Monthly Archives: August 2021

Targeting the Putamen with Gene Therapy Leads to Sustained Improvements in Motor and Non-Motor Functions in Children with AADC Deficiency – PRNewswire

Posted: August 24, 2021 at 10:08 am

SOUTH PLAINFIELD, N.J., Aug. 23, 2021 /PRNewswire/ --PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced the publication of a manuscript, "Gene Therapy in the Putamen for Curing AADC Deficiency and Parkinson's Disease," in the European Molecular Biology Organization Journal. The paper describes a pioneering approach that delivers gene therapy to a specific part of the brain called the putamen, which is helping successfully treat a previously intractable, devastating disorder and transforming the lives of children born with AADC deficiency (AADC-d)1.

"I am excited about what the success of this new approach means for the children and families living with AADC deficiency," said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics. "AADC deficiency is a terrible, life-shortening condition that requires around-the-clock care. The data reported in this article show that the surgical approach of delivering our novel PTC-AADC gene therapy directly to the putamen robustly produces dopamine in the brain that results in sustained and substantial functional improvements in children with AADC deficiency."

Currently there are no approved disease-modifying therapies for treating AADC-d, and the success of symptomatic treatment using combinations of vitamin B6, dopamine (DA) agonists, and monoamine oxidase inhibitors is very limited, especially in severe cases2.

The paper, authored by global experts in the United States, Taiwan, France, Germany, and Japan, describes three clinical trials in which AAV2-hAADC was infused into the putamen of children with AADC-d via brain surgery. Prior to treatment, most of the children with AADC-d had never developed muscle control, could not lift their heads, move on their own or talk, and nearly all were bed ridden. Every child in the trials showed significant improvements following treatment with PTC's novel gene therapy, PTC-AADC1.

The clinical benefits and safety profile of PTC-AADC has been demonstrated across multiple trials, with the first patient dosed more than 10 years ago, in 2010. The trials together represent the largest cohort of AADC-d patients ever studied.

"The remarkable results published have been life-changing for the children we have treated," said co-author and investigator Paul Wuh-Liang Hwu, National Taiwan University Hospital. "Before this treatment, the children with AADC deficiency couldn't lift their heads, but now some can sit and stand with help, and have even begun learning to talk."

AADC deficiency is a debilitating neurological disorder that involve motor dysfunction caused by dopamine deficiencies. Dopamine is a neurotransmitter that is critical for motor and mental development1. The studies demonstrate that the restoration of DA synthesis in the putamen via gene therapy using low doses of AAV2-hAADC is well tolerated, leads to sustained improvements in motor and nonmotor symptoms of AADC deficiency, and beneficial for the patients. The novel gene therapy, PTC-AADC was delivered to the putamen because it is more easily accessible via surgery than other sites, and therefore, may result in fewer surgical complications. In neurological disorders such as AADC-d, the putamen is directly impacted by the loss of DA synthesis in the striatum1.

PTC-AADC is currently under review by the European Medicines Agency's Committee for Medicinal Products for Human Use with an opinion expected in the fourth quarter of 2021.

About aromatic L-amino acid decarboxylase (AADC) deficiencyAADC deficiency is a fatal, ultra-rare genetic disorder that causes severe disability and suffering from the first months of life, affecting every aspect of life physical, mental, and behavioral1,2,[3]. The suffering of children with AADC deficiency is exacerbated by episodes of distressing seizure-like oculogyric crises, which can happen daily and last for hours, causing the eyes to roll up in the head, frequent vomiting, behavioral problems, difficulty sleeping, and life-threatening complications such as respiratory infections and gastrointestinal problems2,[4],[5],[6].

Current management options yield limited improvement for the majority of patients with AADC-d.2Managing patients with AADC-d requires a multidisciplinary team of specialists and complex coordination of care to address significant health issues, including developmental delays, infections, orthopaedic and cardiac complications, and other comorbidities2

While several diagnostic tests for AADC deficiency are available, the condition remains largely undiagnosed or misdiagnosed for other conditions with similar symptoms, such as cerebral palsy and some forms of epilepsy4,[7].

About PTC Therapeutics, Inc.PTC Therapeutics is a science-driven, global biopharmaceutical company focused on the discovery, development and commercialization of clinically differentiated medicines that provide benefits to patients with rare disorders. PTC's mission is to provide access to best-in-class treatments for patients with an unmet medical need, using its ability to globally commercialize products as the foundation to drive investment in a robust and diversified pipeline of transformative medicines. The Company's strategy is to leverage its strong scientific expertise and global commercial infrastructure to maximize value for its patients and other stakeholders. To learn more about PTC, please visit us at http://www.ptcbio.com and follow it on Facebook, on Twitter at @PTCBio, and on LinkedIn.

For More Information:

Investors Kylie O'Keefe+1 (908) 300-0691[emailprotected]

Media Jane Baj+1 (908) 912-9167[emailprotected]

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this release, other than statements of historic fact, are forward-looking statements, including statements regarding: the future expectations, plans and prospects for PTC, including with respect to the expected timing of clinical trials and studies, availability of data, regulatory submissions and responses and other matters; expectations with respect to PTC's gene therapy platform, including any regulatory submissions and manufacturing capabilities; PTC's expectations with respect to the licensing, regulatory submissions and commercialization of its other products and product candidates; PTC's strategy, future operations, future financial position, future revenues, projected costs; and the objectives of management. Other forward-looking statements may be identified by the words, "guidance", "plan," "anticipate," "believe," "estimate," "expect," "intend," "may," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions.

PTC's actual results, performance or achievements could differ materially from those expressed or implied by forward-looking statements it makes as a result of a variety of risks and uncertainties, including those related to: the outcome of pricing, coverage and reimbursement negotiations with third party payors for PTC's products or product candidates that PTC commercializes or may commercialize in the future; expectations with respect to PTC's gene therapy platform, including any regulatory submissions and potential approvals, manufacturing capabilities and the potential financial impact and benefits of its leased biologics manufacturing facility and the potential achievement of development, regulatory and sales milestones and contingent payments that PTC may be obligated to make; significant business effects, including the effects of industry, market, economic, political or regulatory conditions; changes in tax and other laws, regulations, rates and policies; the eligible patient base and commercial potential of PTC's products and product candidates; PTC's scientific approach and general development progress; and the factors discussed in the "Risk Factors" section of PTC's most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K, as well as any updates to these risk factors filed from time to time in PTC's other filings with the SEC. You are urged to carefully consider all such factors.

As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that any product will receive or maintain regulatory approval in any territory, or prove to be commercially successful, including PTC-AADC.

The forward-looking statements contained herein represent PTC's views only as of the date of this press release and PTC does not undertake or plan to update or revise any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after the date of this press release except as required by law.

1Hwu WL, Kiening K, Anselm I et al. Gene Therapy in thePutamen forCuring AADC Deficiency and Parkinson Disease'. EMBOMolecMedicine. 2021. DOI 10.15252/emmm.202114712. Available at: https://www.embopress.org/doi/10.15252/emmm.202114712. Last accessed August 2021.2Wassenberg T, et al. Consensus guideline for the diagnosis and treatment of aromatic l-amino acid decarboxylase (AADC) deficiency. Orphanet J Rare Dis. 2017;12(1):12.3Williams K et al. Symptoms and impacts of aromatic l-amino decarboxylase (AADC) deficiency: A qualitative study. Poster presented at ISPOR 2021, May 17-20, 20214Pearson T et al. AADC deficiency from infancy to adulthood: Symptoms and developmental outcome in an international cohort of 63 patients. J Inherit Metab Dis. 2020 Sep;43(5):1121-1130.5Chien YH, et al. 3-O-methyldopa levels in newborns: Result of newborn screening for aromaticl-amino-acid decarboxylase deficiency. Mol Genet Metab. August 2016;118(4):259-263.6Buesch K et al. Caring for an Individual with Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency: Analysis of Reported Time for Practical and Emotional Care and Paid/Unpaid Help. Poster presented at ISPOR 2021, May 17-20, 2021.7Chien YH, et al. 3-O-methyldopa levels in newborns: Result of newborn screening for aromaticl-amino-acid decarboxylase deficiency. Mol Genet Metab. August 2016;118(4):259-263

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Targeting the Putamen with Gene Therapy Leads to Sustained Improvements in Motor and Non-Motor Functions in Children with AADC Deficiency - PRNewswire

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Genetron Health Reaches Strategic Partnership with Yikon Genomics, Expanding S5 Platforms Reach to Reproductive Health Field – Yahoo Finance

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BEIJING, Aug. 23, 2021 (GLOBE NEWSWIRE) -- Genetron Holdings Limited (Genetron Health or the Company, NASDAQ: GTH), a leading precision oncology platform company in China that specializes in offering molecular profiling tests, early cancer screening products and companion diagnostics development, today announced the signing of a strategic partnership with Shanghai Yikon Genomics Technology Co., Ltd. (Yikon Genomics), a company that focuses on reproductive health diagnostic testing. Genetron Health expects this partnership to contribute to its 2021 revenues.

