What changed in this filing

/stocks — the workspaceLOADING

Item 7. Management’s Discussion and Analysis

2026-03-27 compared with 2025-03-28 · 157 added, 134 removed, 146 unchanged (67% of the section changed)

9 unchanged sentences

We intend that all forward-looking statements be subject to the safe harbor provisions of PSLRA.

Business Overview

Entera is a clinical stage company focused on developing first-in-class oral tablet formats of peptides or protein replacement therapies.

We focus on underserved, chronic medical conditions for which oral administration of a protein therapy has the potential to significantly shift a treatment paradigm.

Our pipeline includes five differentiated, first-in-class oral peptide programs targeting PTH(1-34), GLP-1 and GLP-2.Currently, most protein therapies are administered via frequent intravenous, subcutaneous, or intramuscular injections.

Our pipeline includes differentiated, first-in-class oral peptide programs targeting PTH(1-34), GLP-1/Glucagon and GLP-2.

Currently, most protein therapies are administered via frequent intravenous, subcutaneous, or intramuscular injections.

In chronic diseases where patients require persistent management, these cumbersome, often painful and high-priced injections can create a major treatment gap.

From a technical standpoint, oral delivery of therapeutic proteins is challenging due to the enzymatic degradation within the gastrointestinal tract and poor absorption into the blood stream due to the proteins’ polarity and molecular weight.

We leverage our N-Tab™ platform which is designed to simultaneously stabilize the peptide in the gastrointestinal tract and promote its absorption into the bloodstream.

From a technical standpoint, oral delivery of peptides and therapeutic proteins is challenging due to the enzymatic degradation within the gastrointestinal tract and poor absorption into the blood stream.

We leverage our N-Tab ® platform, which is designed to simultaneously stabilize large (4kD+) hydrophilic peptides in the gastrointestinal tract and promote their absorption into the bloodstream.

EB613 Program

Our most advanced product candidate, EB613, oral PTH(1-34), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low bone mineral density (“BMD”) and high-risk osteoporosis.

EB613 is intended to provide an oral anabolic treatment earlier in an osteoporosis patient’s journey to increase skeletal mass, reduce the risk of fracture and consequently limit the progression of the disease, and its associated disability and mortality.

Our most advanced product candidate, EB613, oral PTH(1-34), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for osteoporosis.

EB613 is intended to provide an oral anabolic treatment earlier in an osteoporosis patient’s journey to increase skeletal mass, reduce the risk of fracture and limit the disease progression, and decrease disability and mortality.

A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (pharmacodynamic/bone turnover biomarker) and secondary endpoints (BMD).

In April 2024, the Phase 2 data was published in the Journal of Bone and Mineral Research (JBMR).

Following Type C and Type D meetings with the FDA, we announced in 2023 the FDA’s concurrence that a 2-year, placebo-controlled phase 3 (registrational) study with Total Hip BMD as primary endpoint could support a new drug application (“NDA”) for EB613, however the SABRE BMD endpoint remained unqualified as a surrogate endpoint by FDA.

In November 2023, the ASBMR announced that the SABRE project team had submitted its full qualification plan to the FDA for the use of BMD as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs.

In March 2024, the ASBMR announced that the FDA had 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.

The EB613 osteoporosis clinical program has been developed under the auspices of this new approach to osteoporosis drug development.

We believe EB613 stands as the first program to potentially avail itself of the ASBMR-SABRE BMD endpoint.

SABRE is expected to provide an update on its FDA interactions and the qualification of the BMD endpoint in 2025.

In July 2025, we announced that in a written response to a Type A meeting request, the FDA agreed that the NDA filing for EB613 could be supported by a phase 3 study in women with postmenopausal osteoporosis, where change in total hip BMD is evaluated as the primary endpoint, and incidence of new or worsening vertebral fractures is evaluated as the key secondary endpoint at 24 months.

In December 2025, the FDA released the Determination for Qualification of BMD qualifying total hip BMD as a surrogate efficacy endpoint for fracture that could be used in future studies of new anti-osteoporosis therapies.

FDA’s suggested a context of use (COU):

“The percentage change from baseline at 24 months in total hip bone mineral density (BMD) assessed by dual-energy X-ray absorptiometry (DXA) can be used as a validated surrogate endpoint for the assessment of investigational therapies for postmenopausal women with osteoporosis at risk for fracture.”

In February 2026, we submitted to the FDA a clinical amendment which included the EB613 Phase 3 protocol, statistical analysis plan and open-label extension synopsis.

Subject to regulatory feedback, we are planning to initiate the Phase 3 study in the second half of 2026.

EB612 Program

Our product candidate, EB612, is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for patients with hypoparathyroidism.

With respect to our EB612 program, we are currently testing new generations of our N-Tab™ Technology with the naked PTH(1-34) peptide to assess the effectiveness of once or twice a day dosing regimens, as well as collaborating with a third party on another peptide in this field.

In June 2024, Phase 1 clinical data for EB612 was presented at the Endocrine Society ENDO 2024 Annual Meeting.

To date, Entera’s proprietary PTH tablets have been safely administered to a total of 102 healthy subjects in Phase 1 studies and 153 patients in Phase 2 studies in osteoporosis and hypoparathyroidism, two diseases that remain underserved with the current standard of care and which disproportionately affect women.

We believe these product candidates, if approved, hold the potential to become standards of care for patients with osteoporosis and hypoparathyroidism.

Our ability to deliver our oral PTH(1-34) peptide in a simple mini tablet format with reproduceable, dose dependent pharmacokinetics and rapid biological responses across gender, age, and health status was highlighted as part of two poster sessions at the ASBMR 2023 Annual Meeting.

We believe our work to date has built the foundation for our oral PTH (1-34) tablets to potentially treat diverse patient populations, including younger men and women athletes at risk of stress fractures.

