Core Insights - Entera Bio Ltd. is advancing its investigational agent EB613, an oral anabolic therapy for post-menopausal women with high-risk osteoporosis, with new pharmacological data to be presented at the ASBMR 2024 Annual Meeting [1][2][3] Company Overview - Entera Bio is focused on developing orally delivered peptides and therapeutic proteins, leveraging its proprietary N-Tab™ technology platform [4] - The company has a pipeline that includes five differentiated oral peptide programs expected to enter clinical trials by 2025 [4] Product Development - EB613 is designed as the first once-daily oral PTH(1-34) mini tablet therapy for post-menopausal women, addressing a significant unmet medical need in osteoporosis treatment [2][3] - Approximately 200 million women globally are affected by post-menopausal osteoporosis, which poses a serious health risk [2] - A Phase 2 study of EB613 met primary and secondary endpoints, and the company is preparing for a Phase 3 registrational study pending FDA qualification of bone mineral density as a surrogate endpoint [4] Upcoming Events - New comparative pharmacological data for EB613 will be presented at the ASBMR 2024 Annual Meeting, scheduled for September 27-30, 2024, in Toronto, Canada [1][4] - The SABRE project update will also be presented, highlighting the FDA's communication regarding bone mineral density as a regulatory endpoint [3][4]

Investors interested in Medical stocks should always be looking to find the best-performing companies in the group. Has Entera Bio Ltd. (ENTX) been one of those stocks this year? A quick glance at the company's yearto-date performance in comparison to the rest of the Medical sector should help us answer this question. Entera Bio Ltd. is one of 1046 companies in the Medical group. The Medical group currently sits at #8 within the Zacks Sector Rank. The Zacks Sector Rank considers 16 different groups, measuri ...

Group 1 - Entera Bio Ltd. (ENTX) has significantly outperformed the Medical sector with a year-to-date return of 336.7%, compared to an average gain of 5.6% for Medical stocks [4] - The Zacks Rank for Entera Bio Ltd. is currently 2 (Buy), indicating strong analyst sentiment and an improving earnings outlook, with a 66.7% increase in the consensus estimate for full-year earnings over the past quarter [3] - Entera Bio Ltd. is part of the Medical - Biomedical and Genetics industry, which includes 506 companies and currently ranks 92 in the Zacks Industry Rank, while the average performance of this group has been a loss of 2.4% this year [5] Group 2 - Assembly Biosciences (ASMB) is another Medical stock that has outperformed the sector with a year-to-date return of 48.4% and also holds a Zacks Rank of 2 (Buy) [4][5] - The consensus EPS estimate for Assembly Biosciences has increased by 14.3% over the past three months, reflecting positive analyst sentiment [5] - The Medical - Generic Drugs industry, to which Assembly Biosciences belongs, has seen a year-to-date increase of 11.1% and currently ranks 52 [6]

JERUSALEM, May 13, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and small therapeutic proteins, today announced that it has been selected to present data for its investigational program EB612 at the Endocrine Society ENDO 2024 Annual Meeting which will be held on June 1-4, 2024 in Boston, Massachusetts. The EB612 program is being developed by Entera to provide the first oral PTH(1-34) tablet peptide replacement t ...

Financial Performance - Total assets decreased to $10,239,000 as of March 31, 2024, down from $11,765,000 as of December 31, 2023, representing a decline of approximately 13.0%[24] - Net loss for the three months ended March 31, 2024, was $2,017,000, compared to a net loss of $2,190,000 for the same period in 2023, indicating a reduction of about 7.9%[27] - Operating expenses totaled $2,062,000 for Q1 2024, down from $2,212,000 in Q1 2023, reflecting a decrease of approximately 6.8%[27] - The accumulated deficit increased to $106,403,000 as of March 31, 2024, from $104,386,000 as of December 31, 2023, representing an increase of approximately 1.9%[24] - For the three months ended March 31, 2024, the company reported operating losses of $2.1 million, a decrease of 6.8% compared to $2.2 million in the same period of 2023[94] - General and administrative expenses for the three months ended March 31, 2024, were $1.3 million, showing a slight increase of 2.6% compared to the same period in 2023[94] - The company has an accumulated deficit of $106.4 million as of March 31, 2024, and expects to continue incurring significant expenses and losses in the foreseeable future[78] Cash Flow and Liquidity - Cash and cash equivalents at the end of Q1 2024 were $9,189,000, a decrease from $11,019,000 at the end of Q4 2023, marking a decline of about 16.6%[24] - The company incurred a net cash used in operating activities of $1,862,000 for Q1 2024, compared to $1,609,000 for Q1 2023, indicating an increase of approximately 15.7%[34] - Cash and cash equivalents as of March 31, 2024, were $9.2 million, which is expected to meet projected operating requirements into the third quarter of 2025[80] - The company reported a net decrease in cash and cash equivalents of $1.8 million for Q1 2024, compared to a decrease of $1.6 million in Q1 2023[110] - The company anticipates needing to raise additional capital to fund operations, which may not be available on favorable terms[81] - Management expresses substantial doubt about the company's ability to continue as a going concern due to recurring losses and negative cash flows[109] - The company has no committed external sources of funds other than the Leerink ATM Program, which may lead to shareholder dilution if additional capital is raised[108] Research and Development - The company plans to initiate a Phase 3 registrational study for its product candidate EB613, targeting post-menopausal women with low bone mineral density and high-risk osteoporosis[38] - The EB613 program, an oral PTH (1-34) tablet, met primary and secondary endpoints in a Phase 2 study with 161 participants, and a Phase 3 study is planned to support a new drug application[60] - Entera's proprietary PTH tablets have been safely administered to 102 healthy subjects in Phase 1 studies and 153 patients in Phase 2 studies, targeting osteoporosis and hypoparathyroidism[63] - The company is collaborating with OPKO Biologics to develop oral tablet formulations of GLP-2 and Oxyntomodulin, with positive in vivo pharmacokinetic results announced in March 2024[66] - The company is exploring the use of PTH(1-34) tablets for treating stress fractures in athletes, with a Phase 2 study expected to begin in the second half of 2024[64] - Research and development expenses for the three months ended March 31, 2024 were $0.7 million, down 21% from $0.9 million in the same period of 2023[95] - The company received approximately $0.5 million in grants from the Israeli Innovation Authority to partially fund research and development, with a royalty rate of 3% on revenues from products developed using these grants[70] - As of March 31, 2024, the total royalty amount payable to the IIA is approximately $460 thousand, with $96,000 already paid related to collaboration agreements[71] Shareholder Information - The company reported a weighted average number of shares outstanding of 36,735,429 for Q1 2024, an increase from 28,809,922 in Q1 2023[27] - Diluted loss per share for the periods ended March 31, 2024, and 2023 excluded options, warrants, and RSUs exercisable into 16,484,665 shares and 7,116,583 shares, respectively, due to antidilutive effects[45] - In March 2024, the company granted 758,331 options to purchase ordinary shares at an exercise price of $0.60 per share, with a fair value of $295 at the date of grant[49] - The company issued 214,088 ordinary shares in April 2024 under the Leerink ATM Program for net proceeds of $545 at a weighted average price of $2.60 per share[53] - The company raised $30 thousand from financing activities in Q1 2024 through the issuance of ordinary shares[115] Strategic Initiatives - The company intends to license its N-Tab™ technology to biopharmaceutical companies for use with their proprietary compounds, indicating a strategy for market expansion[39] - The company is continuously evaluating financing alternatives to support future R&D and operational expenses[107] - The ongoing geopolitical situation in the Middle East has not materially impacted the company's business or operations to date[128] - There have been no material changes in contractual obligations and commitments since the 2023 Annual Report[116] - The company expects existing capital resources to fund operations into Q3 2025, including R&D and completion of Phase 1 PK study[104]