Under the agreement, Yikon Genomics will have the exclusive rights to use Genetron Healths S5 instrument for reproductive health applications in the China market. Yikon Genomics currently offers pre-pregnancy, prenatal and inheritance disorder testing solutions for a network of over 400 hospital partners in China. The partners will cooperate with each other to drive forward registration processes for new assays that are developed on the S5 platform. Genetron Health will also support Yikon Genomics commercialization efforts. GENETRON S5 has been successfully used in many different oncology settings, and through this partnership, will be expanding its applications to include reproductive health, widening the Companys scope of precision medicine.

Approved by the NMPA in 2019 and based on new semiconductor sequencing technology, GENETRON S5 is Chinas desktop, clinical-grade, medium-throughput next generation sequencing (NGS) platform. GENETRON S5s advantages lie in its fast detection, flexible throughput, low initial sample size requirements, and comprehensive range of different applications. Genetron Health has used this platform to develop in-vitro diagnostic (IVD) kits that cover multiple cancer types and different sample types, including the 8-gene Lung Cancer (Tissue) assay. With GENETRON S5, the Company has developed an integrated solution for molecular diagnostics laboratories, and carried out clinical trials and scientific research partnerships with many different organizations. These efforts have enabled hospitals in China to adopt NGS technology for independent, clinical diagnostic use.

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"GENETRON S5s flexible and open characteristics have laid the groundwork for clinical applications in the reproductive health field. We are committed to using an open platform to provide versatile, multi-dimensional solutions for our hospital partners, said Sizhen Wang, co-founder and CEO of Genetron Health. We are pleased to become Yikon Genomics strategic partner. We hope to leverage our respective strengths so that we can introduce a comprehensive range of high-performance, personalized, precision medicine solutions to patients, making innovative genetic technology more accessible to the public."

"Genetron Health focuses on precision medicine and genomics research, possesses a high-quality innovation platform, and has a strong track record of successfully commercializing new technologies, said Sijia Lu, co-founder and CEO of Yikon Genomics. We think there are significant synergies in this partnership, and we are excited to adopt the 'platform + reagent' strategy for Chinas reproductive health market."

About Genetron Holdings Limited

Genetron Holdings Limited (Genetron Health or the Company) (Nasdaq:GTH) is a leading precision oncology platform company in China that specializes in cancer molecular profiling and harnesses advanced technologies in molecular biology and data science to transform cancer treatment. The Company has developed a comprehensive oncology portfolio that covers the entire spectrum of cancer management, addressing needs and challenges from early screening, diagnosis and treatment recommendations, as well as continuous disease monitoring and care. Genetron Health also partners with global biopharmaceutical companies and offers customized services and products. For more information, please visit ir.genetronhealth.com.

About Yikon Genomics

Yikon Genomics, established in 2012, is dedicated to the development and application of single-cell whole-genome amplification and sequencing technologies. The companys primary focus is reproductive health, providing sophisticated testing solutions for pre-pregnancy, prenatal and inheritance disorders in China. Yikon Genomics have partnered with over 400 medical institutions and hospitals in China, as well as a number of world-class research institutes. Its business covers 32 provinces and municipalities in China, and through partnerships with international reproductive medicine centers, has expanded to more than 20 countries worldwide, including the United States, United Kingdom, Russia, and Japan.

Safe Harbor StatementThis press release contains forward-looking statements within the meaning of federal securities laws which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are made under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the Companys beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties, and a number of factors could cause actual results to differ materially from those contained in any forward-looking statement. In some cases, forward-looking statements can be identified by words or phrases such as may, will, expect, anticipate, target, aim, estimate, intend, plan, believe, potential, continue, is/are likely to or other similar expressions. Further information regarding these and other risks, uncertainties or factors is included in the Companys filings with the SEC. All information provided in this press release is as of the date of this press release, and the Company does not undertake any duty to update such information, except as required under applicable law.

Media Relations ContactYanrong Zhaoyanrong.zhao@genetronhealth.com

Investor Relations ContactHoki Lukhoki.luk@genetronhealth.com

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Genetron Health Reaches Strategic Partnership with Yikon Genomics, Expanding S5 Platforms Reach to Reproductive Health Field - Yahoo Finance

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Hepagene Therapeutics, Inc. Announces Positive Results from Phase I Trial of HPG1860 – PRNewswire

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SHANGHAI, Aug.23, 2021 /PRNewswire/ -- Hepagene Therapeutics, Inc., a clinical stage biopharmaceutical company focusing on novel therapies for patients with liver diseases, today announced positive results from its Phase I study of HPG1860 conducted in the United States. HPG1860 is a non-bile acid, potent, selective and full FXR agonist being developed for treatment of non-alcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC). Findings show that treatment with HPG1860 was safe, well-tolerated and demonstrated a robust target engagement with a favorable pharmacokinetic (PK) profile after 14 days of once daily dosing in healthy volunteers. Detailed results will be presented at upcoming AASLD international liver conference.

The Hepagene phase I trial was a first-in-human, randomized, placebo-controlled, double-blind single-ascending dose (SAD) and multiple-ascending dose (MAD) trial, in which healthy volunteers received once-daily HPG1860 doses ranging from 10 mg to 100 mg in the SAD cohorts and 5 mg to 20 mg in the MAD cohorts for 14 days. The primary objective of the trial was to evaluate safety/tolerability and the secondary objectives were to assess PK parameters and FXR target engagement, the latter through measurement of fibroblast growth factor 19 (FGF19) and 7-hydroxy-4-cholesten-3-one (C4), blood biomarkers of bile acid synthesis and metabolic homeostasis that increases and decreases respectively with FXR activation.

HPG1860 was safe and generally well-tolerated with no serious adverse events reported. Most adverse events were mild in severity. Importantly, pruritus only occurred in highest dose cohort (20 mg) and LDL-cholesterol increases were not seen at any dose level. HPG1860 exhibited a favorable PK profile as well as robust FXR target engagement with notable C4 regression 93.1%, 97.0% and 97.6% decrease observed after the last dose in MAD 5 mg, 10 mg and 20 mg cohorts compared with placebo. The magnitude of C4 decrease can be used to project potential liver fat reduction level in NASH patients, with 30% relative liver fat reduction being associated with increased likelihood of histological benefits upon liver biopsy.

"We are encouraged by the overall safety profile of HPG1860, and meaningful target engagement seen at as low as the 5 mg dose level. We plan to evaluate the 3 mg, 5mg and 8 mg dose levels in our upcoming Phase IIa trial in NASH patients," said Que Liu, M.D., PhD, Chief Medical Officer ofHepagene.

"It is encouraging to see that there was no significant increase in LDL cholesterol despite excellent FXR target engagement with sustained C4 suppression." said Rohit Loomba, MD, MHSc, Professor of Medicine, and Director, UCSD NAFLD Research Center, University of California at San Diego, La Jolla, CA.

"NASH is a complex liver disease with multiple pathways involved in liver cell injury, inflammation and fibrosis development. FXRs have been shown to impact the underlying pathology of NASH in a meaningful way. Combination therapy, involving multiple mechanisms of action, is likely going to be needed to combat this disease effectively, providing an opportunity for HPG1860. The early data presented here are very encouraging from a safety and tolerability perspective and I am looking forward to beginning the phase 2 study." said Stephen Harrison, MD, Medical Director of Pinnacle Clinical Research in San Antonio, Texas.

Based on the Phase 1 safety and PK/PD data, Hepagene plans to advance three dose levels of HPG1860 3 mg, 5 mg and 8 mg in a 12-week, randomized, placebo-controlled Phase IIa trial enrolling about 80 patients with NASH in US. The selected doses are projected to inhibit C4 to levels that are likely to result in meaningful reductions in liver fat content. The trial is scheduled to start in the last quarter of 2021, with an interim analysis planned in the first half of 2022.

About HPG1860

HPG1860 is an investigational potent and selective full FXR agonist with a non-bile acid scaffold and is currently in first-in-human clinical phase I study. Through regulation of gene expression of bile acids, FXR serves as a key controller of bile acid homeostasis. FXR has been studied for its role in modulating inflammation and the expression of FXR is down-regulated during NASH development. HPG1860 exhibited superb efficacy and safety profile in preclinical research.

About NASH

Nonalcoholic fatty liver disease (NAFLD) is rapidly becoming the most common liver disease worldwide, with an approximate prevalence of 20-30% in western countries. An estimated 20-25% of these patients will further progress to NASH, marked by steatohepatitis, ballooning and inflammation. Typically, NASH is accompanied with liver fibrosis that can progress to liver cirrhosis and hepatocellular carcinoma.

About Hepagene Therapeutics, Inc.

Hepagene Therapeutics, Inc. devotes its drug discovery and development efforts towards discovering, developing and delivering innovative medicines that help patients prevail over liver diseases, especially non-alcoholic steatohepatitis (NASH), chronic Hepatitis B infection and liver cancer.

