continued to increase investment in clinical development programs. Total revenue for the second quarter of 2026 was $163.6 million, compared with $156.8 million a year earlier. The company recorded a net loss of $8.4 million, or $0.01 per share, improving from a net loss of $148.4 million, or $0.19 per share, in the prior-year quarter. OPKO’s 2025 results included a $91.7 million expense associated with an exchange of convertible notes. → MarketBeat Week in Review – 07/20- 07/24 MarketBeat Week in Review – 7/17 - 7/21 Consolidated operating loss narrowed to $7 million from $60 million in the prior-year period. Chief Financial Officer Adam Logal said the company ended the quarter with more than $300 million in cash, cash equivalents and restricted cash. OPKO also repurchased 9.7 million shares for approximately $13 million during the quarter and had about $94 million remaining under its repurchase authorization. BioReference Health generated $74.5 million in second-quarter diagnostic revenue, down from $101.1 million a year earlier. Logal said the decline was expected following the September 2025 sale of select oncology and oncology-related clinical testing assets to Labcorp. → Volatility Is Back and These 3 Market Tollbooths Are Best Positioned to Profit OPKO Health is the Little Giant of Diversified Healthcare Revenue from the retained diagnostics business declined approximately $1.7 million from the prior year, principally reflecting test-mix changes as OPKO shifted certain unprofitable, higher-priced esoteric testing to strategic partners. Revenue from the company’s 4Kscore prostate cancer test was $6.2 million in the quarter. Diagnostics costs and expenses fell to $69.8 million from $119.3 million. The figure included an $18.1 million gain related to the final earn-out payment from the Labcorp transaction, which offset operating expenses. The diagnostics segment posted operating income of $4.8 million, compared with an operating loss of $18.2 million a year ago. → 2 Stocks Built to Thrive If Inflation Refuses to Fade Management said BioReference is working toward breakeven and sustainable profitability through a more focused geographic footprint, lower headcount, a revised patient-service-center network and a shift toward higher-margin services. Logal said OPKO expects potential expansion of the 4Kscore opportunity in primary care to be more meaningful in 2027 and beyond, pending Medicare-related decisions. Pharmaceutical revenue rose to $89 million from $55.7 million a year earlier. Product sales increased to $42.9 million from $40.7 million, driven by higher international sales volumes, foreign-exchange tailwinds and improved gross-to-net economics for RAYALDEE, partially offset by product-delivery timing in OPKO’s contract development and manufacturing business. RAYALDEE revenue was $8.1 million, compared with $7.2 million in the prior-year period. OPKO’s Pfizer gross-profit share from the NGENLA long-acting pediatric growth hormone product was $6.4 million, up from $6.1 million. The quarter also included $29.4 million in revenue related to Series A2 preferred shares received through OPKO’s partnership with Nicoya for commercialization of RAYALDEE in Greater China. As a result, IP and transfer-of-other revenue rose to $46.1 million from $15 million. Pharmaceutical costs and expenses increased to $88.2 million from $84.4 million as research and development spending rose to $32.7 million from $29.8 million. The segment generated operating income of $8.8 million, compared with an operating loss of $28.7 million in the prior-year quarter. Chairman and Chief Executive Officer Phillip Frost said OPKO continued to advance programs across ModeX Therapeutics and OPKO Biologics. The company opened enrollment for a Phase I/IIa trial of OPKO-88006, a once-weekly dual GLP-1/glucagon agonist. The study will assess ascending doses in healthy volunteers and then evaluate 16 weeks of treatment in participants with presumed metabolic dysfunction-associated steatohepatitis, or MASH. Vice Chairman and President Elias Zerhouni said the initial MASH population is expected to focus on patients with F2 and F3 fibrosis, with an emphasis on F3 where possible. The company plans to evaluate weight loss, tolerability and biomarker changes, including FGF21 levels, before deciding whether to proceed to a larger Phase II program. ModeX expects its in vivo CAR-T candidate, MDX-3001, to enter first-in-human studies by the end of 2026 or in early 2027. Gary Nabel, president and CEO of ModeX Therapeutics, said the company’s initial focus is expected to be autoimmune disease, using a CD19 CAR approach intended to deplete B cells. OPKO is discussing potential partnerships with larger pharmaceutical companies but said those discussions remain at an early stage. MDX-2001, a tetraspecific immuno-oncology candidate for solid tumors, has enrolled 39 patients in Phase I. The company expects dose escalation and regimen optimization to conclude in the third quarter or early fourth quarter of 2026, with early data targeted for late 2026 or early 2027. MDX-2003, an engager-expander candidate directed at CD19 and CD20 in B-cell cancers, is enrolling patients in Phase I. Management said oncology is the initial priority, followed by potential autoimmune development. MDX-2301, a BARDA-funded multispecific COVID-19 antibody program, is expected to complete Phase I enrollment during the third quarter, with early findings anticipated later this year or in early 2027. OPKO’s oral parathyroid hormone program with Entera Bio is advancing toward a planned investigational new drug filing later this year, while its long-acting growth hormone antagonist program for acromegaly is expected to enter clinical trials at the end of 2026. OPKO raised its full-year revenue outlook to $560 million to $585 million. The company expects service revenue of $296 million to $306 million, pharmaceutical product revenue of $164 million to $174 million, and $100 million to $105 million of other revenue from collaborations, including $34 million to $37 million in Pfizer profit share. The company lowered its full-year total cost-and-expense outlook to $710 million to $740 million, excluding future one-time items. It maintained expected R&D investment of $125 million to $135 million, partly offset by anticipated BARDA funding of $18 million to $22 million and reimbursement under its Regeneron collaboration. For the third quarter, OPKO projected revenue of $131 million to $142 million and total costs and expenses of $180 million to $190 million. Third-quarter R&D expense is expected to range from $34 million to $38 million. 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. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "OPKO Health Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for July 2026.