Oral GLP-2 and Oral GLP-1/Glucagon Programs in Collaboration with OPKO Biologics

In September 2023, we entered into the 2023 Collaboration Agreement with OPKO Biologics, Inc., a subsidiary of OPKO.

Under the terms of this agreement, OPKO has agreed to supply its proprietary long-acting GLP-2 peptide and certain OXM analogs for the development of oral tablet candidates using our proprietary N-Tab™ technology.

Under this agreement, we and OPKO have each agreed to be responsible for specific phases of development of the two oral peptides to the point of demonstrated in vivo feasibility.

In March 2024, we announced positive in vivo pharmacokinetic (PK) results from our collaborative research, combining a proprietary long acting GLP-2 agonist developed by OPKO with Entera’s proprietary N-Tab™ technology.

The program is focused on developing the first and only GLP-2 peptide tablet alternative for patients suffering from short bowel syndrome and additional disorders involving mucosal inflammation and nutrient malabsorption.

OXM is a naturally occurring peptide hormone found in the colon, with glucagon-like-peptide 1 (GLP-1) and glucagon dual agonist activity that suppresses appetite and induces weight loss.

OPKO has developed several proprietary, modified OXM analogs as potential candidates for treating obesity, including an injectable pegylated peptide which demonstrated safety in over 430 subjects and significant reductions in weight loss and decreased plasma triglyceride levels in over 110 subjects in completed phase 2 studies.

In September 2024, we jointly announced with OPKO topline pharmacokinetic/pharmacodynamic (PK/PD) results for the OXM program.

The program is focused on developing the first oral dual agonist GLP-1/Glucagon peptide as a potential once-daily tablet treatment for patients with obesity and metabolic disorders using the N-Tab™ platform.

Oral OXM exhibited significant systemic exposure across two in vivo models, a favorable PK profile and bioavailability.

In December 2025, we announced new in vivo PK/PD data supporting the development of a proprietary long-acting PTH (LA-PTH) analog utilizing our N-Tab ® platform.

Preclinical findings demonstrated a markedly prolonged plasma half-life and sustained elevation of serum calcium levels for more than three days following administration of a single oral tablet, in contrast to unmodified PTH(1-34) controls, which showed no calcium response.

These data support the development of a once-daily oral PTH tablet for patients with hypoparathyroidism.

In February 2026, we announced the expansion of our collaboration with OPKO Biologics and OPKO to jointly advance this LA-PTH program.

Under the expanded collaboration, Entera and OPKO each hold a 50% pro-rata ownership interest in the LA-PTH hypoparathyroidism program, and each is responsible for 50% of development costs.

We intend to accelerate development and currently expect to submit an IND application to the FDA in late 2026.

EB618 Program (Oral GLP-1/Glucagon)

In September 2023, we entered into the 2023 Collaboration Agreement with OPKO Biologics.

The program focuses on developing the first oral dual agonist GLP-1/Glucagon peptide as a potential once-daily tablet treatment for patients with obesity and metabolic disorders using the N-Tab ® platform.

Currently, there are no approved dual GLP-1/Glucagon agonists available.

In September 2024, we jointly announced with OPKO topline PK/PD results for the OXM program..

The high plasma concentrations with prolonged systemic exposure were consistent with the reported half-life for semaglutide (Rybelsus®), the only approved oral GLP-1 analog.

Oral OXM showed a statistically significant reduction in plasma glucose levels compared with placebo.

Financial Overview

We are primarily engaged in research and development activities, and we have not derived significant income from our activities.

Since our inception, we have raised a total of $111.1 million from a combination of public and private equity offerings, IIA grants and the exercise of options and warrants.

Since inception, we have incurred significant losses.

For the years ended December 31, 2024 and 2023, our operating losses were $9.6 million and $8.9 million, respectively, and we expect to continue to incur significant expenses and losses for the foreseeable future.

As of December 31, 2024, we had an accumulated deficit of $113.9 million.

Our losses may fluctuate significantly from quarter to quarter and year to year, depending on the timing of our clinical trials, our expenditures on research and development activities, and payments under collaborations agreements.

Our recurring losses from operations, negative cash flows and lack of liquidity raise substantial doubt as to the Company’s ability to continue as a going concern.

Our independent registered public accounting firm included an explanatory paragraph in its report on our financial statements as of, and for the year ended, December 31, 2024, expressing the existence of substantial doubt about our ability to continue as a going concern.

The audited consolidated financial statements included in this Annual Report have been prepared assuming that we will continue as a going concern and do not include adjustments that might result from the outcome of this uncertainty.

If we are unable to raise the requisite funds, we will need to delay certain programs or otherwise curtail or cease operations.

See “Item 1A—Risk Factors-Risks Related to Our Financial Position and Need for Additional Capital.”

As of December 31, 2024, we had cash and cash equivalents of $8.7 million.

As of March 20, 2025 we had cash and cash equivalents of $21 million, of which $8 million has been designated to fund the collaboration activity with OPKO under the 2025 Collaboration Agreement.

Given our current cash position and plans, we believe that our existing cash resources will be sufficient to meet our projected operating requirements into the third quarter of 2026, which include the capital required to fund our ongoing operations, including regulatory expenses and optimization related to the preparation for the planned EB613 phase 3 study in osteoporosis, research and development, the completion of an additional Phase 1 PK study related to our new generation platform and the GLP-2/OXM collaborative research we are conducting with OPKO.

Our ability to commence the Phase 3 study of EB613 in osteoporosis will depend on finalizing discussions with the FDA in connection with its anticipated qualification of the SABRE total hip BMD endpoint and will require additional funding, which may not be available on reasonable terms, or at all.

Any delay or our inability to secure such funding will delay or prevent the commencement of this study.

In order to fund further operations, we will need to raise additional capital.

We may raise these funds through a variety of means, including private or public equity offerings, debt financings, strategic collaborations and licensing arrangements.