SOURCE Hepagene Therapeutics, Inc.

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Early detection of the development of drug resistance | IDR – Dove Medical Press

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Introduction

The lifelong administration of combination antiretroviral therapy (ART) can effectively suppress viral replication and reduce morbidity and mortality of people living with HIV (PLWH).1 There are multiple classes of ART drugs, including nucleoside reverse transcriptase inhibitors (NRTI) including lamivudine (3TC) and azidothymidine (AZT), non-nucleoside reverse transcriptase inhibitors (NNRTI) including nevirapine (NVP), protease inhibitors (PI) including Lopinavir/Ritonavir (LPV/r) and the integrase strand transfer inhibitor (INSTI) raltegravir (RAL).2 In recent years, the rapid expansion of access to ART has led to the emergence of multi-class drug resistance (MDR), defined as a virus mutant with resistance to at least three different drug classes.3

A previous study of a large cohort of cART-experienced patients in Italy showed a dramatic drop in drug resistance from 8085% in 1999 to around 36% in 2018. In recent years (201118), the percentage of isolates with at least three classes of drug resistance has remained stable at around 5% (range 36%).4 The majority of these patients have been found to have a long history of HIV infection, with previous exposure to suboptimal therapies, and to have, over time, accumulated many mutations resistant to several drug classes.4 The viral evolutionary dynamics within these patients that leads to the development of MDR has not been well documented.

Most drug resistance data have been collected from patients infected with HIV-1 subtype B in the United States, Oceania, and Europe. When ART has become increasingly available in new geographic areas, drug resistance in a diverse group of M subtypes and distinct circulating recombinant forms (CRFs) has evolved. CRF01_AE emerged in Southeast Asia in the 1990s, expanded rapidly in China, and is now the most prevalent HIV-1 form in Southeast Asia.5,6 Previous studies have identified a 920% higher resistance mutation frequency at reverse transcriptase positions in CRF01_AE than in subtype B, and a 1218% higher predicted cross-resistance to future therapy options.7 The influence of genetic variation across subtypes has therefore become an active area of research into resistance evolution and disease progression.

In our previous study of the evolutionary patterns during ART failure, plasma and peripheral blood mononuclear cells (PBMC) were longitudinally sampled at different time points from a single patient who suffered several periods of ART failure before successful reduction of viral load. The different intrapatient evolutionary dynamics patterns of env and pol viral segments witness not only the emergence of drug resistant mutants, but also the switch of tropism.8

In the current study, the same longitudinal approach was applied to learn more about the viral evolutionary dynamics during the development of four-class MDR in a single patient infected with the CRF01_AE experiencing ART failure and subsequent mortality. The distribution and percent of drug resistance mutants in the reverse transcriptase (RT), protease (PR) and integrase (IN) genes were determined by next generation sequencing, and the demographic history of the HIV DNA reservoir in PBMC was reconstructed by applying phylodynamics methods.

A 27-year-old patient was diagnosed as HIV-positive in August 2008. PBMC and plasma samples were collected at different time points from September, 2013 to June, 2017 (Figure 1). The study was approved by the institutional review boards of the First Affiliated Hospital, School of Medicine, Zhejiang University (Reference Number: 2020265). Written informed consent was provided by the patient to allow the case details and any accompanying images to be published.

Figure 1 Schematic representing the treatment and sampling protocols used in this study. This patient initiated antiretroviral therapy with 3TC+AZT+NVP in August 2008, switched to 3TC+AZT+LPV/r in August 2013, and to 3TC+AZT+LPV/r+RAL in March 2015. Samples used in the study were collected at different time points shown on top of the schematic. Rectangles represent plasma and circles represent PBMC.

Plasma samples were tested for viral load during treatment. The patient had been diagnosed as HIV-positive in August 2008 and initiated ART with 3TC+AZT+NVP. The ART regimen was switched to 3TC+AZT+LPV/r in August 2013 because of unsuppressed viral load (1*105 copies/mL) and detection of reverse transcriptase resistant mutations, both to NRTI and NNRTI. One month later, in September, 2013, viral load decreased to about 1.4*103 copies/mL, and was under the detection limit (50 copies/mL) from March, 2014 to December 2014. In March, 2015, the ART regimen was changed, to 3TC+AZT+LPV/r+RAL, again due to unsuppressed viral load (5.4*104 copies/mL). By June, 2017, two years later, the viral load had increased, to 1.8*105 copies/mL (Table 1), and was followed by the patients death in August, 2017.

Table 1 Characteristics of Drug-Resistant Mutant Sequences Isolated from Plasma

All collected samples during treatment were sequenced by Sanger sequencing and Next Generation Sequencing (NGS) techniques. The purified PR/RT amplicon and IN amplicon were randomly interrupted by Covaris ultrasonic breaker and then used for library preparation (NEBNext Ultra II DNA Library Prep Kit for Illumina) according to manufacturers instructions. Sequencing was carried out by the Illumina high-throughput sequencing platform (Nova-Seq). After data processing and quality filtering performed to obtain clean data, fastq files were aligned and generated the codon frequency tables using fastq2codfreq script (https://hivdb.stanford.edu/page/codfreq/). Then, the codon frequency tables were submitted to HIVdb-NGS beta for genotypic resistance interpretations and quality control analysis. Minimum detection threshold was set to 1% for all samples, because detection below a frequency of 1% may cause failed quality assessment. ShoRAH was applied to convert NGS sequence variants into haplotypes.9

MUSCLE software (v3.8.31)10 was used to align all RT, PR and IN sequences from plasma viral RNA and cellular DNA collected during the ART therapy. Alignments were manually edited and trimmed to 297 nucleotides for PR (HBX2: 22532549), 903 nucleotides for RT (HBX2: 25503452) and 780 nucleotides for IN (HBX2: 42905069) using BioEdit software (v7.0.9). Shorter sequences and sequences with stop codons or gaps larger than a nucleotide triplet were removed from the alignments. The best-fitting nucleotide substitution model was selected with jModeltest software (v2.1.7),11 using the Akaike Information Criterion (AIC). Phylogenetic trees were inferred using PhyML software (v3.0).12 Bootstrap analysis was performed on 1000 replicates.

The demographic history of the HIV reservoir in PBMC was estimated using the BEAST software13 and implemented in the Bayesian Markov chain Monte Carlo (MCMC) method. The Bayesian skyline model14 and strict clock model were incorporated in the MCMC method. Multiple independent MCMC runs were performed and assessed for consistency. Convergence of relevant parameters and Bayesian skyline results were assessed by effective sample sizes over 200 in Tracer v1.6 (http://tree.bio.ed.ac.uk/software/tracer/).

Over the course of three periods of treatment failure, the patient developed a four-class drug resistant virus population, in which we identified thirteen mutations associated with drug resistance. Five were in the RT gene - M41L, K65R, K70T, Y181C and G190A; four in the PR gene - M46I, I54L, L76V, and I84; and four in the IN gene - E138K, G140A, S147G, Q148R.

Sampling for this study was initiated after the patient was first diagnosed with ART failure, five years after ART treatment was first initiated. By that time, In September, 2013, almost 100% of PBMC virus already had mutants resistant to NRTI and NNRTI, and these levels persisted throughout periods of treatment, even during 2014, when plasma viral load was under the limit of detection.

After the introduction of the protease inhibitor Lopinavir/Ritonavir (LPV/r) to the patients ART, PI resistant mutants developed slowly in PMBC DNA. After one month, none were found; after sixteen months, less than 20% were mutants. After three years (two months prior to the patients death) PI mutants in PMBC DNA were still under 50%. PI resistant mutants in plasma had a different pattern. At sixteen months after the introduction of the PI no sequences could yet be identified because the viral level was too low for amplification. Eventually, substantially higher PI mutant levels were able to be found in plasma - almost 100% two years after a PI drug was switched to ART, by which time viral load had increased to 5.4*104 copies/mL.

Integrase strand transfer inhibitor (INSTI) mutations evolved much more quickly, replacing approximately 75% of the wild genotype in HIV DNA one year after addition of the integrase inhibitor raltegravir to the patients ART, and almost 100% after two years.

INSTI-resistant mutations, E138K, G140A, S147G and Q148R, replaced approximately 75% of the wild genotype in HIV DNA one year after addition of RAL to ART, and almost 100% 14 months later, by which time viral load reached 1.8*105 copies/mL. These results are displayed in Table 1 and Figure 2.

Figure 2 The development of Drug Resistant Mutants in Reverse Transcriptase (RT), Protease (PR) and Integrase (IN) Sequences in DNA from PBMC. Change in percent of drug resistant mutations in RT sequences, PR sequences and IN sequences. The vertical axes represent the percent of drug resistant mutants. Time scale is in calendar years and months.

