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Item 7.01 Regulation FD Disclosure.
On August 1, 2022, Entera Bio Ltd., a company organized under the laws of the State of Israel (the "Company", "we", "us", or "our") made available an updated corporate presentation. A copy of the presentation is attached hereto as Exhibit 99.1 and incorporated by reference in this Item 7.01. A copy of the presentation is also available on our website at https://investors.enterabio.com.

Use of our Website and Social Media to Distribute Material Company Information
We use our website as a channel of distribution for important Company information. We routinely post on our website important information, including press releases, investor presentations and financial information, which may be accessed by clicking on the “Investors” section of www.enterabio.com. We also use our website to expedite public access to time-critical information regarding our Company in advance of or in lieu of distributing a press release or a filing with the SEC disclosing the same information. Therefore, investors should look to the “Investors” section of our website for important and time-critical information.
The information contained in this Item 7.01, including in Exhibit 99.1 attached hereto, is “furnished” and not “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. Such information shall not be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, except to the extent such other filing specifically incorporates such information by reference.
Item 9.01 Exhibits
(d) Exhibits.

Cover Page Interactive Data File.

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Date: August 1, 2022
/s/ Miranda J. Toledano
Name: Miranda J. Toledano
Title: Chief Executive Officer

Exhibit 99.1

 Entera Bio Corporate PresentationAugust 2022  

 Disclaimer  Various statements in this presentation are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this presentation regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.     Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera is contractually obligated to provide, such as those pursuant to Entera’s agreement with Amgen; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with the SEC, as well as the company’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this presentation. The information in this presentation is provided only as of the date of this presentation, and Entera undertakes no obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law. 

 Entera Bio: Leader in Oral Delivery of Therapeutic Proteins   Founded in 2009 (Jerusalem, Israel); IPO in 2018 (Nasdaq: ENTX)  Proprietary 1st in Class Oral PTH Candidates with Demonstrated Clinical Efficacy in Phase 2 Studies  External Strategic Partnerships to Diversify Pipeline and Revenue Streams (e.g. Amgen)   EB613 (oral PTH (1-34), teriparatide) First Oral Bone Forming / Anabolic Drug for Osteoporosis  Phase 2 study met biomarker and 6-month BMD endpoints (ASBMR late-breaker oral presentation, 2021)  6-month lumbar spine BMD data in line with SC Forteo injection; total hip and femoral neck BMD changes were greater than previously reported data with SC Forteo® injection  FDA Type C Meeting based on revised Phase 3 protocol submitted (response expected in H2’2022)  EB612 First Oral PTH for Hypoparathyroidism - Granted Orphan Designation (US, EU)   Pilot 4-month Phase 2 results presented (ASBMR 2015) and published in peer-reviewed journal (JBMR 2021)  Phase 2 PK-PD study versus Natpara presented (ASBMR 2019)  Rapid decline in median serum phosphate levels and maintenance of target calcium levels throughout the study  Novel formulation leverages Entera’s 2nd generation peptide delivery platform (PK study expected in H1’2023)  We Focus on High Unmet Clinical Needs where Oral Delivery of a Protein Therapy Can Significantly Improve the Standard of Care 

 Miranda Toledano, MBA,   Chief Executive Officer  23 years of C-level leadership, principal investment and wall street/ transactional experience in the biotech sector  Art Santora, MD, PhD,   Chief Medical Officer  35 years of special care, academic research, FDA in endocrinology focusing on osteoporosis and other diseases of bone and calcium metabolism; lead clinical physician for Fosamax®   Dana Yaacov, CPA, MBA,   Chief Financial Officer  15 years of finance management and accounting experience  Hillel Galitzer, PhD, MBA ,   Chief Operating Officer  21 years of biotech experience in clinical trial and supply chain operations support and early-stage R&D  Anke Hoppe, BSc,   VP of Clinical Operations  30 years of experience overseeing clinical operations across big pharma, small biotech, and CROs  Gregory Burshtein, PhD,   VP of R&D  18 years experience in oral drug delivery research, formulation and pre-clinical development  Execution Oriented Leadership Team    