Financial Position - As of March 31, 2024, Entera Bio had cash and cash equivalents of $9.2 million, sufficient to meet projected operating requirements into Q3 2025[9]. - Entera's total assets decreased to $10.2 million as of March 31, 2024, from $11.8 million as of December 31, 2023[17]. Expenses - Research and development expenses for Q1 2024 were $0.7 million, a decrease from $0.9 million in Q1 2023[10]. - General and administrative expenses remained stable at $1.3 million for both Q1 2024 and Q1 2023[10]. - Total operating expenses for Q1 2024 were $2.1 million, down from $2.2 million in Q1 2023[11]. Net Loss - The net loss for Q1 2024 was $2.0 million, or $0.05 per ordinary share, compared to a net loss of $2.2 million, or $0.08 per ordinary share, in Q1 2023[11]. Product Development - Entera is developing EB613, the first oral PTH(1-34) osteoanabolic tablet for osteoporosis, with a Phase 2 study showing positive results[12]. - The FDA is expected to rule on qualifying bone mineral density as a surrogate endpoint for fractures within 10 months, which could initiate EB613's pivotal Phase 3 study[6]. - Entera's collaboration with OPKO Health aims to develop oral GLP-2 tablets, which showed plasma levels approximately 10-fold higher than therapeutic concentrations for existing treatments[5]. - The company is also working on the first oral GLP-1/glucagon agonist peptide tablets for obesity, with pharmacokinetic data expected in mid-2024[7].

JERUSALEM, May 10, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and small therapeutic proteins, today reported financial results and key business updates for the quarter ended March 31, 2024. "Entera is off to a strong start in 2024 thanks to the growth strategy we implemented in 2023, expanding our N-Tab™ therapeutic pipeline with potential first in class oral GLP-2, GLP-1/glucagon and PTH(1-34) peptide treatmen ...

Entera Bio Ltd. (ENTX) closed at $1.98 in the latest trading session, marking a -1% move from the prior day. The stock's performance was behind the S&P 500's daily gain of 1.02%. Meanwhile, the Dow gained 0.4%, and the Nasdaq, a tech-heavy index, added 2.03%.Shares of the company witnessed a gain of 19.76% over the previous month, beating the performance of the Medical sector with its loss of 5.2% and the S&P 500's loss of 3.15%.The investment community will be paying close attention to the earnings perform ...

Entera Bio Ltd. (ENTX) ended the recent trading session at $2.24, demonstrating a +0.9% swing from the preceding day's closing price. The stock's performance was ahead of the S&P 500's daily loss of 0.22%. Meanwhile, the Dow experienced a rise of 0.06%, and the technology-dominated Nasdaq saw a decrease of 0.52%.Heading into today, shares of the company had gained 46.05% over the past month, outpacing the Medical sector's loss of 6.22% and the S&P 500's loss of 1.66% in that time.The investment community wi ...

For those looking to find strong Medical stocks, it is prudent to search for companies in the group that are outperforming their peers. Has Entera Bio Ltd. (ENTX) been one of those stocks this year? A quick glance at the company's year-to-date performance in comparison to the rest of the Medical sector should help us answer this question.Entera Bio Ltd. is a member of the Medical sector. This group includes 1051 individual stocks and currently holds a Zacks Sector Rank of #4. The Zacks Sector Rank gauges th ...