International Summit — World Leaders From Dozens of Countries Are Gathering – August 11-15, 2022, To Address Paths To Global Peace

Washington, DC, Aug. 11, 2022 (GLOBE NEWSWIRE) — FOR IMMEDIATE RELEASE

PRESS RELEASE

International Summit in South Korea

Toward Peace on the Korean Peninsula: Toward a World Culture of Peace

The Universal Peace Federation (UPF) is hosting "Summit 2022 and Leadership Conference," a five–day international summit with related peace events at the Jamsil Lotte Hotel in Seoul, South Korea, beginning this week.

World leaders from dozens of countries are gathering from August 11–15, 2022, to address paths to global peace, with a special emphasis on Africa, the Asia Pacific Region and reconciliation between North and South Korea.

A highlight of the August 12 opening ceremony is a presentation of a resolution to propose the development of a Peace Charter, which follows on the foundation of the Seoul Resolution signed at World Summit 2022 (February 2022) in Seoul by former UN Secretary General Ban Ki–moon and Cambodian Prime Minister Hun Sen.

Prominent international speakers will include: Rt. Hon. Stephen Harper, Canadian Prime Minister (2006–2015); Hon. Newt Gingrich, US House Speaker (1995–1999); Hon. Mike Pompeo, US Secretary of State (2018–2021); Hon. Dan Burton, US Congressman (1983–2013); and H.E. Brigi Rafini, Executive General, Community of Sahel–Saharan States and Prime Minister (2011–2021), Niger.

Later that same day, participants will hear about a recent UPF Fact–Finding Delegation for Peace on the Korean Peninsula from experts on Korea, including Gen. Walter Sharp, Commander of United Nations Command, Combined Forces Command and US Forces Korea (2008–2011); Amb. Harry Harris, US Ambassador to Korea (2018–2021); and Amb. Joseph DeTrani, Special Envoy, Six–Party Talks with DPRK (2003–2006). In addition, a special program will feature The Washington Times, now celebrating its 40th anniversary.

Multiple sessions will cover peace efforts in Africa, and feature a Resolution endorsed by African Religious Representatives and led by Imboni Prophet Radebe, founder of The Revelation Spiritual Home in South Africa.

Afternoon sessions will include presentations on threats to religious freedom across the globe that features Pastor Paula White–Cain, Senior Pastor, City of Destiny Church in the US; Hon. Jan Figel, European Union Special Envoy for the promotion of freedom of religion (2016–2019); and Dr. Massimo Introvigne, Managing Director, Center for Studies on New Religions, Italy.

On Saturday, August 13, symposia will be held around themes of unified Korea, a peaceful world, harmonizing science and religion, the women's movement, youth character education, and the role of the media and economics in the 21st century.

On Sunday, August 14, participants will travel to the HJ Global Arts Center in Seorak, outside of Seoul, for a special program hosted by Dr. Hak Ja Han Moon honoring her late husband and UPF co–founder, Rev. Dr. Sun Myung Moon and his lifelong efforts to establish peace around the world.

In addition to UPF International Chair Dr. Thomas G. Walsh, the summit's dozens of speakers will include Sheikh Mansour Diouf, Senegal; Hon. Ibrahim Natatou, Minister of Education, Niger; Hon. Hamza Said Hamza, Minister of Youth and Sports, Somalia; Hon. Adi Koila Nailitikau, First Lady (2009–2015), Fiji; Hon. Mwaba Tony, Minister of Higher Education, DR Congo; Hon. Neziha Labidi, Minister of Women, Family and Children (2016–2020), Tunisia; H.E. Dr. Sok Siphana, Chairman, Asian Vision Institute, Cambodia; Jim Rogers, Chairman of Beeland Interests, Inc.; Bishop Don Meares, Senior Pastor, Evangel Cathedral, USA; H.E. Callista Mutharika, First Lady (2010–2012), Malawi; Dr. Song Yong–cheon, Chair, Sunhak Foundation; Dr. Hwang Sun–jo, President, Sun Moon University; and Dr. Yun Young Ho, Director General, FFWPU International.

UPF is an NGO with General Consultative Status with the Economic and Social Council of the United Nations. It has been hosting dozens of forums and events that promote peacebuilding with leaders of 157 nations that have diplomatic ties to North and/or South Korea, in an effort to explore prospects for the peaceful reconciliation of the Korean Peninsula. The Royal Government of Cambodia has been a co–host to some of these events.