Additional financing may not be available when we need it or may not be available on terms that are favorable to us.

In March 2025, we entered into the 2025 Collaboration Agreement with OPKO and OPKO Biologics to collaborate with respect to the preclinical and clinical development and decision making related to the Oral OXM program for the treatment of obesity, metabolic and fibrotic disorders in humans.

In February 2026, we entered into the A&R Collaboration Agreement which amends and restates the 2025 Collaboration Agreement to expand the scope of the agreement to include the collaboration with respect to the preclinical and clinical development of a daily LA-PTH for the treatment of hypoparathyroidism.

OPKO is planning to initiate a single ascending dose (SAD) and multiple ascending dose (MAD) Phase 1 clinical study with the subcutaneous injection formulation, with data expected by the end of 2026.

We plan to file an IND for the oral OXM tablet formulation thereafter.

For additional information regarding our collaboration agreements with OPKO, see Item 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations—Patent Transfer, Licensing Agreements and Grant Funding—OPKO Collaboration and License Agreements, contained in this Annual Report.

This program focuses on developing the first GLP-2 peptide tablet alternative for patients suffering from short bowel syndrome and additional disorders involving mucosal inflammation and nutrient malabsorption.

We and OPKO completed a proof of concept single dose pharmacokinetic study in rodents.

Oral GLP-2 tablets exhibited significant systemic exposure.

Furthermore, plasma levels achieved with the oral tablet form of the GLP-2 analogue were about 10-fold higher than therapeutic plasma concentrations reported for subcutaneously administered teduglutide (Gattex® label).

The pharmacokinetic analysis of the data obtained following the IV injections of the GLP-2 peptide showed the plasma half-life in rats to be about six times longer than the half-life reported for teduglutide in the same animal model.

This data is consistent with previously reported PK data relating to OPKO’s GLP-2 peptide’s long-acting profile, which had initially been developed as a weekly subcutaneous injection.

Given the challenging compliance rates attributed to injectable GLP-2 therapy and heterogeneity of SBS patients, we believe a daily tablet format may address a significant unmet need in treating and titrating SBS patients more effectively than injectable alternatives.

Patent Transfer, Licensing Agreements and Grant Funding

OPKO Collaboration and License Agreements

2023 Collaboration Agreement

In September 2023, we entered into the 2023 Collaboration Agreement with OPKO Biologics.

Under the terms of this agreement, OPKO has agreed to supply its proprietary long-acting GLP-2 peptide and certain Oxyntomodulin (OXM) analogs for the development of oral tablet candidates using our proprietary N-Tab ® platform.

Under this agreement, we and OPKO have each agreed to be responsible for specific phases of development of the two oral peptides to the point of demonstrated in vivo feasibility.

2025 Collaboration Agreement

Under the 2025 Collaboration Agreement, we granted to OPKO an exclusive, sublicensable and non-transferable, worldwide license to certain of our intellectual property and technology solely to develop, manufacture, and commercialize any GLP-1/Glucagon dual agonist as an oral treatment form for the treatment of obesity, metabolic, cardiovascular, and fibrotic disorders in humans, and OPKO has granted to us a non-exclusive, non-sublicensable and non-transferable license to certain of its intellectual property and technology to the extent necessary for us to perform our obligations in relation to the Program, in each case subject to the exceptions contained therein.

Under the terms of the 2025 Collaboration Agreement, we and OPKO will retain 40% and 60%, respectively, of all proceeds deriving from the Program, and will be responsible for 40% and 60% of the Program’s development costs, respectively.

Following the completion of the Phase 1 stage, we may continue to fund our 40% share of the Program to maintain our right to proceeds or to opt-out (the “Opt-Out”).

If we Opt-Out, then we and OPKO will retain 15% and 85%, respectively, of all proceeds deriving from the Program, while OPKO will be solely responsible for ongoing development and commercialization funding of the Program.

In connection with the execution of the 2025 Collaboration Agreement, we issued and sold to OPKO an aggregate of 3,685,226 Ordinary Shares for a purchase price of $8.0 million, the proceeds of which we have agreed to use solely to fund our development cost obligations under the 2025 Collaboration Agreement, subject to the expiration or termination of the agreement.

A&R Collaboration Agreement

In February 2026, we entered into the A&R Collaboration Agreement with OPKO which amends and restates the 2025 Collaboration Agreement to expand the scope of the agreement to include the collaboration with respect to the preclinical and clinical development of a daily LA-PTH for the treatment of hypoparathyroidism and other indications in addition to the original oral dual agonist GLP-1/glucagon peptide program.

Development costs incurred by the parties with respect to the development of the LA-PTH program will be shared equally between the Company and OPKO.

Oramed Patent Transfer Agreement

In 2011, we entered into the Patent Transfer Agreement with Oramed, pursuant to which Oramed assigned to us all of its rights, title and interest in the patent rights that Oramed licensed to us when we were originally organized, subject to a worldwide, royalty-free, exclusive, irrevocable, perpetual and sub-licensable license granted to Oramed under the assigned patent rights to develop, manufacture and commercialize products or otherwise exploit such patent rights in the fields of diabetes and influenza.

In 2011, we entered into a patent transfer agreement with Oramed Ltd.

(“Oramed”), which we refer to as the Patent Transfer Agreement, pursuant to which Oramed assigned to us all of its rights, title and interest in the patent rights Oramed licensed to us when we were originally organized, subject to a worldwide, royalty-free, exclusive, irrevocable, perpetual and sub-licensable license granted to Oramed under the assigned patent rights to develop, manufacture and commercialize products or otherwise exploit such patent rights in the fields of diabetes and influenza.

Additionally, we agreed not to engage, directly or indirectly, in any activities in the fields of diabetes and influenza that involve the use of, or utilize, the patents underlying the Patent Transfer Agreement.