In the RT gene, K65R and K70T mutations cause low resistance to 3TC and increased susceptibility to AZT. The Y181C and G190A mutants are associated with high-level resistance to NVP. M41L is a non-polymorphic mutation selected by thymidine analogs AZT. In the PR gene, M46I, L76V and I84V are non-polymorphic mutants selected by protease inhibitors. These mutants reduce susceptibility to LPV/r. In the IN gene, E138K, G140A and Q148R are also non-polymorphic mutants, selected by INSTI (RAL). Q148R is associated with high-level reductions in RAL susceptibility, particularly when it occurs in combination with E138K or G140A mutants (Table 2). All drug resistant mutation associations are based on the Stanford drug resistance database.15

Table 2 Characteristics of Drug-Resistant Mutant Sequences Isolated from PBMC

Because there were sufficient sequence data points from PBMC HIV DNA, Bayesian skyline plots were reconstructed to infer the dynamic of the effective population of RT, PR, and IN sequences in the PBMC. The effective population of RT sequences was shown to be stable over the entire testing period. However, the effective population of protease and integrase sequences underwent a significant increase in genetic variation during the period of treatment failure. After the switch of LPV/r to ART, the effective population of PR sequences first decreased and then increased with drug mutants selected by LPV/r. The effective population of IN sequences also decreased after the administration of PI, and stayed low for about six months. After the administration of INSTI, the effective population of IN sequences increased because of the drug resistant mutants selected by RAL. (Figure 3).

Figure 3 Demographic History of RT, PR and IN Sequences in DNA from PBMC. Bayesian skyline plots showing the effective population in the RT sequences (A), PR sequences (B) and IN sequences (C). Median estimates of the effective number of infections using Bayesian skyline (black curve) are shown in each graphic together with 95% highest probability density intervals of the Bayesian skyline estimates (blue area). The vertical axes represent the estimated effective number of infections on a logarithmic scale. Time scale is in calendar years. Vertical dotted lines indicate when a protease inhibitor (PI) and integrase strand transfer inhibitor (INSTI) were added to ART.

In this study, the mutant sequences have emerged during the development of a new four-class drug resistant HIV-1 CRF01_AE variant in a single patient, during several periods of therapy failure. This is a serious and challenging development since PLWHs harboring multi-class drug resistant virus have a high burden of disease, with a worrying incidence of malignancies and poorer survival after treatment failure.3,16

By the studys first sample collection point, almost 100% of viral sequences already had mutants resistant to NRTI and NNRTI in PBMC, so no significant change in the effective population of these sequences was observed over time. However, PI and INSTI drug resistant mutants gradually replaced the wild genotype, and drove the increase of genetic variability in HIV DNA. Demographic histories of these developments were generated by Bayesian skyline plot analysis, and demonstrate the genetic diversity in viral segment sequences over time, expressed as effective population.

This studys sequencing data showed significantly reduced genetic variability in both protease and integrase PBMC-derived variants directly following the administration of PI. A study by Besson et al investigated the decay of HIV DNA on ART and showed that the infected cell populations decline initially but then achieve a steady state with the persistence of about 10% of infected cells during effective ART.17 The different phase of decay occurs from the death of infected cells with different half-lives from days to months.18 The effective population increased when the drug resistant mutants were selected.

One previous study reported that the prevalence of INSTI resistance remained low compared with PI and RT resistance in ART-treated populations, but expanded with increased INSTI use between 2009 and 2016.19 The development of INSTI resistance described in this study suggests how that resistant pathway is evolving. Here the CRF01_AE virion developed INSTI resistant mutants by changes at position Q148, the most common mutant pathways previously described in all subtypes.20 There have been numerous reports of the emergence of substitutions involving position Q148 in response to RAL pressure. As substitutions at position Q148 impart a severe fitness cost,20 they are rapidly compensated for by various secondary resistance mutants, and the addition of at least two secondary mutants seems to confer the highest fold changes in resistance to second-generation INSTIs.21 E138K and G140A, identified in our study, are two of these mutants. The prevalence of the INSTI resistance mutants in CRF01_AE needs further investigation through a larger sample.

Drug-resistant mutants in HIV DNA emerged before they appeared in plasma through the use of next generation sequencing. The difference could be caused by the higher level of cell-associated HIV-1 RNA than in plasma RNA, which may contribute to the generation of new viral genomes, when plasma virus remains below the limit of detection.22 Some mutants could also remain in HIV DNA through persistence and/or proliferation of infected cells. These integrated and unintegrated provirus in latently infected cells may have a delayed contribution to the pool of resistant virus.23

While our study is limited to a single patient and several sampling timepoints, our data set and analysis demonstrated for the first time the evolution of sequences in the development of a four-class drug resistant HIV-1 CRF01_AE virion. It revealed dynamic shifts in the viral population and in drug-resistance mutants, while under the influence of complex ART regimens. This study utilized all samples available for this patient. Collection of baseline samples prior to initiation of ART, and at more sampling time points during treatment, will help us analyze evolutionary change in patient viral population. Our findings also suggested that next generation sequencing can be a very effective tool to detect a low level of drug resistance in HIV DNA, which could be critical for the clinical management of patients, especially those already experiencing virological failure while on particular ART regimens.

Both clinicians and patients need to be aware that a wide pattern of resistance can represent a strong negative prognostic factor for survival. Early detection of the development of drug resistant mutants should become a priority to prevent the further development of resistance through modification of ART regimens and as part of patient education to strengthen adherence to therapy.

The datasets used in this study are available from the corresponding author on reasonable request.

The study was approved by the institutional review boards of the First Affiliated Hospital, School of Medicine, Zhejiang University (Reference Number: 2020265). Written informed consent was provided by the patient to allow the case details and any accompanying images to be published.

We gratefully thank Susan Joyce Herzog for assistance in editing our manuscript.

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work. First co-author: These authors contribute equally to this manuscript: Xiaorong Peng and Yufan Xu.

This study was supported by National Special Research Program for Important Infectious Diseases (No. 2017ZX10202102-002-002).

The authors declare no conflicts of interest for this work.

1. Palella FJ, Delaney KM, Moorman AC, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med. 1998;338:853860. doi:10.1056/NEJM199803263381301

2. Smith SJ, Zhao XZ, Passos DO, Lyumkis D, Burke TR, Hughes SH. Integrase strand transfer inhibitors are effective anti-HIV drugs. Viruses. 2021;13:205. doi:10.3390/v13020205

3. Zaccarelli M, Tozzi V, Lorenzini P, et al. Multiple drug class-wide resistance associated with poorer survival after treatment failure in a cohort of HIV-infected patients. Aids. 2005;19:10811089. doi:10.1097/01.aids.0000174455.01369.ad

4. Armenia D, Di Carlo D, Flandre P, et al. HIV MDR is still a relevant issue despite its dramatic drop over the years. J Antimicrob Chemother. 2020;75:13011310. doi:10.1093/jac/dkz554

5. Feng Y, He X, Hsi JH, et al. The rapidly expanding CRF01_AE epidemic in China is driven by multiple lineages of HIV-1 viruses introduced in the 1990s. Aids. 2013;27:17931802. doi:10.1097/QAD.0b013e328360db2d

6. Peng X, Wu H, Peng X, Jin C, Wu N. Heterogeneous evolution of HIV-1 CRF01_AE in men who have sex with men (MSM) and other populations in China. PLoS One. 2015;10:e0143699. doi:10.1371/journal.pone.0143699

7. Huang A, Hogan JW, Luo X, et al. Global comparison of drug resistance mutations after first-line antiretroviral therapy across human immunodeficiency virus-1 subtypes. Open Forum Infect Dis. 2016;3:ofv158. doi:10.1093/ofid/ofv158

8. Peng X, Xu Y, Huang Y, Zhu B. Intrapatient evolutionary dynamics in an individual infected with HIV-1 CRF01_AE who experienced periods of treatment failure. AIDS Res Hum Retroviruses. 2021;37:139146. doi:10.1089/aid.2020.0213

9. Zagordi O, Bhattacharya A, Eriksson N, Beerenwinkel N. ShoRAH: estimating the genetic diversity of a mixed sample from next-generation sequencing data. BMC Bioinform. 2011;12:119. doi:10.1186/1471-2105-12-119

10. Edgar RC. MUSCLE: a multiple sequence alignment method with reduced time and space complexity. BMC Bioinform. 2004;5:113. doi:10.1186/1471-2105-5-113

11. Darriba D, Taboada GL, Doallo R, Posada D. jModelTest 2: more models, new heuristics and parallel computing. Nat Methods. 2012;9:772. doi:10.1038/nmeth.2109

12. Guindon S, Dufayard JF, Lefort V, Anisimova M, Hordijk W, Gascuel O. New algorithms and methods to estimate maximum-likelihood phylogenies: assessing the performance of PhyML 3.0. Syst Biol. 2010;59:307321. doi:10.1093/sysbio/syq010

13. Drummond AJ, Suchard MA, Xie D, Rambaut A. Bayesian phylogenetics with BEAUti and the BEAST 1.7. Mol Biol Evol. 2012;29:19691973. doi:10.1093/molbev/mss075