The August 11–15 events will have in–person speakers and participants, as well as a large global audience who will join digitally via a high–tech hybrid format.

UPF's works through a set of peacebuilding associations segmented into seven field–based organizations:

  • International Summit Council for Peace (ISCP) and the International Association of First Ladies for Peace (IAFLP)
  • International Association of Parliamentarians for Peace (IAPP)
  • Interreligious Association for Peace and Development (IAPD)
  • International Association for Peace and Economic Development (IAED)
  • International Media Association for Peace (IMAP)
  • International Association of Academicians for Peace (IAAP)
  • International Association of Arts and Culture for Peace (IAACP)

For media inquiries, please contact:

William P. Selig | Communications Director, Universal Peace Federation

Ph: 240–274–1744 | Email: wselig@upf.org | Web: www.upf.org


ROSEN, GLOBAL INVESTOR COUNSEL, Encourages Outset Medical, Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action – OM

NEW YORK, Aug. 11, 2022 (GLOBE NEWSWIRE) —

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Outset Medical, Inc. (NASDAQ: OM) between September 15, 2020 and June 13, 2022, both dates inclusive (the "Class Period"), of the important September 6, 2022 lead plaintiff deadline.

SO WHAT: If you purchased Outset Medical 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 Outset Medical class action, go to https://rosenlegal.com/submit–form/?case_id=6976 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 September 6, 2022. 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 handle 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) defendants had "continuously made improvements and updates to Tablo over time since its original clearance" that required an additional 510(k) application; (2) as a result, Outset Medical could not conduct a human factors study on a cleared device in accordance with FDA protocols; (3) Outset Medical's inability to conduct the human factors study subjected Outset Medical to the likelihood of the FDA imposing a "shipment hold" and marketing suspension, leaving the Company unable to sell Tablo for home use; and (4) as a result, defendants' positive statements about Outset Medical's business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the Outset Medical class action, go to https://rosenlegal.com/submit–form/?case_id=6976 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
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cases@rosenlegal.com
www.rosenlegal.com


The Hunger Factory (I): The Miracle of the Sudden Rise and Fall of Food Prices

The global skyrocketing food prices have been steadily falling earlier than the 22 July Turkey-brokered agreement between Russia and Ukraine that allows both countries’ cereal exports.

What the Russian-Ukrainian conflict has once again laid bare is just how fragile globalised food systems are. Credit: Busani Bafana/IPS

By Baher Kamal
MADRID, Aug 11 2022 – The benchmark for world food commodity prices declined “significantly” in July, with major cereal and vegetable oil prices recording double-digit percentage declines.

The data, released by the UN Food and Agriculture Organization (FAO) on 5 August, adds the FAO Food Price Index averaged 140.9 points in July, down 8.6% from June, “marking the fourth consecutive monthly decline since hitting all-time highs earlier in the year.”

This means that the global skyrocketing food prices have been steadily falling earlier than the 22 July Turkey-brokered agreement between Russia and Ukraine that allows both countries’ cereal exports.

Nevertheless, the business influence on politicians and the media, as well as on world organisations, including the United Nations, have untiringly continued blaming the war in Ukraine for the unprecedented high records of food prices, and also for heavily exacerbating the starvation of billions of people worldwide.

International institutions, governments and corporate actors are using the current crisis, as they have used every crisis: to further consolidate this failed model. False solutions and the redundant calls for failed approaches abound in headlines and international responses

How come that food prices have declined all of a sudden over four consecutive months? The Ukraine war began around five month ago. So?

 

The “miracle” explained

Perhaps one of the most accurate studies explaining the real reasons behind the starvation of one billion people, can be found in the ‘must read’ document elaborated by the international movement created 30 years ago in India by one of the world’s most outstanding scientists and activists, Prof. Vandana Shiva.

The very title of the study: Sowing Hunger, Reaping Profits – A Food Crisis by Design should be enough to understand the deeply rooted causes of what the UN World Food Programme (WFP)’s Red Alert: A Global Food Crisis Like No Other.

Since the Russian invasion of Ukraine, headlines have been dominated by the warnings of risk in global food supply shortages and rising global food prices, all due to the conflict, says the Navdanya International report.

“But, according to many international groups, there is currently no risk of global food supply shortages.” So why are so many countries now facing an increased risk of food insecurity, and in worst cases famine?

What is crucially being overlooked by most diagnosis of the current food crisis is how the problem does not lie in a lack of supply, or lack of market integration, but instead in “how the food system is structured around power.”