Under the terms of the Patent Transfer Agreement, we agreed to pay Oramed royalties equal to 3% of our net revenues generated, directly or indirectly, from exploitation of the assigned patent rights, including the sale, lease or transfer of the assigned patent rights or sales of products or services covered by the assigned patent rights.

Under the terms of the Patent Transfer Agreement, we agreed to pay Oramed royalties equal to 3% of our net revenues generated, directly or indirectly, from our exploitation of the assigned patent rights, including the sale, lease or transfer of the assigned patent rights or sales of products or services covered by the assigned patent rights.

On March 27, 2025, we entered into a Novation Agreement with Oramed, and Oramed NewCo Inc.

("Oramed NewCo") pursuant to which Oramed NewCo replaced Oramed as a party to the Patent Transfer Agreement.

Under the Novation Agreement, Oramed NewCo assumed all of Oramed's rights and obligations under the Patent Transfer Agreement accruing on or after the effective date, Oramed was released from any obligations and liabilities owed to us under the Patent Transfer Agreement accruing or arising after such date, and we were released from any obligations and liabilities owed to Oramed accruing or arising after such date.

All other provisions of the Patent Transfer Agreement remain in full force and effect.

Israeli Innovation Authority Grants

3 unchanged sentences

The royalty rate may increase to 5%, with respect to approved applications filed following any year in which we achieve sales of over $70 million.

The amount that must be repaid may be increased up to six times the amount of the grant received and the interest.

The amount that must be repaid may be increased up to six times the amount of grant received and the interest.

The rate of royalties may be accelerated and the royalty liability may increase (up to three times the amount of the grant amount and the interest), if manufacturing of the products developed with the grant money is transferred outside of the State of Israel.

8 unchanged sentences

Recent Developments Potentially Affecting Our Business

Collaboration and License Agreement with OPKO

On March 16, 2025, we entered into the 2025 Collaboration Agreement with OPKO and its wholly owned subsidiary, OPKO Biologics Ltd., to collaborate with respect to the preclinical and clinical development and decision making related to the Oral OXM program for the treatment of obesity, metabolic and fibrotic disorders in humans (the “Program”).

The Program combines OPKO’s proprietary long-acting oxyntomodulin (OXM, dual targeted GLP-1/Glucagon agonist, OPK-88006) analog and Entera’s proprietary N-Tab™ technology.

Following the completion of the Phase 1 stage, we may continue to fund our 40% share of the Program to maintain our right to proceeds or to opt-out (the “Opt-Out”).

In connection with the execution of the 2025 Collaboration Agreement, we issued and sold to OPKO an aggregate of 3,685,226 Ordinary Shares for a purchase price of $8.0 million, representing a purchase price per share equal to approximately $2.17, which was the volume weighted average price per share for the 30 trading days immediately preceding the date of such agreement.

OPKO has agreed to a customary lockup with respect to such shares, and may not sell or otherwise transfer them for a period of 12 months following the date of the 2025 Collaboration Agreement, and OPKO has additionally agreed to a customary “standstill” provision, pursuant to which, for a 24-month period following the date of the 2025 Collaboration Agreement, OPKO may not acquire additional equity in us or otherwise take certain other actions, in each case without our consent.

We have agreed to use the proceeds from the sale of the foregoing Ordinary Shares solely to fund our development cost obligations under the 2025 Collaboration Agreement, and we have agreed to enter into an escrow arrangement, together with OPKO and an escrow agent, into which such proceeds will be deposited and subsequently disbursed to fund such development costs.

If the 2025 Collaboration Agreement expires or is terminated for any reason, any funds remaining in such escrow will be disbursed to us.

Israel-Hamas War

Israel-Hamas War and Regional Conflicts

In October 2023, Israel was attacked by Hamas, a terrorist organization and entered a state of war.

Since the commencement of these events, there have been continuous rocket strikes across Israel, including with Hezbollah in Lebanon, the Houthi movement which controls parts of Yemen, and with Iran.

As of the date of this Annual Report, the war is ongoing and continues to evolve.

The Company's headquarters and its R&D operations are located in Israel.

Since the commencement of these events, there have been additional active hostilities, including with Hezbollah in Lebanon, the Houthi movement which controls parts of Yemen, and with Iran.

In response to ongoing Iranian aggression and support of proxy attacks against Israel, on June 12, 2025, Israel conducted a series of preemptive defensive air strikes in Iran targeting Iran’s nuclear program and military commanders.

On June 21, 2025, U.S.

President Donald Trump announced that the United States had conducted air strikes against three nuclear sites within Iran.

On October 9, 2025, a ceasefire had been reached.

Israel, Hamas, the United States and other countries in the region agreed to a framework for a ceasefire in Gaza between Israel and Hamas.

On February 28, 2026, United States and Israel conducted preemptive strikes targeting Iranian military infrastructure.

Iran retaliated with extensive ballistic missile and drone attacks against Israel.

On March 2, 2026, Hezbollah resumed hostilities by launching projectiles into northern Israel, ending the November 2024 ceasefire.

Israel responded with airstrikes on Lebanon and ground operations in Southern Lebanon, marking a significant escalation in the regional conflict.

How long and how severe the current conflicts in Gaza, Northern Israel, Lebanon, Iran or the broader region become is unknown at this time and any continued clash among Israel, Hamas, Hezbollah, Iran or other countries or militant groups in the region may escalate in the future into a greater regional conflict.

The Company’s research personnel and some management personnel are located in Israel, however other core activities including clinical, regulatory and supply chain are located outside of Israel.

Currently, such activities in Israel remain largely unaffected.

3 unchanged sentences

Financial Overview

We are primarily engaged in research and development activities, and we have not derived significant income from our activities.

Since our inception, we have raised a total of $111.6 million from a combination of public and private equity offerings, IIA grants and the exercise of options and warrants.

Since inception, we have incurred significant losses.

