Entera Bio Provides Corporate Updates and Financial Results for the Third Quarter of 2022

JERUSALEM, Nov. 10, 2022 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, today announced its financial results for the third quarter of 2022 and provided the following corporate updates.

Corporate Updates:

Achieved FDA Agreement for Pivotal Study of EB613, the World's First Daily Bone Forming Oral PTH Tablet

  • On October 6th, 2022, Entera announced that it had successfully completed its Type C meeting and reached a record agreement with the U.S. Food and Drug Administration (FDA) that a single pivotal Phase 3 placebo–controlled study could support a New Drug Application (NDA) submission for its lead clinical candidate, EB613 under the 505(b)(2) regulatory pathway.
  • Importantly, the FDA also agreed that total hip bone mineral density (BMD), not fracture, could serve as the primary endpoint for the registrational study of EB613; and that Entera could enroll the same post–menopausal osteoporosis patient population that significantly benefited from EB613 treatment during Entera's Phase 2 clinical study which was reported in 2021.
  • EB613 is the first oral, daily tablet formulation of synthetic hPTH (1–34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo which has been the leading anabolic treatment of osteoporosis since 2002 with peak sales of $1.7 billion in 2018 prior to patent expiration. EB613 tablets are simple, small (~ 6 mm wide) and administered once daily.
  • Low BMD osteoporotic patients at high risk of fracture are often reluctant to initiate injectable anabolic (bone forming) therapy and represent an estimated 40% of the 3 million currently treated patients across the United States, while current bone forming injections treat less than 10% of these patients1. As the first daily tablet PTH osteoanabolic treatment, EB613 could significantly impact the osteoporosis treatment paradigm. Patient enrollment in the pivotal phase 3 study is expected to commence in 2023.

New Phase 2 Data Presented at the ASBMR Annual Meeting Demonstrate Statistically Significant Correlation of EB613's Dose Proportional Oral Absorption and Clinical Benefit

  • New findings on EB613 were presented in a poster titled "A Six–month Phase 2 Study of Oral PTH (EBP05) in Postmenopausal Women with Low Bone Mass "" Dose Proportional Absorption and Effect on Lumbar Spine BMD (SUN–591)" at the American Society for Bone and Mineral Research (ASBMR) 2022 Annual Meeting in September.
  • New analyses of hPTH concentration in blood shortly after a dose of EB613 tablets confirmed a strong, statistically significant correlation between mean blood level and the dose of EB613 taken.
  • These findings are consistent with the positive correlation between the change in lumbar spine BMD and EB613 dose after six months of treatment.

"Following a full redesign of our proposed Phase 3 study, timely submission, and successful conclusion of our Type C meeting, our third quarter culminated with the FDA's concurrence with our proposed registrational path for EB613. This was an historic moment for Entera. We believe this is the first osteoporosis program that has reached agreement on both a placebo–controlled design and a BMD endpoint, which we believe speaks to the urgent need for highly effective and more patient friendly treatments to help rebuild bone. EB613 leverages the validated and safe mechanism of action of PTH which has been at the forefront of osteoporosis therapy for the last 20 years, and addresses patients' unease with injections via our simple daily tablet form. We continue to strengthen all functional areas at Entera to remain on track for patient enrollment to commence in 2023, while continuing our strategic discussions and preparing our new formulation of EB612 PTH tablets for hypoparathyroidism to re–enter the clinic in 2023," stated Miranda Toledano, Chief Executive Officer of Entera.

Results for Third Quarter Ended September 30, 2022

Revenues for the three months ended September 30, 2022 were $8,000 compared to $140,000 for the three months ended September 30, 2021. For both the three months ended September 30, 2022 and 2021, the majority of our revenues were attributable to pre–clinical R&D services provided to Amgen as part of our ongoing license agreement. The decrease in revenue for the quarter ended September 30, 2022 as compared to the prior year period was primarily due to finalization of third year pre–clinical R&D services to Amgen. The cost of revenues for the three months ended September 30, 2022 was $6,000 compared to $65,000 for the three months ended September 30, 2021 and were primarily attributed to expenses in connection with R&D services provided to Amgen.

Research and development expenses for the three months ended September 30, 2022 were $1.4 million compared to $1.8 million for the three months ended September 30, 2021. The decrease of $0.4 million was primarily due to a decrease of $0.7 million in pre–clinical activities related to our Phase 3 clinical trial for EB613 and a decrease of $0.1 million related to the completion of our Phase 2 trial for EB613 in September 2021. This decrease was partially offset by an increase of $0.1 million in connection with a one–time employee compensation payment as part of a separation agreement and an increase of $0.3 million attributed to ongoing materials and production costs to supply our Phase 3 clinical trial for EB613.

General and administrative expenses for both the three months ended September 30, 2022 and 2021 were $1.5 million. For the quarter ended September 30, 2022, there was an increase of $0.2 million in professional fees and an increase of $0.1 million in D&O insurance costs, as compared to the 2021 period, which was offset by a decrease of $0.3 million in share–based compensation mainly due to a reversal of share–based compensation expense related to the separation agreement of our former Chief Executive Officer.

