Osteoporosis Program: Phase 2 analysis exploring the dual actions of oral PTH(1-34) tablet treatment, EB613 on trabecular and cortical bone, and Next-Gen EB613 PK/PD data slated for oral and poster presentations at ASBMRShort Bowel Syndome and Rare GI Disorders: PK/PD of oral GLP-2 tablet candidate poster presentation at ESPENCorporate Overview at H.C. Wainwright Investor Conference JERUSALEM, Aug. 28, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and ...

Core Insights - Entera Bio reported a better-than-expected GAAP earnings per share of $0.06 for Q2 2025, contrasting with Wall Street's estimate of a loss of $(0.11) [1] - The company did not report any revenue for the quarter, down from $57,000 in Q2 2024, indicating a 100% year-over-year decline [2] - A significant regulatory breakthrough was achieved with the FDA's concurrence on the design for the Phase 3 trial of EB613, marking a key advancement in the company's product pipeline [5][6] Financial Performance - GAAP EPS for Q2 2025 was $(0.06), better than the estimated $(0.11) [2] - No revenue was reported for Q2 2025, compared to $57,000 in Q2 2024, reflecting a 100% decrease [2] - Research and Development expenses increased by 39.9% to $1.52 million from $1.09 million in Q2 2024 [2] - General & Administrative expenses rose by 5.5% to $1.15 million [2] - Cash and cash equivalents increased by 25.4% to $10.86 million compared to $8.66 million as of December 31, 2024 [2][8] Business Overview - Entera Bio focuses on oral delivery of protein and peptide drugs, utilizing its N-Tab™ technology to enhance stability and absorption of peptides [3] - The company aims to address challenges in pharmaceutical development by providing oral alternatives to injectable therapies [3][4] Key Developments - The FDA's agreement on using total hip bone mineral density as the primary measure of effectiveness for EB613's Phase 3 trial streamlines the regulatory process [5] - Positive results from a completed Phase 2 study of EB613 were presented, showing improvements in bone strength and mineralization compared to placebo [6] - The company is preparing to initiate a pivotal Phase 3 trial for EB613 with the new design [6] Future Outlook - Entera Bio plans to launch a Phase 1 trial for an updated version of EB613 in November 2025 [9] - Development of OPKO-partnered candidates, including an oral GLP-1/glucagon product, is expected to progress in H1 2026 [9] - Management did not provide specific revenue or earnings guidance but highlighted key operational milestones for the upcoming year [9][10]