For the years ended December 31, 2025 and 2024, our operating losses were $11.5 million and $9.6 million, respectively, and we expect to continue to incur significant expenses and losses for the foreseeable future.

As of December 31, 2025, we had an accumulated deficit of $125.4 million.

Our recurring losses from operations, negative cash flows and lack of liquidity raise substantial doubt as to the Company’s ability to continue as a going concern.

Our independent registered public accounting firm included an explanatory paragraph in its report on our financial statements as of, and for the year ended, December 31, 2025, expressing the existence of substantial doubt about our ability to continue as a going concern.

If we are unable to raise the requisite funds, we will need to delay certain programs or otherwise curtail or cease operations.

See “Item 1A—Risk Factors-Risks Related to Our Financial Position and Need for Additional Capital.”

As of December 31, 2025, we had cash and cash equivalents of $14.9 million, of which $7.8 million has been designated to fund the collaboration activity with OPKO under the A&R Collaboration Agreement.

As of March 23, 2026 we had cash and cash equivalents of $12.6 million, of which $7.8 million has been designated to fund the collaboration activity with OPKO under the A&R Collaboration Agreement.

Given our current cash position and plans, we believe that our existing cash resources will be sufficient to meet our projected operating requirements through the middle of the third quarter of 2026, excluding the Phase 3 study of EB613 in osteoporosis.

Our ability to commence the Phase 3 study of EB613 in osteoporosis will require additional funding, which may not be available on reasonable terms, or at all.

Any delay or our inability to secure such funding will delay or prevent the commencement of this study.

In order to fund further operations, we will need to raise additional capital.

We may raise these funds through a variety of means, including private or public equity offerings, debt financing, strategic collaborations and licensing arrangements.

Additional financing may not be available when we need it or may not be available on terms that are favorable to us.

To date, we have not generated any revenue from sales of our products, and we do not expect to receive any revenue from any product candidates that we develop unless and until we obtain regulatory approval and successfully commercialize our products.

In April 2024, the Company entered into a material transfer and research project agreement (the “research services agreement”) with a third party in relation to its EB612 program.

Pursuant to the agreement, the third party has agreed to pay the Company a monthly payment for the research services, as well as reimbursement for external expenses based on an agreed budget.

For the year ended December 31, 2024, the Company recognized total revenues of $181 thousand from this agreement.

The Company recognize revenues according to ASC 606, “Revenues from Contracts with Customers”.

The Company concluded that, because the research services provided under the research services agreement have no alternative use (because, in nature, these services are unique to each customer), and the Company has the right to receive payment for performance completed to date, the Company recognizes revenue over the contract term using the input model method, which is labor hours expended and time lapsed.

Research and Development Expenses

Research and development expenses consist of costs incurred for the development of our N-Tab™ technology platform technology and our product candidates, including:

Research and development expenses consist of costs incurred for the development of our N-Tab ® platform and our product candidates.

We expense both internal and external research and development expenses to operations for the periods in which they are incurred.

We mapped the majority of external research and development costs incurred for our product candidates and development programs.

Internal and certain general external research and development expenses that support multiple programs include:

employee-related expenses, including salaries, bonuses and share-based compensation expenses for employees and service providers in the research and development function;

costs associated with our research and development platform used across programs, process development, manufacturing, consulting fees and preclinical development for earlier stage programs and new technologies;

expenses incurred in operating our laboratories including our small-scale manufacturing facility;

depreciation of research and development equipment, allocated overhead, rent and facilities-related expenses.

External research and development expenses for our main clinical development programs include:

expenses incurred under agreements with CROs and investigative sites that conduct our clinical trials;

expenses related to outsourced and contracted services, such as external laboratories, consulting and advisory services;

supply, development and manufacturing costs relating to clinical trial materials;

other costs associated with pre-clinical and clinical activities;

Research and development activities are the primary focus of our business.

supply, development and manufacturing costs relating to clinical trial materials;

certain consulting and advisory services related to the program.

Research and development activities are our primary focus.

Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.

We expect that our research and development expenses will increase significantly in future periods as we advance our clinical candidates into later stages of clinical development and invest in additional preclinical candidates.

Our research and development expenses may vary substantially from period to period based on the timing of our research and development activities, including due to the timing of initiation of clinical trials and the enrollment of patients in clinical trials.

For the years ended December 31, 2025 and 2024, our research and development expenses were $6.0 million and $4.5 million, respectively.

Research and development expenses for the years ended December 31, 2024 and 2023 were primarily for the development of EB613, EB612 and our collaboration with OPKO related to GLP-2 and OXM.

Research and development expenses for the year ended December 31, 2025 were primarily for the development of EB613 and next-generation of EB613, EB612 and our collaboration with OPKO related to OXM.

The successful development of our product candidates is highly uncertain.

7 unchanged sentences

the terms and timing of any collaborative, licensing and other arrangements that we may establish, including any milestone and royalty payments thereunder.

A change in the outcome of any of these variables with respect to the development of EB613, EB612 or any other product candidate that we may develop could result in significant changes in the costs and timing associated with the development of our product candidates.

For example, if the FDA or other regulatory authority were to require us to conduct preclinical or clinical studies beyond those that we currently anticipate as necessary for development, if we experience significant delays in enrollment in any clinical trials, or if we encounter difficulties in manufacturing our clinical supplies, then we could be required to expend significant additional financial resources and time on the completion of the clinical development.

A change in the outcome of any of these variables with respect to the development of EB613, EB612, OXM or any other product candidate that we may develop could significantly change the costs and timing associated with the development of any such product candidate.

For example, if the FDA or other regulatory authority were to require us to conduct preclinical or clinical studies beyond those that we currently anticipate will be required for the completion of clinical development, if we experience significant delays in enrolment in any clinical trials or if we encounter difficulties in manufacturing our clinical supplies, then we could be required to expend significant additional financial resources and time on the completion of the clinical development.

