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ROSEN, TRUSTED NATIONAL TRIAL COUNSEL, Encourages SVB Financial Group Investors to Secure Counsel Before Important Deadline in Securities Class Action Initiated by the Firm – SIVB, SIVBQ

NEW YORK, March 31, 2023 (GLOBE NEWSWIRE) —

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of SVB Financial Group (NASDAQ: SIVB) (OTC: SIVBQ) between June 16, 2021 and March 10, 2023, inclusive (the "Class Period"), of the important May 12, 2023 lead plaintiff deadline in the securities class action commenced by the Firm.

SO WHAT: If you purchased SVB securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

WHAT TO DO NEXT: To join the SVB class action, go to https://rosenlegal.com/submit–form/?case_id=12882 or call Phillip Kim, Esq. toll–free at 866–767–3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than May 12, 2023. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs' Bar. Many of the firm's attorneys have been recognized by Lawdragon and Super Lawyers.

DETAILS OF THE CASE: According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) the Company failed to disclose to investors the risks presented by impending rising interest rates; (2) the Company failed to disclose to investors that, in an environment with high interest rates, it would be worse off than banks that did not cater to tech startups and venture capital–backed companies; (3) the Company failed to disclose that, if its investments were negatively affected by rising interest rates, it was particularly susceptible to a bank run on Silicon Valley Bank; (4) as a result, defendants' public statements were materially false and/or misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the SVB class action, go to https://rosenlegal.com/submit–form/?case_id=12882 or call Phillip Kim, Esq. toll–free at 866–767–3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the–rosen–law–firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Attorney Advertising. Prior results do not guarantee a similar outcome.

———————————————–

Contact Information:

Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686–1060
Toll Free: (866) 767–3653
Fax: (212) 202–3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com


GLOBENEWSWIRE (Distribution ID 8799796)

GLOBALLY RECOGNIZED ROSEN LAW FIRM Encourages Stanley Black & Decker, Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action – SWK

NEW YORK, March 31, 2023 (GLOBE NEWSWIRE) — WHY: Rosen Law Firm, a global investor rights law firm, announces the filing of a class action lawsuit on behalf of purchasers of the common stock of Stanley Black & Decker, Inc. (NYSE: SWK) between October 28, 2021 and July 28, 2022, both dates inclusive (the "Class Period"). A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than May 23, 2023.

SO WHAT: If you purchased Stanley Black & Decker common stock during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

WHAT TO DO NEXT: To join the Stanley Black & Decker class action, go to https://rosenlegal.com/submit–form/?case_id=13771 or call Phillip Kim, Esq. toll–free at 866–767–3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than May 23, 2023. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs' Bar. Many of the firm's attorneys have been recognized by Lawdragon and Super Lawyers.

DETAILS OF THE CASE: According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) rising interest rates, inflation, and trends in returning to work away from home were in fact quickly eroding then heightened demand for Stanley's tools and outdoor products; (2) the heightened, extraordinary demand Stanley had enjoyed as a result of the COVID–19 pandemic in 2021 and 2022 was returning to 2019 pre–pandemic levels; (3) Stanley's operations were already showing signs of slowing demand; (4) as a result of reorganization, share repurchasing, and dividend growth, Stanley lacked the cash to react with agility to changes in demand; (5) as a result of Stanley's inability to react to a sharp decline in demand, the Company's results and metrics, particularly sales volume, were severely negatively impacted; and (6) as a result, the Company's public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the Stanley Black & Decker class action, go to https://rosenlegal.com/submit–form/?case_id=13771 or call Phillip Kim, Esq. toll–free at 866–767–3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the–rosen–law–firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Attorney Advertising. Prior results do not guarantee a similar outcome.