[PART I – FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Presents unaudited condensed consolidated financial statements, detailing financial position, performance, and cash flows, with a net loss of **$2.7 million** for Q2 2025 and a going concern warning Condensed Consolidated Balance Sheet Highlights (in thousands USD) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $10,858 | $8,660 | | Restricted cash | $8,015 | $0 | | Total current assets | $19,311 | $8,972 | | Total assets | $19,667 | $9,390 | | **Liabilities & Equity** | | | | Total current liabilities | $1,844 | $1,176 | | Total liabilities | $2,411 | $1,310 | | Total shareholders' equity | $17,256 | $8,080 | Condensed Consolidated Statements of Operations (in thousands USD, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $0 | $57 | $42 | $57 | | Research and development, net | $1,520 | $1,086 | $2,643 | $1,821 | | General and administrative | $1,148 | $1,088 | $2,588 | $2,415 | | Operating Loss | $2,668 | $2,165 | $5,231 | $4,227 | | Net Loss | $2,656 | $2,145 | $5,223 | $4,162 | | Loss Per Share (Basic & Diluted) | $0.06 | $0.06 | $0.12 | $0.11 | Condensed Consolidated Statements of Cash Flows Highlights (in thousands USD) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($3,035) | ($3,197) | | Net cash used in investing activities | ($37) | $0 | | Net cash provided by financing activities | $13,286 | $1,246 | | **Net Change in Cash** | **$10,214** | **($1,951)** | - The company's accumulated deficit of **$119.2 million** as of June 30, 2025, raises substantial doubt about its going concern ability due to insufficient funds for the EB613 Phase 3 program[36](index=36&type=chunk)[37](index=37&type=chunk) - A collaboration with OPKO Health, Inc. in March 2025 included an **$8.0 million** equity investment for an oral GLP-1/glucagon dual agonist program, with proceeds held in escrow[53](index=53&type=chunk)[55](index=55&type=chunk)[57](index=57&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical-stage focus, EB613 Phase 3 progress, increased operating losses from R&D, and liquidity challenges for future trials, reinforcing going concern uncertainty [Overview](index=19&type=section&id=Overview) Entera, a clinical-stage company, develops oral peptide therapies, with lead candidate EB613 for osteoporosis receiving positive FDA feedback on its Phase 3 study design - EB613 is the company's most advanced product, developed as the first oral, once-daily bone-building treatment for post-menopausal osteoporosis[71](index=71&type=chunk) - The FDA agreed in July 2025 to a single Phase 3 study design for EB613, using total hip Bone Mineral Density (BMD) as the primary endpoint, enabling program advancement[73](index=73&type=chunk)[74](index=74&type=chunk) - Collaboration with OPKO aims to develop an oral dual agonist GLP-1/Glucagon (OXM) peptide for obesity, with an IND filing planned later this year[81](index=81&type=chunk)[82](index=82&type=chunk)[83](index=83&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Operating losses increased in Q2 and H1 2025, primarily driven by a **40%** and **45%** rise in R&D expenses respectively, due to preparations for the EB613 Phase 3 program Comparison of Operating Results (in thousands USD) | Metric | Q2 2025 | Q2 2024 | Change (%) | H1 2025 | H1 2024 | Change (%) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Operating Loss | $2,668 | $2,165 | 23% | $5,231 | $4,227 | 24% | | R&D Expenses | $1,520 | $1,086 | 40% | $2,643 | $1,821 | 45% | | G&A Expenses | $1,148 | $1,088 | 6% | $2,588 | $2,415 | 7% | - Increased R&D expenses in Q2 and H1 2025 were primarily due to higher consulting and regulatory fees for EB613 Phase 3 program preparations[120](index=120&type=chunk)[127](index=127&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company had **$18.9 million** in cash, sufficient for operations through mid-Q3 2026, but additional capital is needed for the EB613 Phase 3 trial, reinforcing going concern doubts - As of June 30, 2025, cash, cash equivalents, and restricted cash totaled **$18.9 million**, with **$8.0 million** designated for the OPKO collaboration agreement[132](index=132&type=chunk) - Existing cash resources are projected to fund operations through mid-Q3 2026, excluding the capital required for the EB613 Phase 3 program[130](index=130&type=chunk)[136](index=136&type=chunk) - The company raised **$6.0 million** net from its ATM program in January 2025 and received an **$8.0 million** investment from OPKO in March 2025 for their collaboration[134](index=134&type=chunk)[135](index=135&type=chunk) - Substantial doubt about going concern ability persists, necessitating additional capital for future R&D, especially the costly EB613 Phase 3 trial[140](index=140&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Entera Bio Ltd. is not required to provide market risk disclosures - As a smaller reporting company, Entera Bio Ltd. is not required to provide quantitative and qualitative disclosures about market risk[152](index=152&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[153](index=153&type=chunk) - No material changes to internal control over financial reporting occurred during the last fiscal quarter[154](index=154&type=chunk) [PART II – OTHER INFORMATION](index=32&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company is not currently involved in any material legal proceedings[157](index=157&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) Updates risk factors, focusing on the potential impact of the ongoing multi-front war in Israel, which could adversely affect operations, capital raising, and stock price if it escalates - A new risk factor addresses Israel's multi-front war with terrorist groups and state actors[158](index=158&type=chunk)[159](index=159&type=chunk) - While research and some management are in Israel, other core activities like clinical, regulatory, and supply chain are external[159](index=159&type=chunk) - The conflict has not materially impacted business to date, but escalation could lead to operational disruptions, capital raising difficulties, and negative share price impact[161](index=161&type=chunk)[164](index=164&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period - No unregistered sales of equity securities occurred during the period[166](index=166&type=chunk) [Item 3. Defaults Upon Senior Securities](index=33&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - No defaults upon senior securities were reported[167](index=167&type=chunk) [Item 4. Mine Safety Disclosures](index=33&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable to the company[168](index=168&type=chunk) [Item 5. Other Information](index=33&type=section&id=Item%205.%20Other%20Information) No officers or directors adopted or terminated Rule 10b5-1 trading plans during the quarter ended June 30, 2025 - No officers or directors adopted or terminated any Rule 10b5-1(c) trading plans during the quarter[169](index=169&type=chunk) [Item 6. Exhibits](index=33&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including officer certifications, an amendment to the sales agreement, and XBRL data files - Exhibits include officer certifications, an amendment to the Sales Agreement with Leerink Partners LLC, and XBRL interactive data files[170](index=170&type=chunk)