Our research and development expenses for the years ended December 31, 2025 and 2024 are summarized as follows:

Year Ended December 31,

(In thousands)

External Expenses related to EB613

Internal and External expenses related to OXM collaboration with OPKO

Internal and External expenses related to other development program:

Payroll and related expenses

Share-based compensation

Rent and related expenses

Other development expenses

Research and development expenses, net

General and Administrative Expenses

General and administrative expenses consist principally of salaries and related expenses, share-based compensation and related costs for directors and personnel in executive and finance functions.

Other general and administrative expenses include D&O insurance and other insurance, communication expenses, professional fees for legal and accounting services, costs associated with maintaining and prosecuting our intellectual property portfolio and business development expenses.

Other general and administrative expenses include D&O insurance and other insurance, communication expenses, professional fees for legal, accounting and investor relations services, costs associated with maintaining and prosecuting our intellectual property portfolio and business development expenses.

We expect that our general and administrative expenses will increase in the future as we increase our headcount and expand our administrative function to support our operations.

2 unchanged sentences

Taxes on Income

We have not generated taxable income since our inception, and as of December 31, 2024, we had carry-forward tax losses of $83.5 million.

We have not generated taxable income since our inception.

As of December 31, 2025, we had carry-forward tax losses of $91.8 million.

We anticipate that we will be able to carry forward these tax losses indefinitely to future tax years.

3 unchanged sentences

As of December 31, 2025, Entera Bio Inc.

had tax loss carry-forwards of $172 thousand.

had tax loss carry-forwards of $0.2 million.

Results of Operations

9 unchanged sentences

Income tax expenses

Revenues for the year ended December 31, 2024 were $181 thousand, which were attributable to research services we provided pursuant to the research services agreement.

We did not recognize any revenue for the year ended December 31, 2023.

Revenues for the year ended December 31, 2025 and 2024 were $42 thousand and $181 thousand, respectively, which were attributable to research services we provided pursuant to a research services agreement with an external party.

The Company completed the first stage of its obligations under the research services agreement in the first quarter of 2025.

Cost of Revenues

Cost of revenues for the year ended December 31, 2024 was $172 thousand, which was attributable to research services we provided pursuant to the research services agreement.

We did not recognize any cost of revenues for the year ended December 31, 2023.

Cost of revenues for the year ended December 31, 2025 and 2024 was $42 thousand and $172 thousand, respectively, which was attributable to research services we provided pursuant to a research services agreement with an external party.

Research and Development Expenses

Research and development expenses for the years ended December 31, 2024 and December 31, 2023 were each $4.5 million.

There was a decrease of $0.8 million in clinical expenses for our Phase 1 PK study related to our new formulations for EB612, which occurred in 2023.

The decrease was partially offset by an increase of $0.8 million in materials and other consulting, including regulatory required in connection with the optimization processes related to the preparation of the EB613 phase 3 study.

Research and development expenses for the year ended December 31, 2025 were $6.0 million as compared to $4.5 million for year ended December 31, 2024.

The increase of $1.5 million was primarily due to an increase of $0.7 million in other consulting fees, including regulatory fees required in connection with the filing of a type A meeting with the FDA and ongoing optimization processes related to the preparation of the EB613 phase 3 clinical program, an increase of $0.5 million in connection with our internal programs and collaboration programs, an increase of $0.4 million in compensation and an increase of $0.1 million in other expenses.

The increase was partially offset by a decrease of $0.2 million in materials and production costs related to the preparation of the EB613 phase 3 program.

General and Administrative Expenses

General and administrative expenses for the year ended December 31, 2024 were $5.1 million, compared to $4.4 million for the year ended December 31, 2023.

The increase of $0.7 million was mainly attributable to an increase of $0.2 million in patents or other intellectual property rights costs, an increase of $0.3 million in other consultants’ fees and an increase of $0.4 million in compensation.

The increase was partially offset by a decrease of $0.2 million in D&O insurance costs and other costs.

General and administrative expenses for the year December 31, 2025 were $5.5 million as compared to $5.1 million for year ended December 31, 2024.

The increase of $0.4 million was primarily due to an increase of $0.1 million of consultants fees and an increase of $0.3 million in compensation.

Financial Income, Net

Financial income, net for the year ended December 31, 2024 was $58,000, compared to $31,000 for the year ended December 31, 2023.

Financial income, net for the year ended December 31, 2025 was $90 thousand compared to $58 thousand for the year ended December 31, 2024.

Our financial income is composed mainly of interest income from bank deposits and exchange rate differences of certain currencies against our functional currency, which is the U.S.

Financial income, net increased predominantly due to increased interest income on our bank deposits.

Financial income, net increased predominantly due to increased interest income from our bank deposits.

Liquidity and Capital Resources

Since inception, we have incurred significant losses from operations, negative cash flows from operating activities and lack of liquidity.

These factors raise substantial doubt about our ability to continue as a going concern.

Since inception, we have incurred significant losses from operations and negative cash flows from operating activities.

For the years ended December 31, 2025 and 2024, our operating losses were $11.5 million and $9.6 million, respectively.

We expect to continue to incur significant expenses and losses for the next several years as we advance our products through development and provide administrative support for our operations.

As of December 31, 2025, we had an accumulated deficit of $125.4 million.

Since our inception, we have raised a total of $111.1 million, including $36.3 million through at-the-market-offering (“ATM”) programs, an aggregate of $28.9 million in private placements since our IPO, $11.2 million in our IPO in 2018 and $34.7 million in aggregate funding from a combination of IIA grants, exercise of options and warrants and private placements of Ordinary Shares, preferred shares and debt prior to our IPO.

As of December 31, 2024, we had cash and cash equivalents of $8.7 million.

We expect to continue to incur significant expenses and losses for the next several years as we advance our products through development and provide administrative support for our operations.

These factors raise substantial doubt about our ability to continue as a going concern.