The Navdanya International explains how, in fact, the world had already been facing a food and malnutrition crisis long before the current conflict.

 

The corporate power

“From the colonial era, which saw the beginning of extraction and exploitation of small farmers, to the advent of the Green Revolution, and the concretizing of the globalised free trade regime, we have seen the deliberate destruction of small farmers and food sovereignty in favour of corporate power.”

Therefore, it is no coincidence that today we are witnessing the third major food crisis in the last 15 years, the study remarks.

 

Hunger by design?

What the Russian-Ukrainian conflict has once again laid bare is just how fragile globalised food systems are. The current globalised, industrial agri-food system is a food system that creates hunger by design, Prof. Vandana Shiva’s world movement further goes on.

“Worst of all, international institutions, governments and corporate actors are using the current crisis, as they have used every crisis: to further consolidate this failed model. False solutions and the redundant calls for failed approaches abound in headlines and international responses.”

Now more than ever will a food systems transformation toward Food Sovereignty, based on agroecology and increasing biodiversity, help act as a lasting solution to hunger, urges Vandana Shiva’s movement.

 

Under the influence of market lords

In spite of the obvious credibility of all the above, and of the several accurate analyses of numerous world’s experts, politicians, the mainstream media, and the international bodies, continue to attribute all the world’s long-decades standing crises to the current proxy war.

For example, the United Nations Development Programme (UNDP) released on 7 July 2022 a report whose title directly refers to the war in Ukraine: Global cost-of-living crisis catalysed by war in Ukraine sending tens of millions into poverty.

Fortunately, the report also lists some of the real major causes of the world’s growing hunger of which nearly one billion humans have so far fallen victims.

 

Is it all about the war, really?

“Soaring inflation rates have seen an increase in the number of poor people in developing countries by 71 million in the three months since March 2022,” says the report, which was released just 13 days after the entry of Russian troops into Ukraine territory.

Question: Were those 13 days of Ukraine’ proxy war enough to so spectacularly increase the number of world’s hungry people?

UNDP also explains that as interest rates rise in response to soaring inflation, there is a risk of triggering further recession-induced poverty that will exacerbate the crisis even more, accelerating and deepening poverty worldwide.

Question: Were the five-month blocked –and now released– Ukraine’s cereal exports really behind the starvation of the world’s billions of poor?

 

The wider picture

Ukraine is not the world’s single grain producer. Nor is it the Planet’s largest grain exporter. In fact, Ukraine represents 10% of the global supply, as IPS reported in its recent article: The World Was Already Broken. Shall Ukrainian Cereals Fix It Up?

The same applies to Russia, which will also resume its cereal exports in virtue of the 22 July agreement between Moscow and Kieve. With around 118 million tons a year, Russia ranks fourth in the world’s list of the world’s top producers.

The largest one, China, with over 620 million tons, generates more than four-fold the total Russian production. The United States, with 476 million tons, is the world’s second largest cereal producer, nearly three-fold what Russia produces.

Then you have the European Union, with 275 million tons. France alone produces some 63 million tons. And Canada produces more than 58 million tons. Other major cereals producers are India, Brazil, Argentina, and Australia.

 

Starvation at a breathtaking speed

“Unprecedented price surges mean that for many people across the world, the food that they could afford yesterday is no longer attainable today,” says UNDP Administrator, Achim Steiner.

“This cost-of-living crisis is tipping millions of people into poverty and even starvation at breathtaking speed and with that, the threat of increased social unrest grows by the day.”

 

The same story… again?

In its August 2022 Global impact of war in Ukraine: Energy crisis Briefing, the United Nations tells that more people are now forecast to be pushed into food insecurity and extreme poverty by the end of 2022.

“The most recent operational programming update from the WFP estimates that in 2022, 345 million people will be acutely food insecure or at a high risk of food insecurity in 82 countries with a WFP operational presence, implying an increase of 47 million acutely hungry people… due to the ripple effects of the war in Ukraine in all its dimensions.”

Question: Hadn’t the UN Food and Agriculture Organization (FAO) reported on 6 January 2022 that “For 2021 as a whole, averaging across the entire year, the FAO Food Price Index averaged 125.7 points, as much as 28.1 percent above the previous year”?

Hadn’t the FAO Senior Economist Abdolreza Abbassian said that “While normally high prices are expected to give way to increased production, the high cost of inputs, ongoing global pandemic and ever more uncertain climatic conditions leave little room for optimism about a return to more stable market conditions even in 2022”?

