Entera Bio News
128 articles
Entera Bio Presents Positive New Clinical Data from EB613 Phase 2 Trial Demonstrating Significant Bone Density Improvements in Early Postmenopausal Women
Entera Bio Ltd. has reported promising clinical data from a Phase 2 trial of its oral anabolic treatment, EB613, at the 2025 North American Menopause Society Annual Meeting. The data demonstrates significant bone mineral density (BMD) gains in early postmenopausal women, highlighting EB613s potential as a first-in-class oral bone-building therapy. The company plans to initiate a global Phase 3 study following FDA concurrence in July 2025. This development could significantly improve patient access to osteoporosis treatment, addressing barriers associated with injectable therapies.
Product StageFDA approved/pending approval
Entera Bio to Present New Clinical Data from Phase 2 Trial of EB613 at the 2025 North American Menopause Society (NAMS) Annual Meeting
Entera Bio Ltd. is set to present new clinical data from its Phase 2 trial of EB613 at the North American Menopause Society 2025 Annual Meeting. The presentation will focus on bone mineral density outcomes in early postmenopausal women with low bone mass or osteoporosis. EB613 is being developed as the first oral anabolic tablet for osteoporosis, aiming to provide a more accessible treatment option compared to injectable therapies. The Phase 2 trial demonstrated positive results, meeting all biomarker and BMD endpoints without significant safety concerns. This development could potentially broaden access to anabolic therapies for the over 200 million women worldwide living with osteoporosis.
Product Stage
Individual investors are Entera Bio Ltd.'s (NASDAQ:ENTX) biggest owners and were rewarded after market cap rose by US$34m last week
Entera Bio Ltd. is significantly influenced by individual investors, who own 55% of the company, giving them substantial control over management and business strategy. The companys market capitalization increased by $34 million recently, benefiting these investors. Institutional investors also hold a notable portion of the company, suggesting credibility among professional investors. Hedge funds, owning 5.9% of the company, could potentially influence management decisions. Knoll Capital Management is the largest shareholder with 13% ownership. The ownership structure indicates that no single entity has a majority interest, allowing for diverse influence over the companys direction.
Entera Bio Unveils Promising PK Data for First Oral GLP-2 Therapy
Entera Bio Ltd. recently presented promising pharmacokinetic data for its oral GLP-2 analog therapy for short bowel syndrome (SBS) at the ESPEN Congress. The therapy, developed in collaboration with OPKO Health, aims to offer a more convenient alternative to existing treatments like Gattex, which require daily injections. The data demonstrated significant pharmacological advantages, including a longer plasma half-life and higher peak plasma concentrations compared to current therapies. While still in preclinical development, the therapys potential to address a market worth nearly $800 million annually could drive positive investor sentiment. The collaboration with OPKO Health is crucial for advancing this innovative treatment.
Product StagePartners
Entera Bio Reports Positive PK Data for First-in-Class Oral GLP-2 Tablet Treatment for Patients with Short Bowel Syndrome at the 2025 ESPEN Congress
Entera Bio Ltd. announced promising preclinical data for its oral GLP-2 analog, OPK-8801003, at the ESPEN Congress. The data showed a significantly longer biological half-life and higher peak plasma levels compared to the only approved GLP-2 therapy, Gattex®. This development could transform treatment for 30,000 short bowel syndrome patients who currently rely on daily injections. Enteras collaboration with OPKO Health combines OPKOs GLP-2 analog with Enteras N-Tab™ platform, aiming to offer a less invasive, personalized dosing option. The preclinical studies demonstrated robust oral bioavailability, sustained exposure, and a favorable safety profile.
Product StagePartners
Entera Bio Presents Positive Effects of EB613 on Both Trabecular and Cortical Bone in Postmenopausal Women with Osteoporosis at ASBMR 2025
Entera Bio Ltd. announced promising results from its Phase 2 study of EB613, an oral treatment for osteoporosis, demonstrating significant improvements in bone health. The study showed that EB613 significantly increased trabecular and cortical bone parameters after six months, comparable to existing injectable treatments. The company plans to initiate a global Phase 3 study following FDA concurrence in July 2025. Entera Bio aims to address the treatment gap in osteoporosis care by providing an accessible oral alternative to injectable anabolic treatments. The data was presented at the ASBMR 2025 Annual Meeting, highlighting the potential of EB613 to rapidly strengthen bones and improve fracture resistance.
Product StageFDA approved/pending approval
Entera Bio to Unveil Clinical and Non-Clinical Data Across 3 Oral Peptide Programs at Upcoming September Conferences
Entera Bio Ltd., a leader in oral peptides and protein replacement therapies, is advancing its osteoporosis program with the EB613 oral tablet. The company is presenting Phase 2 study results at the ASBMR 2025 Annual Meeting, showing promising effects on bone density in postmenopausal women. Entera is planning a global Phase 3 registration study following FDA alignment. Additionally, Entera is exploring a GLP-2 tablet for short bowel syndrome, utilizing proprietary technology. The company will also present at the H.C. Wainwright 27th Annual Global Investment Conference, indicating ongoing investment interest. These developments highlight Enteras growth potential in the pharmaceutical sector.
Product StageInvestment
Entera Bio Second Quarter 2025 Earnings: US$0.057 loss per share (vs US$0.058 loss in 2Q 2024)
Entera Bio reported a net loss of $2.66 million for the second quarter of 2025, which is a 24% increase in losses compared to the same period in 2024. The companys shares have decreased by 13% over the past week. The article highlights the financial challenges faced by Entera Bio, including a loss per share of $0.057. It also mentions a list of US stocks expected to pay a dividend yield of over 6% next year, although Entera Bio is not explicitly included in this list. The article provides a risk analysis, noting three warning signs for Entera Bio.
Entera Bio Announces Second Quarter 2025 Financial Results and Business Updates
Entera Bio Ltd. has received pivotal FDA agreement on the design of its Phase 3 trial for EB613, an oral anabolic treatment for osteoporosis, marking a significant regulatory milestone. The FDA has confirmed Bone Mineral Density (BMD) as the primary endpoint, streamlining the path to market. This decision supports Enteras strategic vision to address the unmet need for osteoporosis treatments. The company also reported strong financial results, with a cash position of $18.9 million, and highlighted its collaboration with OPKO, which is showing promising preclinical data. Entera plans to continue advancing its pipeline, including the next-gen EB613 expected to enter Phase 1 in November 2025.
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OPKO Health Reports Second Quarter 2025 Business Highlights and Financial Results
OPKO Health, Inc. reported its business highlights and financial results for the second quarter of 2025. Key developments include Mercks advancement of a Phase 1 Epstein-Barr virus vaccine trial in collaboration with OPKO, and ModeXs progress in its immuno-oncology portfolio with several clinical candidates. OPKO also presented promising preclinical data on its novel GLP-1/glucagon receptor dual agonist, OPK-88006, at the American Diabetes Associations Scientific Sessions. Additionally, OPKO is developing an oral tablet formulation of OPK-88006 in collaboration with Entera, which will be presented at the ENDO 2025 annual meeting. These advancements indicate a positive growth trajectory for OPKO Health.
Product StagePartners
Entera Bio Receives FDA Agreement on BMD as Primary Endpoint for EB613 Registrational, Phase 3 Study in Post-Menopausal Women with Osteoporosis
Entera Bio Ltd. announced that the FDA has agreed to support the NDA marketing application for their oral peptide treatment, EB613, with a single phase 3 study. This decision marks a significant milestone for the company, allowing them to advance their clinical development without waiting for the FDAs qualification of the Study to Advance Bone Mineral Density as a Regulatory Endpoint (SABRE). EB613 is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis, addressing a significant unmet medical need. The treatment has shown promising results in phase 2 trials, demonstrating efficacy in increasing bone mass and reducing fracture risk. This regulatory update is expected to accelerate the development and potential approval of EB613, offering a novel treatment option for osteoporosis patients.
Product StageFDA approved/pending approval
OPKO Health’s (OPK) Oral GLP-2 Analog Selected for a Poster Presentation in Collaboration with Entera Bio (ENTX)
OPKO Health, Inc., in collaboration with Entera Bio Ltd., announced the selection of their Oral GLP-2 Analog for a poster presentation at the 47th European Society for Clinical Nutrition & Metabolism Congress. This new therapy, which combines OPKOs long-acting GLP-2 agonist with Enteras N-Tab technology, aims to treat short bowel syndrome by providing an oral alternative to the currently approved injectable treatment, GATTEX. The oral format could improve patient compliance and comfort. OPKO Health is an international biopharmaceutical company developing and selling medicines, including treatments for kidney disease. The collaboration with Entera Bio is seen as a positive development for OPKO Health.
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Companies Like Entera Bio (NASDAQ:ENTX) Are In A Position To Invest In Growth
The article discusses Entera Bios financial situation, focusing on its cash burn and cash reserves. As of March 2025, Entera Bio had $13 million in cash and was debt-free, with a cash burn of $6.4 million over the past year, giving it a cash runway of two years. The company has reduced its cash burn by 16% over the last year, indicating a steady rate of business development. However, Entera Bios operating revenue remains low at $223,000, raising concerns about its ability to sustain growth without additional funding. The article suggests that shareholders should consider the companys potential to raise more cash in the future.