Since our inception and through December 31, 2025, we have raised a total of $111.6 million from a combination of public and private equity offerings, IIA grants and the exercise of options and warrants, including $36.4 million through at-the-market-offering (“ATM”) programs.

As of December 31, 2025, we had cash and cash equivalents and restricted cash of $14.9 million, of which $7.8 million has been designated to fund our obligations under the A&R Collaboration Agreement.

Our primary uses of cash have been to fund research and development, general and administrative and working capital requirements, and we expect these will continue to be our primary uses of cash.

Equity Offerings

On September 2, 2022, we entered into a Sales Agreement with Leerink Partners LLC (f/k/a SVB Securities LLC), as sales agent, to implement an ATM program (the “Leerink ATM Program”) under which we were originally able to sell up to 5,000,000 Ordinary Shares under our currently effective Registration Statement on Form S-3 and a related prospectus supplement forming a part thereof.

On September 2, 2022, we entered into a Sales Agreement with Leerink Partners LLC (f/k/a SVB Securities LLC), as sales agent, to implement an ATM program (the “Leerink ATM Program”) under which we were originally able to sell up to 5,000,000 Ordinary Shares in an at-the-market offering registered under the Securities Act.

The sales agent is entitled to a fixed commission of 3% of the aggregate gross proceeds as well as and reimbursement of expenses.

As of December 31, 2024, we had sold 2,240,156 shares under the Leerink ATM Program for aggregate proceeds of $3.8 million, net of issuance costs.

In January 2025, we sold an additional 2,700,000 Ordinary Shares at $2.29 per share to Point 72 Asset Management, L.P.

for aggregate proceeds of $6.0 million, net of issuance costs.

Subsequent to such sales, in January 2025, we filed a supplement to the prospectus supplement relating to the Leerink ATM Program, which provides us the ability, but not the obligation, to sell up to an additional 30,000,000 Ordinary Shares under the Leerink ATM Program.

As of December 31, 2025, we had sold 4,940,156 Ordinary Shares under the Leerink ATM Program for aggregate proceeds of $9.8 million, net of issuance costs.

We currently have the ability, but not the obligation, to sell up to an additional 30,000,000 Ordinary Shares under the Leerink ATM Program under our currently effective Registration Statement on Form S-3.

On December 20, 2023, we entered into a securities purchase agreement with certain investors (the “Purchasers”), providing for the private placement (the “December 2023 Private Placement”) to the Purchasers of an aggregate of 7,916,879 units (collectively, the “Units”), each Unit consisting of (i) one Ordinary Share (or, in lieu thereof, one pre-funded warrant to purchase one Ordinary Share (the “Pre-Funded Warrants”)) and (ii) one warrant to purchase one Ordinary Share (the “Ordinary Share Warrant”), for aggregate proceeds of approximately $6.6 million (or $0.835 per Unit, which represented the aggregate of the Nasdaq closing price on December 20, 2023 plus $0.125 per Ordinary Share Warrant).

2 unchanged sentences

None of the warrants contain any “ratchet”, “reset” or other adjustments related to financial antidilution.

As of December 31, 2025, we have received approximately $0.6 million of net proceeds from the exercise of outstanding Ordinary Share Warrants.

If all Ordinary Share Warrants were exercised for cash, then the Company would receive additional proceeds of approximately $7.8 million.

1 unchanged sentence

In connection with our entering into the 2025 Collaboration Agreement with OPKO, we issued to OPKO an aggregate of 3,685,226 Ordinary Shares for a purchase price of $8.0 million, representing a purchase price per share equal to approximately $2.17, which was the volume weighted average price per share for the 30 trading days immediately preceding the date of such agreement.

The proceeds received are not reflected in our cash balance as of December 31, 2024.

We have agreed to use the proceeds from the issuance of such Ordinary Shares solely to fund our development cost obligations under the 2025 Collaboration Agreement.

We have agreed to use the proceeds from the issuance of such Ordinary Shares solely to fund our development cost obligations under the A&R Collaboration Agreement.

Funding Requirements

Given our current plans, we believe that our existing cash resources will be sufficient to meet our projected operating requirements into the third quarter of 2026.

This assumes capital required to fund our ongoing operations, including regulatory expenses and optimization related to the preparation for the planned EB613 phase 3 study in osteoporosis, research and development, the completion of an additional Phase 1 PK study related to our new generation platform and the GLP-2/OXM collaborative research we are conducting with OPKO.

Our ability to commence the Phase 3 study of EB613 in osteoporosis will depend on finalizing discussions with the FDA in connection with their anticipated qualification of the SABRE total hip BMD endpoint and will require additional funding, which may not be available on reasonable terms, or at all.

Given our current plans, we believe that our existing cash resources will be sufficient to support the Company’s ongoing operations through the middle of the third quarter of 2026, excluding the initial of the Phase 3 program of EB613.

Our ability to commence the Phase 3 program of EB613 in osteoporosis will require additional funding, which may not be available on reasonable terms, or at all.

Any delay or our inability to secure such funding will delay or prevent the commencement of these studies.

1 unchanged sentence

We have based these estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect.

Because of the numerous risks and uncertainties associated with the development of our product candidates, and the extent to which we may enter into collaborations with third parties for development of these or other product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the development of our current and future product candidates.

Because of the numerous risks and uncertainties associated with the development of our product candidates, and the extent to which we may enter into additional collaborations with third parties for development of these or other product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the development of our current and future product candidates.

Our future capital requirements will depend on many factors, including:

the costs, timing and outcome of clinical trials for, and regulatory review of our oral peptide programs, including EB613 and EB612 and any other product candidates we may develop;

the costs, timing and outcome of clinical trials for, and regulatory review of our oral peptide programs, including EB613 for osteoporosis and EB612 for hypoparathyroidism or other oral peptides for obesity, metabolic disorders and gastrointestinal rare diseases and any other product candidates we may develop;

the costs of development activities for any other product candidates we may pursue;

1 unchanged sentence

our ability to establish collaborations on favorable terms, if at all.

