Entera Bio Submits Clinical Amendment for EB613
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Mar 04 2026
0mins
Entera Bio announced the submission to the U.S. Food and Drug Administration of a clinical amendment providing a streamlined Phase 3 protocol, statistical analysis plan, and open-label extension synopsis to the Company's Investigational New Drug (IND) 505(b)(2) submission, to evaluate EB613. Entera anticipates FDA feedback within 60 days. The Company expects to initiate the Phase 3 study in late 2026, with topline results anticipated in the second half of 2028 - approximately one year earlier than previously expected. "This submission marks a pivotal inflection point for Entera and potentially enables us to get EB613 to patients faster," said Miranda Toledano, Chief Executive Officer of Entera. "Our goal with EB613 is to democratize anabolic treatment and enable millions of women and men to protect their bones earlier and potentially deter the catastrophic consequences of fracture. In a silent and asymptomatic disease, access and ease of administration matters."
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About ENTX
Entera Bio Ltd is an Israel-based clinical-stage biopharmaceutical company focused on the development and commercialization of orally delivered large molecule therapeutics for use in areas with unmet medical need and where adoption of injectable therapies is limited due to cost, convenience and compliance challenges for patients. The Company developed a platform that enables the oral delivery of injectable proteins and large molecules. Entera Bio candidates are EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism. Both EB613 and EB612 are oral formulations of human parathyroid hormone (1-34), or Parathormon (PTH). The products are administered via injection.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Entera Bio Hosts KOL Roundtable on EB613 for Osteoporosis
- Significant Treatment Gap: Approximately two million osteoporotic fractures occur annually in the U.S., and while 92% of gynecologists would prescribe anabolic therapy if an oral option were available, only 12% currently use injectable anabolic agents, highlighting a substantial treatment gap.
- Clinical Potential of EB613: As the first oral anabolic agent, EB613 stimulates bone formation while suppressing bone breakdown, with six-month bone density increments comparable to injectable PTH, potentially transforming the current treatment paradigm.
- Clinical Trial Plans: Entera Bio intends to advance EB613 into Phase 3 trials imminently, designed to evaluate its efficacy both as a monotherapy and in combination with anti-resorptive agents, further validating its application in osteoporosis treatment.
- Increased Patient Acceptance: The oral formulation of EB613 is expected to reduce patient resistance to injectable therapies, significantly enhancing treatment adherence and thereby improving bone health and quality of life.
See More
Entera Bio Secures $10 Million in Private Placement Financing
- Financing Size: Entera Bio successfully issued 7,827,789 units at a price of $1.2775 per unit, raising approximately $10 million, reflecting strong market confidence in its biotechnology developments.
- Potential Gains: If all warrants issued are exercised for cash, Entera could receive an additional $14.5 million, leading to total potential proceeds of approximately $24.5 million, thereby enhancing its financial strength to support R&D.
- Use of Funds: The net proceeds from this financing will be used to initiate the Phase 3 registrational study of EB613 targeting osteoporosis in postmenopausal women, as well as for working capital and general corporate purposes, ensuring the company's ongoing development.
- Legal Support: Greenberg Traurig advised Entera on this transaction, led by Drew M. Altman, showcasing the firm's expertise and influence in the biotechnology sector.
See More
Entera Bio Secures $10 Million in Private Placement Financing
- Financing Size: Entera Bio successfully issued 7,827,789 units at a price of $1.2775 per unit, raising approximately $10 million, reflecting strong market confidence in its biotechnology development.
- Potential Revenue: If all warrants issued are exercised for cash, Entera could receive an additional approximately $14.5 million, leading to total potential proceeds of around $24.5 million, which will provide crucial funding for its ongoing research and development.
- Use of Funds: Entera intends to use the net proceeds from the private placement to initiate its Phase 3 registrational study of EB613 in postmenopausal women with osteoporosis, as well as for working capital and general corporate purposes, highlighting its commitment to research.
- Legal Support: Greenberg Traurig advised on the financing, led by Drew M. Altman, ensuring compliance and smooth execution of the transaction, further solidifying its position in providing legal services within the biotechnology sector.