 Professor John P. Bilezikian  Vice-Chair, Department of Medicine for International Research and Education; Chief, Emeritus, of the Division of Endocrinology; Director, Emeritus, of the Metabolic Bone Diseases Program at Columbia University Medical Center  Professor Maria Luisa Brandi  Professor of Endocrinology, FIRMO Foundation, Italy  Professor Bart Clarke  Professor of Medicine and Consultant, Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic  Professor Felicia Cosman  Professor of Medicine, Emerita, Columbia University College of Physicians and Surgeons, Division of Endocrinology;  Co-Editor in Chief of the journal Osteoporosis International  Professor William Fraser  Professor of Medicine at Norwich Medical School at the University of East Anglia and Consultant in Metabolic Medicine at the Norfolk and Norwich University Hospital, UK  Dr. Roger Garceau  Former Chief Medical Officer and EVP at NPS Pharmaceuticals and Shire plc (Natpara®); Sanofi/Pharmacia  Professor Sophia Ish-Shalom  Vice President of the Israeli Foundation for Osteoporosis and Bone Diseases (IFOB) , Endocrine Clinic Elisha Hospital prior Head of Bone and Mineral  Metabolism Unit, Rambam Health Care Campus , Israel  Professor Socrates Papapoulos  Emeritus Professor in Diseases of Bone & Mineral Metabolism, Advisor Center for Bone Quality, Leiden University Medical Center, The Netherlands  Global Clinical & Scientific Advisory Board    

 Entera Proprietary Oral Delivery Platform  Synergistic Activity of Proteolysis Inhibition and Permeability Enhancement     Oral delivery of most therapeutic proteins is challenging due to poor absorption into the blood stream, enzymatic degradation within the gastrointestinal tract, and variable drug exposure  Note: SNAC (Salcaprozate sodium) increases gastric epithelial membrane fluidity without affecting tight junctions, thereby allowing transcellular passage into systemic circulation of the protein API. SNAC is a component of Novo Nordisk’s Rybelsus® which has been approved by the FDA and EMA.  Absorption Enhancer Dramatically Increases Systemic Plasma Levels of Protein  Stability of Peptide in Solution in presence of Trypsin  Entera’s Proprietary Technology - Synergistically Protects & Transports Large Molecules  1. Prevents the degradation of the therapeutic protein in the GI tract; maintains the integrity of the protein (stability)  2. Enhances peptide absorption by increasing transcellular transport (bioavailability) 

 Program  Target  Preclinical  Phase 1  Phase 2  Phase 3  Partner  Next Milestone  EB613  Osteoporosis  Phase 3  EB612  Hypoparathyroidism  (Orphan Disease)  Human PK  EB613  Non-Union Fractures  Internal Review   GLP-2  Short Bowel Syndrome  Undisclosed  hGH  GH deficiency  Undisclosed  Undisclosed  Anti-  inflammatory  Undisclosed  Undisclosed   Various  Undisclosed  Internal Pipeline Focuses On Approved Injectable Proteins  Partnership Agreements Include Novel Undisclosed Targets     EB612 PTH 1-34 BLA  EB613 PTH 1-34 505b2  Evaluating additional high value therapeutic proteins which could be developed as oral formulations to offer significant benefit to patients   PTH 1-34  PTH 1-34 (2nd generation)  PTH 1-34  Multiple 

 EB613 (oral PTH (1-34), teriparatide) Oral Bone Forming / Anabolic   for the Treatment of Osteoporosis 