[Entera Bio Second Quarter 2025 Results](index=1&type=section&id=Entera%20Bio%20Second%20Quarter%202025%20Results) Entera Bio reported its second quarter 2025 results, highlighting a pivotal FDA agreement for EB613's Phase 3 trial, significant pipeline advancements, and a strengthened financial position [CEO Statement & Key Highlights](index=1&type=section&id=CEO%20Statement%20%26%20Key%20Highlights) Entera Bio secured FDA agreement on EB613's Phase 3 trial design, validating BMD as the primary endpoint, and strengthened its cash position to **$18.9 million**, extending operational runway through mid-Q3 2026 - The FDA agreed to use **Bone Mineral Density (BMD)** as the primary endpoint for the EB613 Phase 3 program, creating a streamlined pathway for the first oral anabolic osteoporosis treatment[3](index=3&type=chunk)[5](index=5&type=chunk)[6](index=6&type=chunk) - The company's cash position is **$18.9 million** as of June 30, 2025, which is expected to fund operations through the **middle of the third quarter of 2026**[3](index=3&type=chunk)[5](index=5&type=chunk)[9](index=9&type=chunk) - Promising pharmacokinetic data was presented for the **oral GLP-1/glucagon dual agonist program** for obesity, developed in collaboration with OPKO[3](index=3&type=chunk)[12](index=12&type=chunk) [Pipeline Updates](index=1&type=section&id=Pipeline%20Updates) Entera Bio reported significant pipeline progress, including a key regulatory agreement for EB613, advancements in hypoparathyroidism, and positive preclinical data from the OPKO collaboration [EB613 (Osteoporosis)](index=1&type=section&id=EB613%20(Osteoporosis)) Entera secured FDA agreement on **Bone Mineral Density (BMD)** as the primary endpoint for EB613's Phase 3 trial, reducing regulatory burden and advancing a next-generation tablet into Phase 1 by November 2025 - The FDA concurred on a single **24-month Phase 3 study** design using change in **total hip BMD** as the primary endpoint and vertebral fracture incidence as the key secondary endpoint[6](index=6&type=chunk) - The **regulatory burden was significantly reduced** as the FDA agreed that dedicated oral carcinogenicity and comprehensive DART studies are not warranted[6](index=6&type=chunk) - A **next-generation EB613 tablet**, utilizing the N-Tab™ technology, is expected to enter a **Phase 1 Safety and PK Study** in **November 2025**[5](index=5&type=chunk)[12](index=12&type=chunk) [Hypoparathyroidism Program](index=2&type=section&id=Hypoparathyroidism%20Program) Entera is developing EB612, an oral PTH(1-34) replacement for hypoparathyroidism, with initial preclinical PK/PD data for a long-acting PTH agonist expected by year-end - **First pre-clinical PK/PD data** for a once-daily tablet format for hypoparathyroidism is expected by the **end of the year**[7](index=7&type=chunk) [OPKO Health Collaboration Programs](index=2&type=section&id=OPKO%20Health%20Collaboration%20Programs) The OPKO Health collaboration shows promising preclinical PK data for oral obesity treatment OPK-88006, with an IND filing planned for H1 2026, and advances in the short bowel syndrome program - Obesity (**OPK-88006**): A mini-pig study showed **plasma levels consistent with the highest subcutaneous dose of Wegovy™**, supporting a **once-daily tablet regimen**. An **IND filing is expected in H1 2026**[12](index=12&type=chunk) - Short Bowel Syndrome (GLP-2): An abstract for the **first-in-class oral GLP-2 analog** was selected for a **poster presentation** at the 47th ESPEN Congress[12](index=12&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Entera Bio reported a **$2.7 million net loss** for Q2 2025, driven by increased R&D for EB613, while maintaining a strong **$18.9 million cash position** with runway through mid-Q3 2026 [Financial Position (Balance Sheet)](index=2&type=section&id=Financial%20Position%20(Balance%20Sheet)) As of June 30, 2025, cash and cash equivalents, including restricted cash, significantly increased to **$18.9 million**, driving total assets to **$19.7 million** - Cash and cash equivalents were **$18.9 million** as of June 30, 2025, including **$8.0 million** in restricted cash designated for the OPKO collaboration[9](index=9&type=chunk) - The current cash on hand is expected to support operations through the **mid-third quarter of 2026**[9](index=9&type=chunk) Balance Sheet Summary (in thousands) | (in thousands) | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | | :--- | :--- | :--- | | Cash and cash equivalents | $10,858 | $8,660 | | Restricted cash | $8,015 | - | | **Total Assets** | **$19,667** | **$9,390** | | Total Liabilities | $2,411 | $1,310 | | **Total Shareholders' Equity** | **$17,256** | **$8,080** | [Financial Performance (Statement of Operations)](index=2&type=section&id=Financial%20Performance%20(Statement%20of%20Operations)) For Q2 2025, the company reported a **$2.7 million net loss**, or **$0.06 per share**, primarily due to a **$0.4 million increase in R&D expenses** for EB613 Phase 3 planning Statement of Operations Summary (in thousands, except per share data) | (in thousands, except per share data) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $1,520 | $1,086 | | General and administrative | $1,148 | $1,088 | | **Total Operating Expenses** | **$2,668** | **$2,174** | | **Net Loss** | **$2,656** | **$2,145** | | Loss Per Share | $0.06 | $0.06 | - The increase in **R&D expenses by $0.4 million** year-over-year was primarily due to regulatory activities and Phase 3 planning for EB613[10](index=10&type=chunk)