A month has gone by since the last earnings report for OPKO Health (OPK). Shares have added about 17.1% in that time frame, outperforming the S&P 500. But investors have to be wondering, will the recent positive trend continue leading up to its next earnings release, or is OPKO Health due for a pullback? Well, first let's take a quick look at the most recent earnings report in order to get a better handle on the recent catalysts for OPKO Health, Inc. before we dive into how investors and analysts have reacted as of late. OPK Q1 Earnings Meet Estimates on Product Gains, Revenues Down Y/Y OPKO Health posted a first-quarter 2026 loss of 7 cents per share, in line with the Zacks Consensus Estimate. The bottom line improved from a loss of 10 cents in the year-ago quarter. OPK’s Detailed Revenues Analysis OPK’s first-quarter revenues fell 25.7% year over year to $124.2 million and missed the Zacks Consensus mark by 4.9%. Results reflected a smaller Diagnostics revenue base after last year’s asset sale, partly offset by higher Pharmaceutical product sales. OPK’s top line was weighed down by weakness in its Diagnostics unit, reflecting a smaller BioReference footprint following the 2025 divestiture. OPK’s Revenues Fall as Diagnostics Base Resets Service revenues declined to $72.2 million from $102.8 million in the year-ago quarter, which witnessed contributions from oncology assets that were subsequently divested. Within Diagnostics, core diagnostics revenues were $65.8 million compared with $70.4 million a year ago. While 4Kscore test revenues were $6.4 million compared with $6.5 million a year ago. Per management, the decline was due to lower clinical test reimbursement rates following the exit of certain higher-priced offerings that carried low or negative gross margins, along with a modest decrease in overall testing volumes. OPK’s Product Growth Lifts Pharmaceutical Segment Total pharmaceutical revenue increased to $52.0 million from $47.1 million in the year-ago quarter, supported by gains in product sales and higher contributions from intellectual property and other items. Revenues from products rose 9.2% to $38.0 million, driven by higher sales volumes from OPKO’s Spanish operations and a favorable foreign exchange impact. Rayaldee revenues were steady at $6.3 million. Revenues from the transfer of intellectual property and other increased to $14.0 million from $12.3 million, helped by higher gross profit share payments for Pfizer’s NGENLA, which totaled $6.4 million compared with $4.5 million a year ago. This was partly offset by lower BARDA contract revenue of $4.1 million compared with $7.0 million in the prior-year period. OPK’s Cost & Margin Analysis OPK’s cost structure improved year over year, contributing to a narrower operating loss despite the revenue decline. For the first quarter, gross profit was $45.8 million compared with $42.6 million a year ago. Gross margin expanded to 36.9% from 28.4%, reflecting lower service costs on the reduced Diagnostics base and the benefit of revenue streams not directly tied to the cost of revenues. Total costs and expenses decreased to $175.2 million from $217.1 million in the first quarter of 2026, reflecting the reduced Diagnostics footprint and continued streamlining. SG&A expense decreased to $48.6 million from $59.1 million. Research and development expense was $29.2 million compared with $30.8 million a year ago. Operating loss improved to $51 million from $67.2 million in the year-ago quarter. OPK’s Balance Sheet & Cashflow Analysis OPK ended the first quarter of 2026 with cash, cash equivalents, marketable securities and restricted cash of $341.9 million. The company also continued returning capital to shareholders, noting approximately $92 million of common stock had been repurchased under its program since authorization in July 2025, including $4.8 million in the first quarter, with about $108.0 million still authorized for future repurchases. Cumulative net cash used in operating activities at the end of first-quarter 2026 was $19.3 million compared with $34.6 million a year ago. Q2 & 2026 Guidance by OPK For the second quarter of 2026, OPK expects total revenues of $127-$132 million, including services revenues of $72-$76 million, product revenues of $38-$42 million and IP and other revenues of $15-$19 million. The company expects Pfizer’s gross profit share of $6-$8 million and BARDA revenues of $5-$7 million within that revenue outlook. Total costs and expenses are projected to be in the range of $180-$190 million, with R&D of $32-$38 million and depreciation and amortization of approximately $24 million. Full-year guidance remains unchanged, calling for total revenues of $530-$560 million and total costs and expenses in the range of $725-$750 million. Since the earnings release, investors have witnessed a downward trend in fresh estimates. The consensus estimate has shifted -14.71% due to these changes. At this time, OPKO Health has a subpar Growth Score of D, though it is lagging a bit on the Momentum Score front with an F. Following the exact same course, the stock has a grade of F on the value side, putting it in the bottom 20% quintile for value investors. Overall, the stock has an aggregate VGM Score of F. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been broadly trending downward for the stock, and the magnitude of these revisions indicates a downward shift. Interestingly, OPKO Health has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. OPKO Health belongs to the Zacks Medical - Instruments industry. Another stock from the same industry, Edwards Lifesciences (EW), has gained 6.5% over the past month. More than a month has passed since the company reported results for the quarter ended March 2026. Edwards Lifesciences reported revenues of $1.65 billion in the last reported quarter, representing a year-over-year change of +16.7%. EPS of $0.78 for the same period compares with $0.64 a year ago. Edwards Lifesciences is expected to post earnings of $0.74 per share for the current quarter, representing a year-over-year change of +10.5%. Over the last 30 days, the Zacks Consensus Estimate remained unchanged. The overall direction and magnitude of estimate revisions translate into a Zacks Rank #3 (Hold) for Edwards Lifesciences. Also, the stock has a VGM Score of D. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report OPKO Health, Inc. (OPK) : Free Stock Analysis Report Edwards Lifesciences Corporation (EW) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

EB613, the first oral anabolic (bone building) peptide tablet for postmenopausal women with osteoporosis – Phase 3 protocol submitted with FDA feedback expected imminently; incremental data submitted to ENDO2026 and ASBMR EB612, the first oral long-acting PTH peptide replacement tablet for hypoparathyroidism – Expanded 50/50 partnership with OPKO; intention to file IND in late 2026; data submitted to ENDO2026 EB618, the first oral OXM (dual GLP-1/Glucagon) tablet for metabolic and fibrotic conditions – data submitted to ENDO2026 Direct Investment led by BVF Partners L.P. to support EB613 pivotal study acceleration and working capital TEL AVIV, May 08, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) ("Entera" or the "Company"), a leader in the development of oral peptides, today reported financial results and key business updates for the quarter ended March 31, 2026. “The first quarter of 2026 solidified Entera’s position as the leading oral peptide therapeutics company. Our N-Tab® platform is developing arguably the richest pipeline of clinical and near-clinical first in class assets, and we are driven by our mission to develop transformative medicines and invest in therapeutic spaces that have been ignored and require urgent attention,” said Miranda Toledano, CEO of Entera. “This begins with our EB613 journey to develop the first oral anabolic to potentially help millions of women preserve their bone health while advocating for much needed innovation in a therapeutic space which disproportionately affects the health of women. In March 2026, we submitted documents to FDA related to EB613’s potential registrational package. This quarter, we also completed a critical Phase 1 bridging study for the single, final tablet formulation of EB613. Additionally, we submitted PK and TPTX proof of concept data for EB612 in hypoparathyroidism and NHP PK data for EB618 in metabolic conditions to ENDO2026 and ASBMR. Each of these milestones has been executed with a strong focus on capital efficiency by a core team that has a unifying commitment to succeed in developing therapeutics that matter,” said Miranda Toledano, Chief Executive Officer of Entera. Key Recent Highlights EB613: First Oral PTH(1-34) Anabolic Tablet for Osteoporosis Streamlined Phase 3 Protocol Submitted to FDA: In March 2026, Entera announced it had submitted a clinical amendment to the FDA providing a streamlined Phase 3 protocol, statistical analysis plan, and extension synopsis under its IND 505(b)(2) for EB613. The planned Phase 3 trial is designed as a multinational, randomized, double-blind, placebo-controlled safety and efficacy study in 750 postmenopausal women with osteoporosis, with percentage change in total hip bone mineral density (BMD) from baseline to month 12 as the primary outcome measure. Entera also submitted a protocol synopsis to conduct an extension study which is designed to evaluate 24 months of EB613 monotherapy treatment or 12 months of EB613 followed by 12 months of treatment with a standard anti-resorptive drug. Next-Gen EB613 Single Tablet Advanced as Phase 3 Candidate: In January 2026, Entera completed a Phase 1 PK and safety bridging study comparing the single-tablet to the multi-tablet formulation of EB613 and Forteo® (teriparatide SC injection, Eli Lilly). Entera plans to advance the single tablet of EB613 into Phase 3. Data has been submitted as an abstract to ENDO2026. Key Opinion Leader (KOL) Webinar on Osteoporosis Treatment Landscape: On April 20, 2026, Entera hosted a virtual KOL roundtable with Dr. Felicia Cosman (Professor of Medicine at Columbia University) and Dr. Steven Goldstein (Professor of Obstetrics and