 EB613: First Oral PTH Drug Candidate for Osteoporosis     *P1NP: amino pro-peptide of type 1 collagen  Osteoporosis: Skeletal disease characterized by low bone mass, micro-architectural deterioration of bone tissue and increased bone fragility leading to an increased susceptibility to fractures. Currently the vast majority of patients have a preference and are treated with oral therapy (bisphosphonates)​  Parathyroid hormone (PTH) is an 84-amino acid hormone and the primary regulator of calcium and phosphate metabolism in bone and kidney. EB613 is an oral formulation of synthetic hPTH (1-34), (teriparatide), a peptide consisting of the first 34 amino acids of PTH (the functional region), developed with Entera’s proprietary drug delivery technology which stabilizes the teriparatide and promotes absorption in the gastrointestinal tract. Subcutaneous Forteo® (teriparatide injection) has been the leading anabolic treatment of osteoporosis since 2002 (with U.S. peak sales of $960m)  Favorable phase 3 safety profile similar to Forteo and differentiated from oral bisphosphonates  The most common adverse events included mild nausea, moderate back pain, moderate headache, and moderate upper abdominal pain  End of Phase 2 Minutes: FDA suggested Entera explore a placebo-controlled study with BMD ASBMR-FNIH STEs as primary endpoint. Type C meeting expected H2’2022  Phase 2 study met primary endpoint showing a statistically significant increase of P1NP*, a marker of bone formation, at 3 months; at 6 months of treatment with EB613, the increase in spine bone mineral density (BMD) was similar in magnitude to that previously reported with SC Forteo ® injections; Increases in total hip and femoral neck BMD with EB613 were greater than those previously reported with SC Forteo ® injections  Indication  Molecule/ Drug Product  Key Efficacy Profile  Key Safety Profile 

 Osteoporosis Results From An Imbalance In The Bone Remodeling Cycle That Occurs When Bone Resorption Outpaces Bone Formation     The Bone Remodeling Cycle can be separated into two distinct processes: Resorption (osteoclasts) and Formation (osteoblasts)  Sources: International Osteoporosis foundation accessed March 2022; Salamanna, F. et al.  Osteoporosis and the Bone Remodeling Cycle  Bone Density Healthy vs. Osteoporotic   Osteoporosis is a disease associated with low bone mass and enhanced skeletal fragility and is most commonly caused by:  Menopause in women  Aging in both women and men  Glucocorticoid steroid use (greater than 3 months) 

 Notes: * Estrogen products are indicated for prevention of osteoporosis as a secondary benefit when used to control menopausal symptoms. Not a 1st line treatment due to adverse reactions, **SERMs – Selective estrogen receptor modulators Sources: Osteoporosis, accessed March 2022, retrieved from: hopkinsmedicine.org; DerSarkissian, C. Osteoporosis: Diagnosis and Treatment. 2021, Retrieved from: webmd.com; Frost & Sullivan, EnteraBio Initiation of Coverage, 2019;.  Osteoporosis Diagnosis  Anabolic   Bone forming  Antiresorptive  Stop or slow bone loss  Bisphosphonates  Estrogen*/HRT  SERMs**  Monoclonal Antibodies  Fosamax® Alendronate  PTH receptor activation  Boniva® Ibandronate Acid  Atelvia® & Actonel®Risedronic Acid  Reclast® Zoledronic Acid  Forteo® Teriparatide  Estrogen only  Evenity®Romosozumab-apqg  Prolia®Denosumab  Tymlos®Abaloparatide  Estrogen + Progestin  Evista® Raloxifene  Calcitonin  RANK-Ligand Inhibitor  Current Osteoporosis Pharmacologic Treatment Is Segmented Into:   Anti-Resorptive & Anabolic Options     EB613Oral PTH (1-34)  Current anabolic (bone forming) approved drugs require daily (Forteo®, Tymlos®) or monthly injections. There are no oral anabolic agents currently available to patients 

 Healthcare Providers Typically Use T-score BMD Classifications, Patient Fracture History and Preference To Drive Therapy Selection     Injections deter many patients from using PTH, contributing to a treatment gap in high-risk patients. An oral formulation of PTH with adequate bioavailability, similar safety and effects on BMD may address this unmet clinical need  Low BMD Category  Percent of Patients with low BMD  Initial Typical Treatment Recommendation  Internists  Endocrinologists  Osteopenia  55%  27%  Vitamin D and Calcium Supplements  High Risk Osteoporosis(T-scores between -2.5 and -3.0 without a history of fractures)  35%  43%  Bisphosphonates; limited Anabolic penetration  Very High Risk Osteoporosis(T-scores ≤ -3.0 or ≤ -2.5 with prior fragility fractures)  10%  23%  Bisphosphonates / Anabolic therapies  T-Score Scale  Bone Mineral Density Results  T-score  Normal Bone Density  +1.0  0  -1.0  Low Bone Density  (Osteopenia)  -1.5  -2.0  -2.5  Osteoporosis*     -3.0  Source: Triangle Insights Primary Research Apr. 2022;, Low BMD Category based on AACE guidelines (Camacho 2020, Endo Practice)  HCPs indicated most of their osteoporosis patients are:  Post-menopausal women (~70%)   Or older men (~15%) 

