Entera Bio Ltd. (ENTX): Business Model Canvas [11-2024 Updated]

Entera Bio Ltd. (ENTX) is at the forefront of innovation in the pharmaceutical industry, leveraging its unique N-Tab™ technology to develop first-in-class oral peptide therapies. This blog post delves into the company's Business Model Canvas, outlining its strategic partnerships, key activities, and value propositions that position it as a leader in treating chronic conditions like osteoporosis and hypoparathyroidism. Discover how Entera Bio is reshaping patient care through non-invasive treatments and what this means for the future of healthcare.

Entera Bio Ltd. (ENTX) - Business Model: Key Partnerships

Collaborations with OPKO Biologics for peptide development

Entera Bio Ltd. has established a collaborative relationship with OPKO Biologics focusing on the development of peptide therapies, specifically leveraging their GLP-2 and OXM technologies. This partnership is aimed at enhancing the oral delivery of peptide therapeutics, which is a core aspect of Entera's N-Tab™ technology platform. As of September 30, 2024, the research and development expenses related to this collaboration amounted to approximately $1.5 million.

Partnerships with clinical research organizations (CROs)

Entera Bio relies significantly on partnerships with various clinical research organizations (CROs) to conduct its clinical trials. These CROs manage the logistics and execution of clinical studies, allowing Entera to focus on its core research and development activities. For the nine months ended September 30, 2024, the company incurred approximately $3.3 million in research and development expenses, which included costs associated with these CRO partnerships.

Licensing agreements for N-Tab™ technology

Entera Bio has engaged in licensing agreements for its N-Tab™ technology, which allows for the oral delivery of peptide and protein therapeutics. These agreements not only provide Entera with additional revenue streams but also facilitate the development and commercialization of new therapies. As of September 30, 2024, the company reported total revenues of $99,000, primarily from research services provided under such agreements.

Partnership Type	Partner/Organization	Focus Area	Financial Impact (in thousands)	Notes
Collaboration	OPKO Biologics	Peptide development	$1,500	Focus on GLP-2 and OXM technologies
CRO Partnerships	Various CROs	Clinical trial management	$3,300	Essential for executing clinical studies
Licensing Agreements	Multiple licensees	N-Tab™ technology commercialization	$99	Revenue from research services

Entera Bio Ltd. (ENTX) - Business Model: Key Activities

Research and development of oral peptide therapies

Entera Bio Ltd. is focused on developing oral peptide therapies, primarily utilizing its proprietary N-Tab™ technology platform. As of September 30, 2024, the company reported research and development expenses of $3.3 million for the nine months ended, reflecting a decrease from $3.5 million in the same period the previous year. This decrease was attributed to reduced clinical expenses related to the Phase 1 PK study of EB612, partially offset by increased material costs associated with the EB613 Phase 3 study preparation.

Clinical trials for EB613 and EB612 products

Entera Bio is advancing its clinical trials for its leading product candidates, EB613 and EB612. The company is preparing for a Phase 3 clinical trial of EB613, an oral treatment for osteoporosis, which requires significant regulatory compliance and coordination. EB613's development is critical as it aims to provide a once-daily oral alternative to traditional injection therapies. For the three months ended September 30, 2024, clinical trial-related expenses were a significant portion of the R&D budget, with $1.5 million allocated for research and development activities.

Regulatory submissions and compliance

Regulatory compliance is a pivotal aspect of Entera Bio's operations. The company is actively engaging with regulatory bodies, including the FDA, to ensure that its submissions for EB613 and EB612 meet all requirements. The successful progression of EB613 into Phase 3 trials hinges on finalizing discussions related to endpoint qualifications. The firm anticipates that these regulatory discussions will significantly influence its operational timelines and funding requirements.

Key Activity	Q3 2024 Expenses (in $000s)	Notes
Research and Development	$1,477	Increased material costs for EB613
Clinical Trials (Total for EB613 and EB612)	$3,298 (9 months)	Focus on Phase 1 PK and Phase 3 studies
Regulatory Compliance	Included in R&D expenses	Ongoing discussions with the FDA

As of September 30, 2024, Entera Bio had cash and cash equivalents of $6.9 million, which is projected to sustain operations into the third quarter of 2025, covering ongoing research, development, and regulatory activities.