14. Minin VN, Bloomquist EW, Suchard MA. Smooth skyride through a rough skyline: bayesian coalescent-based inference of population dynamics. Mol Biol Evol. 2008;25:14591471. doi:10.1093/molbev/msn090

15. Shafer RW. Rationale and uses of a public HIV drug-resistance database. J Infect Dis. 2006;194(Suppl 1):S518. doi:10.1086/505356

16. Galli L, Parisi MR, Poli A, et al. Burden of disease in PWH harboring a multidrug-resistant virus: data from the PRESTIGIO registry. Open Forum Infect Dis. 2020;7:ofaa456. doi:10.1093/ofid/ofaa456

17. Besson GJ, Lalama CM, Bosch RJ, et al. HIV-1 DNA decay dynamics in blood during more than a decade of suppressive antiretroviral therapy. Clin Infect Dis. 2014;59:13121321. doi:10.1093/cid/ciu585

18. van Zyl G, Bale MJ, Kearney MF. HIV evolution and diversity in ART-treated patients. Retrovirology. 2018;15:14. doi:10.1186/s12977-018-0395-4

19. Kamelian K, Lepik KJ, Chau W, et al. Prevalence of human immunodeficiency virus-1 integrase strand transfer inhibitor resistance in British Columbia, Canada between 2009 and 2016: a longitudinal analysis. Open Forum Infect Dis. 2019;6:ofz060. doi:10.1093/ofid/ofz060

20. Anstett K, Brenner B, Mesplede T, Wainberg MA. HIV drug resistance against strand transfer integrase inhibitors. Retrovirology. 2017;14:36. doi:10.1186/s12977-017-0360-7

21. Tsiang M, Jones GS, Goldsmith J, et al. Antiviral activity of bictegravir (GS-9883), a novel potent HIV-1 integrase strand transfer inhibitor with an improved resistance profile. Antimicrob Agents Chemother. 2016;60:70867097. doi:10.1128/AAC.01474-16

22. Scully EP, Gandhi M, Johnston R, et al. Sex-based differences in human immunodeficiency virus type 1 reservoir activity and residual immune activation. J Infect Dis. 2019;219:10841094. doi:10.1093/infdis/jiy617

23. Wang YM, Dyer WB, Workman C, Wang B, Sullivan JS, Saksena NK. Molecular evidence for drug-induced compartmentalization of HIV-1 quasispecies in a patient with periodic changes to HAART. Aids. 2000;14:22652272. doi:10.1097/00002030-200010200-00007

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Nevada County Economic Resource Council: Technology and business go together – The Union of Grass Valley

Posted: at 10:07 am

Technology is defined as the application of scientific knowledge for practical purposes, especially in industry; machinery and equipment developed from the application of scientific knowledge; and the branch of knowledge dealing with engineering or applied sciences.

For Nevada County Economic Resource Councils Gil Mathew, it is evident that separating technology from industry is all but impossible.

In todays world, every industry sector includes technology, the executive director stated. While the ERC is working to connect different industry sectors, be it, education, manufacturing, agriculture, or healthcare but whatever the sector, technology is part of how that group does business.

While Nevada County boasts several technology-based businesses, from AJA to Telestream to Grass Valley (to name a few), the reality is that most businesses rely on tech in some form to operate. The days of handwritten ledgers and snail mail correspondence have all but disappeared. Those who want to succeed in todays business world have learned to embrace technology in a variety of formats from cell phones to computers to programmable machinery technology is deeply embedded in most daily operations.

In the last year, technology has been the basis for meeting and communicating across the world. Social platforms have exploded, and industry leaders have pivoted to find ways to remain relevant while practicing social distancing. Bringing people together remains a vital part of the fabric industry across all sectors.

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The Economic Resource Council is tasked with bringing like industry personnel together to discuss challenges as well as successes and to, hopefully, find common ground within the area businesses to help contribute to a vibrant, thriving economy in Nevada County. Each month a series of meet ups is planned to further that mission.

Teaming with California Manufacturing Technology Consulting (CMTC), the Economic Resource Council is inviting those in the manufacturing sector to a meet-up on Thursday, Sept. 9 from 5 p.m. to 7 p.m. Enticing participants with free pizza and beverages, the evening will focus on networking with peers and a short presentation by Mathew on the topic of ever-changing regulations affecting the specific industry. The event is free but does require an RSVP at info@ncerc.org.

Bringing people together while adhering to state health regulations will undoubtedly be discussed during the event. Safety protocols will be in place to ensure the well-being of all who attend.

Other meet ups including the monthly web development group and the writers forum have stayed online, utilizing the technology of social platforms to continue to bring people together. Those dates and links can also be obtained by emailing the Economic Resource Council.

In October, the Economic Resource Council will bring back the Economic Summit, a well-received afternoon featuring renowned economist Chris Thornberg who will breakdown the fiscal outlook on a national, regional, and local level. Both entertaining and informative, Thornberg has a long history of delivering accurate and pragmatic information around housing, development, and business in a variety of sectors. Tickets for the Oct. 25 event taking place at The Center for The Arts will be limited. Sponsorship, vendor, and participation information is available by contacting the Economic Resource Council.

To become a member and to find out more, use your technology and send any inquires to info@ncerc.org.

Hollie Grimaldi Flores is a freelancer writer in Nevada County. She writes a monthly column on behalf of the Nevada County Economic Resource Council

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Green Financing: Sustainable Lending In The Time Of Climate Change – Qrius

Posted: at 10:07 am

VidhiBatra

Pick up the latest newspaper and browse through the headlines, an issue you will see consistently brought up is that of climate change and its effects on several sectors of the economy. Reports highlighting heat waves, sea level rise and increasing carbon emissions have become common terms, tossed around on a daily basis, for any regular reader.

As is the case with several other industries, financial policy makers have also begun waking up to the damaging impact of climate change, bringing the world on the brink of a fundamental shift in lending and investment behavior.

There has been a surging shift towards Green Financing that aims to increase financial flows from public, private and not-for-profit sectors to sustainable priorities.

The key aim of this is to better manage environmental and social risks while taking up opportunities that encourage a better growth rate alongside environmental benefit and deliver greater accountability.

This cause can be promoted through changes in the countries regulatory frameworks by undertaking investment in clean technologies, financing for sustainable natural resource-based green economies, alignment of a climate-smart economy and so on.

The Green Bond market

Globally, there has been a remarkable interest among firms, especially those of the private sector to scale up investments dedicated to mitigate and adapt to climate change driven by growing concern about these issues and the enormity of the economic costs and financial losses facing the financial sector.

The most obvious reflection of this interest is the rapid growth of the Green Bond market accounting for new issuances surging to more than $250 billion in 2019. So, what is a Green Bond and how is it different from a regular bond market instrument?

The Green Bond is a fixed-income instrument that finances environment-friendly projects and appeals in particular to an expanding pool of investors who are interested in making measurable, beneficial social and environmental impact, while earning commercially appealing returns.

While capital markets play a significant role in transitioning towards a green economy, it is also necessary to understand that a large number of underdeveloped nations do not necessarily depend on such markets for financial assistance. In such cases, traditional financial agents like banks can play an important role in lowering the carbon footprint of rapid growth by redirecting capital flows to environmentally responsible projects and clean technologies.

National adoption of Green Finance

Market regulators, mainly the central banks and governments of different countries can use a combination of policy, guidelines and incentives to steer the national banking systems towards adoption of a clean and green economy. This has been successful in the several countries aiming towards making their overall growth sustainable by adopting climate-conscious outlooks.

For example, green credits such as loans to projects offering energy savings or emission reductions now make up approximately 10% of the portfolios of Chinas top 21 banks owing to mandatory Green Credit Guidelines issued by the Peoples Bank of China.

Moreover, the government of Malaysias Green Technology Financial Scheme has incentivized banks to extend loans actively to green projects by offering a 2% rebate on the total interest charged as well as a 60% guarantee of the total approved loan.

Another interesting type of loan that is gaining traction is the Sustainability-Linked Loan in which the proceeds of the loan are used for general corporate purposes, rather than green projects, but the pricing of the loan is based on the borrowers environmental, social and governance (ESG) score or overall sustainability achievements such as emission reductions.

If the borrower achieves its sustainability target, it benefits from favourable interest rates on the loan. If it fails, it pays a higher rate.

In a nutshell, Climate Change is a global responsibility to be tackled through joint efforts, especially today, when its gradual but imminent effects can be felt directly through depletion of resources, deterioration of natural habitats and rising pollution; putting us at the periphery of destruction.

Green financing of sustainability projects that encourage the economy as a whole to pursue environmental-friendly projects through investment in green technology is the only way to sustain prolonged economic development.

Moreover, it is also a new way to secure financial inclusion by introducing low-risk securities backed by the government, that guarantee lucrative returns by allowing those earlier excluded, to participate in the capital markets.