Wasn’t that 49 days before the Ukraine war started?

Entera Bio Provides Business Highlights and Financial Results for the Second Quarter 2022

JERUSALEM, Aug. 11, 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 and operating results for the quarter ended June 30, 2022.

"We have reset our thesis and executed on several critical milestones in the first half of 2022. On July 18th, we announced the submission of our proposed registrational protocol for EB613 to the U.S. Food and Drug Administration (FDA). We are simultaneously finalizing the validation of an optimized formulation of EB612, while expanding our pre–clinical pipeline with additional anti–inflammatory and metabolic protein candidates. Lastly, we finished the quarter with $17.3 million in cash which, given our revised Phase 3 schedule, is projected to fund our current operations through the first half of 2023," commented Ms. Miranda Toledano, Chief Executive Officer of the Company. "I am incredibly energized by the opportunities ahead. By continuing to carry forward our internal clinical programs and strategic dialogues, we are poised to deliver tremendous value to patients and our shareholders as we reshape the future of Entera. We look forward to providing a comprehensive update to the investment community later this year."

Business Highlights:

Entera expects to hold a Type C Meeting with the FDA to discuss the potential registrational study for its lead clinical asset, EB613 in the second half of 2022. The Phase 3 is designed as an 18 month double blind placebo–controlled study using FNIH–BQP1 total hip Bone Mineral Density (BMD) thresholds as the primary endpoint to evaluate fracture risk, followed by a 6–month open label transition to alendronate. EB613 is the first oral formulation of PTH (1–34), teriparatide, and the first proposed oral anabolic (bone forming) drug candidate to treat post–menopausal women with osteoporosis. EB613 has the same amino acid sequence as Forteo which requires daily subcutaneous injections and reported peak sales surpassing $1.7 billion in 2017, prior to patent expiry. According to early commercial assessments and clinician surveys, it is estimated that less than 10% of osteoporosis patients use current anabolic drugs (including PTH receptor activators currently available such as Forteo and Tymlos ). Despite the validated mechanism of action of these treatments, patients are deterred by their high cost and injectable mode of administration. As the first oral PTH receptor activator EB613 is expected to address this significant unmet clinical need.

Additionally, Entera is finalizing the development of an optimized formulation for EB612 which may enable twice a day administration (versus the previous 4 times a day) to patients with hypoparathyroidism. The Company anticipates conducting a first–in–human PK study of the new formulation in the first half of 2023. Entera previously conducted a pilot 4–month Phase 2 study, results of which were presented (ASBMR 2015) and published in a peer–reviewed journal (JBMR 2021), as well as a Phase 2 PK–PD study versus Natpara, whose findings have also been publicly presented (ASBMR 2019). These studies demonstrated that EB612 induced a rapid decline in median serum phosphate levels and maintenance of target calcium levels throughout the study, even as patients were able to meaningfully reduce their calcium and active vitamin D supplementation which is key to reducing common comorbidities of this disease.

Finally, Entera announced the formation of its Clinical and Scientific Advisory Board (CSAB), comprising world class experts in bone diseases, endocrinology, and metabolic disorders and will be presenting incremental data from its 6–month Oral PTH (EB613) Phase 2 Study in postmenopausal women with low bone mass, at the 2022 Annual Meeting of the American Society for Bone and Mineral Research (ASBMR), which will take place in Austin, Texas from September 9–12, 2022.

Financial Results for the Six–Month Period Ended June 30, 2022

Revenues for the six months ended June 30, 2022 were $112,000 compared to $226,000 for the six months ended June 30, 2021. In this period, the majority of our revenues were attributable to research and development, or R&D services provided to Amgen under our 2018 collaboration agreement. The cost of revenues for the six months ended June 30, 2022 were $87,000 compared to $172,000 for the six months ended June 30, 2021 and were primarily attributed to salaries and related expenses in connection with the R&D services provided to Amgen.

Operating expenses for the six months ended June 30, 2022 were $7.1 million compared to $5.0 million for the six months ended June 30, 2021. Entera's operating loss was $7.1 million for the six months ended June 30, 2022, compared to $4.9 million for the six months ended June 30, 2021.

Research and development expenses for the six months ended June 30, 2022 were $3.1 million, compared to $2.4 million for the six months ended June 30, 2021, an increase of $0.7 million. The increase was primarily due to an increase of $0.7 in materials and production costs and pre–clinical activity as part of the preparation for our Phase 3 clinical trial for EB613 and an increase of $0.4 million in employee's compensation. The increase was partially offset by a decrease of $0.4 million in other clinical trial expenses related to our Phase 2 trial for EB613 that was completed in June 2021.

General and administrative expenses for the six months ended June 30, 2022 were $4.1 million, compared to $2.7 million for the six months ended June 30, 2021, an increase of $1.4 million. The increase of $1.4 million was mainly attributable to an increase of $0.8 million in share–based compensation granted to non–executive directors and employees, an increase of $0.4 million in legal, accounting fees and others consultants and an increase of $0.2 million in D&O insurance costs.

The net comprehensive loss was $7.0 million or $0.24 per ordinary share (basic and diluted) for the six months ended June 30, 2022, compared to $4.9 million, or $0.21 per ordinary share (basic and diluted) for the six months ended June 31, 2021.

As of June 30, 2022, Entera had cash and cash equivalents of $17.3 million, compared to $20.1 million as of March 31, 2021.

Entera expects that the current cash is sufficient to fund the operations through the second quarter of 2023.

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.

ENTERA BIO LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share data)
(Unaudited)
June 30
December 31
2022
2021
Cash and cash equivalents 17,279 24,892
Accounts receivable and other current assets 1,147 437
Property and equipment, net 166 156
Other assets, net 496 502
Total assets 19,088 25,987
Accounts payable and other current liabilities 1,692 3,161
Total non current liabilities 127 261
Total liabilities 1,819 3,422
Total shareholders' equity 17,269 22,565
Total liabilities and shareholders' equity 19,088 25,987

ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
SIX Months ended June 30,
2022 2021
REVENUES 112 266
COST OF REVENUES 87 172
GROSS PROFIT 25 94
OPERATING EXPENSES:
Research and development 3,084 2,351
General and administrative 4,052 2,674
Other income (27 ) (22 )
TOTAL OPERATING EXPENSES 7,109 5,003
OPERATING LOSS 7,084 4,909
FINANCIAL EXPENSES (INCOME), net (104 ) (5 )
LOSS BEFORE INCOME TAX 6,980 4,904
INCOME TAX(BENEFIT) EXPENSE (11 ) (31 )
NET LOSS 6,969 4,873
LOSS PER SHARE BASIC AND DILUTED 0.24 0.21
WEIGHTED–AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE 28,806,217 23,377,668

_____________________________
1 Foundation for the National Institutes of Health Bone Quality Program (FNIH BQP)


Tragic Irony of Hunger Deaths in Karamoja, Uganda Amidst Plenty of Climate Adaptation Technologies

Failed crop in Southwestern Uganda. While there is a lot of focus on Karamoja, most parts of Uganda have been affected by erratic rains leading to crop failure. Credit Wambi Michael/IPS

Failed crop in Southwestern Uganda. While there is a lot of focus on Karamoja, most parts of Uganda have been affected by erratic rains leading to crop failure. Credit Wambi Michael/IPS

By Wambi Michael
Kampala, Aug 11 2022 – Hundreds of people have died of famine in Uganda’s Karamoja region, and local leaders say that some people are now eating grass to survive.

The Famine Early Warning Systems Network (FEWSNET) estimated that about 518,000 people from Karamoja’s poorest families face critical food insecurity resulting from two seasons of crop failure.

Of the 518,000 people with high levels of food insecurity, 428,000 are experiencing phase three (crisis levels of food insecurity), and 90,000 are at phase four (emergency levels of food insecurity).

For the first time in three years, all the nine districts of Karamoja: Kaabong, Moroto, Kotido, Napak, Nabilatuk, Amudat, Karenga, Abim and Nakapiripit are at crisis level or worse according to IPC classification.

The Integrated Food Security Phase Classification (IPC) uses a scale of one to five to measure food insecurity. The situation in Karamoja has reached a crisis level close to catastrophe level.

Nakut Faith Loru, a Member of Parliament for Kabong district, told IPS that the number of those dying from starvation was rising despite efforts by the government to deliver some food relief.

“The hunger situation in Kaabong district is getting worse, especially for the elderly people. They are dying in large numbers due to starvation, with those on the verge of dying avoiding sleep because they fear dying while asleep,” she said

By the end of July, all the districts were facing acute malnutrition at critical levels.

Four-year-old Aleper is among the children under treatment for malnutrition at Kabong general hospital. He is emaciated, a living symbol of the horrors of starvation again killing people daily in remote northeastern Uganda. Aleper’s every rib is visible, his stomach is descended, and tinny folds of skin cover where his buttocks should be.

High food prices have left many families unable to afford nutritious foods – forcing them to find other ways to cope.

“The situation in Karamoja is an example of how a perfect storm of climate change, conflict, rising food costs, the impact of Covid-19 and limited resources is increasing the number of hungry people,” said Abdirahman Meygag, WFP Uganda Representative.

Shocking images of the Karamojong children and the elderly starving to death have exposed how ill-prepared the government has been in response to a situation that some experts say was very predictable.

The Speaker of Uganda’s Parliament, Anita Among, is one of those that have expressed concern about the deplorable situation in the Karamoja region.

“We have seen so many starving people, malnourished children. The government needs to come out clearly on how to address this issue. In the short, medium, and long term,” said Anita Among

The opposition leader in Parliament, Mathias Mpuuga agreed that providing relief aid was not sustainable. “We have a general drought and widespread crop failure in the country. Many people are already reaching out for food,” said Mpuuga.

Farmers from regions other than Karamoja have complained of poor or no harvests. Kaleb Ejioninga from the West Nile region along the border between Uganda and DRC is among those whose crops have withered before harvest.

“We planted maize and sorghum. They all wilted. The government should come to our rescue. If possible, they should find us quick-maturing seed varieties. Because even when the rain comes, if we plant the same seed, they may not grow,” Ejioninga appealed.

Another farmer, Joseph Indiya, told IPS that many farmers were surprised by the rate of crop failure.

“Actually, the soil here is very fertile. We have rivers around. Production has been so high, but this has surprised us this time. There used to be some rain in June and then rain throughout July. But now, there is not even a single drop of rain,” said Indiya.

The irony is that while most of Karamoja and other part is dry, catastrophic flooding in the Eastern Region’s Mbale district killed 29 people and left hundreds homeless after heavy rain, which caused rivers to overflow.

Uganda’s Minister for Agriculture, Frank Tumwebaze, said the situation in Karamoja and elsewhere in Uganda is not different from that in the Horn of Africa where countries like Somalia, Ethiopia, Kenya, South Sudan, and Sudan are faced with food insecurity due to failed rains across four rain seasons.

“The problem is known. Climate change is real. We are going to work with the ministry of finance to see how to make irrigation equipment more accessible. Farming must continue while aware that we cannot continue depending on chances of nature,” Tumwebaze told journalists in Kampala.

UNICEF Representative to Uganda, Munir Safieldin, agrees that the crisis in Karamoja is not different from the situation in the Horn of Africa. He believes the situation could have been averted.

“We must not wait for thousands of children to die. We have said ‘never again’ too many times. We need long-term and predictable funding to help these children and their families,” said Munir Safieldin.

Amidst the crisis of crop failure in Karamoja and other parts of Uganda, there is debate on whether it is caused by climate change or variability. A number of experts believe the situation was highly predicted. They argue farmers have not been helped to adapt or cope with resultant changes.

One of such scientists is Ugandan plant biologist Dr Ambrose Agona, the Director General of the National Agricultural Organisation (NARO).

“I would like to say that Uganda doesn’t suffer much from climate change but suffers from climate variability,” explained Agona.

“Studies conducted recently demonstrated that the total amount of rainfall meant for this country has not changed in terms of volumes. It is not true that we have not had rain during the two failed seasons,” said Agona, whose body is charged with guiding and coordinating all agricultural research in Uganda.

He told IPS that farmers in most parts of Uganda have long thought that the first rain season begins typically around March, and then it continues to June, so they don’t take advantage of the rain that sometimes sets in as early as January.

Agona told IPS that farmers that have taken advantage of the onset of the rain actually harvest, especially when they plant drought-resistant and early-maturing crop varieties.

In June, the FAO office in Uganda released the IPC classification for Karamoja, warning of the crisis.

“The IPC results we have released today are not so different from what we have seen in the last few years. We need to shift our focus from responding to this food insecurity crisis every year after it has already happened,” said Antonio Querido, FAO representative to Uganda.

How does a farmer cope with climate variability?

Veterinarian and researcher Dr William Olaho-Mukani told IPS that the problem in Karamoja and Uganda generally had been the failure to deploy technologies to help farmers farm when there is no rain.

“This is where the problem is. Don’t firefight. Give farmers technologies for water harvesting, quick maturing, and drought-resistant crops,” said Olaho-Mukani.

“Karamoja has a lot of water when it rains. The challenge has been technology transfer. There is a lot of research by NARO, but transferring technology to the farmer has been a problem. We must ensure that they are available at affordable prices.”

In June 2021, Uganda adopted a Technology Action Plan for climate change adaptation. It noted: “The increase in temperature due to climate change will potentially change rainfall seasonality. The erratic and unpredictable weather patterns are likely to disrupt farm calendars with high-level of field-based post-harvest losses.”

The plan, developed with assistance from UN Environment and Global Environment Facility (GEF), suggests surface runoff water harvesting for communities living in uni-model rainfall belts in northern and eastern Uganda and crop breeding technology to have improved seed varieties supplied to 200,000 smallholder farmers.

IPS UN Bureau Report

 


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Pariah Solidarity Between Myanmar & Russia

Russian Foreign Minister Sergey Lavrov arrives in Naypyitaw on Aug. 3. Credit: Ministry of Foreign Affairs of the Russian Federation MFA

By Jan Servaes
BRUSSELS, Aug 11 2022 – On August 3rd residents of the Myanmar capital Naypyitaw were suddenly awakened by the sound of military helicopters in the air. The helicopters hovered over the city all day. The way to the regime’s foreign ministry was also blocked for hours.

Although they did not know the reason, it suggested that someone important was coming to Naypyitaw. They had no idea who the visiting dignitary was because all communications were also disrupted. But Russian media reported that their country’s foreign minister, Sergei Lavrov, was on his way to Naypyitaw.

Lavrov’s visit comes as the junta has sparked renewed international outrage with the recent executions of four opponents, including a former lawmaker and a prominent human rights activist, in the country’s first use of the death penalty in decades. Lavrov previously visited Naypyitaw in 2013.

Prime Minister Min Aung Hlaing has been to Russia several times since 2013, most recently in July. However, he has not yet met the country’s president, Vladimir Putin.

The international response to Myanmar’s coup d’état and Russia’s invasion of Ukraine has led to a toxic convergence between the two “pariah” nations, Sebastian Strangio concludes in The Diplomat on August 5th.

“A true and loyal friend”

The regime’s foreign minister, Wunna Maung Lwin, devised a working lunch for the Russian launch at the Aureum Palace Hotel, owned by U Teza, the chairman of Htoo Group of Companies, one of the main brokers of arms transactions between the military of Myanmar and Russia.

After the meeting, the regime said “to support both sides in the multilateral arena on mutual trust and understanding.” Wunna Maung Lwin expressed “deep appreciation to the Russian Federation, a true friend of Myanmar, for its consistent support to Myanmar, both bilaterally and multilaterally.”

Afterwards, Lavrov met the regime leader Min Aunging in the presidential residence, which has been renamed the “Office of State Administration Council (SAC)” since last year’s coup. Min Aung Hlaing stated that Russia and Myanmar had established diplomatic relations in 1948 and plan to celebrate their Diamond Jubilee next year.

Lavrov commended Myanmar as a “friendly and long-term partner”, adding that the two countries “have a very solid foundation for building cooperation in a wide range of areas”. Lavrov said the Russian government was in “solidarity in dealing with the situation in the country”. He also wished the State Administrative Committee (SAC) success in the elections it plans to organize in August 2023 in order to officially legitimize the takeover.

Calling Russia a “true and loyal friend” is not wrong. In fact, Russia (along with China) has been loyal in supporting the regime in the UN Security Council. As permanent members of the council, these two key nations have used their veto-right to avoid targeting the Myanmar regime.

However, in his comments, Lavrov, made no mention of the junta’s daily air raids on civilians. After all, these advanced fighter jets and helicopters are Russian-made.

Reporting on the meeting between Lavrov and Min Aung Hlaing, the state-run Global New Light of Myanmar wrote of the two nations’ ambitions to become “permanent friendly countries and permanent allies” who will help each other to “manage their internal affairs without outside interference.”

It may sound cynical, “as Myanmar is looking more like Syria or South Sudan every day”, the meeting between Lavrov and Min Aung Hlaing was more like a handshake of “partners in crime.”

Lavrov left for Cambodia on Wednesday afternoon to attend the meeting of foreign ministers of the Association of Southeast Asian Nations (ASEAN). Myanmar’s foreign minister has been banned for failing to implement the April 2021 5-point-consensus plan.

ASEAN Special Envoy Prak Sokhonn, who has made two trips to Myanmar since the coup, tempered expectations for major near-term progress: “I don’t think even Superman can solve the Myanmar problem.”

Russia is the main arms supplier to the junta

To this day, Russia is the major arms supplier to Myanmar’s military. Russia has been accused by human rights groups of selling to the regime many of the weapons it has used to attack civilians since last year’s coup. Moscow has supplied fighter jets, helicopters and air defense systems to Myanmar and it is no secret that regime leaders prefer military equipment from Russia to China.

Moscow has so far seen Naypyitaw primarily as a military and technical partner, with Defense Minister Sergei Shoigu leading efforts to position Russia as the main supplier of advanced weapons to Myanmar. Russia has also provided postgraduate education to at least 7,000 Myanmar officers since 2001.

In addition to military ties, Shoigu also sees benefits in securing a highly committed partner where South and Southeast Asia meet, in addition to Russia’s long-standing partnerships with India and Vietnam. Until recently, the two countries’ economic and non-military trade relations have remained modest, but appear to be deepening.

Moscow now also wants to expand diplomatic, economic, trade and security ties with Myanmar. When Russia invaded Ukraine, the junta was one of the first to support the Kremlin. The junta’s spokesman said Russia was still a powerful nation that plays a role in preserving the balance of power for world peace.

In recent months, the two countries have established direct banking and financing channels to support increased bilateral trade, including Myanmar’s purchase of Russian energy products.

Indeed, in the wake of the coup, major oil and gas multinationals – including Total, Chevron, Petronas, Woodside and Eneos – have announced their withdrawal from Myanmar, and the regime is eager to find replacements to develop and exploit new and existing gas fields.

Russia’s Rosneft, which has been conducting limited onshore oil and gas exploration in Myanmar for a decade, said in April 2021 it planned to drill test wells.

A hug or stranglehold?

As an International Crisis Group (ICG) briefing published on Aug. 4 noted, the Myanmar coup and the war between Russia and Ukraine have pushed the two sides into a strong mutual embrace.

Russia has relentlessly supported the junta since it took power; it was one of the few countries to send representatives to the March 2021 Armed Forces Day parade — which coincided with a violent crackdown on anti-coup protesters — and has continued its arms deliveries to Myanmar.

At the same time, the SAC has expressed strong support for Russia since the invasion of Ukraine. Even though Myanmar’s ambassador to the United Nations, who has pledged his support to the democratic resistance, has voted in favor of resolutions condemning Moscow’s aggression.

The day after the invasion, a junta spokesman said the invasion was “justified for the permanence of their country’s sovereignty”. As late as July, Senior Gen. Min Aung Hlaing went to Moscow, where he spoke with Russian officials about deeper defense cooperation and possible cooperation on energy projects.

“Faced with tougher international sanctions and diplomatic isolation, the two countries are actively exploring ways to strengthen their security and economic ties,” the ICG briefing said. This toxic convergence is inevitable: increasingly isolated from the West, Myanmar’s military regime in Moscow has sought advanced weapon systems and technical training for military officers that may soon be hard-pressed to obtain elsewhere. curb heavy dependence on ‘neighbouring country’ China, which has also chosen to recognize the SAC government.

For Russia, closer relations with Myanmar offer an opportunity to ramp up arms sales, while undermining Western efforts to form a global coalition to counter Russian adventurism in Ukraine. Given their mutually besieged state, the ICG notes, Myanmar and Russia are “likely to ignore the potential long-term downsides of their growing relationship in favor of short-term benefits.”

No way back?

The regime in Myanmar is isolated and faces sanctions and convictions at home and abroad. It has also struggled in the past year to crush the armed resistance. Since the invasion of Ukraine, Moscow has also been confronted with Western sanctions and has been conducting a long and costly military campaign there. As both countries become more heavily sanctioned and diplomatically isolated, the importance of their relations with each other has grown.

Min Aung Hlaing has clearly chosen to wreak utter destruction. He has sent government leaders to prisons, including deposed state adviser Daw Aung San Suu Kyi. Last month, he ordered the execution of prominent activists, including a lawmaker. There seems to be no turning back for the regime.

Jan Servaes was UNESCO-Chair in Communication for Sustainable Social Change at the University of Massachusetts, Amherst. He taught ‘international communication’ in Australia, Belgium, China, Hong Kong, the US, Netherlands and Thailand, in addition to short-term projects at about 120 universities in 55 countries. He is editor of the 2020 Handbook on Communication for Development and Social Change
https://link.springer.com/referencework/10.1007/978-981-10-7035-8

IPS UN Bureau

 


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