Core Insights - Entera Bio Ltd. has achieved a significant milestone with the FDA's agreement to use Bone Mineral Density (BMD) as the primary endpoint for the Phase 3 program of EB613, marking a step towards the first oral anabolic osteoporosis treatment [2][4][5] - The company reported a cash position of $18.9 million as of June 30, 2025, which is expected to support operations through mid-Q3 2026 [9][10] - Entera is advancing multiple programs, including the oral GLP-1/glucagon dual agonist in collaboration with OPKO Health, and is preparing for a Phase 1 study of the next-generation EB613 [2][4][14] Financial Results - For the quarter ended June 30, 2025, Entera reported a net loss of $2.7 million, or $0.06 per share, compared to a net loss of $2.1 million, or $0.06 per share, for the same period in 2024 [10][19] - Research and development expenses increased to $1.5 million from $1.1 million year-over-year, primarily due to regulatory activities and Phase 3 planning for EB613 [10][11] - Total operating expenses for the quarter were $2.7 million, up from $2.2 million in the previous year [11][19] Business Updates - The FDA has waived additional safety studies for EB613, allowing for a streamlined pathway to market [4][5] - Entera's collaboration with OPKO Health is showing strong momentum, particularly in obesity and hypoparathyroidism programs [2][4][14] - The next-generation EB613 is expected to enter Phase 1 clinical trials in November 2025, utilizing Entera's proprietary N-TAB™ technology [4][12]

Core Viewpoint - Entera Bio Ltd. has received FDA agreement to support the NDA marketing application filing for EB613 based on a single 24-month phase 3 study, marking a significant regulatory milestone for the company and the osteoporosis community [1][2] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology platform [5] - The company's lead product candidate, EB613, is an oral anabolic treatment for post-menopausal women with low bone mineral density (BMD) and high-risk osteoporosis [5] Product Development - EB613 is designed as the first oral, once-daily anabolic tablet treatment for osteoporosis, aiming to increase skeletal mass, improve bone microarchitecture, and reduce fracture risk [3][4] - A phase 2 study of EB613 demonstrated significant efficacy, meeting all biomarker and BMD endpoints without major safety concerns [4] Regulatory Context - The FDA's agreement allows Entera to advance its clinical development program without waiting for the qualification of the SABRE initiative, which aims to establish BMD as a regulatory endpoint [2][6] - The SABRE initiative has shown that treatment-related gains in total-hip BMD can predict fracture-risk reduction, with a correlation coefficient of 0.73 [6] Market Need - Osteoporosis affects over 200 million women globally, with a significant portion remaining undertreated despite available injectable treatments [3] - The lack of new FDA-approved osteoporosis drugs since 2019 highlights the urgent need for innovative treatments like EB613 [3]

Core Insights - OPKO Health and Entera Bio announced a first-in-class oral GLP-2 analog for treating Short Bowel Syndrome (SBS), selected for a poster presentation at the ESPEN Congress in September 2025 [1][2] Company Overview - OPKO Health is a multinational biopharmaceutical and diagnostics company focused on establishing industry-leading positions in rapidly growing markets through its discovery, development, and commercialization expertise [6] - Entera Bio is a clinical-stage company developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology for significant unmet medical needs [5] Product Development - The oral GLP-2 tablet program combines OPKO's long-acting GLP-2 agonist with Entera's N-Tab™ technology, aimed at patients with SBS and related gastrointestinal disorders [2] - Current approved therapy for SBS, GATTEX (teduglutide), generates approximately $800 million in annual sales and requires daily subcutaneous injections [4] Market Context - Short Bowel Syndrome affects around 30,000 patients in the US and EU, leading to malabsorption and increased risk of malnutrition [4] - The introduction of an oral tablet format for GLP-2 therapy may improve patient compliance and enable personalized treatment [3]