OPKO Health and Entera Bio Announce Abstract on PK/PD of Oral GLP-2 Tablet for the Treatment of Short Bowel Syndrome Selected for 2025 ESPEN Congress
OPKO Health, Inc. and Entera Bio Ltd. have announced that their joint abstract on a first-in-class oral GLP-2 analog for treating Short Bowel Syndrome (SBS) will be presented at the ESPEN Congress in September 2025. This collaboration combines OPKOs GLP-2 agonist with Enteras N-Tab™ technology, aiming to offer an oral alternative to the currently available injectable therapy, GATTEX®. The oral format could improve patient compliance and personalize treatment. Entera Bio is a clinical-stage company focused on developing oral peptide therapies, with several programs in the pipeline, including treatments for osteoporosis and hypoparathyroidism. The collaboration with OPKO is part of Enteras strategy to transform standard care for significant unmet medical needs.
Product StagePartners
OPKO Health (OPK) to Present OPK-88006 Data at ENDO 2025
OPKO Health, Inc., a diversified healthcare company, is set to present new data for its investigational oral OPK-88006 tablet treatment at ENDO 2025, in partnership with Entera Bio Ltd. The drug targets obesity, metabolic disorders, and fibrotic disorders, and is being developed as a novel dual agonist GLP-1/glucagon peptide. It will be available as a once-daily tablet and a weekly subcutaneous injection. The presentation will highlight the drugs pharmacologic effects and pharmacokinetic profile. This partnership and development are seen as growth-positive for OPKO Health, as it expands its pharmaceutical offerings in the metabolic therapy space.
Product StagePartners
Entera Bio Data for EB613 Effects on Trabecular and Cortical Bone in Post-Menopausal Women with Osteoporosis Selected for Oral Presentation at ASBMR 2025 Annual Meeting
Entera Bio Ltd., a leader in developing oral peptides and protein replacement therapies, announced that its EB613 treatment for osteoporosis was selected for an oral presentation at the ASBMR 2025 Annual Meeting. EB613 is being developed as the first once-daily oral anabolic PTH(1-34) tablet for postmenopausal women with osteoporosis. The Phase 2 study showed promising results, with significant increases in bone mineral density and dual effects on bone formation and resorption. The presentation will further explore these findings using 3D-DXA analysis. This development positions Entera Bio as a potential leader in addressing the treatment gap in osteoporosis care.
Product Stage
OPKO Health and Entera Bio Abstract for First-in-Class Dual GLP-1/Glucagon Tablet Candidate for Patients with Obesity and Metabolic Disorders Selected for Presentation at the ENDO 2025 Annual Meeting
Entera Bio Ltd. and OPKO Health, Inc. have announced new data for their investigational oral OPK-88006 tablet treatment, which will be presented at the ENDO 2025 annual meeting. The companies are collaborating on a novel dual agonist GLP-1/glucagon peptide treatment for obesity and metabolic disorders, available as both a tablet and a weekly injection. Entera Bio is leveraging its proprietary N-Tab™ technology in this collaboration. They plan to file an Investigational New Drug application with the FDA later this year and are preparing for Phase 1 clinical studies. Entera Bio is a clinical-stage company focused on developing oral peptide therapies for unmet medical needs, with several programs in development, including treatments for osteoporosis and hypoparathyroidism.
Product StagePartners
Piper Sandler Reiterates a Buy Rating on Opko Health (OPK) With a $3 PT
Opko Health Inc. has been highlighted as a promising long-term penny stock. The company recently announced the sale of its BioReference laboratory testing businesses for up to $225 million, including a $192.5 million payout at closing and a potential $32.5 million performance-based earnout. Additionally, Opko Health has entered a collaboration with Entera Bio to advance oral GLP-1/glucagon tablet candidates for metabolic disorders and obesity. The company is also progressing with its ModeX immuno-oncology and immunology portfolio, with four potential clinical candidates in the pipeline. Despite these developments, some analysts suggest that AI stocks may offer greater upside potential.
AcquisitionPartners
Entera Bio Announces First Quarter 2025 Financial Results and Business Updates
Entera Bio Ltd. reported financial results and business updates for Q1 2025, highlighting progress in developing oral peptide therapies. The company extended its cash runway to late 2026 through direct investment from OPKO Health Inc., a strategic partner. Entera is advancing its EB613 osteoporosis treatment, with plans for a Phase 1 study in H2 2025. The company is also co-developing Oral OPK-88006 for metabolic diseases with OPKO. Recent management appointments aim to strengthen strategic execution. Entera supports the SABRE initiative, advocating for FDA regulatory reform to use bone mineral density as a surrogate endpoint for osteoporosis drug approval, potentially accelerating innovation in this field.
InvestmentPartnersManagement ChangesProduct Stage
Entera Bio’s EB613 Demonstrates Early Impact on Both Trabecular and Cortical Bone Compartments with 6 Months of Treatment in Post-Menopausal Women with Osteoporosis - Highlighted as Oral Presentation at WCO-IOF ESCEO
Entera Bio Ltd. announced promising results from a Phase 2 study of their oral anabolic therapy, EB613, at the 2025 World Congress on Osteoporosis. The study involved 161 postmenopausal women with osteoporosis, showing that EB613 significantly increased bone mineral density (BMD) compared to placebo. The findings suggest that EB613, the first once-daily oral anabolic PTH(1-34) tablet, could rapidly strengthen bones and improve fracture resistance. The company plans to further investigate the safety and efficacy of EB613 in a Phase 3 trial. The results are consistent with those of subcutaneous teriparatide, indicating a potential breakthrough for non-injectable osteoporosis treatments.
Product Stage
Entera Bio Announces Full Year 2024 Financial Results and Provides Business Updates
Entera Bio Ltd., a leader in developing oral peptides and protein replacement therapies, reported significant advancements in 2024. The company progressed its oral peptide programs, including EB613 for osteoporosis, and increased stockholder value. Entera is preparing for a pivotal Phase 3 study of EB613, pending FDA review of the SABRE initiative, which could redefine regulatory endpoints for osteoporosis treatments. The company has partnered with OPKO Health, Inc. to expand its N-Tab™ platform. Entera aims to address the treatment gap for osteoporosis, a condition affecting millions of women globally, with its innovative oral therapy. The company plans to continue its growth and execution strategy in 2025.
Product StagePartnersExpand
Opko and Entera focus on oral care for obesity and metabolic disorders
Opko Health and Entera Bio have entered into a partnership and license agreement to develop the first oral dual agonist glucagon-like peptide-1 (GLP-1)/glucagon for treating metabolic, fibrotic, and obesity disorders. Opko will hold a 60% ownership interest, while Entera will hold 40%. Opko has invested in Entera by purchasing 3.69 million ordinary shares at $2.17 each to fund the development costs through Phase I. Entera may choose to continue funding to maintain its stake or opt out, retaining a 15% interest. The companies plan to submit an investigational new drug application to the FDA in 2025.
PartnersInvestmentProduct Stage
OPKO Health and Entera Bio Enter into Collaboration Agreement to Advance Oral GLP-1/Glucagon Tablet Candidate into the Clinic to Treat Obesity and Metabolic Disorders
OPKO Health, Inc. and Entera Bio Ltd. have entered into a collaboration and license agreement to develop an oral dual agonist GLP-1/glucagon peptide for treating obesity, metabolic, and fibrotic disorders. The program combines OPKOs oxyntomodulin analog with Enteras N-Tab™ technology. The companies plan to file an Investigational New Drug application with the FDA later this year. OPKO will hold a 60% ownership interest and Entera 40%, with respective responsibilities for development costs. OPKO also purchased shares of Entera to fund its share of development costs. The collaboration aims to provide new treatment options for patients. The program is currently in the clinical trial stage.
PartnersInvestmentProduct Stage
Entera Bio to Participate in Upcoming Events
Entera Bio Ltd., a clinical-stage company, is advancing its development of oral peptide and protein replacement therapies. The company is preparing to initiate a Phase 3 registrational study for its most advanced product candidate, EB613, an oral tablet treatment for osteoporosis. Entera is also developing other oral peptide therapies, including EB612 for hypoparathyroidism and a GLP-2 peptide for malabsorption conditions, in collaboration with OPKO Health. The companys participation in upcoming global healthcare conferences highlights its commitment to addressing unmet medical needs with innovative oral therapies. Enteras proprietary technology platform, N-Tab™, supports its pipeline of first-in-class oral peptide programs.
Product StagePartners
EFFECTS OF EB613 TABLETS [ORAL PTH(1-34)] ON TRABECULAR AND CORTICAL BONE USING 3D-DXA: POST-HOC RESULTS FROM PHASE 2 STUDY Accepted for Oral Presentation at World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases
Entera Bio Ltd., a leader in oral peptide and protein replacement therapies, announced that its abstracts related to EB613 have been accepted for presentation at the World Congress on Osteoporosis. EB613 is being developed as a once-daily oral anabolic PTH(1-34) tablet for high-risk post-menopausal women with osteoporosis. The Phase 2 study demonstrated significant increases in bone mineral density and bone formation. The presentations will occur at the WCO-IOF-ESCEO congress in Rome in April 2025. The company aims to address the treatment gap in osteoporosis care with this innovative oral solution, providing an alternative to injectable treatments.