Operating expenses for the three months ended September 30, 2022 were $2.9 million compared to $3.3 million for the three months ended September 30, 2021. Entera's operating loss was $2.9 million for the three months ended September 30, 2022, compared to $3.2 million for the three months ended September 30, 2021.

The net comprehensive loss was $3.1 million or $0.11 per ordinary share (basic and diluted) for the three months ended September 30, 2022, compared to $3.2 million, or $0.11 per ordinary share (basic and diluted) for the three months ended September 31, 2021.

As of September 30, 2022, Entera had cash and cash equivalents of $14.3 million, compared to $17.3 million as of June 30, 2022. Entera expects that its existing cash resources are sufficient to fund operations through the second quarter of 2023. This assumes ongoing R&D, the Hypo PK study and continued investments in production, analytics, and clinical research operations to enable initiation of EB613 phase 3 during the second half of 2023.

About EB613 (a.k.a. EBP05)

EB613 is the first oral, daily tablet formulation of synthetic hPTH (1–34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo which has been the leading anabolic treatment of osteoporosis since 2002 with peak sales of $1.7 billion in 2018 prior to patent expiration. Entera's Oral PTH formulations have been administered collectively to a total of 225 subjects in two Phase 1 studies and 3 phase 2 studies (including 35 in 2 phase 2 hypoparathyroidism studies). The most recent study was a dose ranging Phase 2 study in postmenopausal women with low bone mass. This study met primary and key secondary endpoints and was presented in a late–breaker oral presentation at the ASBMR 2021 conference. For the primary efficacy endpoint: a statistically significant increase in P1NP (a bone formation marker) at 3 months was achieved. A significant dose response was observed for 0.5, 1.0, 1.5 and 2.5 mg oral PTH doses on P1NP, Osteocalcin and bone mineral density (BMD). Subjects receiving the 2.5 mg dose of EB613 showed significant increases in dose–related BMD at the Lumbar Spine, Total Hip, and Femoral Neck at 6 months. Subjects receiving the 2.5 mg dose of EB613 daily for 6 months had a significant placebo adjusted increase of 3.78% in Lumbar Spine BMD (p<0.008) which is similar to the 3.9% increase in Lumbar Spine BMD seen with Forteo in clinical studies reported in the literature. Increases in Total Hip and Femoral Neck BMD were greater than those previously reported with Forteo at 6 months. EB613 exhibited an excellent safety profile, with no drug related serious adverse events. The most common adverse events included mild nausea, moderate back pain, moderate headache, and moderate upper abdominal pain.

About Entera Bio

Entera is a leader in the development of orally delivered macromolecules therapeutics including peptides and other therapeutic proteins, for use in areas with significant unmet medical need where adoption of injectable therapies is limited due to cost, convenience and compliance challenges for patients. The Company's proprietary, oral drug delivery technology is designed to address the technical challenges of poor absorption, high variability, and the inability to deliver large molecules to the targeted location in the body through the use of a synthetic absorption enhancer to facilitate the absorption of large molecules, and protease inhibitors to prevent enzymatic degradation and support delivery to targeted tissues. The Company's most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism are in clinical development. Entera also licenses its technology to biopharmaceutical companies for use with their proprietary compounds and, to date, has established a collaboration with Amgen Inc. For more information on Entera Bio, visit www.enterabio.com.

Contact:

Entera Bio:
Ms. Miranda Toledano
Chief Executive Officer
Entera Bio
Email: miranda@enterabio.com

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release 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 press release 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 press release. The information in this press release is provided only as of the date of this press release, 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 LTD.

CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share data)
(Unaudited)
September 30 December 31
2022 2021
Cash and cash equivalents 14,323 24,892
Accounts receivable and other current assets 867 437
Property and equipment, net 152 156
Other assets, net 198 502
Total assets 15,540 25,987
Accounts payable and other current liabilities 1,193 3,161
Total non current liabilities 35 261
Total liabilities 1,228 3,422
Total shareholders' equity 14,312 22,565
Total liabilities and shareholders' equity 15,540 25,987


ENTERA BIO LTD.

CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)

Three Months ended September 30,
2022 2021
REVENUES 8 140
COST OF REVENUES 6 65
GROSS PROFIT 2 75
OPERATING EXPENSES:
Research and development 1,413 1,771
General and administrative 1,460 1,535
Other income (6 ) (11 )
TOTAL OPERATING EXPENSES 2,867 3,295
OPERATING LOSS 2,865 3,220
FINANCIAL EXPENSES, net 8 7
LOSS BEFORE INCOME TAX 2,873 3,227
INCOME TAX (BENEFIT) EXPENSE 194 (13 )
NET LOSS 3,067 3,214
LOSS PER SHARE BASIC AND DILUTED 0.11 0.11
WEIGHTED–AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE 28,809,922 28,680,833

___________________________
1
Triangle Insights Group June 2022 Analysis, EB613 Osteoporosis Opportunity


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Dante Genomics to present at The Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum

NEW YORK, Nov. 07, 2022 (GLOBE NEWSWIRE) — Dante Genomics, a global leader in genomics and precision medicine, announced that the Company will be participating in The Canaccord Genuity MedTech Diagnostics and Digital Health and Services Forum. Andrea Riposati, CEO of Dante Genomics, will present at the conference on Thursday, November 17, 2022 at 9:30 AM Eastern Time.

A live and archived webcast of the presentation will be available at the conference link here.

About Dante Genomics

Dante Genomics is a global genomic information company building and commercializing a new class of transformative health and longevity applications based on whole genome sequencing and AI. The Company uses its platform to deliver better patient outcomes, prevention, enhanced diagnostics and personalized medicine. The Company's assets include one of the largest private genome databases with research consent, proprietary software designed to unleash the power of genomic data at scale and proprietary processes which enable an industrial approach to genomic sequencing.

Contact:
Laura D'Angelo
VP of Investor Relations
ir@dantelabs.com
+39 0862 191 0671
www.dantegenomics.com


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Dante Genomics creates separate drug discovery and development company Genomic Biopharma Inc.

NEW YORK, Oct. 26, 2022 (GLOBE NEWSWIRE) — Dante Genomics, a global leader in genomics and precision medicine, today announced the creation of Genomic Biopharma Inc., a separate drug discovery and development company to distinguish the separate business streams of each entity. Genomic Biopharma Inc. will present two abstracts on two drug programs at the 2022 American Society of Human Genetics (ASHG) Annual Meeting, the first of which is a top scoring abstract at the meeting titled:

  • Abstract Title: A computational approach to design a COVID–19 vaccine against a predicted SARS–CoV–2 variant: high immunogenicity, efficacy and safety of DELLERA vaccine
    Presentation Date/Time: Wednesday, October 26, 2022, 3:00 PM – 4:45 PM Pacific Time
  • Abstract Title: Novel siRNA–based therapeutic approach for Megacystis Microcolon Intestinal Hypoperistalsis Syndrome (MMIHS)
    Presentation Date/Time: Thursday, October 27, 2022, 3:00 PM – 4:45 PM Pacific Time

"Dante Genomics has delivered genomic insights and diagnoses to thousands of individuals, ending many years–long diagnostic odysseys," said Mattia Capulli, Chief Scientific Officer of Dante Genomics. "Through the creation of Genomic Biopharma Inc. we will realize our vision to support the discovery and development of personalized medicine, so that no one is diagnosed with a disease for which there is no treatment."

Genomic Biopharma Inc. was created as a fully integrated drug discovery and development company, with a pipeline of drug programs for treatments and therapies focused on infectious and rare diseases. The Company develops its pipeline based on findings from Dante Genomics' proprietary database of whole genomes. Genomic Biopharma's core technology, the GBI AI, uses predictive algorithms and genomic data mining to support the identification of novel RNA–based therapeutics.

"Personalized medicine requires an integrated approach from data to clinical trials," said Andrea Riposati, CEO of Dante Genomics. "We created Genomic Biopharma as a separate, independent company, to achieve the vision of personalized medicine and unlock the new era of genomic data based therapeutics."

Dante Genomics provided initial funding and resources to Genomic Biopharma Inc. to kick off the new entity's endeavors and programs. The two companies are now independent.

About Genomic Biopharma Inc.

Genomic Biopharma Inc. is a drug discovery and development company building a pipeline of drug programs focused on bringing to market treatments and therapies for infectious and rare diseases. The Company develops its pipeline based on findings from Dante Genomics' proprietary database of whole genomes. Genomic Biopharma's core technology, the GBI AI, uses predictive algorithms and genomic data mining to support the identification of novel RNA–based therapeutics.

Contact:
info@genomicbiopharma.com
www.genomicbiopharma.com


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Taconic Biosciences Launches First and Only Super Immunodeficient Mouse Models Lacking Residual Murine Fc Gamma Receptors, for Improved Antibody Therapy Assessment

RENSSELAER, N.Y., Oct. 24, 2022 (GLOBE NEWSWIRE) — Taconic Biosciences, a global leader in providing drug discovery animal model solutions, has launched the FcResolv NOG portfolio, the first and only super immunodeficient mouse models lacking residual murine Fc gamma receptors (FcRs) known to confound results in antibody–based therapy studies.

Murine FcRs can cause false positives or false negatives, leading to incorrect conclusions and derail drug discovery. FcResolv NOG models knock out these receptors for greater clarity in antibody–based drug studies, affording investigators greater confidence and more translatable data with fewer studies and fewer animals. With applicability in oncology, immuno–oncology, and autoimmune disease, FcResolv NOG models are suitable for engrafting a wide range of human cells and tissues, including simultaneous human tumor engraftment and immune system humanization.

"Antibody–based therapies represent one of the fastest–growing classes of drugs, creating a pressing need for better preclinical tools to assess therapeutics such as monoclonal antibodies, antibody–drug conjugates, and bispecific antibodies," said Dr. Michael Seiler, vice president of commercial products at Taconic. "Taconic's FcResolv NOG portfolio enables researchers to evaluate drug candidates like these on their own merits, free of interference from residual murine Fc gamma receptor activity."

FcResolv NOG models eliminate the false negatives that occur when an antibody–based therapeutic's Fc domain interacts with murine FcRs as well as the false positives that result when FcRs trigger residual murine immune activity. They also eliminate costly deconvolution steps otherwise needed to distinguish true drug efficacy from off–target effects mediated through the mouse immune system. With more reliable answers, researchers can target their drug discovery investments more strategically and effectively.

The FcResolv NOG model portfolio is based on the super immunodeficient CIEA NOG mouse . The portfolio currently includes two models:

  • FcResolv NOG, for tumor xenografts using cell lines or patient–derived tumors, engraftment of other normal or pathological human cells and tissues, and immune system humanization studies
  • FcResolv hIL–15 NOG, which supports engraftment of human NK cells and is suitable for efficacy studies on antibody–based therapeutics with an antibody–dependent cellular cytotoxicity (ADCC) mechanism of action

To learn more about the FcResolv NOG portfolio, visit www.Taconic.com/fcresolv. Or call 1–888–TACONIC (888–822–6642) in the US, +45 70 23 04 05 in Europe, or email info@taconic.com.

About Taconic Biosciences, Inc.

Taconic Biosciences is a fully licensed, global leader in genetically engineered rodent models and services. Founded in 1952, Taconic provides the best animal solutions so that customers can acquire, custom–generate, breed, precondition, test, and distribute valuable research models worldwide. Specialists in genetically engineered mouse and rat models, microbiome, immuno–oncology mouse models, and integrated model design and breeding services, Taconic operates service laboratories and breeding facilities in the U.S. and Europe, maintains distributor relationships in Asia and has global shipping capabilities to provide animal models almost anywhere in the world.

Media Contact:

Louise Baskin, Senior Director New Product Pipeline

303–432–2495

Louise.Baskin@taconic.com


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Entera Bio Announces FDA Agreement for a Single Phase 3 Clinical Trial to Support an NDA for EB613 for the Treatment of Osteoporosis

JERUSALEM, Oct. 06, 2022 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, announced today the successful conclusion of its Type C meeting and agreement from the U.S. Food and Drug Administration (FDA) that a single Phase 3 placebo–controlled study could support a New Drug Application (NDA) submission of EB613 (oral hPTH (1–34), teriparatide tablets) under the 505(b)(2) regulatory pathway. The FDA also agreed that Total Hip Bone Mineral Density (BMD) could serve as the primary endpoint for the registrational study of EB613 in post–menopausal osteoporosis patients.

The single pivotal Phase 3 clinical trial includes a 24–month placebo–controlled duration with change in Total Hip BMD assessed as the primary endpoint. The 2:1 randomization (EB613 vs. placebo) and planned 400 patients exposed to EB613 are expected to be sufficient to support both the safety and efficacy assessments for the NDA. Furthermore, the FDA agreed with Entera's proposed enrollment of post–menopausal women with osteoporosis based on a BMD T–score of –2.5 to –3.0 and no major fracture history. This patient population is consistent with that studied during Entera's Phase 2 6–month dose ranging study of EB613, which met all primary and key secondary endpoints of biochemistry and BMD. Finally, Entera intends to submit relative PK data comparing its oral tablet form of teriparatide, EB613 versus the subcutaneous injection of teriparatide, Forteo to support the 505(b)(2) pathway.

“This is a major milestone for Entera. We greatly appreciate the opportunity to work collaboratively with the FDA, which was essential for reaching concurrence on all critical elements proposed for the registrational path of EB613," said Miranda Toledano, Chief Executive Officer of Entera. "We have agreement with FDA to continue to treat the same patient population that significantly benefited from EB613 treatment during our Phase 2 study. These low BMD patients at high risk of fracture are often reluctant to initiate injectable anabolic (bone forming) therapy and represent a large unmet need; 40% of the 3 million currently treated patients across the United States, according to our market research. As the first daily tablet PTH osteoanabolic treatment, we believe EB613 could significantly impact the osteoporosis treatment paradigm. We look forward to advancing EB613 into Phase 3 and initiating patient enrollment during 2023," said Miranda Toledano, Chief Executive Officer of Entera.

About EB613 (a.k.a. EBP05)

EB613 is the first and most advanced oral, daily tablet formulation of synthetic hPTH (1–34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo which has been the leading anabolic treatment of osteoporosis since 2002 with peak sales of $1.7 billion in 2018 prior to patent expiration. Entera's Oral PTH formulations have been administered collectively to a total of 225 subjects in two Phase 1 studies and 3 phase 2 studies (including 35 in 2 phase 2 hypoparathyroidism studies). The most recent study was a dose ranging Phase 2 study in postmenopausal women with low bone mass. This study met primary and key secondary endpoints and was presented in a late–breaker oral presentation at the ASBMR 2021 conference. For the primary efficacy endpoint: a statistically significant increase in P1NP (a bone formation marker) at 3 months was achieved. A significant dose response was observed for 0.5, 1.0, 1.5 and 2.5 mg oral PTH doses on P1NP, Osteocalcin and bone mineral density (BMD). Subjects receiving the 2.5 mg dose of EB613 showed significant increases in dose–related BMD at the Lumbar Spine, Total Hip, and Femoral Neck at 6 months. Subjects receiving the 2.5 mg dose of EB613 daily for 6 months had a significant placebo adjusted increase of 3.78% in Lumbar Spine BMD (p<0.008) which is similar to the 3.9% increase in Lumbar Spine BMD seen with Forteo in clinical studies reported in the literature. Increases in Total Hip and Femoral Neck BMD were greater than those previously reported with Forteo at 6 months. EB613 exhibited an excellent safety profile, with no drug related serious adverse events. The most common adverse events included mild nausea, moderate back pain, moderate headache, and moderate upper abdominal pain.

About Entera Bio

Entera is a leader in the development of orally delivered macromolecules therapeutics including peptides and other therapeutic proteins, for use in areas with significant unmet medical need where adoption of injectable therapies is limited due to cost, convenience and compliance challenges for patients. The Company's proprietary, oral drug delivery technology is designed to address the technical challenges of poor absorption, high variability, and the inability to deliver large molecules to the targeted location in the body through the use of a synthetic absorption enhancer to facilitate the absorption of large molecules, and protease inhibitors to prevent enzymatic degradation and support delivery to targeted tissues. The Company's most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism are in clinical development. Entera also licenses its technology to biopharmaceutical companies for use with their proprietary compounds and, to date, has established a collaboration with Amgen Inc. For more information on Entera Bio, visit www.enterabio.com.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release 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 press release 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 press release. The information in this press release is provided only as of the date of this press release, 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 Hosting Key Opinion Leader Webinar on the Treatment Landscape for Osteoporosis and EB613’s Potential Impact on Wednesday, September 28th @ 10am ET

JERUSALEM, Sept. 21, 2022 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company"), a leader in the development of orally delivered peptides and therapeutic proteins, today announced that it will host a key opinion leader (KOL) webinar on the company's lead asset EB613, and its potential impact on the osteoporosis market on Wednesday, September 28, 2022 at 10:00am ET.

The webinar will feature presentations from KOLs John P. Bilezikian, MD, PhD, from Columbia University, Felicia Cosman, MD, also from Columbia University, and Bart L. Clarke, MD, from Mayo Clinic. The event will provide insight into the current treatment landscape and unmet medical need for post–menopausal women with osteoporosis. The discussion will focus on Entera Bio's development of EB613, a proprietary formulation of PTH (1–34, teriparatide) as the first potential orally administered osteoanabolic treatment. Entera leadership will review their Phase 2 EB613 data, which will be followed by an overview of the Company's proposed registrational Phase 3 plan submitted to FDA.

A live Q&A session will follow the presentations. To register for the event, please click here.

Dr. John Bilezikian, the Dorothy L. and Daniel H. Silberberg Professor of Medicine at the Vagelos College of Physicians & Surgeons, Columbia University, is Vice Chair of the Department of Medicine for International Education and Research and Chief, Emeritus, of the Division of Endocrinology. He is Director, Emeritus, of the Metabolic Bone Diseases Program at Columbia University Medical Center.

Dr. Bilezikian received his undergraduate training at Harvard College, his medical training at the College of Physicians & Surgeons, and his residency training at Columbia Presbyterian Medical Center, and his training in Metabolic Bone Diseases and in Endocrinology at the NIH under the tutelage of Dr. Gerald Aurbach. He belongs to the American Society of Bone and Mineral Research (ASBMR) and the International Society of Clinical Densitometry (ISCD), both of which he served as President.

Dr. Bilezikian's major research interests are related to the clinical investigation of metabolic bone diseases, particularly primary hyperparathyroidism, hypoparathyroidism and osteoporosis, His studies of parathyroid hormone in these disorders regarding etiology, clinical manifestations, pathophysiology, mechanisms of skeletal involvement, and therapy are known throughout the world as landmark contributions to our knowledge of these disorders. Over 900 publications and numerous awards speak to these active original investigative initiatives as well as his authorship of many reference sources of endocrinology and metabolic bone diseases.

Dr. Felicia Cosman is a clinical scientist, osteoporosis specialist, Professor of Medicine, Emerita, at Columbia University and North American Co–Editor in Chief of the journal Osteoporosis International since 2016. She received a BA from Cornell, MD from Stony Brook, and completed internship, residency and endocrinology fellowship at Columbia University College of Physicians and Surgeons. She received the ACE Distinction in Endocrinology Award in 2019 and the ASBMR Bartter Award for clinical research in September 2020.

Dr. Cosman has had many grants from NIH, DOD, foundations and industry, and has published over 190 peer–reviewed papers and over 50 book chapters. The main focus of her research has been in the use of anabolic medications and treatment sequencing. Dr. Cosman has investigated the effect of teriparatide on biochemical and bone densitometry outcomes, bone strength by finite element analysis, and cellular action using iliac crest bone biopsy. She also studied the effect of teriparatide on bone formation in the human femoral neck in patients undergoing hip arthroplasty and performed a series of studies investigating cyclic, combination and sequential regimens of teriparatide and antiresorptive agents. Dr. Cosman has been a primary investigator on multiple studies evaluating the efficacy of abaloparatide and romosozumab treatment for osteoporosis. She is also well known for her work evaluating the importance of treatment sequence to optimize the effect of anabolic and antiresorptive medications, longterm treatment strategies, and implementing therapeutic goals for osteoporosis management.

Dr. Bart L. Clarke is Consultant and a member of the Metabolic Bone Disease Core Group in the Division of Endocrinology, Diabetes, Metabolism, and Nutrition at the Mayo Clinic, and Professor of Medicine in the Mayo Clinic College of Medicine. His current clinical research interests include postmenopausal osteoporosis, glucocorticoid– and transplantation–induced osteoporosis, parathyroid disorders, rare bone diseases, new anabolic therapies for osteoporosis, and tumor–induced osteomalacia. He is Past–President and a former Council member of the American Society for Bone and Mineral Research, and a member of the Endocrine Society, American Association of Clinical Endocrinologists, and the American College of Physicians. He is on the editorial board for the Journal of Bone and Mineral Research, Bone, and Osteoporosis International, served on the FDA Reproductive Health Drug Advisory Board, and is a current Chair of the Mayo Clinic Institutional Review Board.

About EB613
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 which represent the functional region. Subcutaneous Forteo (teriparatide injection) has been the leading anabolic treatment of osteoporosis since 2002. EB613 utilizes Entera's oral drug delivery platform which promotes enteric absorption and stabilizes teriparatide in the gastrointestinal tract. Entera's Oral PTH formulations have been administered collectively to a total of 225 subjects in two Phase 1 studies and 3 phase 2 studies (including 35 in 2 phase 2 hypoparathyroidism studies). The most recent study was a dose ranging Phase 2 study in postmenopausal women with low bone mass. This study met primary and key secondary endpoints and was presented in a late–breaker oral presentation at the ASBMR 2021 conference. For the primary efficacy endpoint: a statistically significant increase in P1NP (a bone formation marker) at 3 months was achieved. A significant dose response was observed for 0.5, 1.0, 1.5 and 2.5 mg oral PTH doses on P1NP, Osteocalcin and bone mineral density (BMD). Subjects receiving the 2.5 mg dose of EB613 showed significant increases in dose–related BMD at the lumbar spine, total hip, and femoral neck at 6 months. Subjects receiving the 2.5 mg dose of EB613 daily for 6 months had a significant placebo adjusted increase of 3.78% in lumbar spine BMD (p<0.008) which is similar to the 3.9% increase in lumbar spine BMD seen with Forteo in clinical studies reported in the literature. Increases in total hip and femoral neck BMD were greater than those previously reported with Forteo . EB613 exhibited an excellent safety profile, with no drug related serious adverse events. The most common adverse events included mild nausea, moderate back pain, moderate headache, and moderate upper abdominal pain.

About Entera Bio

Entera is a leader in the development of orally delivered macromolecules therapeutics including peptides and other therapeutic proteins, for use in areas with significant unmet medical need where adoption of injectable therapies is limited due to cost, convenience and compliance challenges for patients. The Company's proprietary, oral drug delivery technology is designed to address the technical challenges of poor absorption, high variability, and the inability to deliver large molecules to the targeted location in the body through the use of a synthetic absorption enhancer to facilitate the absorption of large molecules, and protease inhibitors to prevent enzymatic degradation and support delivery to targeted tissues. The Company's most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism, are in clinical development. The Company recently completed the phase 2 study for EB613 and has a Type C meeting scheduled with FDA with respect to its Phase 3 program in H2 2022. Entera also licenses its technology to biopharmaceutical companies for use with their proprietary compounds and, to date, has established a collaboration with Amgen Inc. For more information on Entera Bio, visit www.enterabio.com.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release 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 press release 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 press release. The information in this press release is provided only as of the date of this press release, 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 to Present at H.C. Wainwright 24th Annual Global Investment Conference

JERUSALEM, Sept. 12, 2022 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, today announced that the Company will present and host 1×1 meetings at the upcoming H.C. Wainwright 24th Annual Global Investment Conference.

Presentation Date: Wednesday, September 14, 2022
Time: 3:30 PM ET
Presenter: Miranda Toledano – CEO
Conference Website https://hcwevents.com/globalconference/

About Entera Bio
Entera is a leader in the development of orally delivered macromolecules therapeutics including peptides and other therapeutic proteins, for use in areas with significant unmet medical need where adoption of injectable therapies is limited due to cost, convenience and compliance challenges for patients. The Company's proprietary, oral drug delivery technology is designed to address the technical challenges of poor absorption, high variability, and the inability to deliver large molecules to the targeted location in the body through the use of a synthetic absorption enhancer to facilitate the absorption of large molecules, and protease inhibitors to prevent enzymatic degradation and support delivery to targeted tissues. The Company's most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism are in clinical development. The Company recently completed the phase 2 study for EB613 and has a Type C meeting scheduled with FDA with respect to its Phase 3 program in H2 2022. Entera also licenses its technology to biopharmaceutical companies for use with their proprietary compounds and, to date, has established a collaboration with Amgen Inc. For more information on Entera Bio, visit www.enterabio.com.


Entera Bio Presents Dose Proportional Absorption and Correlation to BMD Clinical Response Data from its Phase 2 Study of EB613 in Post-Menopausal Osteoporosis Patients at the ASBMR 2022 Annual Meeting

JERUSALEM, Sept. 12, 2022 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, today announced the details of "A Six–month Phase 2 Study of Oral PTH (EBP05) in Postmenopausal Women with Low Bone Mass "" Dose Proportional Absorption and Effect on Lumbar Spine BMD (SUN–591)" poster presentation at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting 2022, being held from September 9–12th in Austin, Texas. The full text of the abstract will be published to the ASBMR meeting website, and the e–poster will be viewable on Entera's website as of Sunday September 11th as of 1pm CT.

The correlation results were derived from Entera's six–month phase 2 Study of lead clinical candidate, EB613 (EBP05), the first daily oral hPTH (1–34) teriparatide formulation in 161 post–menopausal women with low bone mass. The primary endpoint of change in P1NP at 3 months and secondary endpoints of change in lumbar spine (LS), total hip and femoral neck Bone Mineral Density (BMD) were met, as previously reported (ASBMR 2021 poster FRI–237 and oral presentation LB–1116). The current abstract and poster presentation reveals excellent correlations between the dose of the oral formulation of EB613 and teriparatide hPTH(1–34) plasma concentrations at the 15 min time point (R =0.996) and a linear dose response for the change in lumbar spine BMD after 6 months of treatment (R =0.998).

"These new analyses of blood hPTH concentration shortly after a dose of oral EB613 tablets confirm a strong, statistically significant correlation between mean blood level and the dose of EB613 taken. This finding is consistent with excellent correlation between change in lumbar spine BMD and dose of EB613 after 6 months of treatment," Said Dr. Arthur Santora, Chief Medical Officer at Entera.

"We are encouraged by this important correlation analysis from our positive phase 2 study of EB613. Recent debates at the ASBMR annual conference highlight the importance of potentially earlier intervention with osteoanabolic agents capable of repairing bone structure and increasing mass; versus initial treatment with anti–resorptive drugs that mostly stop bone loss. EB613 has unique potential in the osteoporosis treatment paradigm as the first convenient, daily tablets form of osteoanabolic treatment," said Miranda Toledano, Chief Executive Officer of Entera.

About EB613 (a.k.a. EBP05)

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 which represent the functional region. Subcutaneous Forteo (teriparatide injection) has been the leading anabolic treatment of osteoporosis since 2002. EB613 utilizes Entera's oral drug delivery platform which promotes enteric absorption and stabilizes teriparatide in the gastrointestinal tract. Entera's Oral PTH formulations have been administered collectively to a total of 225 subjects in two Phase 1 studies and 3 phase 2 studies (including 35 in 2 phase 2 hypoparathyroidism studies). The most recent study was a dose ranging Phase 2 study in postmenopausal women with low bone mass. This study met primary and key secondary endpoints and was presented in a late–breaker oral presentation at the ASBMR 2021 conference. For the primary efficacy endpoint: a statistically significant increase in P1NP (a bone formation marker) at 3 months was achieved. A significant dose response was observed for 0.5, 1.0, 1.5 and 2.5 mg oral PTH doses on P1NP, Osteocalcin and bone mineral density (BMD). Subjects receiving the 2.5 mg dose of EB613 showed significant increases in dose–related BMD at the lumbar spine, total hip, and femoral neck at 6 months. Subjects receiving the 2.5 mg dose of EB613 daily for 6 months had a significant placebo adjusted increase of 3.78% in lumbar spine BMD (p<0.008) which is similar to the 3.9% increase in lumbar spine BMD seen with Forteo in clinical studies reported in the literature. Increases in total hip and femoral neck BMD were greater than those previously reported with Forteo . EB613 exhibited an excellent safety profile, with no drug related serious adverse events. The most common adverse events included mild nausea, moderate back pain, moderate headache, and moderate upper abdominal pain.

About Entera Bio

Entera is a leader in the development of orally delivered macromolecules therapeutics including peptides and other therapeutic proteins, for use in areas with significant unmet medical need where adoption of injectable therapies is limited due to cost, convenience and compliance challenges for patients. The Company's proprietary, oral drug delivery technology is designed to address the technical challenges of poor absorption, high variability, and the inability to deliver large molecules to the targeted location in the body through the use of a synthetic absorption enhancer to facilitate the absorption of large molecules, and protease inhibitors to prevent enzymatic degradation and support delivery to targeted tissues. The Company's most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism are in clinical development. The Company recently completed the phase 2 study for EB613 and has a Type C meeting scheduled with FDA with respect to its Phase 3 program in H2 2022. Entera also licenses its technology to biopharmaceutical companies for use with their proprietary compounds and, to date, has established a collaboration with Amgen Inc. For more information on Entera Bio, visit www.enterabio.com.


Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release 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 press release 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 press release. The information in this press release is provided only as of the date of this press release, 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.


TMA Precision Health and Dante Genomics partner to help children with rare diseases through clinical whole genome sequencing solutions

NEW YORK, Sept. 08, 2022 (GLOBE NEWSWIRE) — Dante Genomics, a global leader in genomics and precision medicine, today announced its partnership with TMA Precision Health, a company on a mission to improve the lives of rare disease patients everywhere, offering clinical whole genome sequencing to rare disease patients as the first step in diagnosing and treating disease with more personalized medicine.

"The simple act of providing a whole genome sequence is likely the single most important piece of healthcare for a patient with a rare disease, and no child or family should have to needlessly suffer because they can't afford it," said Joshua Resnikoff, CEO and Cofounder of TMA Precision Health. "Our mission is to bring this service to those that need it most. We are thrilled to partner with Dante Genomics to bring the highest quality genomic sequencing and interpretation services to our patients around the globe."

Dante Genomics will provide 30X whole genome sequencing, clinical interpretation and personalized genomic reports to TMA's patient network of more than 3.5 million people living with rare diseases for the purposes of diagnosis.