 Source: IQVIA prescription data (note the capture rate of IQVIA may be low due to injectable administration of anabolic drugs on the market); TIG Primary Research Apr. 2022  IQVIA-Based  HCP Primary-Based  Total Osteoporosis Treated Population  ~3.16M  ~3.23M   Bisphosphonate Patients  ~1.74M (~55%)  ~1.74M (~54%)   SERMs Patients  ~206K (~7%)  ~206K (~6%)   Rank-Ligand Inhibitor Patients  ~1.14M (~36%)  ~1.02M (~32%)   Anabolic Patients  ~65K (~2%)  ~260K (~8%)  Bisphosphonates include Fosamax®, Boniva®, Atelvia®, Reclast®, and generic versions of listed products; SERMs include Evista® and generic raloxifene; Rank-Ligand Inhibitors include Prolia®; Anabolics include Evenity®, Forteo®, generic teriparatide, and Tymlos®  Share of Osteoporosis Treated Population by Medication Class   IQVIA-Based  HCP-Based  Estimated Treated Population by Class of Osteoporosis Medication  Anabolic Treated Patients Comprise Less Than 10% of Currently Treated Osteoporosis Patients     Population Treated   by Class of Osteoporosis Medication (2021) 

 EB613 Poised To Create A Paradigm Shift In The Treatment of Osteoporosis As The First Oral Anabolic Therapy  Key Product Needs  Forteo®  (Lilly)  Tymlos® (Radius)  Evenity®  (Amgen)  Prolia®  (Amgen)  Bisphosphonates(generics)  Entera   EB613  Treats Osteoporosis  Rebuilds Bone  Oral Dosing  No Refrigeration  Self-Administered   *  Source: Triangle Insights Primary Research Apr. 2022  *Zoledronic acid is administered by intravenous administration  Current Anabolic drugs, including PTH (1-34) (teriparatide) injections - Forteo® or Generics, Tymlos® and Evenity® increase the rate of bone formation but require daily or monthly injections  EB613 is positioned as the first potential oral anabolic PTH treatment for osteoporosis  Bisphosphonates (oral daily pills) are the most common treatment of post-menopausal osteoporosis – orally administered and inexpensive, but many patients progress and have low tolerance  There have been no new oral drugs in >10 years 

 EB613 Phase 2 ResultsA Six-Month Study of Oral PTH in Postmenopausal Women with Low Bone Mass – 6 Month Bone Mineral Density (BMD) Results   

 EB613 Phase 2 Clinical Trial Design  Arm 1: Placebo tablets QD  Arm 2: 0.5 mg *  Arm 3: 1.0 mg *  Arm 4:  1.5 mg QD  Arm 5: 2.5 mg QD * **  Arm 6: 2.5mg titrated QD **  Key inclusion criteria  50+ years old and 3+ years post menopause   Low bone mass  Key exclusion criteria  Osteoporosis treatment within last 2 years  Known medical predisposition  Severe osteoporosis that precludes placebo  Randomization N=160 (target)  Endpoints  Data  3 M Partial** & Final interim analysis of primary endpoint  6 M Final analysis / Topline data – All endpoints  Primary – at 3 months  Serum P1NP change from baseline at 3 months  Secondary – at 6 months  BMD change from baseline at 6 months  P1NP, Osteocalcin, Bone Alkaline Phosphatase  Serum CTX, Urine NTX/Creatinine  Plasma hPTH (1-34) at T15 min  6-Month, Randomized Dose-Ranging Placebo-Controlled Study  Conducted at 4 sites in Israel between June 2019 and May 2021; Final enrollment =161  * Following an interim analysis, a 2.5mg arm was added and recruitment to the 0.5mg & 1.0 mg arms was stopped  ** Following AEs typical of orthostasis additional subjects in the 2.5mg group received 1.5mg for 1 month, 2.0mg for the next month and 2.5mg during months 3 to 6 (Titrated).   Screening  Treatment* 