———————————————–

Contact Information:

Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686–1060
Toll Free: (866) 767–3653
Fax: (212) 202–3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com


GLOBENEWSWIRE (Distribution ID 8799816)

ROSEN, A GLOBAL AND LEADING LAW FIRM, Encourages Signature Bank Investors to Secure Counsel Before Important Deadline in Securities Class Action Filed by the Firm – SBNY, SBNYP

NEW YORK, March 31, 2023 (GLOBE NEWSWIRE) — WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Signature Bank (NASDAQ: SBNY, SBNYP) between March 2, 2023 and March 12, 2023, both dates inclusive (the "Class Period"), of the important May 15, 2023 lead plaintiff deadline, in the securities class action commenced by the Firm.

SO WHAT: If you purchased Signature Bank securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

WHAT TO DO NEXT: To join the Signature Bank class action, go to https://rosenlegal.com/submit–form/?case_id=12988 or call Phillip Kim, Esq. toll–free at 866–767–3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than May 15, 2023. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Many of these firms do not actually litigate securities class actions. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs' Bar. Many of the firm's attorneys have been recognized by Lawdragon and Super Lawyers.

DETAILS OF THE CASE: According to the lawsuit, throughout the Class Period, defendants made materially false and/or misleading statements and/or failed to disclose, among other things, that: (1) Signature Bank did not have the strong fundamentals that it represented itself as having in the days immediately prior to its takeover, or otherwise took action that left it susceptible to a takeover by the New York Department of Financial Services ("DFS"); (2) as a result, it became a target for regulatory action by the DFS, and (3) as a result, defendants' public statements were materially false and/or misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the Signature Bank class action, go to https://rosenlegal.com/submit–form/?case_id=12988 or call Phillip Kim, Esq. toll–free at 866–767–3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the–rosen–law–firm or on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm.

Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm's attorneys are ranked and recognized by numerous independent and respected sources. Rosen Law Firm has secured hundreds of millions of dollars for investors.

Attorney Advertising. Prior results do not guarantee a similar outcome.

———————————————–

Contact Information:

Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686–1060
Toll Free: (866) 767–3653
Fax: (212) 202–3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com


GLOBENEWSWIRE (Distribution ID 8799836)

RVYL FINAL DEADLINE NOTICE: ROSEN, A TOP RANKED LAW FIRM, Encourages RYVYL Inc. f/k/a Greenbox POS Investors to Secure Counsel Before Important April 3 Deadline in Securities Class Action Filed by the Firm – RVYL, GBOX

NEW YORK, March 31, 2023 (GLOBE NEWSWIRE) —

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Ryvyl Inc. f/k/a Greenbox POS (NASDAQ: RVYL, GBOX): (i) pursuant and/or traceable to the registration statement and prospectus issued in connection with the Company's January 29, 2021 public offering (the "Offering"); and/or (ii) between January 29, 2021 and January 20, 2023, both dates inclusive (the "Class Period"), of the April 3, 2023 lead plaintiff deadline in the securities class action commenced by the Firm.

SO WHAT: If you purchased Ryvyl securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

WHAT TO DO NEXT: To join the Ryvyl class action, go to https://rosenlegal.com/submit–form/?case_id=11425 or call Phillip Kim, Esq. toll–free at 866–767–3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than April 3, 2023. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs' Bar. Many of the firm's attorneys have been recognized by Lawdragon and Super Lawyers.

DETAILS OF THE CASE: According to the lawsuit, the Registration Statement was false and/or misleading and/or failed to disclose that: (1) the Company would restate certain financials; (2) the Company's internal controls were inadequate; (3) the Company downplayed and obfuscated its internal controls issues; and (4) as a result, the Registration Statement was materially false and/or misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the Ryvyl class action, go to https://rosenlegal.com/submit–form/?case_id=11425 or call Phillip Kim, Esq. toll–free at 866–767–3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the–rosen–law–firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Attorney Advertising. Prior results do not guarantee a similar outcome.

———————————————–

Contact Information:

Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686–1060
Toll Free: (866) 767–3653
Fax: (212) 202–3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com


GLOBENEWSWIRE (Distribution ID 8799783)

Information on the Total Number of Voting Rights and Shares

REGULATED INFORMATION

Information on the Total Number of Voting Rights and Shares

Mont–Saint–Guibert (Belgium), March 31, 2023, 10:30 pm CET / 4:30 pm ET "" In accordance with article 15 of the Law of 2 May 2007 on the disclosure of large shareholdings, Nyxoah SA (Euronext Brussels and Nasdaq: NYXH) publishes the below information following the issue of new shares.

  • Share capital: EUR 4,859,382.45
  • Total number of securities carrying voting rights: 28,286,985 (all ordinary shares)
  • Total number of voting rights (= denominator): 28,286,985 (all relating to ordinary shares)
  • Number of rights to subscribe to securities carrying voting rights not yet issued:
    • 55 "2016 ESOP Warrants" issued on November 3, 2016, entitling their holders to subscribe to a total number of 27,500 securities carrying voting rights (all ordinary shares);
    • 100 "2018 ESOP Warrants" issued on December 12, 2018, entitling their holders to subscribe to a total number of 50,000 securities carrying voting rights (all ordinary shares);
    • 430,500 "2020 ESOP Warrants" issued on February 21, 2020, entitling their holders to subscribe to a total number of 430,500 securities carrying voting rights (all ordinary shares); and
    • 1,326,375 "2021 ESOP Warrants" issued on September 8, 2021, entitling their holders to subscribe to a total number of 1,326,375 securities carrying voting rights (all ordinary shares); and
    • 700,000 "2022 ESOP Warrants" issued on December 28, 2022, entitling their holders to subscribe to a total number of 700,000 securities carrying voting rights (all ordinary shares).

*

* *

Contacts:
Nyxoah
David DeMartino, Chief Strategy Officer
david.demartino@nyxoah.com
+1 310 310 1313

Attachment


GLOBENEWSWIRE (Distribution ID 1000801556)

Informations sur le Nombre Total de Droits de Vote et d'Actions

INFORMATIONS RGLEMENTES

Informations sur le Nombre Total de Droits de Vote et d'Actions

Mont–Saint–Guibert (Belgique), le 31 mars 2023, 22:30h CET / 16:30h ET "" Conformment l'article 15 de la loi du 2 mai 2007 relative la publicit des participations importantes, Nyxoah SA (Euronext Brussels and Nasdaq: NYXH) publie les informations ci–dessous suite l'mission de nouvelles actions.

  • Capital: EUR 4.859.382,45
  • Nombre total de titres avec droits de vote: 28.286.985 (tous des actions ordinaires)
  • Nombre total de droits de vote (= dnominateur): 28.286.985 (tous lis aux actions ordinaires)
  • Nombre de droits de souscrire des titres avec droits de vote non encore mis:
    • 55 "2016 Warrants ESOP" mis le 3 novembre 2016, donnant le droit leurs dtenteurs de souscrire un nombre total de 27.500 titres avec droits de vote (tous des actions ordinaires);
    • 100 "2018 Warrants ESOP" mis le 12 dcembre 2018, donnant le droit leurs dtenteurs de souscrire un nombre total de 50.000 titres avec droits de vote (tous des actions ordinaires);
    • 430.500 "2020 Warrants ESOP" mis le 21 fvrier 2020, donnant le droit leurs dtenteurs de souscrire un nombre total de 430.500 titres avec droits de vote (tous des actions ordinaires);
    • 1.326.375 "2021 Warrants ESOP" mis le 8 septembre 2021, donnant le droit leurs dtenteurs de souscrire un nombre total de 1.326.375 titres avec droits de vote (tous des actions ordinaires); et
    • 700.000 "2022 Warrants ESOP" mis le 28 dcembre 2022, donnant le droit leurs dtenteurs de souscrire un nombre total de 700.000 titres avec droits de vote (tous des actions ordinaires).

*

* *

Contacts:
Nyxoah
David DeMartino, Chief Strategy Officer
david.demartino@nyxoah.com
+1 310 310 1313

Pice jointe


GLOBENEWSWIRE (Distribution ID 1000801556)

Entera Bio Provides 2022 Corporate Milestones and Financial Results for the Year Ended December 31, 2022

JERUSALEM, March 31, 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 announced a summary of 2022 corporate achievements and financial results for the year ended December 31, 2022.

"The year 2022 and 2023 year to date, has been a critical time for Entera, during which focus, optimization and execution across our organization has been paramount to adequately prepare our EB613 program to become phase 3 ready, from a clinical, regulatory, and manufacturing standpoint. EB613 (oral PTH(1–34), teriparatide) is positioned as the first potential daily tablet anabolic therapy for the treatment of post–menopausal women with low Bone Mineral Density (BMD) and osteoporosis. In addition, we have continued to harness our scientific capabilities and intellectual property to expand our proprietary platform with novel drug candidates, including a new generation for EB612, potentially the first PTH (1–34) peptide replacement therapy in tablet form for the treatment of hypoparathyroidism," stated Miranda Toledano, Chief Executive Officer of Entera.

A brief review of key EB613 related milestones:

  • In June 2021, Entera reported positive results from its double–blind, placebo–controlled Phase 2 study of EB613 in 161 post–menopausal women with low BMD and osteoporosis. The study met all PD/ biomarker, BMD endpoints, and demonstrated a generally well tolerated safety profile. It was also noted that EB613 had a differentiated biomarker and BMD profile versus historical 6–month data reported with daily subcutaneous injections of Forteo in a similar population.
  • In January 2022, Entera received FDA's End of Phase 2 meeting minutes which conveyed concern with the previously proposed Phase 3 study, based on a 12–month non–inferiority head–to–head design versus Forteo and whether such a trial would be successful.
  • In response to the FDA's End of Phase 2 minutes, Entera re–designed the proposed phase 3 to potentially align with FDA's suggestion to explore a placebo–controlled phase 3 design with a Total Hip BMD (TH BMD) endpoint, given emerging seminal publications from the FNIH BQP–ASBMR project.
  • On July 18th, 2022, Entera announced that the FDA had granted Entera's request for a Type C Meeting based on the revised phase 3 registrational protocol for EB613.
  • On October 6th 2022, Entera announced the conclusion of its Type C meeting and concurrence with the FDA that a single well designed Phase 3 placebo–controlled study with a proposed primary endpoint of TH BMD may support a New Drug Application (NDA) submission of EB613; and that a relative PK study comparing its oral tablet form of teriparatide, EB613 versus the subcutaneous injection of teriparatide, Forteo , may be utilized as a scientific bridge to support the 505(b)(2) NDA pathway.
  • On February 15th, 2023, Entera announced that a Type D meeting had been accepted by the FDA. As part of its briefing documents for the Type D process, Entera aimed to confirm that the protocol fully met FDA's expectations, including the analysis of the primary TH BMD endpoint and the population PK evaluations.

"We look forward to continuing our dialogue with the FDA and reaching consensus to de–risk our potential pivotal regulatory pathway for EB613. It is our belief that Entera stands as the first osteoporosis drug development company to potentially pursue a placebo–controlled registrational study with a BMD (rather than fracture) endpoint. We are cognizant that to be successful in pioneering a path takes time and the agency's partnership to move forward successfully. From a corporate finance perspective, Entera has sufficient cash on hand into Q3 2024 including the read–out from our planned next generation platform PK study, which may enable us to advance the EB612 program for the treatment of hypoparathyroidism into Phase 2 in 2024. From a strategic standpoint, we will continue to hold both strategic and other discussions to determine the best path forward to finance our pivotal program for EB613. This process is of course dependent on when we conclude our regulatory discussions with FDA. This has been a challenging year for the Company, and I am proud of our resilience and accomplishments," stated Miranda Toledano, Chief Executive Officer of Entera.

Financial Results for the year Ended December 31, 2022

Revenues for the year ended December 31, 2022 and 2021 were $134,000 and $571,000, respectively, mainly attributable to research and development, or R&D services provided to Amgen and other third parties under material transfer agreements. The cost of revenues for the year ended December 31, 2022 was $101,000 as compared to $373,000 for the year ended December 31, 2021 and primarily attributed to expenses in connection with R&D services provided and reimbursed by Amgen.

Research and development expenses for the year ended December 31, 2022, were $5.8 million, as compared to $6.8 million for the year ended December 31, 2021. The decrease was primarily attributed to completion of pre–clinical activities related to our Phase 3 clinical trial for EB613 which was offset by continued materials and production expenses related to clinical supply and a one–time payment to our former President. in 2021.

General and administrative expenses for the year ended December 31, 2022 were $7.3 million, compared to $5.7 million for the year ended December 31, 2021. The increase was mainly attributable to an increase in non–cash share–based compensation granted to directors and executive officers and a one–time payment to our former Chief Executive Officer.

Operating expenses for the year ended December 31, 2022 were $13 million compared to $12.4 million for the year ended December 31, 2021. Entera's operating loss was $13 million for the year ended December 31, 2022, compared to $12.2 million for the year ended December 31, 2021.

Net loss was $13.1 million or $0.45 per ordinary share (basic and diluted) for the year ended December 31, 2022, compared to $12.2 million, or $0.47 per ordinary share (basic and diluted) for the year ended December 31, 2021.

As of December 31, 2022, Entera had cash and cash equivalents of $12.3 million. Entera expects that its existing cash resources are sufficient to meet our 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 EB612. This does not include the capital required to fund our proposed Phase 3 pivotal program for EB613 in osteoporosis.

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 mini daily 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 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 LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share data)
(Unaudited)
December 31 December 31
2022 2021
Cash and cash equivalents 12,309 24,892
Accounts receivable and other current assets 540 437
Property and equipment, net 139 156
Other assets, net 139 502
Total assets 13,127 25,987
Accounts payable and other current liabilities 1,341 3,161
Total non–current liabilities 32 261
Total liabilities 1,373 3,422
Total shareholders' equity 11,754 22,565
Total liabilities and shareholders' equity 13,127 25,987

ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
Year ended
December 31,
2022 2021
REVENUES 134 571
COST OF REVENUES 101 373
GROSS PROFIT 33 198
OPERATING EXPENSES:
Research and development 5,848 6,771
General and administrative 7,253 5,690
Other income (51 ) (46 )
TOTAL OPERATING EXPENSES 13,050 12,415
OPERATING LOSS 13,017 12,217
FINANCIAL EXPENSES(INCOME), net (83 ) 29
LOSS BEFORE INCOME TAX 12,934 12,246
INCOME TAX EXPENSE(BENEFIT) 137 (59 )
NET LOSS 13,071 12,187
LOSS PER SHARE BASIC AND DILUTED 0.45 0.47
WEIGHTED–AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE 28,808,090 28,133,770


GLOBENEWSWIRE (Distribution ID 8799784)

ROSEN, GLOBALLY RESPECTED INVESTOR COUNSEL, Encourages Rite Aid Corporation Investors to Secure Counsel Before Important Deadline in Securities Class Action Commenced by the Firm – RAD

NEW YORK, March 31, 2023 (GLOBE NEWSWIRE) — WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Rite Aid Corporation (NYSE: RAD) between April 26, 2018 and March 13, 2023, both dates inclusive (the "Class Period"), of the important May 19, 2023 lead plaintiff deadline in the securities class action commenced by the firm.

SO WHAT: If you purchased Rite Aid securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

WHAT TO DO NEXT: To join the Rite Aid class action, go to https://rosenlegal.com/submit–form/?case_id=9388 or call Phillip Kim, Esq. toll–free at 866–767–3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than May 19, 2023. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources or any meaningful peer recognition. Many of these firms do not actually litigate securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs' Bar. Many of the firm's attorneys have been recognized by Lawdragon and Super Lawyers.