Product Stage
US Penny Stocks: 3 Picks With Market Caps Over $60M
Entera Bio Ltd. is a clinical-stage biotech company focused on developing oral peptide or protein replacement therapies for unmet medical needs. With a market cap of $88.4 million, the company is pre-revenue and faces potential liquidity challenges due to having less than a year of cash runway and no debt. Despite reducing losses by 2.8% annually over the past five years, Entera Bio remains unprofitable and is not expected to achieve profitability in the next three years. The companys experienced management and board provide some stability amid high share price volatility and significant net losses.
Product Stage
Is Entera Bio (NASDAQ:ENTX) In A Good Position To Deliver On Growth Plans?
Entera Bio, an unprofitable company, has seen a significant increase in its share price by 225% over the last year. However, the company is experiencing a high cash burn rate, spending $8.0 million annually with only $6.9 million in cash reserves as of September 2024. This gives it a cash runway of approximately 10 months, indicating an urgent need to reduce cash burn or raise additional funds. Despite a small revenue of $99,000 in the past year, the company has increased its cash burn by 19%, suggesting increased investment in future growth. Entera Bio may need to consider raising capital through debt or equity to sustain its operations.
Entera Bio to Present at the Oppenheimer 35th Annual Healthcare Life Sciences Conference
Entera Bio Ltd., a clinical-stage company specializing in orally delivered peptides and therapeutic proteins, announced its participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference in February 2025. The company is advancing its pipeline, including EB613, an oral osteoanabolic tablet for osteoporosis, which has shown promising results in Phase 2 trials. Entera plans to initiate a Phase 3 study for EB613 in the second half of 2025. Additionally, Entera is developing EB612 for hypoparathyroidism and collaborating with OPKO Health on oral peptide therapies for obesity and gastrointestinal conditions. The companys innovative approach and strategic partnerships position it for growth in addressing unmet medical needs.
Product StagePartners
Entera Bio Reports Q3 2024 Financial Results and Provides Business Updates
Entera Bio Ltd., a company specializing in oral peptides and therapeutic proteins, reported its financial results and business updates for Q3 2024. The company highlighted its pivotal clinical asset, EB613, an oral PTH(1-34) tablet for post-menopausal women with osteoporosis. Enteras N-Tab™ platform has shown consistent performance across various programs. The company anticipates a significant FDA ruling on osteoporosis drug regulatory endpoints in January 2025, which could benefit EB613. Entera aims to address the treatment gap in osteoporosis, a major womens health issue. Recent pharmacological data for EB613 was presented at the ASBMR 2024 Annual Meeting, indicating progress in their clinical trials.
Entera Bio Ltd. (ENTX) Reports Q3 Loss, Tops Revenue Estimates
Entera Bio Ltd. reported a quarterly loss of $0.08 per share, which was worse than the Zacks Consensus Estimate of a $0.05 loss, resulting in an earnings surprise of -60%. Despite this, the company posted revenues of $0.04 million, surpassing the consensus estimate by 5%. Entera Bios stock has increased by 191.7% since the beginning of the year, outperforming the S&P 500s gain of 25.2%. The companys future stock performance will depend on managements commentary and earnings outlook. Currently, the stock holds a Zacks Rank #3 (Hold), indicating it is expected to perform in line with the market. The consensus EPS estimate for the coming quarter is -$0.06 with $0.04 million in revenues.
Are Medical Stocks Lagging Argenx (ARGX) This Year?
The article discusses the performance of argenex SE (ARGX) within the Medical sector, highlighting its strong year-to-date performance. ARGX has gained about 42.7% this year, significantly outperforming the average return of 7.2% for Medical companies. The company holds a Zacks Rank of #1 (Strong Buy), indicating positive analyst sentiment and an improved earnings outlook. The Zacks Consensus Estimate for ARGXs full-year earnings has increased by 87.4% over the past three months. The article also mentions Entera Bio Ltd. (ENTX), another Medical stock with a high return of 206.7% this year. Both companies are part of the Medical - Biomedical and Genetics industry, with ARGX performing better than its industry peers.
ENTX & OPK Stock May Gain Following Positive PK/PD Research Data
Entera Bio Ltd. (ENTX) and OPKO Health, Inc. (OPK) announced positive topline pharmacokinetic/pharmacodynamic (PK/PD) results from their collaborative research on a long-acting oxyntomodulin (OXM) analog. This program aims to develop the first oral dual agonist GLP-1/glucagon peptide for treating obesity and metabolic disorders. Despite the positive results, ENTX shares fell by 1.5%, while OPK shares remained flat. The global weight management market is projected to grow significantly, which could benefit both companies. The research demonstrated significant systemic exposure and favorable pharmacokinetic profiles in animal models. The companies plan to present these findings at a future clinical meeting.
Partners
Entera Bio and OPKO Health Provide Update on PK/PD Results of Oral Oxyntomodulin (GLP-1/Glucagon) Peptide Tablet Candidate for Obesity and Metabolic Disorders
Entera Bio Ltd. and OPKO Health, Inc. announced positive topline results from their collaborative research on an oral dual agonist GLP-1/glucagon peptide for treating obesity and metabolic disorders. The study demonstrated significant systemic exposure and favorable pharmacokinetic profiles in rodent and pig models. The collaboration aims to develop the first oral oxyntomodulin (OXM) analog, leveraging Enteras N-Tab™ technology and OPKOs OXM analog. The companies plan to present these findings at an upcoming clinical conference. Enteras CEO expressed satisfaction with the progress, indicating continued efforts towards IND-enabling studies.
Partners
Is Entera Bio (ENTX) Stock Outpacing Its Medical Peers This Year?
Entera Bio Ltd. (ENTX) has shown strong performance in the Medical sector, outperforming its peers with a year-to-date return of 253.3%. The company holds a Zacks Rank of #2 (Buy), indicating a positive earnings outlook. Over the past three months, the Zacks Consensus Estimate for ENTXs full-year earnings has increased by 8%, reflecting improved analyst sentiment. The Medical sector, in general, has returned an average of 10.9% year-to-date. Another strong performer in the sector is argenex SE (ARGX), with a year-to-date return of 37.3% and a similar Zacks Rank of #2 (Buy). Both companies belong to the Medical - Biomedical and Genetics industry, which has gained an average of 2.3% this year.
Is Entera Bio (ENTX) Outperforming Other Medical Stocks This Year?
Entera Bio Ltd. (ENTX) has shown strong performance in the Medical sector, outperforming its peers with a year-to-date return of 178.3%, compared to the sectors average of 12.7%. The company holds a Zacks Rank of #2 (Buy), indicating positive analyst sentiment and an improving earnings outlook, with the Zacks Consensus Estimate for full-year earnings moving 8% higher in the past quarter. Another notable performer in the sector is Akebia Therapeutics (AKBA), which has also outperformed with a 25% year-to-date return and a Zacks Rank of #2 (Buy). Investors are advised to keep an eye on these stocks for continued solid performance.
We're Keeping An Eye On Entera Bio's (NASDAQ:ENTX) Cash Burn Rate
Entera Bio, listed on NASDAQ as ENTX, has seen a significant increase in its stock price, up 139% over the past year. Despite being unprofitable, the company has managed its cash burn effectively, reducing it by 8.9% over the last year. As of June 2024, Entera Bio had $9.1 million in cash reserves and a cash burn rate of $7.3 million annually, giving it a cash runway of approximately 15 months. The company has a market capitalization of $60 million, and it is likely to raise more cash through issuing new shares or taking on debt. The article suggests that while there are risks associated with cash-burning companies, Entera Bios situation appears manageable.
Investment
Entera Bio to Participate in Upcoming Investor and Scientific Conferences
Entera Bio Ltd., a leader in the development of orally delivered peptides and small therapeutic proteins, announced that its management will be participating in various investor and scientific conferences. The company is focused on developing oral peptide or protein replacement therapies for significant unmet medical needs. Its pipeline includes five differentiated, first-in-class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The companys most advanced product candidate, EB613, is being developed for post-menopausal women with low BMD and high-risk osteoporosis. The company is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP-2 peptide tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health.
InvestmentManagement Changes
All You Need to Know About Entera Bio (ENTX) Rating Upgrade to Buy
Entera Bio Ltd. has been upgraded to a Zacks Rank #2 (Buy), reflecting an upward trend in earnings estimates. The Zacks rating system tracks EPS estimates for the current and following years from sell-side analysts, and is a powerful factor influencing near-term stock price movements. The rating upgrade for Entera Bio is essentially a positive comment on its earnings outlook that could have a favorable impact on its stock price. For the fiscal year ending December 2024, Entera Bio is expected to earn -$0.23 per share, a change of 25.8% from the year-ago reported number.