Entera Bio's N-Tab Platform and Pipeline - Entera Bio's proprietary N-Tab platform transforms peptides into orally bioavailable tablets, potentially unlocking patient acceptance and driving superior health outcomes[7, 19] - The company's lead asset, EB613, is a differentiated Phase 3 asset poised for blockbuster sales as a first-in-class oral PTH(1-34) anabolic tablet treatment for osteoporosis, a condition affecting over 200 million people worldwide[7, 27] - Entera has a rich pipeline with multiple blockbuster opportunities in high-impact therapeutic areas, including EB612 for hypoparathyroidism, OXM for obesity/metabolic disorders, and GLP-2 for GI inflammatory disorders and short bowel syndrome[7, 8] - The company's cash runway extends into H2 2026, with multiple catalysts expected in the next 12 months[8] EB613 for Osteoporosis - EB613 is positioned as the first oral anabolic treatment to support earlier intervention in osteoporosis, addressing a substantial treatment gap[7, 28] - A Phase 2 study of EB613 in post-menopausal women with low bone mass or osteoporosis demonstrated a faster onset of action and higher increases in BMD at the cortical bone (femoral neck and hip region)[23] - EB613's Phase 2 results showed a distinct dual mechanism of increased bone formation (P1NP) and reduced bone resorption (CTX)[44] - Phase 2 data indicated that EB613 increased BMD at all major skeletal sites, with placebo-adjusted BMD change of EB613 2.5mg from Baseline to Month 6 as Compared with Published Forteo® Data[56, 57] GLP-1/Glucagon and GLP-2 Programs - Entera is developing an oral GLP-1/Glucagon (OXM) dual agonist tablet for metabolic disorders and obesity in partnership with OPKO, with an IND filing expected late 2025/early 2026[8, 104, 116] - Pre-clinical data supports the development of once-daily oral GLP-2 analog tablets for short bowel syndrome (SBS), a rare disease affecting approximately 30,000 patients across the US and EU[8, 106, 108]

Core Insights - Entera Bio Ltd. is advancing EB613, an oral anabolic treatment for postmenopausal women with osteoporosis, which has been selected for presentation at the ASBMR 2025 Annual Meeting [1][4] - EB613 is designed to be the first once-daily oral PTH(1-34) tablet, aiming to provide a viable treatment option for patients at high risk of fractures [2][4] - The Phase 2 study demonstrated significant increases in bone mineral density (BMD) across all measured skeletal sites compared to baseline and placebo [2][4] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology platform [5] - The company is preparing to initiate a Phase 3 registrational study for EB613 following FDA qualification of a quantitative BMD endpoint [5] - Entera's pipeline includes other innovative oral therapies targeting conditions such as hypoparathyroidism and obesity [5] Industry Context - Osteoporosis is a significant health concern, affecting approximately 200 million women globally, with a high risk of fragility fractures in older adults [3] - The current injectable anabolic treatments are not suitable for many patients, highlighting the need for oral alternatives like EB613 [4]

Core Viewpoint - OPKO Health and Entera Bio are advancing the development of an oral treatment, OPK-88006, for obesity and metabolic disorders, with new pharmacologic data to be presented at the ENDO 2025 annual meeting [1][2]. Company Overview - OPKO Health is a multinational biopharmaceutical and diagnostics company focused on establishing leading positions in rapidly growing markets through its discovery, development, and commercialization expertise [5]. - Entera Bio is a clinical-stage company developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology to address significant unmet medical needs [4]. Product Development - OPK-88006 is a dual agonist GLP-1/glucagon peptide being developed as both a once-daily oral tablet and a weekly injectable treatment [2][3]. - The oral formulation aims to provide a simpler titration process and improved tolerability for patients, with a focus on sustainable weight loss to mitigate comorbidities like severe fatty liver and sleep apnea [3]. - Both companies plan to file an Investigational New Drug application with the U.S. FDA for OPK-88006 later this year, with Phase 1 clinical studies in preparation [3]. Clinical Trials and Research - The upcoming presentation at the ENDO 2025 meeting will showcase in vivo pharmacokinetic and pharmacodynamic results for OPK-88006 [4]. - Entera's advanced product candidate, EB613, is also in development as the first oral treatment for post-menopausal women with low bone mineral density and high-risk osteoporosis, with a Phase 2 study already meeting its endpoints [4].