To put it simply, a greener economy ensures future security, social inclusion alongside prolonged and equitable growth.

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What the Olympic hockey pitch taught us about the circular economy – Investment Week

Posted: at 10:07 am

But actually, it was not just the action on the pitch that was special, but the pitch itself.

Other than being an unmissable bright blue, for the first time in Olympic history, conventional oil-based plastics were not used for the pitch surface as organisers have instead opted for turf made 60% from re-growable raw materials.

In this case, Brazilian sugar cane that has already been processed for food. The manufacturers claim that the bio-polyethylene surface will require two-thirds less water than previous Olympic turfs, and that for every kilo of the material used in the turf, five kilos of CO2 will be captured.

Using sugar cane in this way is a genius example of the circular economy in action.

In other words an economy in which resources are kept in use for as long as possible and are continuously reused and recycled to extract the maximum economic value.

Who would have thought excess sugar cane could have a useful economic life in providing gold medal opportunities on a hockey pitch?

The circular economy concept has been around for a while now, but it is quickly becoming a key priority for many governments given it is seen as a vital piece in the puzzle to achieving net zero by 2050.

The EU, for instance, has made the circular economy a central tenant of their Green Deal, estimating that it could result in an additional 0.5% of GDP across the EU by 2030 and creating around 700,000 new jobs.

It is a no-brainer for the planet, too.

The European Commission estimates that half of all greenhouse gas emissions and more than 90% of biodiversity loss and water stress stems from the extraction and processing of natural resources.

It is a monumental waste of energy to go through this process time and time again without using as many materials as possible from something that has already been made.

For businesses, too, there are obvious advantages to using resources over and over again, including less spending on materials which can boost profitability and make businesses less sensitive to fluctuations in the price of materials. For investors, therefore, businesses operating in the circular economy have clear advantages in generating attractive and stable cash flows.

It may, at first, appear to be a challenge turning the concept into an investment strategy, but when you scratch the surface there are opportunities all around.

Take waste management, for example. Our growing global population is putting considerable stress on the way we manage waste. But for some businesses this presents an opportunity.

Staying in Japan, the environmental company Daiseki provides waste disposal services to industrial businesses in Japan, and has a core competence in industrial waste management and lead battery recycling.

But the circular economy idea is also taking hold in many other sectors and many other walks of life. None more so than in clothing. Oxfam estimates that 13 million items of clothing end up in landfills each week, mainly the rejects of recycling banks and charity shops, with many items being exported to Ghana to be sold on or dumped.

When another elite athlete, Dame Ellen MacArthur, returned from sailing round the world single-handedly with minimum resources, she realised that the world was not so different from the boat with finite resources. On her return she set up a foundation to encourage businesses to design out waste, keeping products and materials in use and to regenerate natural eco-systems.

One of the foundation's many initiatives is the Jeans Redesign' project, in which 60 companies are making jeans from stronger fabrics and biodegradable denim, with water that is 98% recycled and dye that doesn't spill into the environment. New business models will emerge to ensure that these same jeans can be collected, sorted and recycled once again so they do not end in the landfill.

As the technology allowing consumers to reuse, reduce and recycle materials continues to improve, the global resource management value chain will provide exciting opportunities for businesses that are able to harness the power of the circular economy, and investors interested in resource efficiency.

Going round in circles is not bad thing after all.

Caroline Langley is co-manager of Quilter Cheviot's Climate Assets Fund

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EnviroGold Global Appoints one of Women in Mining UK’s Top 100 to Board of Directors – GlobeNewswire

Posted: at 10:07 am

TORONTO, Aug. 23, 2021 (GLOBE NEWSWIRE) -- EnviroGold Global Limited (EnviroGold Global or the Company) (CSE:NVRO), a clean technology company accelerating the worlds transition to a circular resource economy, is pleased to announce the appointment of Philipa Varris as a Director of the Company effective immediately. The Company is also pleased to announce the appointment of Leah Dionne as Corporate Secretary of the Company effective immediately.

Philipa Varris has held leadership positions in environment, health, safety and community management in the mining sector for over 25 years, primarily in Africa and Australasia and across a number of mineral commodities. Philipa has been awarded the Australian Centenary Medal for leadership in Australias largest community consultation and strategic vision development initiative and was recognized in 2020 as one of the WIM UK 100 Global Inspirational Women in Mining. Philipa holds an MSc in Natural Resources, is a Chartered Environmental Professional with the AusIMM and is a qualified Board candidate with Corporate Directors International. Philipa is the Executive Vice President, Head of Sustainability with Golden Star Resources.

Leah Dionne is the Managing Director of Corporate Advisory Services for Partum Advisory Services Corp., a leading Vancouver corporate administration and financial reporting firm. Leah Dionne has 14 years collective experience working in leading Canadian law firms, and for publicly-traded companies. During her career, she has focused on securities and corporate finance and assists with managing public company listing requirements with a focus on the CSE, TSXV, NEO and TSX stock exchanges, as well as listings on the OTC Markets. Through Partum she helps clients navigate complex corporate compliance matters, financings and IPO preparations for the Canadian markets.

The Company also announces the resignation of Roger Bethell from the Board of Directors. The Company would like to thank Roger for his time, services, and for the valuable contributions he made during his tenure as a director.

About EnviroGold Global

EnviroGold Global is a clean technology company capitalizing environmental stewardship and sustainably supplying the worlds increasing demand for precious, critical, and strategic metals by reclaiming unrecovered value from mine tailings and resource development waste streams. EnviroGold Global leverages proprietary technology, superior operationalized knowledge, and an ag ile, efficient culture to recover valuable metals, recharge critical resources and accelerate the worlds transition to a sustainable circular resource economy. EnviroGold Global is actively expanding the Companys significant reprocessing pipeline.

Further Information

Dr. Mark B. ThorpeEnviroGold Global Limited

Telephone: +1 (416) 777 6720Email: mark.thorpe@envirogoldglobal.com

Jonathan L. Robinson, CFAInvestor Relations Contact

Telephone: +1 (416) 669 1001Email: JRobinson@oakhillfinancial.ca

Forward Looking Statements

This news release contains "forward-looking statements" within the meaning of applicable securities laws. All statements contained herein that are not clearly historical in nature may constitute forward-looking statements.

Generally, such forward-looking information or forward-looking statements can be identified by the use of forward-looking terminology such as "plans", "expects" or "does not expect", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases or may contain statements that certain actions, events or results "may", "could", "would", "might" or "will be taken", "will continue", "will occur" or "will be achieved". The forward-looking information and forward-looking statements contained herein include, but are not limited to, statements regarding the implementation of ESG and corporate governance policies, the Companys expansion of its reprocessing pipeline, and the Companys ability to accelerate the worlds transition to a circular resource economy. Forward-looking information in this news release are based on certain assumptions and expected future events, namely: the Companys ability to continue as a going concern; the continued commercial viability and growth in the clean technology and mining waste reprocessing industry; continued approval of the Companys activities by the relevant governmental and/or regulatory authorities; the continued development of clean technology and mining waste reprocessing technology; and the continued growth of the Company. These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the potential inability of the Company to continue as a going concern; the Companys inability to accelerate the worlds transition to a circular resource economy the risks associated with the mining and mining waste recycling industry in general; increased competition in the clean technology and waste reprocessing market; the potential unviability of the clean technology and mining waste reprocessing market; incorrect assessment of the value and potential benefits of various transactions; risks associated with potential governmental and/or regulatory action with respect to clean technology and mining waste reprocessing; risks associated with a potential collapse in the value of clean technology and waste reprocessing; and risks relating to the Companys potential inability to expand its reprocessing pipeline.

Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect the Companys expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.

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Sun never sets on Indians, the spirit of Overseas Indians working for Global growth – thepolicytimes.com

Posted: at 10:07 am

Once British Empire was known as one where Sun never sets as they were ruling countries across the globe. They were forced to leave all these and now they are basically part of the UK. Sunset and sunrise are the continuous universal process which is known to the world. But in todays geopolitical scenario Indians do not have a sunset. India has the worlds largest network of overseas population. They are one of the most widely spread and diverse communities across the world from the most advanced USA to Zimbabwe, from Japan to Burkina Faso, there are more than 210 countries where 32 million overseas Indians live. The Overseas Indians still maintain strong cultural and social linkages with India, through food habits, social mores, marriages, Bollywood, etc. Our country has long been an important player in the global supply of professionals and students. The scale and magnitude of emigration or the brain drain from India continue to be voluminous quantitatively as well as qualitatively for both these categories. India has acknowledged and welcomed the contribution the overseas Indians have made to its development by way of remittances, deposits which are more than US$80 billion. They have brought a good amount of technology along with propriety to them and their relatives here. In turn, India has developed several measures to meet its aspirations by providing protection of its interests in India and abroad. India became proactive in interceding with the host countries when problems arose even though they had gone on their own contracts. In countries where the Indians are powerful and influential, they became Indias unofficial ambassadors, who promote Indian interests there. On balance, both sides benefited from this cooperation.