 EB613 Predictive Profile Of Bone Biomarkers and Significant Dose-Dependent Increases in BMD  2.5mg selected as Phase 3 dose – sustained “anabolic window” from Month 3 to Month 6 in patients treated with EB613. A significant dose response of 0.5, 1.0, 1.5 and 2.5 mg doses on Month 1 P1NP and Osteocalcin (P<0.0001). Serum CTX decreased 21% from baseline at Month 6 (p<0.01) while P1NP was unchanged  Oral PTH produced a statistically significant Dose Response in Lumbar Spine BMD (p<0.0001)  Presented at Late Breaker LB-1116 and Poster FRI-237– ASBMR 2021  

 Notes: 1. Cosman, et al. Current Osteoporosis Reports (2021) 19:189–205; 2. Leder BZ et.al. JCEM (2015) (historical data from Abaloparatide vs. Forteo)  * P< 0.05. ** P< 0.01  *  **  **  **  0.8% Placebo vs 1.1% Teriparatide  Difference = 0.3% at Femoral Neck2  0.4% Placebo vs 0.5% Teriparatide  Difference = 0.1% at Total Hip2  3.78  2.73  2.76  1.84  EB613 Positively Impacts Lumbar Spine, Femoral Neck and Total Hip BMD at 6 Months, With Excellent Statistical Significance  EB613 produced a statistically significant dose response in lumbar spine BMD (p<0.0001), a statistically significant dose response in femoral neck BMD (p<0.002) and total hip BMD (p<0.008)   EB613 appears to have a greater impact on femoral neck and total hip BMD than previously reported studies involving SC injection Forteo®1,2   Placebo Adjusted BMD by Site of Measurement  Pooled (Titrated + Non-Titrated) 2.5mg   Non-Titrated 2.5mg  

 EB613: 6 Month Placebo Adjusted BMD by Site at 2.5mg Dose  Presented at Late Breaker LB-1116 and Poster FRI-237– ASBMR 2021   At 6 months of treatment with 2.5mg EB613:  The increase in spine BMD was similar in magnitude to that previously reported with SC injection Forteo  Increases in total hip and femoral neck BMD were greater than those previously reported with SC injection Forteo  1.6% Placebo vs 5.5% Teriparatide   Difference = 3.9%  Placebo adjusted Lumbar Spine BMD  Placebo adjusted Femoral Neck BMD  0.8% Placebo vs 1.1% Teriparatide  Difference = 0.3%   Placebo Adjusted Total Hip BMD  0.4% Placebo vs 0.5% Teriparatide  Difference = 0.1%   Historical data   (Leder BZ et.al. JCEM 2015) 

 EB613 Phase 2 Adverse Event Profile  Adverse event profile similar to that observed with Forteo, and typical of orthostatic hypotension  EB613 not associated with serum calcium increases or hypercalcemia adverse events   Greater than 90% of subjects tolerated the 2.5 mg dose well, after titration (1.5mg for 1 month, 2.0mg for the next month and 2.5mg during months 3 to 6)  AEs commonly attributed to vasodilatation with subcutaneous injectable PTH were observed - headache, nausea, presyncope and dizziness There were no serious drug-related AEs  Subject disposition  Placebo   (N=43)  EBP05 0.5 mg orally QD (N=25)  EBP05 1 mg orally QD (N=29)  EBP05 1.5 mg orally QD (N=28)  EBP05 2.5 mg orally QD (N=19)  EBP05 2.5 mg titrated   orally QD (N=17)  N  %  N  %  N  %  N  %  N  %  N  %  Randomized  43  100  25  100  29  100  28  100  19  100  17  100  Discontinued Before Month 3  3  7  3  12  2  6.9  4  14.3  7  36.8  1  5.9  Discontinued from Study Before Month 6  5  11.6  3  12  3  10.3  6  21.4  9  47.4  1  5.9 