DETAILS OF THE CASE: According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) Until at least June 2019, Rite Aid filled at least hundreds of thousands of unlawful prescriptions for controlled substances that lacked a legitimate medical purpose, including for potentially lethal opioids such as oxycodone and fentanyl; (2) Rite Aid pharmacists filled these prescriptions despite clear "red flags" that indicated that the prescriptions were unlawful; (3) Rite Aid ignored evidence that its stores were dispensing unlawful prescriptions, and intentionally deleted internal notes about suspicious prescribers written by concerned pharmacists; (4) by knowingly filling unlawful prescriptions for controlled substances, Rite Aid violated the Controlled Substances Act and, where Rite Aid sought reimbursement from federal healthcare programs, also violated the False Claims Act; (5) as a result, it was at risk of prosecution by federal authorities such as the United States Department of Justice ("DOJ") and (6) as a result, Defendants' statements about its business, operations, and prospects, were materially false and misleading and/or lacked a reasonable basis at all times. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the Rite Aid class action, go to https://rosenlegal.com/submit–form/?case_id=9388 or call Phillip Kim, Esq. toll–free at 866–767–3653 or email pkim@rosenlegal.com or cases@rosenlegal.com for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor's ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the–rosen–law–firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Attorney Advertising. Prior results do not guarantee a similar outcome.

———————————————–

Contact Information:

Laurence Rosen, Esq.
Phillip Kim, Esq.
The Rosen Law Firm, P.A.
275 Madison Avenue, 40th Floor
New York, NY 10016
Tel: (212) 686–1060
Toll Free: (866) 767–3653
Fax: (212) 202–3827
lrosen@rosenlegal.com
pkim@rosenlegal.com
cases@rosenlegal.com
www.rosenlegal.com


GLOBENEWSWIRE (Distribution ID 8799792)

Our Wonderful Differences Enriches Societies

On the occasion of World Autism Awareness Day on 2 April 2023, IPS is republishing ‘When Is Too Much Autism Awareness Still Not Enough?’

By Saima Wazed and Zain Bari Rizvi
DHAKA, Bangladesh, Mar 31 2023 – When is too much Autism awareness still not enough? This thought recurs every April as we near World Autism Day on April 2, and parents reach out to me after reading enthusiastic and well-meaning news and journal articles – which are actually harmful and hurtful.

Saima W. Hossain

In 2008, along with a few dedicated parents and professionals, we began our effort to raise awareness around Autism Spectrum Disorder (ASD). We eventually came together to form an advocacy, capacity-building, and research-based not-for-profit organization (Shuchona Foundation) established in 2014.

Today, we feel our work in Bangladesh, through effective national and international partnerships with equally dedicated parents and professionals, has impacted the country. Professional training, extensive awareness activities, and inclusion in social situations are demonstrable. The best part is that parents no longer view themselves as victims punished by fate for having a child with a disability.

Despite all the efforts in educating people in the many sectors of our country, including the formulation of a detailed National Strategic Plan, it is shocking to still find blatant disregard for the truth. I have, therefore, requested a parent, a former Shuchona Foundation head of operations and now a member of our executive board, to share her thoughts. Nothing speaks the truth louder and stronger than the person who has been on the receiving end of the discriminatory, hurtful, and unethical behaviour than the parent who hears it over and over again.

Here below excerpts of what I learned from Zain Bari Rizvi

If I had a Taka (Bangladesh currency) for each time someone said: ‘But he looks so normal,’ when I share that my son is on the Autism Spectrum, I would have been able to take early retirement at a villa in the Maldives!

Zain Bari Rizvi

I do not blame these mostly well-meaning people and their lack of awareness when widely read, and circulated dailies choose to use photos of children with Downs Syndrome to illustrate what children with Autism look like. Autistic traits cannot be captured with a still photograph, and most individuals with ASD look just like any other typical peer.

This sort of misrepresentation is not innocent and borders on dangerously harmful.

Deliberately associating a congenital genetic condition with a neurodevelopmental one will confuse the readers into thinking they are the same. This may also prevent parents and caregivers of children with Autism from seeking early intervention services that could potentially improve outcomes because they will have the false sense of comfort that their child ‘looks normal’, aka neurotypical.

There is no one true face of Autism because it is a not-one-size-fits-all spectrum disorder. It stays true to this famous quote by an Autism Advocate and Autistic person, Dr Stephen Shore: “If you’ve met one individual with autism, you’ve met one individual with autism.”

I am not a psychologist nor an expert, but as a parent who had the privilege to be educated and used my spare time and resources to do research, this incorrect and harmful visual misrepresentation enrages and upsets me.

Bangladesh has made considerable strides in Autism advocacy and policy changes due to extraordinary efforts by the leadership team at Shuchona Foundation. The Foundation has selflessly spearheaded the job of educating and opening the minds and hearts of people about what it entails to be on the Autism Spectrum. Because of their single minded dedication to this cause, we, in Bangladesh, are finally having a discourse on what Autism is and acknowledge and accept the differences in our children with Autism. We also have access to world-class services like early interventions such as ABA therapy and parent/caregiver engagement without shame or guilt.

And if there is one thing I learnt working closely with Shuchona Foundation, the key to making a difference is “to acknowledge that people will not always get it right but to look out for whether they want to learn to make it right”.

As World Autism Day on April 2 nears, my humble request to journalists and mainstream media is to do your duty of imparting factual and medically sound knowledge and information. Learn from your mistakes and ensure your stories and visual representations are accurate because media has the power to help or harm.

As I watch my feisty, opinionated and uber affectionate ASD child thrive in a typical school and social setting thanks to early childhood interventions and therapy, I shudder at the thought of what could have been our reality if I had paid heed to the photos of what Autism looks like in Bangladesh media.

I hope those reading this will take heed. Autism is a complex state of being, and no two autistics are alike. Every time I meet and spend time with someone with Autism, I am amazed at how unique, creative, and what a gift they are to the world. I want to change how we treat those we deem to be different, not change who they are.

For centuries all we have done is find creative ways to separate the majority from the minority. I hope the two years of the global pandemic will finally make us realize that when one group of people mistreat another, be it through military, financial or social power, we all suffer, not just the ones we discriminate against.

Saima Wazed Hossain is Advisor to the Director-General, World Health Organization (WHO), on Mental Health and Autism. She is Chairperson, National Advisory Committee for Autism and NDDs, Bangladesh and Chairperson, Shuchona Foundation. She is a specialist in Clinical Psychology and an expert on Neurodevelopment disorders and mental health. Her efforts have led to international awareness, policy and program changes, and the adoption of three international resolutions at the United Nations and WHO.

Zain Bari Rizvi is a Board Member of Shuchona Foundation, an Operations and Finance professional who is a passionate advocate for people with Autism and a mother of two children.

IPS UN Bureau

 


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Excerpt:

On the occasion of World Autism Awareness Day on 2 April 2023, IPS is republishing ‘When Is Too Much Autism Awareness Still Not Enough?’

CIVICUS Report Exposes a Civil Society Under Attack

The State of Civil Society report from CIVICUS, the global civil society alliance which was officially launched on March 30, 2023, exposes the gross violations of civic space. Credit CIVICUS

The State of Civil Society report from CIVICUS, the global civil society alliance which was officially launched on March 30, 2023, exposes the gross violations of civic space. Credit CIVICUS

By Joyce Chimbi
NAIROBI, Mar 31 2023 – As conflict and crises escalate to create human emergencies that have displaced over 100 million people worldwide, civil society’s vital role of advocating for victims and monitoring human rights cannot be over-emphasised.

The 2022 Nobel Peace Prize award to activists and organisations in Belarus, Russia and Ukraine for working to uphold human rights in the thick of conflict underpins this role.

Yet this has not stopped gross violations of civic space as exposed by the State of Civil Society report from CIVICUS, the global civil society alliance, which was officially launched on March 30, 2023.

“This year’s report is the 12th in its annual published series, and it is a critical look back on 2022. Exploring trends in civil society action, at every level and in every arena, from struggles for democracy, inclusion, and climate justice to demands for global governance reform,” said Ines Pousadela from CIVICUS.

The report particularly highlights the many ways civil society comes under attack, caught in the crossfire and or deliberately targeted. For instance, the Russian award winner, the human rights organisation Memorial, was ordered to close in the run-up to the war. The laureate from Belarus, Ales Bialiatski, received a 10-year jail sentence.

