To instigate foreign investment, increase the attractiveness and efficiency of the capital market, and enhance regional and international market competitiveness: The Capital Market Authority Approves the Rules for Foreign Investment in Securities

Announcement (Link)

RIYADH, Kingdom of Saudi Arabia, May 05, 2023 (GLOBE NEWSWIRE) — The Capital Market Authority (“CMA”) approved the Rules for Foreign Investment in Securities (the "Rules”), Amendments to the Investment Accounts Instructions, Amendments to the Implementing Regulation of the Companies Law for Listed Joint Stock Companies and Amendments to the Glossary of Defined Terms Used in the Regulations and Rules of the Capital Market Authority, which shall be effective as of the date of their publications.

The approval of the Rules, Instructions and Glossary aim to develop the provisions regulating foreign investment in securities, facilitate access to the regulatory frames regulating foreign investment in securities by collecting the regulating provisions in a single regulatory document, as well as facilitating qualified foreign investors' (QFIs') entry procedures to invest in the Saudi capital market.

The last Amendments comprised considering facilitating the QFIs' requirements, facilitating disclosure requirements and continuous obligations to ease Saudi capital market entry with the aim of minimizing the differences between QFIs and other investor categories in the Saudi market.

The Amendments also comprised developing the qualification conditions that must be met by the QFI to invest in the shares listed in the Main Market and removing the requirements on application for qualification and QFI's assessment agreement. The approved Rules only requiring the QFI to open an investment account in accordance with the Investment Accounts Instructions issued by CMA. This is to ensure the obligation of the capital market institution to make sure that the QFI is meeting all relevant qualification conditions.

Furthermore, the amendments included developing conditions on the investment of the non–resident foreign investors in listed securities through Swap Agreements, including removing the requirement on the duration of such swap agreements, as well as removing the requirement to notify the CMA prior to entering into a Swap Agreement.

The Amendments also included adding a new channel for foreign investment in securities listed on the main market by enabling all foreign natural and legal persons to invest in securities listed on the main market through discretionary portfolios management by Capital Market Institutions.

As of its effective date, the Rules shall replace the Rules for Qualified Foreign Financial Institutions Investment in Listed Securities, Instructions for the Foreign Strategic Investors' Ownership in Listed Companies and the Guidance Note for the Investment of Non–Resident Foreigners in the Parallel Market.

The approval of these rules is expected to have a positive impact on boosting liquidity in the Saudi market, deepening and raising its attractiveness, and enhancing its global status. The rules will also contribute to the transformation of knowledge and experiences in local capital institutions and investors, thereby enhancing the role played by institutional investors in the Saudi capital market.

It is worth noting that the CMA issued the updated edition of the Rules in 2018, which resulted in a 179% increase in the number of QFIs from 2018 to 2022 . In addition, the foreign investors' ownership ratio of the free float total market value increased from 3.77% in 2018 to 14.21% by the end of 2022.

The approval of the Rules came after CMA has published the Draft Rules for Foreign Investment in Securities on the Unified Electronic Platform for Consulting the Public and Government Entities (Public Consultation Platform) affiliated with the National Competitiveness Center (NCC), and the CMA's website for public consultation for a period of (30) calendar days.

Within its Vision 2030, the Kingdom aims to be an attractive and instigating investment destination to continue expanding, as it has developed structural reforms in the financial and economic aspects that have contributed to raising economic growth rates and maintaining financial stability and sustainability, which in turn, helps in attracting foreign investments.

Through its strategic plan; the CMA seeks to position the Saudi capital market as main market in the Middle East and one of the leaders financial markets in the world, and to be an advanced market and attractive to domestic and foreign investment, enabling it to play a pivotal role in developing the economy and diversifying its sources of income in line of the Kingdom's Vision 2030.

The Rules for Foreign Investment in Securities, the Amended Investment Accounts Instructions, the Amended Implementing Regulation of the Companies Law for Listed Joint Stock Companies and the Amended Glossary of Defined Terms Used in the Regulations and Rules of the Capital Market Authority can be viewed via the following links:

The Rules for Foreign Investment in Securities

The Amended Investment Accounts Instructions

The Amended Implementing Regulation of the Companies Law for Listed Joint Stock Companies

The Amended Glossary of Defined Terms Used in the Regulations and Rules of the Capital Market Authority

Capital Market Authority
Communication & Investor Protection Division

About CMA:
The Capital Market Authority (CMA) in Saudi Arabia unofficially started in the early fifties, and continued to operate successfully, until the government set its basic regulations in the eighties. The current Capital Market Law is promulgated and pursuant to Royal Decree No. (M/30) dated 2/6/1424H, which formally brought it into existence. The CMA is a government organization applying full financial, legal, and administrative independence, and has direct links with the Prime Minister.

For more information about CMA, please visit the official website:

A photo accompanying this announcement is available at:–7c79–458e–87eb–2da58d688e6c

GLOBENEWSWIRE (Distribution ID 8833372)

Entera Bio Announces Q1 2023 Financial Results and Corporate Updates

JERUSALEM, May 05, 2023 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, today reported corporate updates and financial results for the first quarter ended March 31, 2023.

"Our primary objectives for 2023 are to finalize our discussion with the FDA regarding our registrational phase 3 study for EB613 in post–menopausal women with low bone mineral density (BMD) and osteoporosis, and to update on our PK study which will assess the potential for a novel oral PTH(1–34) candidate for the treatment of hypoparathyroidism," said Miranda Toledano, the Company's Chief Executive Officer. "We also remain focused on our earlier stage R&D initiatives with peptides that best align to our technology, such as GLP–2."

Corporate Updates for First Quarter 2023:

  • Concluded Type D Meeting with the FDA Related to EB613. Entera previously reported that it will continue discussions with the agency until final guidance is received on the proposed statistical evaluation of its primary endpoint. This is likely to occur pursuant to the FDA's evaluation and qualification of the Foundation for the National Institutes of Health Bone Quality Project (FNIH BQP)1. Entera plans to provide an update on its discussions with the FDA as the year progresses. Meanwhile, the Company continues to strengthen its ecosystem of endocrinology and women's health advisory board for EB613 with the addition of Dr. Steve Goldstein, a global leader in menopause health and former President of the North American and International Menopause Society.
  • Institutional Review Board (IRB) Accepted and the Company Plans to Initiate Next Generation Platform PK Study in H1'2023. Topline results expected in H2'2023 including the potential for a novel candidate to treat hypoparathyroidism with once or twice a day oral PTH(1–34) tablets. This initiative builds on prior PK and Phase 2 results of an earlier generation of EB612 in hypoparathyroidism patients.
  • Entera Oral GLP–2 Pre–Clinical Manuscript Accepted for Publication by the International Journal of Peptide Research and Therapeutics. Based on this work, Entera believes GLP–2 represents a strong candidate for its oral delivery platform and warrants further development as an injection free alternative to patients suffering from short bowel syndrome and other disorders requiring parenteral nutrition.
  • Amgen Research Collaboration. After over four years of collaborative pre–clinical work evaluating the use of Entera's delivery technology with one molecule selected by Amgen, both collaborators have agreed to discontinue the Research Collaboration and License Agreement entered into in 2018 out of mutual convenience.

1 FNIH BQP is also knows as the ASBMR FNIH–SABRE, American Society for Bone and Mineral Research–Foundation for the National Institutes of Health (FNIH) Strategy to Advance BMD as a Regulatory Endpoint (SABRE)

Financial Results for the Three Months Ended March 31, 2023

As of March 31, 2023, Entera had cash and cash equivalents of $10.7 million. Entera expects that its existing cash resources are sufficient to meet its projected operating requirements into the third quarter of 2024, which includes the capital required to fund our ongoing operations, including R&D and the completion of the Phase 1 PK study related to the new formulation of EB612.

Research and development expenses for the three months ended March 31, 2023 were $0.9 million, as compared to $1.7 million for the three months ended March 31, 2022. The decrease of $0.8 million was primarily due to a decrease of $0.6 million in materials and production costs and a decrease of $0.2 million in employee compensation, including share–based compensation.

General and administrative expenses for the three months ended March 31, 2023 were $1.3 million, as compared to $2.2 million for the three months ended March 31, 2022. The decrease of $0.9 million was mainly attributable to a decrease of $0.6 million in employee compensation, including share–based compensation, a decrease of $0.2 million in professional fees and a decrease of $0.1 million in D&O insurance costs.

Operating expenses for the quarter ended March 31, 2023 were $2.2 million, as compared to $3.8 million for the quarter ended March 31, 2022. Entera's operating loss was $2.2 million for quarter ended March 31, 2023, as compared to $3.8 million for the quarter ended March 31, 2022.

Net loss was $2.2 million, or $0.08 per ordinary share (basic and diluted), for the quarter ended March 31, 2023, as compared to $3.8 million, or $0.13 per ordinary share (basic and diluted), for the quarter ended March 31, 2022.

About Entera Bio

Entera is a leader in the development of orally delivered macromolecules, including peptides and other therapeutic proteins. The Company focuses on significant unmet medical needs where a daily mini tablet form of a peptide treatment or replacement therapy holds the potential to transform the standard of care. The Company's most advanced product candidates, EB613 for the treatment of high risk, post–menopausal osteoporosis and EB612 for the treatment of hypoparathyroidism, are in clinical development. EB613 is the first oral, once daily mini tablet presentation of synthetic hPTH (1–34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo , which requires daily SC injections. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/biomarker) and secondary endpoints (BMD) in a dose dependent manner and was presented at the ASBMR 2021 Annual Conference. A phase 1 PK study of novel PTH formulations is planned for H1 2023 to ascertain feasibility of a new hypo candidate (a prior formulation had positive Phase 2a data announced in 2015 and published in JBMR 2019) and for another potential indication. For more information on Entera Bio, visit

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.

(U.S. dollars in thousands, except share data)
March 31 December 31
2023 2022
Cash and cash equivalents 10,691 12,309
Accounts receivable and other current assets 682 540
Property and equipment, net 136 139
Other assets, net 97 139
Total assets 11,606 13,127
Accounts payable and other current liabilities 1,494 1,341
Total non–current liabilities 32 32
Total liabilities 1,526 1,373
Total shareholders' equity 10,080 11,754
Total liabilities and shareholders' equity 11,606 13,127

(U.S. dollars in thousands, except share and per share data)

Three Months Ended
March 31,
2023 2022
Research and development 931 1,690
General and administrative 1,294 2,171
Other income (13 ) (12 )
OPERATING LOSS 2,212 3,835
NET LOSS 2,190 3,784

GLOBENEWSWIRE (Distribution ID 8833207)