 18 M Treatment  Screening  EB613 Proposed Phase 3 Clinical Trial Design  Arm 1:   EBP05 2.5mg (N=400)  2:1 Randomization N=600 (target)  A Global Phase 3, 18-Month, Placebo-Controlled Study (2:1), with a 6-Month Alendronate Extension   Designed to address FDA suggestion - Placebo-Controlled study, BMD endpoint (ASBMR-FNIH Criteria)  Open label Alendronate (N=600)  Titration to 2.5mg Dose   Key inclusion criteria  50+ yrs old and 5+ yrs post menopause   BMD: T-score -2.5 to -3.0   Key exclusion criteria  Osteoporosis treatment w/in last 2 yrs  Known medical predisposition  Severe osteoporosis that precludes placebo  6M Extension  Endpoints  Arm 2:  Placebo tablets (N=200)  Primary –Fracture risk reduction based on total hip BMD STEs  FNIH, fracture specific surrogate thresholds using Total Hip BMD at 18 months  Secondary –   BMD changes from baseline  Bone turnover Biomarkers  Exploratory -  24 month BMD changes   Bone turnover Biomarkers  Data  18 M Final analysis / Topline data – Primary & Secondary endpoints  24 M Final analysis / Topline data – Exploratory Post Extension period endpoints 

 ASBMR-FNIH BMD Regulatory Endpoint Backgrounder  Message from the president of the ASBMR on June 23rd 2022: The FDA Biomarkers Qualification Program accepted the ASBMR-Foundation for the National Institutes of Health (FNIH) Strategy to Advance BMD as a Regulatory Endpoint (SABRE) project team’s Qualification Plan to use the treatment-related change in bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs  The FNIH collected data from over 50 randomized trials and individual data from over 170,000 patients  The FNIH conducted a meta-regression of 38 placebo-controlled trials of 19 therapeutic agents1 and a meta-regression analyses of 91,779 individual patient data from 23 randomized placebo-controlled trials2  The FNIH concluded that total hip (TH) BMD, as opposed to lumbar spine and femoral neck BMD, was found to be the best predictor of fracture risk reduction, at all sites (vertebral, non-vertebral and hip)  FNIH’s submission of the Full Qualification Package, for final approval by the FDA, is expected by the end of the year3  Bouxsein et. al. Journal of Bone and Mineral Research, Vol. 33, 2018, pp 1–11  Black et. al. Lancet Diabetes Endocrinol 2020; 8: 672–82  FNIH, June 1, 2022 press release https://fnih.org/news/announcements/fda-approves-biomarkers-qualification-plan-first-surrogate-endpoint-anti  

 EB613 Phase 3 Clinical Trial Design Background – ASBMR-FNIH STEs  The primary endpoint proposed for EB613 Phase 3 is based on the ASBMR- FNIH’s Surrogate Threshold Effect (STE) using Total Hip (TH) BMD as the predictor of significant fracture reduction for all different fracture types.  Placebo adjusted TH BMD STEs:  1.42% - vertebral fractures  1.83% - all fractures  2.13% - nonvertebral fractures  3.18% - hip fractures  Entera’s proposed Phase 3 study will evaluate the % change in BMD of EB613 measured at the hip vs. placebo  This change will be tested to see which STEs are surpassed. Beginning with vertebral followed by all fractures and nonvertebral fractures.  Eastell et. al. Journal of Bone and Mineral Research, 2021, pp 1–7 

 EB613 Positioning  EB613, as a first in class oral PTH treatment, may potentially offer a viable anabolic (bone formation) therapeutic option to lower the risk of fracture for high risk (based on low BMD score or prior fracture history) osteoporotic patients   PTH receptor activation is a mechanistically validated and key target in the treatment of osteoporosis (Forteo® and Tymlos®)   Based on third party research, many high-risk patients (approximately 35-40% of the estimated 3.2 million treated patients in the US) are reluctant to take daily injections and only turn to currently injectable anabolic drugs when their disease becomes very severe (with multiple fractures)  EB613 Phase 3 design is in accordance with End of Phase 2 suggestion by FDA to explore a placebo-controlled study using the ASBMR-FNIH BMD Biomarker Tool  18 month double blind placebo-controlled treatment phase followed by 6-month transition to alendronate adheres to a real-world treatment paradigm and ensures all patients will receive active treatment  Based on recent third-party market research, healthcare providers would support the use of anabolics earlier in the treatment paradigm - yet hampered to date due to difficulty of administration (injectables) and price 