Mandeep Tiwana stressed that the repression of civic voices and actions is far from unique. In Ethiopia, “activists have been detained by the state. In Mali, the ruling military junta has banned activities of CSOs that receive funding from France, hampering humanitarian support to those affected by conflict. In Italy, civil society groups face trial for rescuing migrants at sea.”

Ines Pousadela at the launch of the CIVICUS State of Civil Society Report. Credit: Joyce Chimbi/IPS

Ines Pousadela at the launch of the CIVICUS State of Civil Society Report. Credit: Joyce Chimbi/IPS

Spanning over six chapters titled responding to conflict and crisis, mobilising for economic justice, defending democracy, advancing women’s and LGBTQI+ rights, sounding the alarm on the climate emergency and urging global governance reform, the analysis presented by the report draws from an ongoing analysis initiative, CIVICUS Lens.

On responding to conflict and crisis, Oleksandra Matviichuk from the Center for Civil Liberties in Ukraine spoke about the Russian invasion and the subsequent “unprecedented levels of war crimes against civilians such as torture and rape. And, a lack of accountability despite documented evidence of crimes against civilians.”

Bhavani Fonseka, from the Centre for Policy Alternatives, Sri Lanka, addressed the issue of mobilising for economic justice and how Sri Lanka captured the world’s attention one year ago through protests that start small in neighbourhoods and ultimately led to the President fleeing the country.

Launched in January 2022, CIVICUS Lens is directly informed by the voices of civil society affected by and responding to the major issues and challenges of the day.

Through this lens, a civil society perspective of the world as it stands in early 2023 has emerged: one plagued by conflict and crises, including democratic values and institutions, but in which civil society continues to strive to make a crucial difference in people’s lives.

On defending democracy, Amine Ghali of the Al Kawakibi Democracy Transition Center in Tunisia spoke about the challenge of removing authoritarian regimes, making significant progress in levels of democracy only for the country to regress to authoritarianism.

“It starts with the narrative that democracy is not delivering; let me have all the power so that I can deliver for you. But they do not deliver. All they do is consolidate power. A government with democratic legitimacy demolishing democracy is where we are in Tunisia,” he said.

Erika Venadero from the National Network of Diverse Youth, Mexico, spoke about the country’s journey that started in the 1960s towards egalitarian marriages. Today, same-sex marriages are provided for in the law.

On global governance reforms, Ben Donaldson from UNA-UK spoke about global governance institutional failure and the need to improve what is working and reform what is not, with a special focus on the UN Security Council.

“It is useful to talk about Ukraine and the shortcomings of the UN Security Council. A member of the UN State Council is unable to hold one of its members accountable. There are, therefore, tensions at the heart of the UN. The President of Ukraine and many others ask, what is the UN for if it cannot stop the Ukraine invasion?”

Baraka, a youthful climate activist and sustainability consultant in Uganda, spoke about ongoing efforts to stop a planned major pipeline project which will exacerbate the ongoing climate crisis, affecting lives and livelihoods.

His concerns and actions are in line with the report findings that “civil society continues to be the force sounding the alarm on the triple threat of climate change, pollution and biodiversity loss. Urging action using every tactic available, from street protest and direct action to litigation and advocacy in national and global arenas.”

But in the context of pressures on civic space and huge challenges, the report further finds that “civil society is growing, diversifying and widening its repertoire of tactics.”

Moving forward, the report highlights 10 ideas, including an urgent need for a broad-based campaign to win recognition of civil society’s vital role in conflict and crisis response as well as greater emphasis by civil society and supportive states on protecting freedom of peaceful assembly.

Additionally, the need for civil society to work with supportive states to take forward plans for UN Security Council reform and proposals to open up the UN and other international institutions to much greater public participation and scrutiny.

In all, strengthening and enhancing the membership and reach of transnational civil society networks to enable the rapid deployment of solidarity and support when rights come under attack was also strongly encouraged.

IPS UN Bureau Report

 


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