The world has seen many epidemics but all of them were largely contained within the regions where they originated. But COVID-19 has hit nearly every country in the world in just over three months and many countries have registered several more cases than China, where the virus originated. The presence of a virus anywhere is clearly a threat to people everywhere. Globalized cities are the most vulnerable and, by extension, any country that transacts through them is at risk. Most of the Indians stayed wherever they were and worked hard for the country where they stayed to come out of the pandemic state. They were very effective as medical practitioners as also other areas of importance to serve humanity to their best capacity. That means more global cooperation, not less and in this, there is a very big role for India and Indians abroad as 32.10 million Indians are the most spread people globally. There are 13.46 million non-resident Indians (NRIs), those holding an Indian passport, and 18.68 million personsof Indian Origin(PIOs) but ordinarily residing outside the country, spread across more than 210 nations, according to the MEA. But 8.9 million of them live in just six countries. Among them, the largest number of Indians, 3.4 million, live in the United Arab Emirates, which is approximately 27% of all NRIs around the world. Another 2.6 million are in Saudi Arabia while Kuwait, Oman, Qatar, and Bahrain were home to another 2.9 million NRIs.

The major positive impact has been the rapid increase in remittances from Indians abroad, but the economic costs of remittances are often high. A strong relationship with its population abroad is important for India. Indians in the West Asian countries also account for annual remittances of over US$40 billion. Remittances and investment should only be one element of that relationship. It is also the duty of the government to ensure that the demands of sections of the Diaspora who lack political and economic clout is also given attention and that they do not feel neglected.

Skills and knowledge are the driving forces of economic growth and social development for any country. India is blessed with 65% of its youth in the working-age group. As compared to other developed and developing countries, India has a unique window of opportunity for another 20-25 years called the demographic advantage. If India can skill its people with the requisite life skills, job skills, or entrepreneurial skills in the years to come the demographic advantage can be converted into the dividend wherein those entering the labor market or are already in the labor market contribute productively to economic growth both within and outside the country.

An extensive new report found that by 2030, more than 85 million jobs could go unfilled because there arent enough skilled people to take them. Indeed, the study finds that by 2030, there will be a global human talent shortage or roughly equivalent to the population of Germany. Left unchecked, in 2030 that talent shortage could result in about US$8.5 trillion in unrealized annual revenues. Governments and private organizations must make talent strategy a key priority and take steps now to educate, train, and upskill their existing workforces.

Much of the shortage is based on simple demography. Japan and many European nations, for instance, have had low birth rates for decades. In the United States, most baby boomers will have moved out of the workforce by 2030, but younger generations will not have had the time or training to take many of the high-skilled jobs left behind. A major crisis is looming over organizations and economies throughout the world. By 2030, expectations for skilled workers will outstrip supply, resulting in a global talent shortage of more than 85.2 million people. Signs are already emerging that within two years there wont be enough talent to go around. In countries with low unemployment and booming manufacturing production, including the Czech Republic, Poland, Hungary, and Slovakia, a labor shortage has already accelerated automation and increased use of roboticsnot to replace people, but because there arent enough of them to fill the factories.

Left unchecked, the financial impact of this talent shortage could reach US$8.452 trillion in unrealized annual revenue by 2030, equivalent to the combined GDP of Germany and Japan. The United States alone could miss out on US$1.748 trillion in revenue due to labor shortages, or roughly 6% of its entire economy. While leaders are betting heavily on technology for future growthas per survey report says that 67% of CEOs believe technology will be their chief value generator in the future of workthey cannot discount the value of human capital. Even companies that are using more robotics foresee a growing need for human talent with advanced skills; for example, redeploying people from the factory floor, where robots can perform repetitive work, to the research laboratory. The problem, however, is the mismatch between technological advances, including automation, artificial intelligence (AI), and machine learning, and the skills and experience workers need to leverage these advanced tools. Technology cannot deliver the promised productivity gains if there are not enough human workers with the right skills. This has set the scene for a global talent crunch.

The talent crunch, as modeled in this study, refers to the gap between talent supply and expectation at three critical milestones: 2020, 2025, and 2030. Despite the risk, by examining the scale, impact, and timing of the talent crunch and what it means for organizations over the long term. The global growth, demographic trends, under-skilled workforces, and tightening immigration mean that even significant productivity leaps enabled by technological advances will be insufficient to prevent the talent crunch.

More granularly, we examined talent supply and demand in each of the 20 economies as a whole and within three major knowledge-intensive industriesfinancial and business services (including insurance and real estate), technology, media, and telecommunications (TMT), and manufacturingand at three distinct skill levels, referenced throughout as:

The scale and impact of the talent crisis at each milestone in terms of skilled employee shortages and what they imply in terms of lost opportunity for value creation. For instance, the United States financial services sector will suffer the most from stunted growth due to lack of talent, with US$435.69 billion in projected unrealized economic output, equal to about 1.5% of the countrys entire economy.

For the all-important technology sector. a labor-skills shortage will reach 4.3 million workers by 2030, or 59 times the number of employees of Alphabet, Googles parent company. On the positive side, India is projected to have a skilled-labor surplus of around 245.3 million workers by 2030, the only country in our study expected to have a surplus, owing mainly to its vast supply of working-age citizens and government programs to boost workers skills. Fortunately, there is time to mitigate the risk. Governments and organizations must make talent strategy a key priority and take steps now to educate, train, and upskill their existing workforces.

The gap between the growth in demand and the growth in the supply of talent, 2011 to 2021

(Red indicates trend deceit, green a trend surplus, yellow a broad balance. Numbers show trend growth as annual percentages.)

This global skills shortage could result in US$8.452 trillion in unrealized annual revenue by 2030equivalent to the combined GDP of Germany and Japan. The impact of the talent crunch is so significant that the continued predominance of sector powerhouses is in question, from London as a global financial services center to the United States as a technology leader to China as a key manufacturing base. As a result, organizations may be prompted to relocate their headquarters and operational centers to places where the talent supply is more plentiful. Governments will be forced to invest in improving their peoples skills to avert corporate flight and to defend their nations income and status.

Secured Governance for Overseas Indians through Education A Channel for Prosperity through Knowledge Growth

Secured Governance for skill development is a strategy that relates to the develop a relationship between the development of Education infrastructures to various other sectors along with various institutions as partners and Government as governing body to foster, coordinate and create a defined Skill Training Centre along with various existing educational infrastructure or to create a new cluster/s on strategically defined locations that improves and develops the center as a whole through regional strategies, technology, and interdependency among various other sectors of growth.

The skill gap in India is addressed effectively by the National Skill Development Policy (NSDP) Government having recognized that skill development will play a vital role in transforming India into an economic power to reckon with had set a target of skilling 500 million people. For this, the country has rightly understood the need to set up many Skills Universities including Private Skills Universities in partnership with the industry.

There is a high correlation between skill levels and building skill capital. The National Skills Qualification Framework (NSQF) has defined levels of skills based on outcomes such as

Thus, the levels vary from skills involving simple and routine physical or manual task(Level 1) to skills involving the operation of machinery and electronic equipment (Level 2) to skills involving records of work (Level 3) to decision making and creativity based contribution (Level 4 High-end Skills).

NSQF further classified skills into Domains Specific Skills and Soft Skills and concluded that Skills Universities conceptualized with a clear mandate of skill education can alone offer the necessary practical real-world training in industrial and services sectors to lay the foundation for the required skills training system in India. In the wake of the Skill India Mission, some Skills Universities have come up to provide standards in the Skills field. These Universities exercise constant ingenuity and are providing innovative models.

The concept of secured governance does not believe that dramatic changes can be achieved only through a revolution that requires upturning all the procedures evolved through years of efforts and experience. It realizes the tools for bringing about effective and sustainable changes are already available in the system. They can be made more effective by defining linkages, effective response mechanisms, and dynamic feedback systems. Emphasis is placed on defining the relationship between sectors of growth, institutions, and government to foster coordination and create an environment that improves the system through regional strategies, technology and by taking cognizance of the myriad of interdependencies.

Secured governance for Education has major characteristics like participation, rule of law, transparency, and responsiveness, at each stage of its operations and in developing a robust education system in the country. With improved resource allocation, enhanced governance, Interdependency among sectors, and transparency in the system going hand in hand with development and effective use of Information Technology and Innovation can deliver a safer, cleaner, and more accountable delivery of self-sustaining Education infrastructure and services.

More Potential to reap more Remittance through Secured Governance:

Indias population is huge at 1.38 billion. It is fast expanding at a rate of 17% and integrating rapidly into the global economy. India is among the young countries in the world, with the proportion of the workforce in the age group of 15-59 years, increasing steadily. However, presently only 2% of the total workforce in India have undergone skills training. India has a great opportunity to meet the future demands of the world, India can become the worldwide sourcing hub for a skilled workforce. Besides over 65% of Indias large population is below 35 years of age; a robust skills training and certification system for these large numbers is a mammoth task.