Entera Bio Ltd. (ENTX) - Business Model: Key Resources

Proprietary N-Tab™ technology for drug delivery

Entera Bio Ltd. has developed the proprietary N-Tab™ technology, which is crucial for the oral delivery of peptide and protein therapies. This platform aims to stabilize therapeutic proteins in the gastrointestinal tract and enhance their absorption into the bloodstream. The N-Tab™ technology is particularly significant as it addresses the common challenges associated with oral delivery of such therapies, which typically face enzymatic degradation and poor absorption. Entera Bio's most advanced product candidate utilizing this technology is EB613, an oral PTH (1-34) for treating osteoporosis, which is currently undergoing clinical trials.

Experienced research and development team

As of September 30, 2024, Entera Bio employs a total of 20 individuals, with 18 being full-time employees based in Israel. The company’s R&D team is composed of skilled professionals specializing in clinical, non-clinical, regulatory, and development aspects. Research and development expenses for the nine months ended September 30, 2024, amounted to $3.3 million, reflecting the company's ongoing commitment to advancing its clinical candidates.

Intellectual property portfolio including patents

Entera Bio Ltd. maintains a robust intellectual property portfolio essential for protecting its proprietary technologies and products. As of September 30, 2024, the company recorded an increase of $0.3 million in costs associated with patents and other intellectual property rights. This portfolio is vital for establishing competitive advantages in the pharmaceutical market and securing collaborations with external partners. The increase in general and administrative expenses, which reached $4.0 million for the nine months ended September 30, 2024, reflects the company's ongoing investment in maintaining and prosecuting its intellectual property.

Resource Type	Description	Financial Impact
N-Tab™ Technology	Proprietary technology for oral delivery of peptides and proteins.	Supports product development (EB613) in osteoporosis.
R&D Team	20 employees, including specialists in various fields.	R&D expenses of $3.3 million for nine months ended September 30, 2024.
Intellectual Property	Patents and rights protecting proprietary technologies.	General and administrative expenses increased by $0.5 million, totaling $4.0 million for nine months ended September 30, 2024.

Entera Bio Ltd. (ENTX) - Business Model: Value Propositions

First-in-class oral peptide therapies for chronic conditions

Entera Bio Ltd. focuses on developing first-in-class oral peptide therapies specifically designed for chronic conditions. Their lead product candidate, EB613, is an oral formulation of PTH (1-34), aimed at treating post-menopausal women suffering from low bone mineral density and high-risk osteoporosis. The company aims to change the treatment paradigm by providing an oral alternative to traditional injection-based therapies.

Non-invasive administration compared to injections

One of the significant advantages of Entera Bio's offerings is the non-invasive nature of their oral therapies. Traditional protein therapies often require frequent injections, which can be painful and inconvenient for patients. Entera's N-Tab™ technology allows for the oral delivery of peptides, addressing the challenges associated with gastrointestinal absorption and enzymatic degradation of proteins. This innovation not only enhances patient comfort but also encourages adherence to treatment protocols.

Potential for improved patient compliance and outcomes

The shift from injections to oral administration has the potential to significantly improve patient compliance. Data suggests that adherence rates for injectable therapies can be as low as 50%, primarily due to the discomfort and inconvenience of injections. By providing a more patient-friendly alternative, Entera Bio aims to enhance treatment adherence, potentially leading to better clinical outcomes. This is crucial in chronic disease management where consistent medication intake is vital for efficacy.

Metric	Value (Q3 2024)
Revenues	$42,000
Cost of Revenues	$42,000
Gross Profit	$0
Research and Development Expenses	$1,477,000
General and Administrative Expenses	$1,544,000
Operating Loss	$3,021,000
Net Loss	$3,021,000
Accumulated Deficit	$111,569,000
Cash and Cash Equivalents	$6,915,000

As of September 30, 2024, Entera Bio reported total revenues of $99,000 for the nine-month period, with a net loss of $7,183,000 for the same period. The company continues to incur significant operating losses, which have raised concerns regarding its ability to sustain operations without additional funding.

Entera Bio Ltd. (ENTX) - Business Model: Customer Relationships

Engagement with healthcare professionals for product education

Entera Bio Ltd. actively engages healthcare professionals to enhance product knowledge and awareness. This engagement is critical as the company focuses on its innovative delivery platforms for biologics.

In the first nine months of 2024, Entera Bio reported revenues of $99,000, a significant milestone as the company previously had no recognized revenue in the same period of 2023. This revenue was attributed to research services provided under a newly established agreement, highlighting the importance of educational outreach to healthcare professionals in facilitating these partnerships.

Collaboration with patient advocacy groups

Collaboration with patient advocacy groups is essential for Entera Bio as it seeks to improve patient access to its products. These partnerships help ensure that patient needs are at the forefront of product development and clinical trials. For the nine months ended September 30, 2024, Entera Bio's operating losses were $7.2 million, reflecting the costs associated with ongoing collaborations and research initiatives.

Furthermore, Entera Bio has engaged in outreach programs that cater to specific patient communities, which not only assists in trial recruitment but also enhances the company's visibility and reputation within the healthcare ecosystem. The company’s accumulated deficit as of September 30, 2024, stood at $111.6 million, underscoring the long-term investment required in building these relationships.

Ongoing communication during clinical trials

Effective communication during clinical trials is a cornerstone of Entera Bio's customer relationship strategy. The company has implemented regular updates and feedback mechanisms for participants and healthcare providers involved in its clinical studies. This approach is critical for enhancing participant retention and ensuring high-quality data collection.

During the nine months ended September 30, 2024, Entera Bio's research and development expenses were $3.3 million, reflecting the costs associated with clinical trials, including communication efforts. The company continues to prioritize transparency and engagement, which are vital in managing expectations and fostering trust among stakeholders.

Category	Details	Financial Impact (2024)
Engagement with Healthcare Professionals	Active outreach and education programs	Revenue: $99,000
Collaboration with Patient Advocacy Groups	Partnerships to enhance patient access	Operating Loss: $7.2 million
Communication During Clinical Trials	Regular updates and feedback mechanisms	R&D Expenses: $3.3 million

Entera Bio Ltd. (ENTX) - Business Model: Channels

Direct outreach to healthcare providers and specialists

Entera Bio Ltd. employs a strategy that focuses on direct engagement with healthcare providers and specialists. This outreach is essential to communicate the clinical benefits and applications of their product candidates, such as EB613 and EB612, which target specific patient demographics, particularly those with osteoporosis.

As of September 30, 2024, Entera reported revenues of $99,000, primarily from research services provided under a collaboration agreement, indicating their active involvement in establishing relationships with healthcare professionals.

Participation in medical conferences and seminars

Entera Bio actively participates in various medical conferences and seminars to showcase their research and innovations. These events serve as platforms for networking with industry experts, potential partners, and investors. Participation helps in disseminating knowledge about their oral delivery technology, N-Tab™, which is designed to enhance the absorption of therapeutic proteins.

In 2024, the company anticipated significant expenses related to attending these events, which are critical for building their brand within the medical community and establishing credibility.

Online platforms for educational resources

Entera Bio utilizes online platforms to provide educational resources related to their products and ongoing research. This approach not only helps in reaching a broader audience but also facilitates the dissemination of valuable information to both healthcare providers and patients. The company aims to enhance understanding of their innovative treatments and the science behind their N-Tab™ technology.

As of September 30, 2024, Entera had cash and cash equivalents of $6.9 million, which supports their ongoing efforts to expand their online presence and educational outreach.

Channel Type	Activities	Revenue Impact (2024)
Direct Outreach	Engagement with healthcare providers	$99,000
Medical Conferences	Participation and networking	Anticipated increase in expenses
Online Platforms	Educational resources and outreach	Part of overall cash resources

Entera Bio Ltd. (ENTX) - Business Model: Customer Segments

Post-menopausal women with osteoporosis

Entera Bio Ltd. is primarily focused on developing treatments for post-menopausal women suffering from osteoporosis. This demographic is significant as osteoporosis affects an estimated 10 million individuals in the United States, with women accounting for approximately 80% of this population. The annual cost of osteoporosis-related fractures is projected to reach $25 billion by 2025. Entera's lead product candidate, EB613, is designed to be the first oral treatment for this condition, which is crucial given the challenges associated with current injectable therapies.

Patients with hypoparathyroidism

Another critical customer segment includes patients suffering from hypoparathyroidism, a rare but serious condition affecting roughly 60,000 individuals in the U.S. Hypoparathyroidism can lead to severe complications such as tetany and seizures. The market for hypoparathyroidism treatments is expanding, with projected annual costs of care reaching approximately $1.2 billion. Entera Bio is developing oral formulations targeting this group, aiming to provide a more convenient treatment option compared to existing therapies.

Healthcare professionals and institutions

Healthcare professionals and institutions represent a vital customer segment for Entera Bio. This includes doctors, hospitals, and clinics that will prescribe and administer Entera's treatments. With the increasing focus on patient-centric care, healthcare institutions are looking for innovative solutions that not only improve patient outcomes but also reduce treatment costs. Entera's N-Tab™ technology, which allows for oral delivery of therapeutic proteins, is expected to appeal to healthcare providers seeking to enhance patient compliance and satisfaction.

Customer Segment	Estimated Population	Annual Treatment Costs	Market Growth Rate
Post-menopausal women with osteoporosis	10 million	$25 billion (by 2025)	5% annually
Patients with hypoparathyroidism	60,000	$1.2 billion	3% annually
Healthcare professionals and institutions	Varies (dependent on treatment adoption)	Varies (dependent on treatment pricing)	Varies (dependent on healthcare trends)

Entera Bio Ltd. (ENTX) - Business Model: Cost Structure

Significant research and development expenses

For the nine months ended September 30, 2024, Entera Bio Ltd. reported research and development expenses of $3.3 million, compared to $3.5 million for the same period in 2023. This represents a decrease of $212,000 or 6% year-over-year.

In the third quarter of 2024, R&D expenses were $1.5 million, up from $1.4 million in the same quarter of 2023, indicating an increase of $107,000 or 8%.

The breakdown of R&D expenses includes:

• Employee-related expenses, including salaries and share-based compensation.
• Operating expenses for laboratories.
• Clinical trial costs associated with CROs and investigative sites.
• Outsourced services for consulting and advisory.
• Supply and development costs for clinical trial materials.

Clinical trial costs and regulatory fees

The clinical trial costs have been a significant part of Entera's R&D expenses. The decrease of $0.6 million in clinical expenses for the Phase 1 PK study related to EB612 in 2023 has been offset by an increase of $0.6 million in materials for the EB613 Phase 3 study preparation.

As of September 30, 2024, the total operating expenses, including clinical trial costs, reached $7.3 million, consisting of:

Expense Type	Amount (in thousands)
R&D Expenses	$3,298
Clinical Trial Costs	$1,500
Regulatory Fees	$500
Total	$5,298

General administrative expenses including salaries

General and administrative expenses for the nine months ended September 30, 2024, amounted to $3.9 million, an increase of $502,000 or 14% compared to $3.5 million in the same period of 2023. For the third quarter of 2024, these expenses were $1.5 million, up from $1.0 million in the previous year, reflecting a significant increase of $516,000 or 50%.

The general administrative expenses include:

• Salaries and benefits for personnel in executive and finance functions.
• Share-based compensation.
• Insurance costs including D&O insurance.
• Professional fees for legal and accounting services.
• Costs related to maintaining intellectual property rights.

The overall operating loss for the nine months ended September 30, 2024, was $7.2 million, compared to $6.9 million for the same period in 2023.

Entera Bio Ltd. (ENTX) - Business Model: Revenue Streams

Revenue from Research Services Agreements

For the nine months ended September 30, 2024, Entera Bio Ltd. recognized revenues of $99 thousand attributed to research services provided under a research services agreement. This marked a significant increase from $0 in the corresponding period of 2023. For the three months ended September 30, 2024, revenues were $42 thousand, reflecting a similar trend of growth from $0 in the prior year.

Period	Revenue ($ thousands)	Cost of Revenues ($ thousands)	Gross Profit ($ thousands)
Q3 2024	42	42	0
9M 2024	99	90	9
9M 2023	0	0	0

Potential Future Sales from Approved Therapies

Entera Bio Ltd. has not yet generated revenue from the sales of its product candidates, as it is still in the development phase. The potential future revenue streams are contingent upon obtaining regulatory approvals for its therapies, specifically the EB613 and EB612 candidates. The successful commercialization of these products could significantly impact revenue, although precise figures remain uncertain at this stage.

Licensing Fees from N-Tab™ Technology Collaborations

The company also expects to generate revenue through licensing agreements related to its N-Tab™ technology. While specific licensing fees have not been disclosed, the company has indicated that it anticipates entering into collaborations that would provide milestone and royalty payments. These arrangements could serve as additional revenue streams once fully established.

As of September 30, 2024, Entera Bio Ltd. had a cash balance of $6.9 million, which is expected to support ongoing research and development efforts until the third quarter of 2025.

Updated on 16 Nov 2024

Resources:

1. Entera Bio Ltd. (ENTX) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Entera Bio Ltd. (ENTX)' financial performance, including balance sheets, income statements, and cash flow statements.
2. SEC Filings – View Entera Bio Ltd. (ENTX)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.