Gynecology at NYU Grossman School of Medicine and former President of both the International Menopause Society and the North American Menopause Society) to gain endocrinology and gynecology insights into how the clinician ecosystem treats osteoporosis today. The KOLs highlighted the critical unmet demand for an oral anabolic in this silent, asymptomatic disease and EB613’s potential to transform the paradigm. A replay of the video is available at the following link: https://www.youtube.com/watch?v=2z6oOgwAWmg EB612: First-in-Class Oral Long-Acting PTH(1-34) Replacement Tablet for Hypoparathyroidism Expanded OPKO 50/50 Partnership Accelerates Path to Clinic, Funded Through Phase 1: In February 2026, Entera and OPKO amended and restated their 2025 Collaboration Agreement to advance the first oral long-acting PTH (LA-PTH) analog as a once-daily tablet for patients with hypoparathyroidism. The EB612 program has been prioritized, with an expectation to file an IND application in late 2026. TPTX and PK study data completed during the quarter have been submitted as abstracts to ENDO2026. EB618: First-in-Class Oral Dual GLP-1/Glucagon (OXM) Tablet for Obesity and Metabolic Disease In March 2025, Entera and OPKO announced that the potential initiation of EB618 would occur pursuant to analysis of the Phase 1 SAD/MAD studies that OPKO plans to initiate with subcutaneous once weekly injectable OXM. Pharmacokinetic data for the oral OXM tablet developed by Entera in NHP has been submitted to ENDO2026. Corporate Highlights Geno J. Germano Appointed Chairman of the Board: In February 2026, Mr. Germano, formerly Group President of Pfizer’s Global Innovative Pharmaceutical Business, succeeded Gerald Lieberman as Chairman. Mr. Germano brings more than three decades of leadership experience across development, commercialization, and global operations at Pfizer, Wyeth, and other leading biopharmaceutical companies, and has served on the board of directors of Sage Therapeutics, Bioverativ Inc., and The Medicines Company, among others. Steve Rubin Joined Board of Directors: In February 2026, Steve Rubin, Executive Vice President of Administration and director at OPKO, joined Entera’s Board of Directors. Mr. Rubin brings three decades of experience in corporate governance and strategic oversight of drug development across multiple public biotechnology companies. Financial Results for the Quarter Ended March 31, 2026 Cash and cash equivalents as of March 31, 2026, were $11.9 million. As of May 8, 2026, cash and cash equivalents were $20.4 million, inclusive of the proceeds from the private placement led by BVF Partners L.P. in April 2026 and the $7.8 million restricted cash which is designated to fund the OPKO collaboration including EB612 and EB618. The Company’s available funds are expected to support operations through the first quarter of 2027, including activities related to the preparation of the planned Phase 3 registrational study of EB613. Research and development expenses for the three months ended March 31, 2026 were $2.3 million, as compared to $1.1 million for the three months ended March 31, 2025. General and administrative expenses for the three months ended March 31, 2026 were $1.3 million, as compared to $1.4 million for the three months ended March 31, 2025. Total operating expenses for the three months ended March 31, 2026 were $3.5 million, as compared to $2.6 million for the three months ended March 31, 2025. Net loss was $3.5 million, or $0.07 per ordinary share (basic and diluted), for the three months ended March 31, 2026, as compared to $2.6 million, or $0.06 per ordinary share (basic and diluted), for the three months ended March 31, 2025. About Entera Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages a disruptive and proprietary technology platform (N-Tab®) and its pipeline of first-in-class oral peptide programs. The Company’s most advanced product candidate, EB613 (oral PTH(1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet for osteoporosis. A placebo-controlled, dose-ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is also developing the first oral Long Acting PTH(1-34) tablet as a replacement therapy for patients with hypoparathyroidism (EB612), the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide tablet for the treatment of obesity and metabolic syndromes; and the first oral GLP-2 tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health, Inc. For more information on Entera, visit www.enterabio.com or follow us on LinkedIn, Twitter, and Facebook. Cautionary Statement Regarding Forward Looking Statements Various statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy, clinical development activities, collaboration arrangements and expected financial and operational results are forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law. Company Contact: [email protected] ENTERA BIO LTD. CONDENSED CONSOLIDATED BALANCE SHEETS (U.S. dollars in thousands) ENTERA BIO LTD. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (U.S. dollars in thousands, except share and per share data) (Unaudited)