See More
Entera Bio Secures Private Placement Financing
- Private Placement Agreement: Entera Bio has entered into a securities purchase agreement with funds affiliated with BVF Partners L.P., planning to issue 7.83 million units at a price of $1.2775 per unit, with expected gross proceeds of approximately $10 million, enhancing the company's liquidity for future R&D.
- Warrant Issuance: Each unit includes one ordinary share and a five-year warrant with an exercise price of $1.24 per share, and if all warrants are exercised, the company could receive an additional $14.5 million, bringing total potential proceeds to about $24.5 million, further improving financial flexibility.
- Clinical Research Support: The company intends to use the net proceeds to initiate a phase 3 registrational study of EB613 in postmenopausal women with osteoporosis, with EB613 being the first once-daily oral osteoanabolic drug that has met key goals in phase 2 studies, indicating strong market potential.
- Stock Price Fluctuations: ENTX shares have traded between $0.91 and $3.22 over the past year, closing at $1.26 with a 10.53% increase, but are down 4.76% in premarket trading at $1.20, reflecting market caution regarding the financing news.
See More
Entera Bio Secures $10M in Private Placement Agreement
- Financing Scale: Entera Bio has signed a securities purchase agreement with BVF Partners to issue 7.83 million units at $1.2775 each, expecting gross proceeds of about $10 million, reflecting market confidence in its fundraising capabilities.
- Warrant Structure: Each unit consists of one share (or pre-funded warrant) and a five-year warrant to purchase 1.5 shares at $1.24 each, representing an 11.7% premium to the March 31 closing price, providing investors with potential upside.
- Potential Proceeds: If all warrants are exercised for cash, the company could receive an additional $14.5 million, bringing total potential proceeds to approximately $24.5 million, which would significantly bolster funding for future research and development.
- Use of Funds: The company plans to utilize the proceeds, along with existing cash, primarily to fund a Phase 3 study of EB613 and for general corporate purposes, underscoring its commitment to drug development and strategic growth initiatives.
See More
Entera Bio Reports FY 2025 Financial Results
- Earnings Highlights: Entera Bio's FY 2025 GAAP EPS stands at -$0.25, beating expectations by $0.03, indicating a slight improvement in financial performance despite remaining in a loss position.
- Revenue Performance: The company reported revenue of $0.04M, a significant decline of 77.8% year-over-year, reflecting weak market demand and sales challenges that could impact future liquidity and investor confidence.
- Cash Position: As of December 31, 2025, Entera Bio had cash and cash equivalents of $14.9 million, including $7.8 million in restricted cash earmarked for the OPKO collaboration, demonstrating cautious financial management amid operational challenges.
- Operating Cash Flow: The net cash used in operating activities for FY 2025 was $7.4 million, indicating the company's reliance on external financing to sustain daily operations, which may pose risks to its long-term viability.
See More
Entera Bio Hosts KOL Roundtable on EB613 for Osteoporosis
- Significant Treatment Gap: Approximately two million osteoporotic fractures occur annually in the U.S., and while 92% of gynecologists would prescribe anabolic therapy if an oral option were available, only 12% currently use injectable anabolic agents, highlighting a substantial treatment gap.
- Clinical Potential of EB613: As the first oral anabolic agent, EB613 stimulates bone formation while suppressing bone breakdown, with six-month bone density increments comparable to injectable PTH, potentially transforming the current treatment paradigm.
- Clinical Trial Plans: Entera Bio intends to advance EB613 into Phase 3 trials imminently, designed to evaluate its efficacy both as a monotherapy and in combination with anti-resorptive agents, further validating its application in osteoporosis treatment.
- Increased Patient Acceptance: The oral formulation of EB613 is expected to reduce patient resistance to injectable therapies, significantly enhancing treatment adherence and thereby improving bone health and quality of life.
See More
Entera Bio Secures $10 Million in Private Placement Financing
- Financing Size: Entera Bio successfully issued 7,827,789 units at a price of $1.2775 per unit, raising approximately $10 million, reflecting strong market confidence in its biotechnology developments.
- Potential Gains: If all warrants issued are exercised for cash, Entera could receive an additional $14.5 million, leading to total potential proceeds of approximately $24.5 million, thereby enhancing its financial strength to support R&D.