 EB612 Oral PTH (1-34) For the Treatment of Hypoparathyroidism 

 Hypoparathyroism: PTH Orphan Indication with Sub-Par Clinical Care  References:   https://rarediseases.org/rare-diseases/hypoparathyroidism   https://www.takeda.com/en-us/newsroom/news-releases/2019/takeda-issues-us-recall-of-natpara-parathyroid-hormone-for-injection-due-to-the-potential-for-rubber-particulate/  TransCon™ PTH Top-Line Phase 3 Data from PaTHway (ascendispharma.com)     How many people are affected by HypoPT?  Approximately 200K afflicted with hypoparathyroidism in the US, EU and Japan  What is the market opportunity in HypoPT?  Current standard of care creates long term co-morbidities   Natpara® (parathyroid hormone) injection was approved in 2015 and was withdrawn from US market in September 2019; Natpara® had sales of $230m in 2018, its 3rd full year of sales, before it was recalled. The recall was not connected to the safety or efficacy of parathyroid hormone  TransCon PTH, an investigational once-daily long-acting prodrug of parathyroid hormone (PTH(1-34)) U.S. FDA regulatory submission on track for Q3 and EU MAA for Q4 2022, according to Ascendis  Hypoparathyroidism (HypoPT) is a rare condition in which the parathyroid glands fail to produce sufficient levels of Parathyroid hormone (PTH)   PTH (along with vitamin D and calcitonin) plays a role in regulating the levels of calcium and phosphorus in the blood and in determining bone growth and bone cell activity  HypoPT is characterized by hypocalcemia and hyperphosphatemia  Clinical management includes frequent high doses of calcium and activated Vitamin D which are associated with severe long-term morbidities:  Unmet Need and Market Opportunity  Hypoparathyroidism Overview  Cardiovascular Heart failure, blood vessel calcification  Neurologic Cognitive impairment, basal ganglia calcification  Skeletal Reduced bone turnover  Renal Kidney stones, renal failure 

 EB612: First Oral PTH (1-34) Tablets for Hypoparathyroidism, Summary of PK and Pilot Phase 2 Data   Efficacy:   42% reduction (p=0.001) from baseline in median calcium supplement use   Maintenance of median Ca levels above the lower target level for Hypoparathyroidism patients (>7.5 mg/dL) throughout the study  Rapid decline of 23% (p=0.0003) in median serum phosphate levels 2 hours following the first dose that was maintained for the duration of the study  Safety: One subject experienced 4 AEs and left the study after the first day (withdrew consent), another subject experienced an SAE prior to the administration of the first dose and, hence, unrelated to the study  Phase 2, open-label, 2-period partial crossover study to evaluate the PK and PD (NCT03516773)  Population: N=16 with hypoPT ≥1 year, taking supplemental Ca and either alfacalcidol or calcitriol  Treatment: two doses (0.75 and 2.25) and three regimens of Oral hPTH (1-34) and Natpara® [hPTH(1-84)] 100 μg SC injection QD  Efficacy: Oral hPTH (1-34) 2.25 mg QID for one day is associated with an increase in serum albumin-corrected calcium and 1,25(OH)2D and a decrease in serum phosphate  The magnitude of these changes are comparable to Natpara® 100 μg QD  Two, thee and four doses/day regimens showed a dose-dependent increase in 1,25(OH)2D, indicating that the long-term treatment even with the less frequent regimens may be an effective treatment option  Safety: There were no treatment emergent adverse events of hypercalcemia reported and no treatment-emergent Serious Adverse Events  Oral Calcium Intake   Per Protocol Analysis (N=15)  Improved/ Decreased Urinary Ca Excretion Over a 24-Hour Period  Study Design  Phase 2a, open-label, multicenter pilot study to evaluate the safety, tolerability and PK (NCT02152228)  Population: N=19 with hypoPT≥1 year, taking ≥1gr/day Ca and 25(OH)D 20ng/ml  Treatment: first 3 doses of PTH (1-34) 0.75 mg/dose administered at research center; subjects then self administered 4 times/day  Results 

 EB612 Positioning  EB613 is potentially the first oral PTH (1-34) treatment of hypoparathyroidism  Hypoparathyroidism (HypoPT) is a rare condition in which the parathyroid glands fail to produce sufficient levels of Parathyroid hormone (PTH)   Pilot Phase 2 oral presentation (ASBMR 2015) and peer-reviewed publication in JBMR (March 2021)  42% reduction (p=0.001) from baseline in median calcium supplement use  Maintenance of median Ca levels above the lower target level for Hypoparathyroidism patients (>7.5 mg/dL) throughout the study  Rapid decline of 23% (p=0.0003) in median serum phosphate levels 2 hours following the first dose that was maintained for the duration of the study  80% of the subjects had a decrease in urinary calcium levels by the end of the study  Phase 2 PK-PD study versus Natpara presented (ASBMR 2019)  Novel formulation leverages Entera’s 2nd generation peptide delivery platform (PK study expected in H1’2023) 

 Key Short-Term Catalysts      EB613  FDA Type C Meeting on Phase 3 Protocol (H2’2022E)  ASBMR Additional Data from Phase 2 6-Month BMD Study (September 11, 2022E)   EB613  EB612  PK Data from 2nd Generation Formulation for Hypoparathyroidism (H1’2023E)  EB613  Phase 3 Pivotal Study Initiation for Osteoporosis (H1’ 2023E)   Phase 2/3 (pending FDA discussion) Initiation for Hypoparathyroidism (H2’2023E)  EB612 

 Thank YouContact:Entera Bio:Ms. Miranda ToledanoChief Executive OfficerEmail: miranda@enterabio.com 


 EB613 Phase 3 Clinical Trial Design - FNIH  June 23rd, 2022 message from the president of the ASBMR (American Society for Bone and Mineral research) Dr. Ebeling reported on the FNIH progress and support from the ASBMR1.  https://www.asbmr.org/about/council/presidents-corner-detail/message-from-asbmr-president-peter-ebeling-ao-frac-7  “Dear Colleagues:I am very happy to announce that the US Food and Drug Administration (FDA) Biomarkers Qualification Program recently accepted the ASBMR-Foundation for the National Institutes of Health (FNIH) Strategy to Advance BMD as a Regulatory Endpoint (SABRE) project team’s Qualification Plan to use the treatment-related change in bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs.Indeed, this is the first qualification plan accepted by the FDA for a surrogate endpoint under the 21st Century Cures Act, a remarkable achievement for the Project Team. This team, including ASBMR members Dennis Black, Mary Bouxsein and Richard Eastell, now plans to submit a Full Qualification Package based on this approved plan for final approval by the FDA before the end of this year.The ASBMR is proud to financially support this critical initiative. Achieving FDA approval to utilize BMD as a surrogate endpoint in future osteoporosis drug development trials could provide patients with more options to fight a disease that leads to debilitating fractures that cause disability, loss of independence and even death. It is also likely to attract more researchers to the musculoskeletal field, enabling a new horizon of discoveries to help our patients.” 

 EB613 Phase 3 Clinical Trial Design Background - FNIH  The Foundation for National Institutes of Health (FNIH) – Bone Quality Project (BQP), supported by the FDA and other public, private and academic partners has been evaluating the potential use of existing biomarkers such as BMD to enable the development of anti osteoporosis drugs since 2013.1  The FNIH-BQP has been working closely with the FDA to ensure alignment with the FDA’s requirements and expectations as evident from extensive correspondence between the FNIH and FDA.2  https://fnih.org/our-programs/biomarkers-consortium/programs/bone-quality-project 2. https://fda.force.com/ddt/s/ddt-project?ddtprojectid=97 3. file:///C:/Users/HILLEL-THINK/Downloads/265-FNIH-Legacy-project-transition-to-507-process_1.pdf  FDA responded to the proposed use of percentage change in BMD in our original Letter of Intent in 2016, stating that “Percentage change in DXA BMD should be the most appropriate measure as this metric would not be affected by the DXA machine type or normative database used. However, there may be a threshold of percent change in BMD, above which we are comfortable with stating fracture risk reduction has been demonstrated.”  Aug. 2018 FNIH Status update to the FDA3 

 Entera Proprietary Oral Delivery Platform: Key Advantages and Validation  Significantly Increased Bioavailability of Macromolecules  Reduced Pharmacokinetic Variability  Versality Across Molecular Weight and Target Profile  Advantageous Stability versus Injectables  Controlled Onset of Action, Minutes to Hours  Simple Production Process Preserving API activity  IP Protection across existing and next generation of our platform