We continuously evaluate various financing alternatives in the public or private equity markets or through license of our N-Tab™ technology to additional external parties through partnerships or research collaborations as we will need to finance future research and development activities, general and administrative expenses and working capital through fund raising.

We continuously evaluate various financing alternatives in the public or private equity markets or through license of our N-Tab ® platform to additional external parties through partnerships or research collaborations as we will need to finance future research and development activities, general and administrative expenses and working capital through fund raising.

However, there is no certainty about our ability to obtain such funding.

3 unchanged sentences

If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us.

If we are unable to raise additional funds through equity or debt financings or collaborations, when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts.

If we are unable to raise additional funds through equity or debt financing or collaborations, when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts.

Year Ended December 31, 2025 Compared to Year Ended December 31, 2024

The following table sets forth the primary sources and uses of cash for each of the years set forth below:

The following table sets forth the primary sources and uses of cash:

Year ended December 31,

3 unchanged sentences

Net Cash provided by financing activities

Effect of Exchange Rate changes on cash and cash equivalents

Net decrease in cash and cash equivalents

Net Cash Used in Operating Activities

Net Cash used in operating activities for the year ended December 31, 2024 was $6.8 million, consisting primarily of our operating loss of $9.6 million, and a decrease of $0.2 million in our working capital and other expenses which was partially offset by approximately $2.6 million of share-based compensation and depreciation expenses.

Net Cash used in operating activities for the year ended December 31, 2023 was $7.3 million, consisting primarily of our operating loss of $8.9 million and an increase of $0.2 million in our working capital, which was partially offset by approximately $1.8 million of share-based compensation and depreciation expenses.

The decrease of $0.5 million in cash used in operating activities for the year ended December 31, 2024 compared to the same period in 2023 was mainly attributed to an increase of $0.7 million in our operating loss and a decrease of $0.4 million in working capital and others primarily due to payments to suppliers and services providers, which was partially offset by a decrease of $0.8 million in share-based compensation and depreciation expenses.

Net Cash used in operating activities for the year ended December 31, 2025 was $7.4 million, consisting primarily of our operating loss of $11.5 million, which was partially offset by approximately $2.8 million of share-based compensation and depreciation expenses and a decrease of $1.3 million in changes in operating assets and liabilities and other expenses.

Net Cash used in operating activities for the year ended December 31, 2024, was $6.8 million, consisting primarily of our operating loss of $9.6 million, which was partially offset by approximately $2.6 million of share-based compensation and depreciation expenses and a decrease of $0.2 million in changes in operating assets and liabilities and other expenses.

The increase of $0.6 million in cash used in operating activities for the year ended December 31, 2025 compared to 2024 was mainly attributed to an increase of $1.9 million in our operating loss, a decrease of $1.1 million in changes in operating assets and liabilities and other expenses primarily due to payments to suppliers and services providers, which was partially offset by an increase of $0.2 million in share-based compensation and depreciation expenses.

Net Cash Used in Investing Activities

Net Cash used in investing activities for the years ended December 31, 2024 and December 31, 2023 primarily consisted purchase of property and equipment

Net Cash used in investing activities for the years ended December 31, 2025 and December 31, 2024 consisted of purchase of property and equipment.

Net Cash Provided by Financing Activities

Net cash provided by financing activities for year ended December 31, 2024 consisted of the net proceeds of $3.8 million from the issuance of Ordinary Shares under the Leerink ATM Program and $0.8 million from the issuance of Ordinary Shares upon the exercise of outstanding options and warrants.

Net Cash provided by financing activities for the year ended December 31, 2023 primarily reflects net proceeds of $6 million from issuance of the Units in the December 2023 Private Placement.

Net cash provided by financing activities for year ended December 31, 2025 consisted of the net proceeds of $6.1 million from the issuance of Ordinary Shares under the Leerink ATM Program, $0.5 million from the issuance of Ordinary Shares upon the exercise of warrants and $7.1 million from issuance of Ordinary Shares in connection with the entry into the 2025 Collaboration Agreement.

Net Cash provided by financing activities for the year ended December 31, 2024 consisted of net proceeds of $3.8 million from the issuance of Ordinary Shares under the Leerink ATM Program and $0.8 million from the issuance of Ordinary Shares upon the exercise of outstanding options and warrants.

Severance Obligations

15 unchanged sentences

These policies relate to the more significant areas involving management’s judgments and estimates and they require our most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of the matters that are inherently uncertain.

Share-Based Compensation

In 2013 and in 2018, we adopted share-based compensation plans for employees, directors and service providers.

Our share-based compensation plan adopted in 2013 governs the issuance of equity incentive awards prior to our initial public offering, and the share-based compensation plan adopted in 2018 governs the issuance of equity incentive awards from and after the closing of our initial public offering.

As part of the plans, we grant employees, directors and service providers, from time to time and at our discretion, options to purchase our Ordinary Shares and restricted share units.

The fair value of the services received in exchange for the grant of the options is recognized as an expense in our statements of comprehensive loss with a corresponding adjustment to equity in our statements of financial position.

The total amount is recognized as an expense ratably over the service period of the options, which is the period during which all vesting conditions are expected to be met.

We estimate the fair value of options granted to employees, directors and service providers using the Black-Scholes option pricing model, which requires the input of highly subjective assumptions, including (a) the expected volatility of our shares, (b) the expected term of the award, (c) the risk-free interest rate, (d) expected dividends and (e) the fair value of our Ordinary Shares at the date of grant.

The fair value of the RSU's were measured according to the market price at the grant date.

The following table summarizes the allocation of our share-based compensation expense:

(in thousands )

Cost of revenues

Research and development

General and administrative

Recently Issued Accounting Pronouncements

3 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis