Daily Archives: May 3, 2022

Insulets 2021 Sustainability Report Reveals Progress on Strategy to Deliver Growth with Purpose – Yahoo Finance

Posted: May 3, 2022 at 9:33 pm

ACTON, Mass., May 02, 2022--(BUSINESS WIRE)--Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod brand of products, today announced the release of its 2021 Sustainability Report. The publication highlights the Companys success in Environmental, Social, and Governance (ESG) issues across Insulets global markets and describes the progress Insulet has made in building upon its sustainability strategy.

"It is more important than ever to integrate sustainability into our business while pursuing our mission to simplify and improve the lives of people with diabetes worldwide," said Shacey Petrovic, President and Chief Executive Officer. "We are now driving measurable impact on critical environmental, social, and governance issues. I am proud of the remarkable progress we have made in a short amount of time, and I know that our accomplishments will motivate continued growth."

As described in the Sustainability Report, Insulet executed several purpose-driven projects designed to build resilient operations, drive sustainable product innovation, and expand the Companys social impact while reducing its effect on the environment.

While supply chains around the world were disrupted in 2021, Insulet achieved 100% fulfillment of customer orders, due to the Companys dual and local sourcing efforts. Throughout the year, Insulet built resilience by managing climate-related risks and opportunities, and making advancements in products, packaging, and operations that improve sustainability at all phases of the products lifecycle. For example, in the European Union, U.K., and Canada, more than 135 metric tons of Pods* were diverted from landfills through product takeback programs. With solar roof panels at its United States headquarters in Acton, Massachusetts, the Company generated almost 800 kilowatt hours of renewable energy.

Insulet continued to build an inclusive culture to foster employee wellbeing. The Company offered comprehensive, flexible working arrangements to support employees and expand the talent pool. Over 500 employees participated in our seven Employee Resource Groups, a two-fold increase in participation from our inaugural year in 2020. Additionally, aligned with its commitment to embed diversity, equity, and inclusion throughout all levels of Insulet, the Company reached 60% gender and ethnic diversity on its Board of Directors.

Story continues

"As I reflect on our journey, we have much to be proud of, and there is more ahead to challenge and excite us," said Lisa Brady, Vice President of Global Sustainability and Chief Sustainability Officer. "We remain inspired by our sustainability vision to Deliver growth with purpose: Innovating to improve lives and preserve our planet, and we look forward to leading systemic change on key environmental, social, and economic issues."

The 2021 report applies the Sustainability Reporting Standards issued by the Global Reporting Initiative (GRI), the most prevalent international standards used to report an organizations sustainability impact and performance. This years report also continues to align with the Sustainability Accounting Standards Board (SASB). SASB is the leading standard used by investors and public companies to ensure standardization in reporting on ESG issues and specifically how they impact financial performance.

The full report can be found at investor.insulet.com under Environmental, Social & Governance.

* These metrics reflect data for the European Union, U.K., and Canada

About Insulet Corporation:

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulets latest innovation, the Omnipod 5 Automated Insulin Delivery System, is a tubeless automated insulin delivery system, integrated with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and is fully controlled by a compatible personal smartphone. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit: insulet.com and omnipod.com.

2022 Insulet Corporation. Omnipod is a registered trademark of Insulet Corporation in the United States of America and other various jurisdictions. All rights reserved.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220502005118/en/

Contacts

Investor Relations: Deborah R. GordonVice President, Investor Relations(978) 600-7717dgordon@insulet.com

Media: Angela Geryak WiczekSenior Director, Corporate Communications(978) 932-0611awiczek@insulet.com

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Sage Therapeutics Announces First Quarter 2022 Financial Results and Highlights Pipeline and Business Progress – Business Wire

Posted: at 9:32 pm

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today reported business highlights and financial results for the first quarter ended March 31, 2022.

Current events have put a spotlight on the need for significant progress in brain health disorders, and at Sage, weve made a strong start to 2022 with the initiation of our rolling regulatory submission for zuranolone in major depressive disorder and meaningful progress across our entire pipeline, said Barry Greene, Chief Executive Officer at Sage Therapeutics. We are currently executing four Phase 2 studies across our neuropsychiatry and neurology franchises, and we recently presented encouraging data from our SAGE-718 program in patients with mild cognitive impairment due to Parkinsons disease and mild cognitive impairment and mild dementia due to Alzheimers disease at key scientific forums. Most importantly, across our programs we remain focused on innovation that emphasizes outcomes that are most important to patients, as we progress our mission to pioneer solutions to deliver life-changing brain health medicines, so every person can thrive.

First Quarter 2022 Portfolio UpdatesSage is advancing a portfolio of clinical programs featuring internally discovered novel chemical entities with the potential to become differentiated products intended to improve brain health by targeting the GABAA and NMDA receptor systems. Dysfunction in these systems is thought to be at the core of numerous neurological and neuropsychiatric disorders.

Depression FranchiseSages depression franchise features zuranolone, Sages next-generation positive allosteric modulator (PAM) of GABAA receptors being evaluated in clinical development as a treatment for major depressive disorder (MDD) and postpartum depression (PPD), and ZULRESSO (brexanolone) CIV injection, approved by the U.S. Food and Drug Association (FDA) as the first treatment specifically indicated for PPD. Zuranolone has received Breakthrough Therapy Designation for the treatment of MDD and Fast Track Designation for the treatment of PPD from the FDA.

Zuranolone is being evaluated, in collaboration with Biogen, as a potential rapid-acting, oral, once-daily, two-week treatment for MDD and PPD in the LANDSCAPE and NEST clinical development programs, respectively. The LANDSCAPE and NEST programs include five positive clinical trials in people with MDD and PPD, as well as the ongoing SKYLARK Study. Additionally, Shionogi completed a positive Phase 2 study with zuranolone in MDD. In the first quarter of this year, Sage and Biogen announced that the CORAL Study met the study objectives. In meeting its pre-defined objectives, the CORAL Study supports the potential of zuranolone, when co-initiated with standard of care, to accelerate the benefit of depression treatment compared to treatment with antidepressant treatments (ADTs) alone.

Yesterday, Sage and Biogen announced the initiation of a rolling New Drug Application (NDA) submission to the FDA for zuranolone in MDD with plans to complete the submission in the second half of 2022. An associated NDA filing for PPD is anticipated in early 2023 pending results from the SKYLARK Study.

The Company expects to achieve the following milestones across its depression franchise in 2022, with plans to share additional analyses from completed and ongoing studies at scientific forums throughout the year:

Neuropsychiatry FranchiseSages neuropsychiatry franchise features SAGE-718, the Companys first-in-class NMDA receptor PAM and lead neuropsychiatric drug candidate, in development as a potential oral therapy for cognitive disorders associated with NMDA receptor dysfunction, potentially including Huntingtons disease (HD), Parkinsons disease (PD) and Alzheimers disease (AD). SAGE-718 received Fast Track Designation from the FDA for development of SAGE-718 as a potential treatment for HD.

Sage is advancing a robust clinical program for SAGE-718 with multiple ongoing or planned Phase 2 studies, including the DIMENSION and SURVEYOR Studies in people with HD cognitive impairment, the lead indication for SAGE-718, the PRECEDENT Study in people with mild cognitive impairment (MCI) associated with PD and a Phase 2 study in people with MCI and mild dementia due to AD.

Additionally, the Company recently presented data from completed SAGE-718 studies in PD and AD cognitive impairment at key scientific forums. Data from the Companys Phase 2 open label PARADIGM Study presented at the AD/PD 2022 Advances in Science & Therapy International Conference on Alzheimers and Parkinsons Diseases and Related Neurological Disorders, showed that SAGE-718 given once daily for 14 days was associated with improvements in executive function and learning and memory at Day 14 in patients with MCI due to PD. Additionally, sustained effects and improving trends were seen out to Day 28. Data from the Phase 2 open-label LUMINARY Study in individuals with MCI and mild dementia due to AD presented at the American Academy of Neurology showed that SAGE-718 given once daily for 14 days was generally well-tolerated and associated with improved executive performance and learning and memory. At Day 14, improvements from baseline were observed in multiple tests of executive functioning and learning and memory. Statistically significant improvement was also observed in the Montreal Cognitive Assessment at Day 28.

The Company expects to achieve the following milestones across its neuropsychiatry franchise in 2022:

Sage also plans to share additional analyses from studies completed with SAGE-718 to date throughout 2022.

Neurology FranchiseSages neurology franchise features SAGE-324 and SAGE-689. SAGE-324, a next-generation PAM of GABAA receptors and Sages lead neurology program, is in development as a potential oral therapy for neurological conditions, such as essential tremor (ET), epilepsy and PD. SAGE-689 is an intramuscular GABAA receptor PAM in development as a potential therapy for disorders associated with acute GABA hypofunction.

Sage and its collaborator, Biogen, are currently enrolling people in the Phase 2b KINETIC 2 placebo-controlled study of SAGE-324 in ET following positive results from the KINETIC Study. The KINETIC 2 Study is a Phase 2b dose-ranging study with the primary goal of defining the dose and frequency for SAGE-324 in ET with a good tolerability profile and a dosing schedule to maintain plasma concentrations needed for sustained tremor symptom control in treating ET.

Sage also plans to initiate a Phase 2 long-term open label safety study with SAGE-324. The study is designed to evaluate the long-term safety and tolerability of SAGE-324 in ET, with incidence of treatment-emergent adverse events as the primary endpoint.

SAGE-689 continues in Phase 1 development.

The Company expects to achieve the following milestones across its neurology franchise in 2022:

Sage also plans to share additional analyses from studies completed with SAGE-324 to date throughout 2022.

Early DevelopmentSage is progressing its early development programs with IND-enabling studies underway for SAGE-319 and SAGE-421.

Business UpdatesSage announced today that Mark Pollack, M.D., joined the Company as Senior Vice President, Medical Affairs. Dr. Pollack will lead Sages global medical affairs efforts across all Sage programs, with a focus on supporting the Companys external relationships with the scientific community. Dr. Pollack joins Sage from Myriad Genetics, where he served as Chief Medical Officer of the Neuroscience Business Unit. Additionally, Dr. Pollack brings 35 years of proven leadership in scientific research and medical practice, including positions as Chair of the Department of Psychiatry and Behavioral Sciences at Rush University Medical Center, Professor of Psychiatry at Massachusetts General Hospital and Harvard Medical School.

ANTICIPATED 2022 MILESTONES

FINANCIAL RESULTS FOR THE FIRST QUARTER 2022

FINANCIAL GUIDANCE

Conference Call InformationSage will host a conference call and webcast today, Tuesday, May 3, at 8:00 a.m. ET to discuss its first quarter 2022 financial results and recent corporate updates. The live webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available on Sage's website approximately two hours after the completion of the event and will be archived for up to 30 days.

About Sage TherapeuticsSage Therapeutics is a biopharmaceutical company fearlessly leading the way to create a world with better brain health. Our mission is to pioneer solutions to deliver life-changing brain health medicines, so every person can thrive. For more information, please visit. http://www.sagerx.com.

Forward-Looking StatementsVarious statements in this release concern Sage's future expectations, plans and prospects, including without limitation our statements regarding: plans for completion of our rolling NDA filing for zuranolone in MDD and associated submission for zuranolone in PPD, and the potential timing of such activities; our belief in the regulatory filing pathways for zuranolone; the potential profile and benefit of zuranolone in MDD and PPD; the potential for regulatory approval and commencement of commercialization of zuranolone; other planned next steps for the program; anticipated timelines for reporting clinical trial results, commencement of trials, and initiation of new activities; our plans for advancement of our pipeline; our belief in the potential profile and benefit of our product candidates; potential indications for our product candidates; the potential for success of our programs, and the opportunity to help patients in various indications; the mission and goals for our business; and our expectations with respect to 2022 year-end cash, no receipt of milestones from collaborations in 2022 and funding of future operations. These statements constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: we may experience delays or unexpected hurdles in our efforts to complete our rolling NDA submission for zuranolone in MDD and our planned submission in PPD and we may not be able to complete the submissions on the timelines we expect or at all; the FDA may find inadequacies and deficiencies in our NDA for zuranolone, including in the data we submit, despite prior discussions, and may decide not to accept the NDA for filing; even if the FDA accepts the NDA for filing, the FDA may find that the data included in the NDA are not sufficient for approval and may not approve the NDA; the FDA may decide that the design, conduct or results of our completed and ongoing clinical trials for zuranolone, even if positive, are not sufficient for approval in MDD or PPD and may require additional trials or data which may significantly delay and put at risk our efforts to obtain approval and may not be successful; even if our NDA is successfully filed and accepted, the FDA may not meet expected review timelines for our NDA; other decisions or actions of the FDA or other regulatory agencies may affect our efforts with respect to zuranolone and our plans, progress or results; we may experience negative results in the ongoing SKYLARK Study in PPD that negatively affect our ability to file an NDA for approval of zuranolone in PPD; results of ongoing or future studies may impact our ability to obtain approval of zuranolone or impair the potential profile of zuranolone; success in earlier clinical trials of any of our product candidates may not be repeated or observed in ongoing or future studies, and ongoing and future clinical trials may not meet their primary or key secondary endpoints which may substantially impair development; unexpected concerns may arise from additional data, analysis or results from any of our completed studies; we may encounter adverse events at any stage of development that negatively impact further development or that require additional nonclinical and clinical work which may not yield positive results; we may encounter delays in initiation, conduct or completion of our ongoing and planned clinical trials, including as a result of slower than expected site initiation or enrollment, the need or decision to expand the trials or other changes, that may impact our ability to meet our expected timelines and increase our costs; decisions or actions of the FDA or other regulatory agencies may affect the initiation, timing, design, size, progress and cost of clinical trials and our ability to proceed with further development or may impair the potential for successful development; the anticipated benefits of our ongoing collaborations, including the achievement of events tied to milestone payments or the successful development or commercialization of products and generation of revenue, may never be achieved; the need to align with our collaborators may hamper or delay our development and commercialization efforts or increase our costs; our business may be adversely affected and our costs may increase if any of our key collaborators fails to perform its obligations or terminates our collaboration; the internal and external costs required for our ongoing and planned activities, and the resulting impact on expense and use of cash, may be higher than expected which may cause us to use cash more quickly than we expect or change or curtail some of our plans or both; we may never be able to generate meaningful revenues from sales of ZULRESSO or to generate revenues at levels we expect or at levels necessary to justify our investment; we may not be successful in our efforts to gain regulatory approval of products beyond ZULRESSO and, even if successfully developed and approved, we may not achieve revenues from such products at the levels we expect; our expectations as to year-end cash and sufficiency of cash to fund future operations may prove not to be correct for these and other reasons such as changes in plans or actual events being different than our assumptions; we may be opportunistic in our future financing plans even if available cash is sufficient; additional funding may not be available on acceptable terms when we need it; the number of patients with the diseases or disorders for which our products are developed, the unmet need for additional treatment options and the potential market for our current or future products may be significantly smaller than we expect; any of our products that may be approved in the future may not achieve market acceptance or we may encounter reimbursement-related or other market-related issues that impact the success of our commercialization efforts; and we may encounter technical and other unexpected hurdles in the development and manufacture of our product candidates or the commercialization of our marketed product which may delay our timing or change our plans, increase our costs or otherwise negatively impact our business; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent annual/quarterly report, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today, and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

Financial Tables

Three Months Ended March 31,

2022

2021

$

1,582

$

1,583

286

187

78,018

58,056

46,477

39,847

124,781

98,090

(123,199

)

(96,507

)

1,168

708

(24

)

35

$

(122,055

)

$

(95,764

)

$

(2.07

)

$

(1.64

)

59,028,858

58,374,219

Sage Therapeutics, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(in thousands)

(unaudited)

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Progress Pride Flag to Fly in Oak Bluffs – The Vineyard Gazette – Martha’s Vineyard News

Posted: at 9:32 pm

The LGBTQ+ progress pride flag will fly over Oak Bluffs for two weeks in June to coincide with pride month, following a select board discussion Tuesday that saw dozens of community members advocate for the flag to be flown in town.

Please dont turn back the hands of time by disallowing such a flag from being raised in our community, Marthas Vineyard NAACP representative Jennelle Gadowski said.

The progress pride flag is an LGBTQ+ flag designed in 2018 that includes stripes to represent people of color and the transgender community, alongside the larger LGBTQ community.

The flag will be raised beneath the American flag on the Ocean Park flagpole on June 1 during a flag raising ceremony approved earlier this week by the parks commission. The flag will remain raised for two weeks, including through the Oak Bluffs pride parade on June 11, which will march down Circuit avenue and end in Ocean Park.

The select board approved raising the flag in a 4-1 vote. Board member Jason Balboni was the lone dissenter, arguing that a non-governmental flag should not be flown on the same pole as the American flag. Mr. Balboni said he would prefer to see a new flag pole erected specifically for the purpose of flying community flags. In this capacity he said he would like to see the progress pride flag flown through the whole month of June.

So Im not completely a bad guy, he joked. Just a lot.

Board member Brian Packish said he personally agreed with Mr. Balboni but considering the long line of speakers advocating for the flag at the meeting, he said it was his job to represent the will of the community.

Im not here serving as an individual, he said.

Throughout the meeting, speakers stood before the select board to offer their personal experiences and underscore the meaning of the flag for the LGBTQ+ community.

Us taking that stand is so important at this time, Larkin Stallings said, citing national discussion surrounding the handling of LGBTQ+ identity in schools.

Last summers display of pride flags on our Island made a huge impression, Alex Palmer said, adding that flying the progress pride flag is an opportunity for Oak Bluffs to display its values to the world.

Speakers also took aim at a proposed flag policy the town is considering, regarding community flags in general. Members of the board argued that a policy is needed due to potential legal vulnerabilities, such as accusations that the town may fly one community flag over another.

Were constantly working around challenges around how we handle the flag, Mr. Packish said.

Arthury Hardy-Doubleday, attorney and president of the Marthas Vineyard NAACP, argued that discretion over which flags to fly and when is a power the board should have, and approach with careful thought.

I think adopting the policy as written, it ties your hands behind your back, Mr. Hardy-Doubleday said.

The board decided to forgo a decision on a flag policy, and create a subcommittee comprising two select board members and a handful of members of the public to work toward a new draft for the policy.

I think theres a way that we can thread this needle, Mr. Hardy-Doubleday said.

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Annual Progress Edition spread over two editions – The Ely Echo

Posted: at 9:32 pm

Submitted by Admin1 on Fri, 04/29/2022 - 14:37

This week is part one of the Ely Echos 2022 Progress Edition. Part two will be printed in next weeks paper.We were impressed with the number of stories for this years Progress Edition said Echo editor Tom Coombe. We spread the stories over two weeks last year and people really liked it so were doing the same thing this year.In the past year businesses changed hands, made improvements and changed locations.The Progress Editions are a chance to meet new owners and find out about new businesses or improvements at existing businesses, said Echo publisher Nick Wognum.Elys business district hasnt seen the huge increase in sales prices that has occurred in the residential market.Business sales have been right on the mark in town. Well see what happens with out of town business sales like resorts, said Wognum. The residential housing market has really skyrocketed and people are seeing that now in their market valuations.

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Crispr Therapeutics: Progress, Risk, And Reward – Seeking Alpha

Posted: at 9:32 pm

vchal/iStock via Getty Images

In my previous article, I had a hold rating on CRISPR Therapeutics (NASDAQ:CRSP). My reasoning behind the hold rating was the risks involved with investing in CRISPR. The company was and continues to be a pre-revenue company that is completely reliant on the FDA approving the company's method of treating disease. Further, because CRISPR has not even filed for regulatory submission, I believed the risks involved in CRISPR to be too big. At the time, the progress seemed slow with future potentials of the CRISPR Cas-9 barred by years of research regulatory filings. However, my views on the company have slightly changed. The past few months of rapid progress have shown promising results and the potential to make risk to reward chances more attractive along with their valuations. A plan for regulatory filing in late 2022 is on track with immuno-oncology and in-vivo programs making significant progress with an impressive pace of development. Therefore, given continuous rapid progress towards reaching the potential of the CRISPR Cas-9, I believe CRISPR Therapeutics can be a cautious buy.

(If you are unfamiliar with CRISPR Cas-9 technology and its potential, please go back to my previous article.)

Immuno-oncology program is designed to teach our immune system to recognize and protect the body against specific cancer cells.

Since my previous article, significant progress has been made in CTX 110, 120, and 130 programs. Starting with CTX 110 targeting to treat CD19, after the initial dose testing, the company has found evidence of a dose-dependent response resulting in further progress in testing CTX 110 to test for its safety and efficacy during the consolidation dosing trial. The data for the phase 1 test will come out later in 2022. Further, CTX 120 treating relapsed myeloma and CTX 130 treating solid tumors and hematologic malignancies by targeting CD 70 data are expected to be compiled during the first half of 2021.

What I initially believed to be a talk of the distant future has changed. According to the National Institute of Health, the median development time of a single cancer drug was 7.3 years with about $648 million in costs. Some drugs took up to 12 years to develop. These past results and statistics compared to the progress of CRISPR Therapeutics showed the magnitude of their achievements and potential.

CRISPR Therapeutics was founded in 2013, and in December 2017, the company announced its clinical trial application. Then, in 2019, the company started the first clinical tests of CTX 110 with a CTX120 study quickly following in 2020 with CTX130 following later in 2020. Finally, in January 2020, VCTX210 clinical trials started. Thus, since the start of the company's first clinical test, 4 solutions have followed in a span of about four and a half years. Considering that CTX001 will be filed for approval in 2022 with CTX110 to follow in 2024, the pace of innovation and development continues to be outstanding even in comparison to the average cancer drug development speed of already established companies.