- Use of Funds: The net proceeds from this financing will be used to initiate the Phase 3 registrational study of EB613 targeting osteoporosis in postmenopausal women, as well as for working capital and general corporate purposes, ensuring the company's ongoing development.
- Legal Support: Greenberg Traurig advised Entera on this transaction, led by Drew M. Altman, showcasing the firm's expertise and influence in the biotechnology sector.
See More
Entera Bio Secures $10 Million in Private Placement Financing
- Financing Size: Entera Bio successfully issued 7,827,789 units at a price of $1.2775 per unit, raising approximately $10 million, reflecting strong market confidence in its biotechnology development.
- Potential Revenue: If all warrants issued are exercised for cash, Entera could receive an additional approximately $14.5 million, leading to total potential proceeds of around $24.5 million, which will provide crucial funding for its ongoing research and development.
- Use of Funds: Entera intends to use the net proceeds from the private placement to initiate its Phase 3 registrational study of EB613 in postmenopausal women with osteoporosis, as well as for working capital and general corporate purposes, highlighting its commitment to research.
- Legal Support: Greenberg Traurig advised on the financing, led by Drew M. Altman, ensuring compliance and smooth execution of the transaction, further solidifying its position in providing legal services within the biotechnology sector.
See More
Entera Bio Secures Private Placement Financing
- Private Placement Agreement: Entera Bio has entered into a securities purchase agreement with funds affiliated with BVF Partners L.P., planning to issue 7.83 million units at a price of $1.2775 per unit, with expected gross proceeds of approximately $10 million, enhancing the company's liquidity for future R&D.
- Warrant Issuance: Each unit includes one ordinary share and a five-year warrant with an exercise price of $1.24 per share, and if all warrants are exercised, the company could receive an additional $14.5 million, bringing total potential proceeds to about $24.5 million, further improving financial flexibility.
- Clinical Research Support: The company intends to use the net proceeds to initiate a phase 3 registrational study of EB613 in postmenopausal women with osteoporosis, with EB613 being the first once-daily oral osteoanabolic drug that has met key goals in phase 2 studies, indicating strong market potential.
- Stock Price Fluctuations: ENTX shares have traded between $0.91 and $3.22 over the past year, closing at $1.26 with a 10.53% increase, but are down 4.76% in premarket trading at $1.20, reflecting market caution regarding the financing news.
See More
Entera Bio Secures $10M in Private Placement Agreement
- Financing Scale: Entera Bio has signed a securities purchase agreement with BVF Partners to issue 7.83 million units at $1.2775 each, expecting gross proceeds of about $10 million, reflecting market confidence in its fundraising capabilities.
- Warrant Structure: Each unit consists of one share (or pre-funded warrant) and a five-year warrant to purchase 1.5 shares at $1.24 each, representing an 11.7% premium to the March 31 closing price, providing investors with potential upside.
- Potential Proceeds: If all warrants are exercised for cash, the company could receive an additional $14.5 million, bringing total potential proceeds to approximately $24.5 million, which would significantly bolster funding for future research and development.
- Use of Funds: The company plans to utilize the proceeds, along with existing cash, primarily to fund a Phase 3 study of EB613 and for general corporate purposes, underscoring its commitment to drug development and strategic growth initiatives.
See More
Entera Bio Reports FY 2025 Financial Results
- Earnings Highlights: Entera Bio's FY 2025 GAAP EPS stands at -$0.25, beating expectations by $0.03, indicating a slight improvement in financial performance despite remaining in a loss position.
- Revenue Performance: The company reported revenue of $0.04M, a significant decline of 77.8% year-over-year, reflecting weak market demand and sales challenges that could impact future liquidity and investor confidence.
- Cash Position: As of December 31, 2025, Entera Bio had cash and cash equivalents of $14.9 million, including $7.8 million in restricted cash earmarked for the OPKO collaboration, demonstrating cautious financial management amid operational challenges.
- Operating Cash Flow: The net cash used in operating activities for FY 2025 was $7.4 million, indicating the company's reliance on external financing to sustain daily operations, which may pose risks to its long-term viability.
See More