Investment
Entera Bio Reports Q2 2024 Financial Results and Provides Business Updates
Entera Bio Ltd., a leader in the development of orally delivered peptides and small therapeutic proteins, reported financial results and key business updates for Q2 2024. The company is preparing for FDAs potential landmark ruling on the ASBMR-FNIH SABRE regulatory endpoint for osteoporosis drugs. Entera welcomed Dr. Rachel Wagman as Key Clinical Advisor to lead EB613 clinical development. The company continues to collaborate with a third party on the development of another PTH replacement treatment for hypoparathyroidism. As of June 30, 2024, Entera had cash and cash equivalents of $9.1 million.
InvestmentManagement ChangesExpand
Entera’s EB613, the First Once Daily PTH(1-34) Tablet Treatment Dedicated to Post-Menopausal Women with High Risk Osteoporosis Abstract Selected for Presentation at the ASBMR 2024 Annual Meeting - Key SABRE Update Also Expected
Entera Bio Ltd. has announced that new comparative pharmacological data for its investigational agent EB613 vs. Forteo® was selected for presentation at the American Society for Bone and Mineral Research (ASBMR) 2024 Annual Meeting. EB613 is being developed as the first once-daily oral anabolic (bone forming) PTH(1-34) mini tablet therapy for post-menopausal women with high risk osteoporosis. The company is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint which is expected to occur by January 2025.
InvestmentExpand
3 Meme Stocks to Buy and Hold for Potential 300% Returns in 3 Years
The article discusses the potential of three meme stocks - Cronos, Entera Bio, and Bitfarms - to deliver significant returns in the next three years. Cronos, a cannabis company, is expected to benefit from increasingly friendly regulations in the sector and has a strong cash buffer for investments and potential acquisitions. Entera Bio, a clinical-stage biotech company, has a promising product candidate for the treatment of high-risk, post-menopausal osteoporosis. Bitfarms, a Bitcoin miner, is well-positioned for aggressive expansion with a zero-debt balance sheet and strong liquidity.
InvestmentExpand
3 Meme Stocks That Can Surge by 200% Before 2025
The article discusses the potential of three meme stocks - Bitfarms, Archer Aviation, and Entera Bio - to deliver high returns. Bitfarms, a Bitcoin miner, is expected to surge due to its revenue and EBITDA growth potential. Archer Aviation, an electric vehicle take-off and landing (eVTOL) company, is backed by Stellantis and United Airlines and is expected to commercialize eVTOL in the U.S. next year. Entera Bio, a clinical-stage biotech company, is working towards the commercialization of orally delivered peptides and other therapeutic proteins, with its most advanced product candidate, EB613, for the treatment of post-menopausal osteoporosis.
Investment
3 Clinical-Stage Biotech Stocks to Buy for Multibagger Returns
The article discusses the potential of investing in clinical-stage biotech stocks, focusing on three companies: Entera Bio, Adicet Bio, and Actinium Pharmaceuticals. Entera Bio, valued at $63 million, has seen a 100% rally in the last 12 months and is developing EB613 for the treatment of post-menopausal osteoporosis. Adicet Bio has seen a 53% decline in the last 12 months but has received FDA approval for a fast-track designation for ADI-001. Actinium Pharmaceuticals has remained steady over the last 12 months and is developing Iomab-B, currently in Phase 3 clinical trials. The author suggests these stocks have the potential for significant returns over the next 24 to 36 months.
Investment
3 Meme Stocks to Buy on the Dip: June 2024
The article discusses the potential of certain meme stocks for investment. These include Riot Platforms, Aurora Cannabis, and Entera Bio. Riot Platforms is considered undervalued with strong fundamentals and a zero-debt balance sheet. Aurora Cannabis is expected to see action with the upcoming U.S. Presidential elections and potential for cannabis legalization. Entera Bio, a clinical-stage biotech company, is seen as a good opportunity to buy before the stock surges. The article suggests these stocks have potential for a rally and are good buys on the dip.
Investment
Rags to Riches: 3 Penny Stocks That Could Make Early Investors Rich
The article discusses three penny stocks with potential for significant growth: Joby Aviation, Entera Bio, and Solid Power. Joby Aviation, a flying car company, is expected to grow as the industry is estimated to reach $29 billion by 2030 and $1 trillion by 2040. The company recently acquired Xwing, a developer of autonomous technology for aviation. Entera Bio, a clinical-stage biotech company, has a promising product candidate, EB613, for high-risk post-menopausal osteoporosis treatment. Solid Power, a company focused on commercializing solid-state batteries, has the backing of major automotive players like BMW and Ford. The company is also deepening its partnership with SK On.
InvestmentAcquisition
7 Penny Stocks to Turn $3 Into $1 Million Within 36 Months
The article discusses seven penny stocks that are expected to deliver high returns over the next three years. These include Bitfarms, a Bitcoin miner with strong fundamentals and expansion plans; Archer Aviation, an eVTOL company with FAA certification and global expansion plans; Ring Energy, an oil & gas exploration company with a positive growth track record; Standard Lithium, a lithium company with a partnership with Equinor; Entera Bio, a biotech company with a promising pipeline; Curaleaf Holdings, a cannabis company with a presence in 17 states in the U.S. and expansion plans in Europe; and Blink Charging, an EV charging company with robust growth visibility.
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3 Penny Stocks to Turn $50,000 Into $1 Million: June 2024
The article discusses three high-risk penny stocks with potential for significant returns over the next three to four years. These include Cronos Group, a cannabis company with a strong balance sheet and cash buffer of $855 million, which is expanding into new markets. Entera Bio, a clinical-stage biotech company with a market valuation of $78 million, is working on orally delivered peptide and protein therapeutics for unmet medical needs. Blade Air Mobility, which provides air transportation alternatives to congested ground routes in the U.S., has an asset-light business model and robust growth outlook.
Investment
Under-$10 Picks: 3 Biotech Stocks That Can Double Before the End of 2024
The article discusses three biotech stocks under $10 that have impending catalysts. Actinium Pharmaceuticals, a clinical-stage biopharma company, has a cash buffer of $84 million expected to fund operations into the second half of 2026. Adicet Bio, a clinical-stage biotechnology company, received fast track designation from the U.S. Food and Drug Administration for ADI-001, a major catalyst for stock upside. Entera Bio, a clinical-stage biotech company, has cash runway through the first half of 2025 and multiple programs expected to enter clinical stage in 2025.
Investment
Meme Mania Meets Medicine: 3 Biotech Stocks Primed to Soar
The article discusses the impact of meme frenzy on biotech stocks, particularly those with ambitious growth plans. It highlights the example of Novavax, whose stock price increased by 328% in a month following news of a partnership with Sanofi. The article also identifies other biotech companies that could potentially see a similar surge, including Atossa Therapeutics, Entera Bio, and Actinium Pharmaceuticals. These companies are developing treatments for conditions such as breast cancer, osteoporosis, and cancer, and have seen significant stock price increases in the past year.
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Entera Bio Reports Phase 1 Clinical Data of First-in-Class, Oral PTH(1-34) Peptide Candidate (EB612) for Patients with Hypoparathyroidism at ENDO 2024
Entera Bio Ltd. has announced Phase 1 clinical data for its hypoparathyroidism focused investigational program, EB612. The program aims to provide the first oral PTH daily tablet hormone replacement therapy for patients suffering from hypoparathyroidism. The data reported from this Phase 1 clinical study include pharmacokinetic (PK), pharmacodynamic (PD) and safety results from the application of a new generation of Entera’s N-Tab™ technology platform and EB612. The companys CEO, Miranda Toledano, stated that the findings reaffirm the ability of their N-Tab™ platform to develop simple oral tablet treatments of important peptide therapeutics.
Investment
Has Entera Bio (ENTX) Outpaced Other Medical Stocks This Year?
Entera Bio Ltd. has been performing well in the medical sector, outperforming many other companies with a year-to-date return of about 275%. The companys earnings outlook has improved, with the Zacks Consensus Estimate for its full-year earnings moving 66.7% higher in the past quarter. The company currently has a Zacks Rank of #2 (Buy). Another medical stock that has been performing well is PetIQ, with a year-to-date return of 5.1% and a Zacks Rank of #1 (Strong Buy).
Investment
The Next Novavax? 3 Biopharma Stocks to Buy Before They Boom
Novavaxs stock, which had been lagging in the race for the COVID-19 vaccine, has seen a significant boost following a deal with Sanofi, with the stock increasing by 280% last month. The article suggests that with the potential return of the meme stock frenzy, now is a good time to invest in biotech stocks. It also discusses three other biotech stocks to consider: Acasti Pharma, Entera Bio, and Karyopharm Therapeutics. All three companies are working on promising drug pipelines and have potential for significant growth.
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Are Medical Stocks Lagging Entera Bio (ENTX) This Year?
Entera Bio Ltd. has been identified as a strong performer in the medical sector, with a year-to-date return of 336.7%, significantly outperforming the average return of 5.6% for the sector. The companys full-year earnings estimate has also increased by 66.7% in the past quarter, indicating a positive outlook. Another strong performer is Assembly Biosciences, with a year-to-date return of 48.4%. Both companies are recommended for investors interested in medical stocks.
Investment
Vanda (VNDA) Rises on Positive Data From Motion Sickness Study
Vanda Pharmaceuticals Inc. has reported positive data from a second phase III study for its drug, tradipitant, which is being developed to prevent vomiting induced by motion sickness. The study confirmed earlier results that showed the drugs efficacy. The company plans to submit a new drug application for tradipitant to the FDA for the treatment of motion sickness in Q4 2024. The successful development and potential approval of tradipitant would address a significant patient population in the US, as around 30% of the population suffers from motion sickness under ordinary travel conditions.
Investment
Entera Bio Appoints Dr. Rachel B Wagman as Key Clinical Advisor and Scientific Advisory Board Member
Entera Bio Ltd. has announced the appointment of Rachel B Wagman, MD, FACE, FACP, as Key Clinical Advisor and Member of its Scientific Advisory Board. Dr. Wagman brings over 20 years of experience in metabolic bone disease and women’s health research and drug development. She has successfully advanced the development of five molecules, including the osteoporosis products teriparatide (Forteo®), denosumab (Prolia®) and romosozumab (Evenity®) through clinical development, registration, and lifecycle management. The company believes her appointment will significantly benefit the continued development of their oral peptide pipeline.
Management Changes
Entera Bio to Present Phase 1 Data from First-in-Class, PTH(1-34) Peptide Tablets (EB612) for the Treatment of Hypoparathyroidism at ENDO 2024
Entera Bio Ltd. announced that it will present data for its investigational program EB612 at the Endocrine Society ENDO 2024 Annual Meeting. The EB612 program is being developed to provide the first oral PTH(1-34) tablet peptide replacement therapy for patients suffering from hypoparathyroidism. The data from the Phase 1 study includes PK and early PD results from the application of a new generation of Entera’s N-Tab™ technology platform with an unmodified PTH(1-34) peptide.
Customers
Entera Bio Reports Q1 2024 Financial Results and Provides Business Updates
Entera Bio Ltd. has reported positive financial results and key business updates for Q1 2024. The company has expanded its N-Tab™ therapeutic pipeline with potential first in class oral GLP-2, GLP-1/glucagon and PTH(1-34) peptide treatments for patients with GYN/endocrine, metabolic and gastrointestinal disorders. The company also announced positive in vivo PK results from its program combining OPKO Health, Inc.’s long acting GLP-2 analogue with N-Tab™ technology. As of March 31, 2024, Entera had cash and cash equivalents of $9.2 million and expects its existing cash resources to meet its projected operating requirements into the third quarter of 2025.
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Are Medical Stocks Lagging Arbutus Biopharma (ABUS) This Year?
Arbutus Biopharma is outperforming its peers in the medical sector, according to Zacks Investment Research. The companys stock has returned 11.2% so far this year, compared to an average gain of 1.5% for medical stocks. The Zacks Consensus Estimate for Arbutus Biopharmas full-year earnings has also moved 0.9% higher over the past three months, indicating improving analyst sentiment and a positive earnings outlook. The company currently has a Zacks Rank of #2 (Buy).
Investment
Entera Bio Ltd. (ENTX) Stock Slides as Market Rises: Facts to Know Before You Trade
Entera Bio Ltd. saw a 1% decrease in its latest trading session, closing at $1.98. Despite this, the companys shares have gained 19.76% over the past month, outperforming the Medical sector and the S&P 500. The investment community is closely watching the companys upcoming earnings release, with expectations of a 25% increase from the prior-year quarter. The company currently holds a Zacks Rank of #1 (Strong Buy), indicating positive analyst forecasts. The Zacks Rank system has a strong track record of predicting stock performance.
Investment
Why the Market Dipped But Entera Bio Ltd. (ENTX) Gained Today
Entera Bio Ltd. saw a 0.9% increase in its recent trading session, closing at $2.24. This performance was ahead of the S&P 500s daily loss of 0.22%. Over the past month, the companys shares have gained 46.05%, outpacing the Medical sectors loss of 6.22% and the S&P 500s loss of 1.66%. The investment community is closely monitoring the companys performance ahead of its forthcoming earnings report. Analysts predict an EPS of -$0.06, indicating a 25% growth compared to the same quarter last year. The company currently carries a Zacks Rank of #1 (Strong Buy).
Investment
Can You Afford to Ignore These 3 Biotech Stocks Up Over 160% in 2024?
Biotech companies Alpine Immune Sciences, Entera Bio, and Rezolute have seen significant growth in their stock prices, surging over 160% year-to-date. Alpine Immune Sciences promising autoimmune drug, Povetacicept, has led to a substantial $4.9 billion buyout offer from Vertex Pharmaceuticals. Entera Bio has advanced its clinical pipeline, notably its leading compounds EB613 for osteoporosis and EB612 for hypoparathyroidism. Rezolute has seen increased investment from major shareholder and director Handok Inc., with two large stock purchases totaling approximately $17 million. All three companies have promising clinical trials and research collaborations underway.
Investment
Is Entera Bio (ENTX) Outperforming Other Medical Stocks This Year?
Entera Bio Ltd. has been outperforming its peers in the Medical sector, with a year-to-date return of 343.3%, compared to the sectors average gain of 2.4%. The companys full-year earnings estimate has also increased by 66.7% over the past 90 days, indicating a positive earnings outlook. The company currently holds a Zacks Rank of #1 (Strong Buy). Another Medical stock, FibroGen, has also performed well this year, with a return of 53.5%.
Investment
Here's Why You Should Invest in Entera Bio (ENTX) Stock Now
Entera Bio, a biotech company that develops oral peptide therapies, has seen its stock surge 117.7% in the past year. The companys leading pipeline candidate is EB613, an oral tablet for treating osteoporosis. A phase IIb study of the EB613 tablets met the primary and secondary endpoints and the company plans to begin a phase III study once the FDA qualifies the treatment-related change in bone mineral density as a surrogate endpoint for fractures. Entera Bio also plans to advance five potential first-in-class oral peptide programs into clinical development in 2025.
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Entera Bio Announces Publication of Oral PTH(1-34) Peptide Tablets (EB613) Phase 2 Trial Data in the Journal of Bone and Mineral Research
Entera Bio Ltd. has announced the publication of data from the Phase 2 Trial of its lead clinical compound, EB613, for the treatment of post-menopausal women with low bone mineral density (BMD) or osteoporosis. The study found that the highest dose of the oral tablet produced an increase in markers of bone formation while simultaneously decreasing the markers of bone breakdown. Significant gains in bone mineral density of the spine and hip were observed at the end of the 6-month study and there were no significant safety concerns. The company is preparing to initiate a Phase 3 registrational study for EB613.
Customers
Entera Bio Announces Key Regulatory Milestone for Oral PTH(1-34) Peptide (EB613) Phase 3 Program: FDA Ruling on Qualifying BMD as a Surrogate Endpoint for Osteoporosis Drugs is Expected Within 10 Months
Entera Bio Ltd. announced that the U.S. Food and Drug Administration (FDA) has communicated to the SABRE project team that a ruling to qualify the treatment-related change in bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs would be provided within 10 months. This is significant for Enteras lead clinical candidate, EB613, a first-in-class PTH(1-34) daily tablet treatment for osteoporosis. The company believes EB613 stands as the first program to potentially avail itself of the landmark SABRE initiative.
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OPKO Health (OPK) And Entera Bio Announce Data for GLP-2
OPK Health, Inc. and Entera Bio Ltd. have announced positive pharmacokinetic outcomes from their joint study that combines Enteras N-Tab technology with a long-acting, proprietary GLP-2 agonist created by OPK. The goal of the program is to create the first and only GLP-2 peptide pill substitute for individuals with short bowel syndrome (SBS) and other conditions that cause inflammation of the mucosa and loss of nutrients. The companies are looking forward to updating these data later in 2024.
Partners
12 Best Biotech Penny Stocks to Invest In
The article discusses the growth and investment in the biotech sector, with a focus on Eli Lilly and Company. The company has seen a significant increase in investments and has made several acquisitions and collaborations, including DICE Therapeutics, POINT Biopharma, Versanis Bio, Emergence Therapeutics, Mablink Biosciences, Immunitrack, and Sigilon Therapeutics. The company also plans to expand its manufacturing capacity. The CEO of Eli Lilly, Dave Ricks, highlighted the companys efforts towards increasing the resilience of drug manufacturing and growing top lines through key partnerships. The companys revenue grew by 28% in Q4, with new products growing by over $2 billion.
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We Think Entera Bio (NASDAQ:ENTX) Can Afford To Drive Business Growth
Entera Bio, a software-as-a-service business, has been losing money for years while growing its recurring revenue. Despite this, the companys cash burn rate has reduced by 42% over the last year, indicating some degree of prudence. As of December 2023, Entera Bio had US$11m in cash and was debt-free, with a cash runway of around 18 months. The companys cash burn relative to its market cap is quite good, and it is suggested that it would not have much trouble raising more cash for growth. However, this would result in some dilution for shareholders.
Investment
Entera Bio Announces Robust Pharmacokinetic Data for First-in-Class Oral GLP-2 Peptide Tablet Treatment for Patients with Short Bowel Syndrome
Entera Bio Ltd. has announced positive pharmacokinetic results from its research in collaboration with OPKO Health, Inc. The research is focused on developing the first and only GLP-2 peptide tablet alternative for patients suffering from short bowel syndrome and other disorders involving mucosal inflammation and nutrient malabsorption. The study’s objectives were met with oral GLP-2 tablets exhibiting significant systemic exposure. Entera and OPKO completed a proof of concept single dose pharmacokinetic study in rodents as the first validation for oral administration of the GLP-2 treatment.
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Entera Bio Announces Full Year 2023 Financial Results and Provides Business Updates
Entera Bio Ltd. reported its financial results for the fourth quarter and year ended December 31, 2023. The company highlighted its progress in the development of orally delivered peptides, with five potential first-in-class oral peptide programs expected to advance into the clinic by the end of 2025. The company also reported a net loss of $8.9 million for the year ended December 31, 2023, compared to a net loss of $13.1 million for the year ended December 31, 2022. Entera Bio Ltd. expects to have sufficient cash to fund operations through the first half of 2025.
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Entera Bio Regains Compliance with Nasdaq Minimum Bid Price Requirement
Entera Bio Ltd., a leader in the development of orally delivered peptides, has regained compliance with the minimum bid price requirement under NASDAQ Listing Rule 5550(a)(2) for continued listing on The NASDAQ Capital Market. The companys shares were required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive business days, which was achieved on March 1, 2024. Entera Bio is currently developing several oral peptide or protein replacement therapies for significant unmet medical needs.
Public Trading
Entera Bio to Present at the Oppenheimer 34th Annual Healthcare Life Sciences Conference
Entera Bio Ltd., a leader in the development of orally delivered peptides and therapeutic proteins, will participate in the Oppenheimer 34th Annual Healthcare Life Sciences Conference in February 2024. The companys CEO, Miranda Toledano, will present a business overview and update. Entera is a clinical stage company with a focus on developing oral peptide or protein replacement therapies. The companys pipeline includes five first-in-class oral peptide programs, expected to enter into the clinic (Phase 1 to Phase 3) by 2025.
InvestmentManagement Changes
Entera Bio Receives Extension from Nasdaq to Regain Compliance with Minimum Bid Price Rule
Entera Bio Ltd., a leader in the development of orally delivered peptides and therapeutic proteins, has received an extension of 180 calendar days from the Nasdaq Stock Market to regain compliance with the Nasdaq’s minimum $1.00 bid price requirement for continued listing on the Nasdaq Capital Market. The company has until June 24, 2024, to regain compliance, and if it fails to do so, its shares will be subject to delisting. The notification from Nasdaq has no effect on the company’s business operations or on the listing or trading of the company’s shares.
Public Trading
Entera Bio Announces Closing of Private Placement - Extends Cash Runway into 2025
Entera Bio Ltd., a leader in the development of orally delivered peptides and therapeutic proteins, announced that it has closed a private placement with certain existing and new investors on December 22, 2023. The company issued and sold 7,916,879 units at a price of $0.835 per unit, generating gross proceeds of approximately $6.6 million. This extends the companys cash runway into 2025. The company intends to use the net proceeds from the private placement for general working capital purposes. Network 1 Financial Securities Inc., consulted by Intuitive Venture Partners, acted as lead placement agent for the private placement.
Investment
Entera Bio Announces Closing of Private Placement - Extends Cash Runway into 2025
Entera Bio Ltd., a leader in the development of orally delivered peptides and therapeutic proteins, has closed a private placement with certain existing and new investors. The company issued and sold 7,916,879 units at a price of $0.835 per unit, raising approximately $6.6 million. This extends the companys cash runway into 2025. If all warrants were exercised for cash, Entera would be entitled to receive additional proceeds of approximately $7.9 million. The company intends to use the net proceeds from the private placement for general working capital purposes.
Investment
חברת אנטרה משיקה טיפול חדשני באוסטאופורוזיס
Entera Bio, a leader in the development of orally delivered peptides and therapeutic proteins, has reported interim data from an ongoing Phase 1 study designed to evaluate and compare the early pharmacokinetic and pharmacodynamic profile of the current generation and several next-generation compositions of its oral peptide platform. The study initially compared the PK profile of Enteras Phase 3 candidate, once-daily oral mini-tablets of PTH(1-34) (EB613, also known as EBP05 formulation), with subcutaneous PTH(1-34) 20 μg (Forteo®).
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Interim Results from Ongoing Clinical Study Confirm EB613 Optimized Profile for Osteoporosis Treatment and Potential for Entera’s Next Generation Oral Peptide Platform
Entera Bio Ltd. reported interim data from an ongoing Phase 1 study assessing the pharmacokinetic and early pharmacodynamic profile of its oral peptide platform. The study compared the profile of Enteras Phase 3 candidate, oral once-daily PTH(1-34) mini-tablets (EB613), with subcutaneous PTH(1-34) 20 g (Forteo). EB613 demonstrated a rapid and dose-proportional increase in plasma drug concentrations of PTH(1-34) at all doses tested. The companys next generation platform also showed robust bioavailability with novel oral peptide compositions. Entera is preparing to initiate a Phase 3 registrational study for EB613.
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Entera Bio Reports Q3 2023 Financial Results, Highlights Transformational Steps and Unveils Vision as Premier Oral Peptide Company with Five Potential Programs in Development
Entera Bio Ltd. has reported its Q3 2023 financial results and corporate updates. The company is focusing on the development of orally delivered peptides and small therapeutic proteins. It aims to move five high-value, first-in-class programs into the clinic by the end of 2025. The company has announced a collaboration with OPKO Health, Inc. to expand its oral delivery technology. Entera Bio has sufficient cash on hand to enable key read-outs from its significant pipeline expansion efforts over the coming year. As of September 30, 2023, Entera had cash and cash equivalents of $7.6 million.
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Entera Bio Reports Key Milestone Relating to Oral PTH (1-34) Peptide (EB613) Phase 3 Program: ASBMR-SABRE Has Submitted to FDA the Full Qualification Plan to Approve BMD as a Surrogate Endpoint for Osteoporosis
Entera Bio Ltd. has submitted a full qualification plan to the U.S. Food and Drug Administration (FDA) for the use of bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs. The submission is part of the SABRE project, which is the first surrogate endpoint undergoing qualification by the FDA under the 21st Century Cures Act. The companys EB613, an oral osteoanabolic tablet treatment for osteoporosis, could be the first program to use the BMD endpoint. Entera is preparing to initiate a Phase 3 registrational study for EB613.
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Entera Bio Reports Rapid Pharmacodynamic (PD) Response and Consistent Pharmacokinetic (PK) Data for its First-in-Class Oral PTH(1-34) Mini Tablets at the ASBMR 2023 Annual Meeting
OPKO Health (OPK) Ties Up for Oral Peptide Tablet Formulations
OPKO Health, Inc.’s subsidiary, OPKO Biologics, Inc., has entered into a Research Collaboration Agreement with Entera Bio Ltd. The agreement involves OPKO Health supplying its proprietary long-acting Glucagon-Like Peptide-2 (GLP-2) peptide and certain Oxyntomodulin (OXM) analogs for the development of oral tablet formulations using Entera’s proprietary oral delivery technology. Both companies will be responsible for specific phases of development of the two oral peptides. The partnership is expected to significantly strengthen OPKO Health’s global business.
Partners
Entera Bio Announces Collaboration with OPKO Biologics to Develop Oral Peptide Tablet Formulations for Obesity and Intestinal Malabsorption Syndromes
Entera Bio Ltd. and OPKO Biologics, Inc., a subsidiary of OPKO Health, Inc., have entered into a Research Collaboration Agreement. Under the terms of the Agreement, OPKO will supply its proprietary long-acting GLP-2 peptide and certain Oxyntomodulin (OXM) analogs for the development of oral tablet formulations using Entera’s proprietary oral delivery technology. The collaboration will enable Entera to expand its oral delivery technology across additional high value peptides. OPKO has developed several proprietary, modified OXM analogs as potential candidates for treating obesity.
Partners
Entera Bio to Participate in Upcoming Investor Conferences
Entera Bio Ltd., a leader in the development of orally delivered peptides and therapeutic proteins, announced its participation in upcoming investor conferences. The companys CEO, Miranda Toledano, will be presenting at the H.C. Wainwright 25th Annual Global Investment Conference and the BIO Investor Forum. Entera is currently developing its most advanced product candidate, EB613, for the treatment of post-menopausal women with low BMD and high-risk osteoporosis. The company is also working on EB612 for the treatment of hypoparathyroidism and expects to report results from a phase 1B PK study in the second half of 2023.
InvestmentManagement Changes
Is Entera Bio (NASDAQ:ENTX) In A Good Position To Invest In Growth?
The article discusses Entera Bios cash burn rate and its impact on the company. It analyzes the companys cash reserves and cash runway, indicating that the end of the cash runway is in sight unless cash burn reduces drastically. The article also mentions that Entera Bio has reduced its cash burn by 34% over the last year. However, it raises concerns about the companys ability to raise more cash for growth, as its cash burn equates to about 39% of its market value. Overall, the article suggests that while there are some promising signs, the companys cash burn is risky and makes investors slightly nervous.
Investment
Entera Bio to Present Two Abstracts on its First-in-Class, Once Daily Oral hPTH(1-34) Peptide Tablets (EB613) for the Treatment of Post-Menopausal Women at High Risk of Fracture at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting
Entera Bio has been selected to present data for its investigational agent EB613 at the ASBMR 2023 Annual Meeting. EB613 is being developed as the first once-daily oral anabolic therapy for post-menopausal women with high-risk osteoporosis. The company aims to address the treatment gap in current osteoporosis care. The presentation will focus on the pharmacokinetic profile and the rapid pharmacodynamic effect of EB613. Entera Bio is a leader in the development of orally delivered peptides and therapeutic proteins. Its most advanced product candidates, EB613 and EB612, are in clinical development for the treatment of osteoporosis and hypoparathyroidism, respectively.
Customers
Entera Bio Announces Q2 2023 Financial Results and Corporate Updates
Entera Bio Ltd. has reported its financial results for Q2 2023 and provided updates on its corporate activities. The company has been focusing on three main areas: advancing its EB613 program, developing a new generation for EB612, and expanding its technological capabilities. The companys 2022 R&D plan resulted in pre-clinical validation of new generations of its oral peptide delivery platform. Entera Bio expects to announce data from its Phase 1B study of its new generation platform in H2 2023. The company also reported a net loss of $4.5 million for the six months ended June 30, 2023.
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Entera Bio Adds Sanofi Commercial Leader, Haya Taitel to its Board of Directors
Entera Bio has appointed Haya Taitel, Head of Sanofis Global Transplant Franchise, as an independent director to the Companys Board of Directors. Taitels experience in building commercial organizations and her expertise in late-stage product development and payor and channel strategies will be valuable as Entera prepares its global strategy for EB613s phase 3 program and future pipeline. Taitel recognizes the potential of EB613 and its unique positioning in treating post-menopausal women with osteoporosis. Entera aims to make a difference with its platform technology and core products, including EB613 and other pipeline candidates. Taitel has over 30 years of experience in the biopharma industry and currently serves as the Head of Sanofis Global Transplant Franchise.
Management Changes
Entera Bio First Quarter 2023 Earnings: US$0.076 loss per share (vs US$0.13 loss in 1Q 2022)
Entera Bio Ltd. (ENTX) Reports Q1 Loss, Misses Revenue Estimates
Entera Bio Announces Q1 2023 Financial Results and Corporate Updates
Will Entera Bio Ltd. (ENTX) Report Negative Q1 Earnings? What You Should Know
Entera’s Oral Delivery of GLP-2 Pre-Clinical Data to be Published in Peer Reviewed, International Journal of Peptide Research and Therapeutics
Menopause Luminary, Dr. Steven R. Goldstein, Joins Entera’s Clinical and Scientific Advisory Board
Entera Bio Provides Guidance from FDA Type D Meeting Related to EB613 Pivotal Program
Entera Bio Ltd. (ENTX) Reports Q4 Loss, Lags Revenue Estimates
Entera Bio Provides 2022 Corporate Milestones and Financial Results for the Year Ended December 31, 2022
Entera Bio Regains Compliance with Nasdaq Listing Requirements
Will Entera Bio (NASDAQ:ENTX) Spend Its Cash Wisely?
Entera Bio, a pharmaceutical company, is facing concerns over its rate of cash burn. As of September 2022, the company had cash reserves of $14m and a cash burn of $13m over the trailing twelve months, giving it a cash runway of approximately 13 months. The companys cash burn has increased by 61% over the last year, which could lead to a significant reduction in its cash runway if the trend continues. Entera Bios cash burn equates to about 37% of its market value, indicating that it may need to issue new shares or take on debt to raise more cash.
Investment
Entera Bio (ENTX) to Report Q4 Earnings: What's in the Cards?
Entera Bio Announces FDA’s Acceptance of a Type D Meeting Review to Affirm Design of the Pivotal, Phase 3 Protocol for EB613 PTH Mini Tablets, as the First Oral Osteoanabolic Treatment of Post-Menopausal Osteoporosis
Entera Bio to Participate in the SVB Securities Global Biopharma Conference
Entera Bio Ltd. (ENTX) Outpaces Stock Market Gains: What You Should Know
Entera Bio Ltd. (ENTX) Flat As Market Gains: What You Should Know
Entera Bio Ltd. (ENTX) Stock Sinks As Market Gains: What You Should Know
Entera Bio Ltd. (ENTX) Flat As Market Sinks: What You Should Know
Entera Bio Ltd. (ENTX) Gains As Market Dips: What You Should Know
Entera Bio Provides Corporate Updates and Financial Results for the Third Quarter of 2022
Entera Bio Ltd. has announced its Q3 2022 financial results and provided updates on its corporate activities. The company has achieved FDA agreement for a pivotal study of EB613, the worlds first daily bone-forming oral PTH tablet. The FDA has agreed that total hip bone mineral density, not fracture, could serve as the primary endpoint for the registrational study of EB613. The companys revenues for Q3 2022 were $8,000, compared to $140,000 for Q3 2021. As of September 30, 2022, Entera had cash and cash equivalents of $14.3 million.
Investment
Entera Bio Announces FDA Agreement for a Single Phase 3 Clinical Trial to Support an NDA for EB613 for the Treatment of Osteoporosis
Entera Bio Ltd. has announced the successful conclusion of its Type C meeting with the U.S. Food and Drug Administration (FDA). The FDA has agreed that a single Phase 3 placebo-controlled study could support a New Drug Application (NDA) submission of EB613, an oral treatment for post-menopausal osteoporosis patients. The FDA also agreed that Total Hip Bone Mineral Density (BMD) could serve as the primary endpoint for the registrational study of EB613. The company plans to initiate patient enrollment during 2023.
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Entera Bio Presents Dose Proportional Absorption and Correlation to BMD Clinical Response Data from its Phase 2 Study of EB613 in Post-Menopausal Osteoporosis Patients at the ASBMR 2022 Annual Meeting
Entera Bio announced the details of a six-month Phase 2 study of their oral PTH formulation, EB613, in postmenopausal women with low bone mass. The study showed positive results, with a strong correlation between the dose of EB613 and teriparatide plasma concentrations, as well as a linear dose response for the change in lumbar spine bone mineral density (BMD) after 6 months of treatment. The company is encouraged by these findings and highlights the potential of EB613 as a convenient, daily tablet form of osteoanabolic treatment for osteoporosis. Entera Bio is a leader in the development of orally delivered macromolecules therapeutics and has a proprietary oral drug delivery technology. Their most advanced product candidates, EB613 and EB612, are in clinical development for the treatment of osteoporosis and hypoparathyroidism, respectively.
Customers
Entera Bio Announces Formation of Clinical and Scientific Advisory Board and Poster Presentation at ASBMR 2022 Annual Meeting
Entera Bio has announced the formation of its Clinical and Scientific Advisory Board (CSAB) and the presentation of new data from its Oral PTH Phase 2 Study at the 2022 Annual Meeting of the American Society for Bone and Mineral Research. The CSAB consists of experts in bone diseases, endocrinology, and metabolic disorders. The study focuses on postmenopausal women with low bone mass and osteoporosis. The results showed a statistically significant increase in bone mineral density (BMD) in subjects receiving the oral PTH treatment. Entera Bios proprietary oral drug delivery technology aims to address the challenges of poor absorption and variability in large molecule therapeutics. The companys most advanced product candidates, EB613 and EB612, are in clinical development for the treatment of osteoporosis and hypoparathyroidism, respectively.
PartnersCustomers
Entera Bio Announces Departure of Dr. Phillip Schwartz, the Company's President of Research & Development to Pursue Outside Opportunities
Dr. Phillip Schwartz, the President of Research & Development and Founder of Entera Bio Ltd., has announced his resignation from his current role effective July 21, 2022. Dr. Schwartz will remain as a consultant to the company. His resignation was not due to any disagreement with the company. Entera Bio has recently announced new leadership to carry out Dr. Schwartzs vision for the company. Dr. Schwartz expressed confidence in the new management team and their ability to move Entera forward. The company is focused on the development of orally delivered peptides and therapeutic proteins for areas with unmet medical needs. Their lead compound, EB613, is moving into Phase 3 clinical development for the treatment of osteoporosis. Entera Bio also has a collaboration with Amgen Inc.
Management Changes
אנטרה ביו פרסמה תוצאות טובות לטיפול באוסטיאופורוזיס
Antera Bio, a company developing oral medications as an alternative to injections for osteoporosis and other bone diseases, has reported positive results from a trial. Patients who received the drug gained bone mass in the spine, and the difference between the drug group and the placebo group was significant. Following the announcement, the companys stock rose by 44% and is now traded at a value of $154 million on NASDAQ. The company plans to enter a phase III trial, which may be the last before marketing. If the product gives good results, the company will likely be able to register its product for marketing, making it the first oral osteoporosis drug approved for marketing in the US.
CustomersPartners
Entera Bio Receives Foundational Patent for its Oral PTH using its Platform Oral Protein Delivery Technology in European Union
Entera Bio has been granted a patent by the European Patent Office for its oral delivery technology for large molecule therapeutics. The patent covers Enteras oral PTH formulations for the treatment of osteoporosis and hypoparathyroidism. This patent adds to the companys existing patents in strategic countries including the USA, China, Japan, Australia, New Zealand, and Israel. Entera CEO Spiros Jamas stated that the patent provides robust protection of the companys intellectual property and strengthens its leadership position in the oral delivery of proteins. Entera is currently in Phase 2 clinical development for its product candidates EB613 for osteoporosis and EB612 for hypoparathyroidism. The companys oral drug delivery technology addresses the challenges of poor absorption and high variability of large molecules.
Investment
Our First Look At Entera Bio (NASDAQ:ENTX)
Entera Bio, an Israeli-based biopharma company, has reported positive trial results for its candidate EB613 to treat osteoporosis. The company plans to pursue approval for EB613 in the US and is seeking FDA guidance for a Phase 3 clinical trial. Entera Bio also has another drug candidate, EB612, which has been granted Orphan Drug designation but has faced delays in development. Analysts have shown optimism towards Entera Bio, with increased price targets. The company has a collaboration deal with Amgen and is looking for new partners to fund and assist with development. The companys cash position is expected to fund operations until Q2 2022.
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Entera Bio Ltd Announces Completion of Enrollment In Phase 2 Clinical Trial of Eb613 In Osteoporosis
Entera Bio Ltd. has completed enrollment in the Phase 2 clinical trial of EB613, an orally delivered human parathyroid hormone (1-34) for the treatment of osteoporosis. The trial showed positive results, with a significant dose-dependent trend in lumbar spine bone mineral density (BMD) increase. The company expects to report interim 3-month biomarker data for all enrolled patients in Q1:21 and final BMD data in Q2:21. The results will inform the design of a potential global Phase 3 clinical trial. Entera Bio has sufficient funds to support its operations until Q2:21.
Customers
Entera Bio Ltd. Announces Highly Encouraging Oral PTH Market Survey Results
Entera Bio Ltd Provides Update on Phase 2 Clinical Trial of EB613 in Postmenopausal Women With Osteoporosis
Entera Bio Ltd. has received approval from Institutional Review Boards (IRBs) to amend its Phase 2 protocol for testing higher doses of EB613, an orally delivered PTH 1-34 for the treatment of osteoporosis. The interim Phase 2 biomarker and safety data showed positive effects of EB613 on bone remodeling, leading to the evaluation of higher doses in the trial. The two lower doses have been discontinued, and new patient enrollment now includes a 2.5 mg dose, 1.5 mg dose, and placebo. The company expects to complete enrollment in Q3:20 and plans to report biomarker and six-month BMD data in early Q1:21 and early Q2:21, respectively. If successful, Entera intends to meet with the FDA to discuss the results and design a potential Phase 3 clinical trial for regulatory approval.
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Entera Bio Stock Forecast, Price & News (NASDAQ:ENTX)
Entera Bio, a clinical-stage biopharmaceutical company, is expected to see a decrease in earnings in the coming year, from ($0.31) to ($0.76) per share. However, the companys stock has a forecasted upside of 755.7% from its current price of $0.88, according to analysts consensus price target of $7.50. Entera Bios lead product candidates include the EB612, which is in Phase II clinical trials for the treatment of hypoparathyroidism; and EB613 that has completed Phase II clinical trials for the treatment of osteoporosis. The company has a research collaboration and license agreement with Amgen Inc.
Investment
Frost & Sullivan Publishes Immediate Report on DNA Biomedical Solutions Ltd.
Entera Bio Ltd., a subsidiary of DNA, has announced a research and development agreement with pharmaceutical giant Amgen for pre-clinical drug candidates. The agreement allows Entera to use its proprietary drug delivery platform to develop oral versions of one preclinical large molecule program selected by Amgen. Entera could receive up to $270 million in aggregate payments and tiered royalties. The company will retain IP rights to its technology. This collaboration demonstrates the clinical and economic potential of Entera. The target price for Entera remains unchanged at $0.33 per share.
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Entera Bio signs $270m Amgen licensing deal
Entera Bio has entered into a research collaboration and license agreement with Amgen in inflammatory disease and other serious illnesses. The agreement could be worth up to $270 million in milestone payments and royalties. Entera will use its proprietary drug delivery platform to develop oral formulations for one preclinical large molecule program that Amgen has selected. Amgen also has an option to select up to two additional programs to include in the collaboration. Entera will receive a modest initial technology access fee from Amgen and will be responsible for preclinical development at Amgen’s expense. Entera will retain all IP rights to its drug delivery technology, which will be licensed exclusively to Amgen for Amgen’s nominated drug targets.
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Entera Bio lists on Nasdaq at fourth attempt
Israeli drug development company Entera Bio has raised $11 million on Nasdaq at a company valuation of $91 million. The company is developing treatments for osteoporosis and a rare thyroid condition. This was their fourth attempt to list on Nasdaq.
Investment
Entera Bio Gives Nasdaq IPO Another Shot
Jerusalem-based biomed company Entera Bio Ltd. has filed for an initial public offering (IPO) on Nasdaq for the fourth time since 2014. The IPO is expected to have a positive impact on the companys growth. Entera is a clinical stage company focused on developing technology for the oral delivery of large molecule-based drugs. It aims to provide treatments for osteoporosis, bone disorders, and the orphan disease hypoparathyroidism. Entera has previously raised $26.5 million, with its latest funding round of $13 million completed in October 2017. The IPO details and timeline have not been disclosed. Entera is a subsidiary of D.n.a Biomedical Solutions Ltd., which holds a 27% stake in the company.
Public Trading
Entera Bio files for $50m Nasdaq IPO
Entera Bio, a subsidiary of DNA Biomedical Solutions, has filed for a Nasdaq IPO to raise up to $50 million. The company develops drugs for hypoparathyroidism, osteoporosis, and bone healing. It recently raised $12.5 million in a bridge private placement financing round. Phase II/III trials for the hypoparathyroidism treatment are set to begin in Q1 2018. The drug has received FDA orphan status for the treatment of rare diseases.
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Entera Bio raising $10m at $94m valuation
Entera Bio plans to raise $10 million at a company value of $94 million to develop a drug for the treatment of osteoporosis and primary hypoparathyroidism. DNA Biomedical Solutions Ltd. will invest $5 million and own 30% of Entera. Other potential investors include the Pontifax fund and individuals associated with Kite Pharma. Enteras products are based on technology that allows for oral administration of drugs. A phase II/III trial for a drug to treat primary hypoparathyroidism is scheduled to begin in Q1 2018. The drug has orphan-drug status, which provides expedited trial routes and protection from competition once approved.
InvestmentAcquisition
Entera Bio files for Nasdaq IPO
Entera Bio, a drug development company, has filed a draft prospectus with the US Securities and Exchange Commission (SEC) for a Nasdaq IPO. The company has decided to pursue an IPO instead of merging with Alcobra. The funds raised in the IPO, expected to be in the tens of millions of dollars, will be used for Phase II/III trials of Entera Bios drug for the treatment of Hypoparathyroidism. DNA Biomedical Solutions Ltd., which holds 36% of Entera Bios shares, saw its market cap increase to NIS 43 million. Entera Bio aims for a company valuation of $75 million after the IPO. The IPO is expected to take place in September 2017.
Public Trading
Israeli drug developer Entera Bio raises $7.5m
Pharmaceutical company Entera Bio has raised $7.5 million in a loan convertible into shares. The investment was led by Pontifax and included participation from private investors, many of whom are associated with immunotherapy company Kite Pharma. The announcement caused a 5% increase in DNA Biomedicals share price and added NIS 42 million to the companys market cap. Entera Bio is developing orally administered drugs, with its leading drug being a treatment for hypoparathyroidism. The company hopes to begin Phase III trials soon. DNA Biomedical owns 51% of Entera Bio.
Investment
DNA Biomedical jumps on subsidiary's osteoporosis results
Entera Bio, a subsidiary of DNA Biomedical Solutions Ltd., announced favorable interim results of the second stage of its Phase I clinical trial for its oral treatment for osteoporosis. The company successfully achieved the maximum concentration of the active ingredient in the blood, demonstrating the safety and absorption of the drug. Entera Bios oral drug is based on an intravenous drug for osteoporosis and aims to replace the need for injections. The company expects to receive the final results of the clinical trial in a few months and plans to submit an investigational new drug application with the US FDA. The drug on which Entera Bios oral treatment is based had $930 million in sales in 2011.
Investment
Oramed Pharmaceuticals Announces Successful Phase 1 Clinical Trial Results for EnteraBio