CRISPR Therapeutics has announced that the first patient has been dosed in phase 1 clinical trial of VCTX210 for the treatment of type 1 diabetes. The goal of the current clinical trial is to allow the patients to create their own insulin within their bodies. Further, CRISPR Therapeutics has announced that they will be starting and making progress on multiple in-vivo projects simultaneously in the coming 18 to 24 months. I believe this news creates significantly bigger potential considering the accessibility of the in-vivo solutions. Therefore, utilizing ex-vivo approaches as a stepping stone, CRISPR Therapeutics is continuing its fast progress towards a regulatory filing of multiple in-vivo programs in the coming years.

It has become more likely for the company to be on schedule for its CTX-001 regulatory filing in late 2022. Given this timeline, CTX-001 might be in the market in 2023 creating a strong foundation for the company's reputation and future growth. The excitement around the potential after the filing may cause a sudden spike in the company's stock price.

CRISPR Therapeutics currently has a market capitalization of about $4.3 billion as a pre-revenue company. I initially believed this to be expensive. However, considering the current pace of development with an expected CTX001 filing for approval later in 2022 with oncology platforms to follow shortly after, I believe the current market capitalization can be attractive for risk-tolerant investors. Investment in CRISPR Therapeutics at this stage may not be for every investor, but investors who are willing to endure the volatility, potential delays, and chances of failure may find CRISPR attractive.

Once the flywheel starts rolling, CRISPR Therapeutics will likely thrive; however, because the company is still in the clinical phase or pre-revenue phase, the risks in investing in CRISPR Therapeutics are still large. There may be significant delays due to unexpected side effects, or FDA and EMA reviews may be prolonged or delayed because this is such a new technology and needs careful decision-making. Whatever the reason may be, delays will likely be detrimental to the company. Further, it may be years until CRISPR generates consistently growing revenues since the approval may not immediately mean demand for this product. Finally, It is not even relevant to talk about the company's future profitability yet.

However, I believe that given the current valuations and the potential from the ongoing progress, it may be worth a small initial position in the speculative portfolio.

CRISPR Therapeutics is at the center of innovation. Utilizing the CRISPR Cas-9 technology to edit parts of our genome, the company is rewriting the ex-vivo and in-vivo approaches to treating a multitude of diseases that have been considered incurable in the past. To my surprise, the pace of innovation shown through the progress made by CRISPR Therapeutics in the past few months showed the massive potential of the CRISPR technology in relation to the risks it possesses. Therefore, considering the potential of the innovation and the pace of innovation shown through the company's progress, I believe CRISPR Therapeutics is a cautious buy.

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The Terrifying Cherry Blossoms at Night of the Japanese Military – SOFREP

Posted: at 9:31 pm

Sakura, or Japanese cherry blossom, is Japans unofficial national flower. With the lovely shades of pink and white, these blossoms create beautiful scenery. However, the Japanese Militarys Operation Cherry Blossoms at Night during World War II was far from being lovely. That was because it was a codename for their plan to attack civilians in the United States by delivering weaponized bubonic plague.

The plan was inspired by the Director of Unit 731, Surgeon General Shiro Ishii of the biological warfare unit of the Imperial Japanese Army located in Harbin, Manchukuo. There, they conducted research on the use of chemical and biological warfare agents by experimenting with the Allied prisoners of war, some of which were said to be survivors of the Bataan Death March. They tested them with bubonic plague, anthrax, smallpox, botulism, and cholera. They also dropped bombs of biological agents on Chinese military and civilian targets to further confirm their effectiveness. Unconfirmed reports suggested that around 500,000 Chinese were killed by Japanese biological warfare.

Early on, the Japanese forces wanted to use biological weapons against the US and Filipino forces defending the Bataan Peninsula by dropping bombs filled with plague-carrying fleas. However, the US troops surrendered even before the plan commenced.

In 1945, when situations were getting desperate for Japan, Ishii devised the plan that they codenamed Operation Cherry Blossoms at Night, although it was also known as Operation PX. The idea was to use five new I-400-class submarines, each with three Aichi M6A Seiran float-planes, to sail the Pacific ocean and launch the aircraft with either plague of flea-filled bombs that would crash into the cities of the West Coast, with San Diego being the first target, followed by Los Angeles and San Francisco. The submarine crews would also infect themselves and run to the shore in a one-way suicide mission. Chief of the Army General Staff Yoshijiro Umezu rejected the idea, mainly because they did not have five I-400 submarines. Apart from that, he said, If bacteriological warfare is conducted, it will grow from the dimension of war between Japan and America to an endless battle of humanity against bacteria. Japan will earn the derision of the world.

It was not until August 1945 that he developed an interest in carrying out the plan, with the possibility of producing more I-400s by the proposed attack date in September.

Japans I-400-class submarines were the largest of its type ever built until the nuclear ballistic missile submarines in the 1960s were produced by the US and Soviet Union. The I-400 was 400-feet long, had a displacement of some 6,000 tons, carried 21-inch torpedo tubes forward, a 5.5-inch deck gun, plus a triple-mount 25 mm antiaircraft gun with a range that could reach any location worldwide and back to Japan. They also had a 100 ft watertight hanger than stored three floatplane dive bombers that could be launched from a steam catapult and then recovered with a crane.

The Cherry Blossoms at Night operations were all set and were supposed to be carried out had the Japanese forces not surrendered on August 15. Regardless, they still had a final plan to use their biological weapons just after their surrender, with Ishiis plan to stage suicide germ attacks against the US occupation troops that were in Japan. This did not happen, too, as Umezu and Kawabe disagreed with the idea, not wanting Ishii to die in a suicide mission. They instead asked him to wait for the next opportunity, which never really came.

On August 22, the Japanese submarines were ordered to destroy all their sensitive equipment related to the operation. The I-400 and I-401 fired off all their torpedoes and then catapulted their float-planes with their wings still unfolded, sinking all of them at the bottom of the deep abyss. When the war ended, the US Navy was still able to recover around 24 surviving Japanese submarines, three of which were I-400s that they all took to Sasebo. The Soviets, under the Japanese surrender agreement, expressed intent to inspect these submarines, so the US Navy sailed the I-400, I-401, I-201, I-203, and I-14 to Pearl Harbor to keep the Soviets from gaining access to Japanese submarine technology.

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The Terrifying Cherry Blossoms at Night of the Japanese Military - SOFREP

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Avoid Chinas stockmarket heres what to invest in instead – MoneyWeek

Posted: at 9:31 pm

I was lucky enough to attend the Students for Liberty conference, LibertyCon 2022, in Prague last weekend.

Oh, my goodness. What a beautiful city is Prague! Id never been before, but I shall be returning ASAFP.

While there, I heard a talk by Li Schoolland, a Chinese-American businesswoman, who is the director of external relations Asia Pacific for the Acton Institute. She fled China in 1984, having survived Chairman Maos Cultural Revolution.

She made the case that China, not the US, is the paper tiger. What did she mean and what does it imply for investors and the Chinese economy?

The expression paper tiger is used to describe something that appears powerful or threatening, but is in fact weak and vulnerable.

The term was made famous by Mao Zedong, the notorious chairman of the Chinese Communist Party and founder of the Peoples Republic of China, in 1957. He said: All the reputedly powerful reactionaries are merely paper tigers. The reason is that they are divorced from the people.

Look! Was not Hitler a paper tiger? Was Hitler not overthrown? I also said that the tsar of Russia, the emperor of China and Japanese imperialism were all paper tigers. As we know, they were all overthrown.

US imperialism has not yet been overthrown and it has the atom bomb. I believe it also will be overthrown. It, too, is a paper tiger.

Theres rather a lot to unpick there. As time is of the essence, we shall ignore that classic of the Godwins Law genre (whoever mentions Hitler first loses the argument), as well as the hypocrisy of criticising authoritarian rulers for being divorced from the people.

Schoollands main argument was that today Chinas regime is divorced from the people and so is a paper tiger. As an authoritarian, corrupt and often incompetent planned economy, it is vulnerable. The events of the past week would seem to bear her out.

Dont buy Chinese stocks! she said. There are so many frauds. Many exist solely to secure funds, with no operating business behind them. Over 60% of Chinas market capitalisation is state owned. If you buy stocks, you are supporting an authoritarian regime.

Even something like TikTok (ByteDance is the parent company) is under the regime. Ive been unable to verify this: but Schoolland argued that, never mind its use as a surveillance tool, if you read the small print, then once uploaded, your videos effectively become the property of the Chinese state.

Like TikTok, central bank digital currencies (CBDCs) a field in which China very much has the lead are a useful surveillance tool. Those tools will now be used on all those athletes who downloaded money apps during the Olympics. As well as to control, they will be used to market stuff. The app will know if you need a loan, say, as well as what type of loan and what your circumstances are, and so will begin marketing financial products to you.

Property is no better as an asset class. Over 30% of the build cost of a property in China is government bribery, she says. Im not quite sure how you verify that figure, but it doesnt sound implausible.

Meanwhile, despite all the pictures you might see of amazing buildings in Chinas cities, says Schoolland, more than 43 million people still live on less than a dollar a day although that has come down from more than 100 million in the 2000s.

China is heavily indebted too, which makes it vulnerable. Its debt-to-GDP ratio, Schoolland argues, is greater than the stated 70%. Its closer, in fact, to 275%.

Shanghai is unravelling with the extended lockdown there. Supply chains are breaking down. There is much discontent and, Schoolland insists, revolution is very much in the air. China needs a new system, not just a new leader, she says.

The evidence of the past few weeks hints that Schoolland may well have a point.

Supply chains have been disrupted, inflation is biting especially in food and energy prices, interest rates are being held down, the currency is at its weakest since late 2020, international funds are selling out of Chinese assets, attempts to lure domestic investment into capital markets arent working, the stockmarket is down by over 20% this year and a slowing property market is also eroding wealth.

On top of everything else, the evidence of the last two years is that viruses are beyond government control, and that lockdowns do more damage than good. Nevertheless, President Xi Jinping remains committed to Covid zero. Irony of ironies, he blames Covid on the germ warfare of US imperialism.

But you cant just ignore China as an investor; its too big. The way to play it, for me, is to be in the business of selling it stuff.

Xi has committed to boosting infrastructure construction to bolster the economy. Planned investment this year amounts to at least $2.3trn, according to Bloomberg. Load up on base metal mining stocks, is my advice.

The Peoples Bank of China has declared it will promote the healthy and stable development of markets and provide a good monetary and financial environment and that liquidity will remain reasonably ample.

We are back to that centrally-planned economy thing again. Oh dear.

But that money has to go somewhere.

Dominics film, Adam Smith: Father of the Fringe, about the unlikely influence of the father of economics on the greatest arts festival in the world is now available to watch on YouTube.

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Avoid Chinas stockmarket heres what to invest in instead - MoneyWeek

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A Perfect Storm Could Make Measles a Nightmare in 2022, WHO and UNICEF Warn – Gizmodo Australia

Posted: at 9:31 pm

The once nearly vanquished disease measles is making a worrying comeback. This week, the World Health Organisation and UNICEF reported that global cases of the viral illness have so far jumped almost 80% in 2022 compared to last year. Without immediate action, the conditions are ripe this year for a large-scale resurgence of the vaccine-preventable illness, they warn.

According to data collected by the organisations, there were around 17,000 measles cases reported in the first two months of 2022 a 79% increase over cases reported during the same period in 2021. The majority of cases have come from countries in Africa and the Mediterranean, such as Somalia, Yemen and Afghanistan. And as of April 2022, theyve tracked 21 large outbreaks in the last 12 months.

Measles is a highly contagious disease (moreso than even the latest Omicron variant of the coronavirus). So in unprotected populations, it can swiftly spread and cause widespread illness. And given the early start, the WHO and UNICEF fear that millions of cases could happen this year. For context, about 860,000 cases were reported in 2019 the highest annual number since 1996.

Signs of measles infection include flu-like symptoms along with a distinct rash that usually starts in the face several days later. Though most people dont develop serious complications, it can be deadly, especially to younger malnourished children. In 2019, its estimated that over 200,000 people were killed by measles, mostly children under five. Recently, its also become apparent that even a mild case of measles can effectively reset the immune system, causing us to forget our immunity to other infectious diseases, at least temporarily.

Despite its threat, measles is easily preventable, thanks to a highly effective vaccine (97% effective with the full two doses) that provides lifelong protection against infection. Vaccination has steadily eroded the global incidence of measles over the decades, and for a time, it appeared as if measles would be eradicated. But because the germ is so contagious, it requires high vaccine coverage in a population at least 95% to provide herd immunity and protect those too young or otherwise unable to get vaccinated. And sadly, the world has been losing ground in vaccinating everyone lately, leading to the return of measles in many areas, including the U.S., though it remains locally eliminated here.

The last few years of the pandemic have seen lower reported case numbers of measles but also further gaps in vaccination coverage. Adding to the trouble has been ongoing warfare in Afghanistan and more recently Ukraine, which has disrupted routine vaccination programs and has led to the mass displacement of refugees. These pandemic- and war-related disruptions, along with the return to socialising for many, will likely allow measles to explode back onto the world stage, the WHO and UNICEF warn.

It is encouraging that people in many communities are beginning to feel protected enough from COVID-19 to return to more social activities. But doing so in places where children are not receiving routine vaccination creates the perfect storm for the spread of a disease like measles, said Catherine Russell, UNICEF executive director, in a statement.

In 2020 alone, according to their data, around 23 million children missed out on their recommended vaccines, a number higher than 2019. And unless we can catch up soon, measles threatens to become the sort of nightmare this year it often used to be.

The covid-19 pandemic has interrupted immunization services, health systems have been overwhelmed, and we are now seeing a resurgence of deadly diseases including measles. For many other diseases, the impact of these disruptions to immunization services will be felt for decades to come, said Tedros Adhanom Ghebreyesus, director-general of the WHO. Now is the moment to get essential immunization back on track and launch catch-up campaigns so that everybody can have access to these life-saving vaccines.

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A Perfect Storm Could Make Measles a Nightmare in 2022, WHO and UNICEF Warn - Gizmodo Australia

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Debut novelist to give reading and take part in Q&A at Lancashire university – Lancashire Telegraph

Posted: at 9:29 pm

EDGEHill University will welcome a debut novelist back to campus for a reading of her book exploring survivalism and the legacy of Chernobyl.

Dr Philippa Holloways first novel The Half-Life of Snails is set across a narrative split between North Wales and Ukraine during a time of civil unrest.

The free reading and Q&A will take place at Edge Hill University on Wednesday 11 May from 4.30pm to 6pm.

Professor Jo Crotty, director of Institute for Social Responsibility at Edge Hill University and an expert in the former Soviet Union, will host the Q&A and draw on her experiences of travelling to Chernobyl and Kyshtym the site of a 1957 nuclear accident.

She said:"ISR is delighted to welcome Dr Philippa Holloway to celebrate the release of her debut novel,The Half-Life of Snails.

"This event willexplore the themes of the book, including nuclear power and communities, the legacy of disaster, borderlands and the use of psychogeography as research for fiction writing,and a guest appearance by Alex Lockwood, author ofThe Chernobyl Privileges."

A former Graduate Teaching Assistant at Edge Hill, Dr Holloway is an internationally published short fiction writer and academic, and a Senior Lecturer in English and Creative Writing at Staffordshire University. Her debut novel is drawn from extensive research in Chernobyls Exclusion Zone and North Wales.

The Q&A will be held with Edge Hill academics:

The event is free but people are asked toregister their place in advance.

ISR aims to make a positive impact on societal issues through cross-disciplinary research and knowledge exchange activities.Italsoregularly holdsevents,seminars, workshops and lecturesso check for updatesor join the mailing list.

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Debut novelist to give reading and take part in Q&A at Lancashire university - Lancashire Telegraph

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Author and Speaker Matthew Cossolotto Urges Oberlin and Other Jurisdictions to Recognize May 4th as Make a Promise Day (MAPD) – Digital Journal

Posted: at 9:27 pm

Cossolotto is the author of The Joy of Public Speaking and the forthcoming Embrace Your Promise Power with a foreword by Jack Canfield. This initiative is part of his global campaign to establish MAPD as the only unofficial holiday dedicated to personal empowerment, goal achievement and integrity enhancement

Cossolotto is an author, guest speaker, executive speechwriter, and speech coach. His senior-level leadership communications career spans the corridors of power on both sides of the Atlantic from NATO headquarters in Brussels, Belgium, to the Speakers Office in the U.S. House of Representatives. A former aide to Congressman Leon Panetta, Cossolotto has coached and penned speeches for senior executives at a wide range of organizations, including UCLA, GTE, Pepsi-Cola International, and other Fortune 100 corporations.

What Is Promise Power?Its the innate power we all possess, something almost instinctive in the human experience that values promise-keeping and decries promise-breaking. Author and political philosopher Hannah Arendt observed that Promises are the uniquely human way of ordering the future. And yet self-help authors and success coaches have largely neglected this potent force for personal empowerment. Embrace Your Promise Power and Make a Promise Day bring it to the fore by extolling an old-fashioned virtue: We must take responsibility for our lives, and this begins with doing what we promise to do.

Cossolotto explains that there are no costs involved in adopting a MAPD Proclamation. But there are many benefits that will accrue to any local, state or national jurisdiction that encourages citizens to embrace their promise power. Cossolotto is asking supporters to urge appropriate authorities in their town, city, county, state (or province) and country to adopt a Make A Promise Day Proclamation similar to the following:

MODEL MAKE A PROMISE DAY PROCLAMATION

Whereas, Make a Promise Day is the only unofficial holiday dedicated to personal empowerment, goal achievement and integrity enhancement;

Whereas, Make A Promise Day encourages individuals to turn important goals into heartfelt promises thereby increasing the probability of reaching those goals;

Whereas, celebrating Make A Promise Day will have the effect of enhancing accountability, personal responsibility and integrity;

Whereas, the (INSERT JURISDICTION/OFFICE) recognizes the value of highlighting the power of making and keeping promises on the part of all members of society, including students, teachers, community organizations, businesses and political leaders;

Now therefore be it resolved, that the (INSERT JURISDICTION/OFFICE) hereby designates and proclaims May 4th of (INSERT YEAR) and each year thereafter to be Make A Promise Day and encourages organizations and individual members of the community to celebrate Make A Promise Day in a manner they deem to be suitable and appropriate.

Cossolotto knows about the power of making a promise from personal experience. He made a promise to his mother on her deathbed that he would finish writing a book she had been encouraging him to write and dedicate it to her memory. By making and keeping that heartfelt promise, Cossolotto embarked on an unexpected path: becoming a personal empowerment author and speaker whose mission is to help millions of people around the world achieve their dreams, keep their promises and reach their peak potential on and off the podium.

In his foreword to Cossolottos forthcoming book, Jack Canfield writes: When Matthew first told me about the heartfelt promise he made to his mother I was hooked. You could say he had me at I promise. There was something very attractive, almost magnetic, about this concept. And I say that as somebody who has been intimately involved in the personal development field for many years. Ive seen and heard just about everything With a promise your heart and emotions are fully engaged. Because of this, a promise is what I call a personal empowerment twofer. It combines The Power of Intention with The Law of Attraction.

Joe Bidens Promise to his SonIn his best-selling book, Promise Me, Dad, President Joe Biden recounts the moving story about his son, Beau, who was losing his battle against brain cancer. Close to the end of his life, Beau asked his father to promise him that he would be OK after he (Beau) passed away. At first, Biden responded vaguely that he would be OK. But that wasnt good enough for Beau. He made his father promise, PROMISE, that he would not use Beaus death as a reason to turn in but as a reason to turn out, to continue to be engaged and not to withdraw from public life. Joe Biden made a heartfelt promise to his dying son and Cossolotto believes that promise was a factor in Bidens decision to run for President of the United States in 2020.

Make a Promise Day: May the Fourth Be with You!You might be wondering why Cossolotto selected May 4th for Make A Promise Day. When you say those two magic words I promise you generate an unstoppable force that propels you in the direction of your goals and dreams. With that in mind, Cossolotto was hit by an epiphany some years ago: Make A Promise Day had to be on May 4th because then we could say the following sentence and it would make sense: May the Fourth be with you!

Yes, Cossolotto admits its a silly pun on the famous blessing from the Star Wars movies (May the Force be with you!). And yes, because of this association with that movie franchise some people already think of May 4th as Star Wars Day. But Cossolotto didnt know about Star Wars Day when he settled on May 4th. Besides, theres no reason Star Wars fans and advocates of MAPD cant share the same date. Doing so will not cause a disturbance in the Force.

Make a Promise. Make a DifferenceCossolotto states: My interest in promoting Make A Promise Day and the power of making a promise more generally goes beyond helping people change their lives for the better. Thats a big part of it. But Im also interested in transforming the world. Making the world a better place.

President John F. Kennedy wrote: One person can make a difference, and everyone should try. Cossolotto says: If you want to make a difference in the world, start by making a promise. The world can be transformed one person and one promise at a time.

The following four-part mantra sums up the power of a promise and the purpose behind Make a Promise Day: Make a Promise. Keep Your Word. Change Your Life. Transform the World.

About Matthew CossolottoA former NATO speechwriter, Matthew Cossolotto is the author of The Joy of Public Speaking (available on Amazon.com) and the forthcoming Embrace Your Promise Power with a foreword by Jack Canfield, co-creator of the Chicken Soup for the Soul series. Cossolottos books and related coaching/speaking programs feature a unique combination of three power tools: Habits, Speaking and Promises. He calls this the Triad Empowerment System, based on his trilogy of books: The Seven Mindful Habits of SUCCESS; The Joy of Public Speaking; and Embrace Your Promise Power. Visit http://www.ThePodiumPro.com.

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Author and Speaker Matthew Cossolotto Urges Oberlin and Other Jurisdictions to Recognize May 4th as Make a Promise Day (MAPD) - Digital Journal

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