"There are so many people, especially children, suffering from undiagnosed rare diseases around the world, and it is this unmet need that we are working to serve every day," said Andrea Riposati, CEO and co–founder of Dante Genomics. "We must work to end any diagnostic odyssey for these patients and reduce the time to diagnosis from years to days. Children with a rare disease, in any country, deserve the best clinical care, and TMA Precision Health is at the frontier to bring genomic driven care to the countries with the highest unmet need."

Dante Genomics will utilize the genomic data related to this partnership to advance internal research related to novel target identification and drug development with the ultimate goal to go beyond diagnosis to treatment of rare disease.

TMA will incorporate the data from this partnership to continue growing the largest rare disease database in the world, with a focus on developing precision medicine solutions for rare patients everywhere.

About TMA Precision Health
TMA Precision Health is on a mission to provide personalized care and health equity for rare disease patients around the world. Our unique access to more than 3.5 million rare disease patients powers our ability to build on–demand comprehensive datasets of paired de–identified medical records and whole genomic sequencing and identify rare patients for clinical trials, giving our pharma partners a competitive edge when researching new insights and developing new treatments for this area of critically unmet need. For more information, please visit tmaprecisionhealth.com and follow us on LinkedIn.

About Dante Genomics
Dante Genomics is a global genomic information company building and commercializing a new class of transformative health and longevity applications based on whole genome sequencing and AI. The Company uses its platform to deliver better patient outcomes from diagnostics to therapeutics with assets including one of the largest private genome databases with research consent, proprietary software designed to unleash the power of genomic data at scale and proprietary processes which enable an industrial approach to genomic sequencing.

Contacts:
Joshua Resnikoff
CEO of TMA Precision Health
info@tmaprecisionhealth.com
www.tmaprecisionhealth.com

Laura D'Angelo
VP of Investor Relations
ir@dantelabs.com
+39 0862 191 0671
www.dantegenomics.com


Zenas BioPharma Appoints Simon Lowry, M.D. as Chief Medical Officer

WALTHAM, Mass. and SHANGHAI, China, Sept. 07, 2022 (GLOBE NEWSWIRE) — Zenas BioPharma, a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune–based therapies for patients in need around the world, today announced the appointment of Simon Lowry, M.D., as the company's Chief Medical Officer. Dr. Lowry brings over 20 years of broad clinical expertise in the design and execution of early to late–stage clinical programs to Zenas, where he will lead the company's global clinical, medical affairs, and pharmacovigilance functions.

"We are delighted to welcome Dr. Lowry to Zenas at this pivotal time for the company as we commence two phase three registration trials for our lead product candidate, obexelimab, in the fourth quarter of this year and initiate first–in–human clinical trials for multiple pipeline programs," said Hua Mu, M.D., Ph. D, Chief Executive Officer at Zenas. "Dr. Lowry's proven leadership, broad clinical development background, and extensive global clinical trial experience will further strengthen our ability to execute on our mission to transform the lives of patients with unmet medical needs by bringing best–in–class immune–based therapies to patients."

Dr. Simon Lowry added, "There are many patients with autoimmune and rare diseases in need of effective new treatment options. The deeply experienced and talented Zenas team has made impressive progress advancing the company's pipeline in a very short period of time, and I look forward to leading the ongoing advancement of Zenas' clinical programs through commercialization while further expanding the company's pipeline of innovative programs."

Dr. Lowry is a medical doctor with 20 years of experience at large and emerging pharmaceutical and biotechnology companies directing successful development programs, leading clinical and medical affairs teams, and interacting with regulatory agencies across multiple areas of medicine, including rheumatology, immunology, and ophthalmology. Prior to joining Zenas, Dr. Lowry was Chief Medical Officer at Kinevant Science, a clinical–stage biopharmaceutical company focused on treating rare inflammatory and autoimmune diseases. Dr. Lowry was previously Head of Immunology R&D at Roivant Sciences, leading all development stage immunology assets into clinical development, and served as a key member of the leadership team. He also served as Chief Medical Officer at Sun Pharma North America, where he was responsible for four branded therapeutic areas (Immunology & Dermatology, Ophthalmology, Neurology and Oncology), and led all aspects of development and medical functions (including clinical development, medical information, field medical, HEOR, publications / medical communications, and operations). Early in his career, he worked at Novartis, where he served as Vice President, Global Medical Affairs Franchise Head, Immunology & Dermatology, and Pfizer, where he served in roles of increasing responsibility, including as Vice President, Oncology Medical Affairs Group Leader.

Prior to his pharmaceutical/ biotechnology career, Dr. Lowry practiced internal medicine at various institutions in the UK and Australia. He received his BA from Trinity Hall, Cambridge University, UK and his MB BChir medical degree from Cambridge University School of Clinical Medicine.

About Zenas BioPharma

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune–based therapies for patients around the world. With clinical development and operations in the US and China, Zenas is rapidly advancing a deep pipeline of innovative therapeutics that continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those facing autoimmune and rare diseases. For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on Twitter at @ZenasBioPharma and LinkedIn.

Investor and Media Contact:
Joe Farmer
Zenas BioPharma
IR@zenasbio.com