Even India has the largest population of English speakers. Due to its colonial legacy, English became a part of the Indian education system, which has now become an advantage. Indians thus have an edge over other countries due to their fluency in English.

Equipping the workforce with the skills required for the jobs of today and those of tomorrow is a strategic concern in the national growth and development outlook of India.

The most widely recognized immediate benefit from the international labor migration remains the flow of remittances, which not only augments scarce foreign exchange but also provides a potential source of additional savings and capital formation. India could look at preparing the workforce for global opportunities so that it can utilize its premium position as the human resource reservoir. Given the dynamic labor markets, it is also important the workforce learns and readies itself as quickly as possible.

India will continue to play a greater role for sustained growth and with Indians with better skills ready to take up the challenges for all the countries. Indians going abroad are equivalent to Export of Supercomputer and India should plan this properly and effectively with Education and skilling from Education playing a good role.

Most of the Indians abroad are highly skilled and professional enough to deserve great pay. By 2025, Indias demographic dividend is expected to contribute 25% of a global workforce. They can be made more effective by defining linkages, effective response mechanisms, and dynamic feedback systems. Emphasis is placed on defining a relationship between sectors of growth, institutions, and government to foster coordination and create an environment that improves the system through regional strategies, technology and by taking cognizance of the myriad of interdependencies.

India is the only country expected to have a surplus of highly skilled financial and business services labor by 2030. India is projected to have a skilled-labor surplus of around 245.3 million workers by 2030, the only country that is expected to have a surplus, owing mainly to its vast supply of working-age citizens and government programs to boost workers skills.

We could contribute greatly to the worlds labor-intensive manufacturing jobs. India could play a vital role in this greater global opportunity in technology and other knowledge-intensive fields. A designated region intended to attract foreign investment, retain local students, build a regional reputation by providing access to high-quality education and training for both international and domestic students, and create a knowledge-based economy. A multitude of education HUBs can include different combinations of domestic/international institutions, branch campuses, and foreign partnerships, within the designated region. Businesses worldwide need management graduates who have the tools to succeed globally leadership skills, cultural awareness, foreign language proficiency, and an understanding of how the global marketplace functions. Outbound Exchange Program wherein we send our students to associated universities or corporate houses for skill development and knowledge exchange. Inbound Exchange Program will facilitate initiatives for welcoming students from other countries to facilitate knowledge transfer targeting at least 10% of the students from other universities.

India is a rapidly rising economic power and will also by 2020 be the youngest country in the world with 64% of its population in the working-age group. Through secured governance establish a vibrant institutional framework in the educational system. India could capture a greater global opportunity in technology and other knowledge-intensive fields.

By,Dr. P. Sekhar, Chairman,Global Smart Cities Panel & Micro Tech Global Foundation

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Sun never sets on Indians, the spirit of Overseas Indians working for Global growth

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The Overseas Indians still maintain strong cultural and social linkages with India, through food habits, social mores, marriages, Bollywood, etc. Our country has long been an important player in the global supply of professionals and students.

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TPT News Bureau

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THE POLICY TIMES

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Sun never sets on Indians, the spirit of Overseas Indians working for Global growth - thepolicytimes.com

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Li-Cycle Welcomes Lithium Industry Veterans to Board of Advisors – Business Wire

Posted: at 10:07 am

TORONTO--(BUSINESS WIRE)--Li-Cycle Holdings Corp. (NYSE: LICY) ("Li-Cycle" or "the Company"), an industry leader in lithium-ion battery resource recovery and the leading lithium-ion battery recycler in North America, today announced that John Mitchell and Govind Arora have joined the Companys Board of Advisors.

Mr. Mitchell and Mr. Arora both have an exceptional track record leading prominent companies at the senior executive level and join Li-Cycle at a critical juncture following its listing on the New York Stock Exchange. They will be providing management advisory services to Li-Cycles senior management team, leveraging their experience and expertise in the areas of business development, commercial support and strategic and business planning. The other members of the Board of Advisors are Dr. Yuan Gao and Dr. Ahmad Ghahreman, who have been providing technical advisory services to the Company over the past several years.

"John and Govind both have impressive backgrounds and were looking forward to leveraging their expertise as we pursue our growth plan, said Ajay Kochhar, co-founder, President and Chief Executive Officer of Li-Cycle. They are aligned with our vision to create a truly circular battery supply chain by utilizing our breakthrough commercial technology to transform end-of-life batteries and battery production waste into materials of great value for our customers and partners.

John Mitchell

Li-Cycle has already served as a catalyst for tremendous, positive change in the lithium-ion battery market, said Mr. Mitchell. Li-Cycles technology is second to none and I look forward to working closely with Ajay and his best-in-class management team as the Company continues to disrupt an industry that needs a low-cost and sustainable battery supply chain.

Mr. Mitchell brings more than 30 years of experience in executive leadership roles in specialty chemicals, energy materials, utility infrastructure, and industrial gases. He is currently a partner and co-founder of Blue Horizon Advisors and Blue Horizon Capital, focused on the worlds transition to the new energy economy by supporting leading companies to scale and providing index-based investment products across the new energy economy thematic. Previously, he served as President of Lithium for the Albemarle Corporation, where he guided Albemarles lithium division to a global market leading position. Prior to Albemarle, Mr. Mitchell served as Rockwood Lithiums North American President, Environmental Management Corporations President, and Senior Advisor to Lindes business in Africa and South America.

Mr. Mitchell holds his B.S. in Materials Engineering from Drexel University.

Govind Arora

Li-Cycle is a pioneer, establishing a proven lithium-ion battery recycling technology before it became the prevalent topic that it is presently, said Mr. Arora. The Company has a robust global growth strategy that will be essential in contributing to a circular lithium-ion battery market that continues to demonstrate rapidly growing demand for critical, finite materials.

Mr. Arora brings more than 20 years of experience in energy materials, the automotive industry, industrial automation, and the aerospace industry. He currently serves as a partner and co-founder of Blue Horizon Advisors and Blue Horizon Capital. Previously, he was Chief Commercial Officer for Albemarle Corporations Lithium business, which is the global leader in advanced lithium materials as well as a thought leader within the energy storage value chain. Prior to Albemarle, Mr. Arora led several businesses to achieve high growth, serving as President of Stanley Black & Deckers Latin American Group, Chief Financial Officer for Stanley Black & Deckers Global Emerging Markets business and Chief Financial Officer for Honeywells process solutions business in Asia, based out of China.

Mr. Arora holds a B.A. in Business Administration from California State University, Fullerton and acquired his Executive MBA in International Business from the Thunderbird School of Global Management.

Dr. Yuan Gao and Dr. Ahmad Ghahreman

As disclosed above, Mr. Mitchell and Mr. Arora will be joining the Companys existing Advisory Board members, Dr. Yuan Gao and Dr. Ahmad Ghahreman.

Dr. Gao is Vice-Chairman of the board of directors of Qinghai Taifeng Pulead Lithium-Energy Technology Co. Ltd. (Pulead), one of Chinas leading lithium-ion battery cathode producers and a key player in the lithium-ion battery supply chain. Dr. Gao was previously President and Chief Executive Officer of Pulead and prior to joining Pulead in 2014, he held senior positions with Molycorp Inc. and FMC Corp.s lithium division. Dr. Gao originally obtained his BSc from the University of Science and Technology of China, and his PhD in Physics from the University of British Columbia.

Dr. Ghahreman has over 15 years of hydrometallurgical/wet chemistry experience. He has deep expertise in the advanced recovery of many of the constituents in lithium-ion batteries, gained in the context of primary resource mineral processing and hydrometallurgy. Dr. Ghahreman has a bachelors degree and a masters degree in Materials Science and Engineering from Sharif University of Technology, Tehran, Iran, and earned his Ph.D. in Materials Engineering from The University of British Columbia, Vancouver, BC. Upon completing his Ph.D., Dr. Ghahreman joined the Technology Centre of Barrick Gold Corp. in Vancouver, as an NSERC Industrial Research & Development (IRDF) Postdoctoral Fellow. He joined The Robert M. Buchan Department of Mining at Queens University as an Assistant Professor in January 2014.

About Li-Cycle Holdings Corp.

Li-Cycle (NYSE:LICY) is on a mission to leverage its innovative Spoke & Hub Technologies to provide a customer-centric, end-of-life solution for lithium-ion batteries, while creating a secondary supply of critical battery materials. Lithium-ion rechargeable batteries are increasingly powering our world in automotive, energy storage, consumer electronics, and other industrial and household applications. The world needs improved technology and supply chain innovations to better manage battery manufacturing waste and end-of-life batteries and to meet the rapidly growing demand for critical and scarce battery-grade raw materials through a closed-loop solution. For more information, visit https://li-cycle.com/.

CAUTION CONCERNING FORWARD-LOOKING STATEMENTS

Certain statements contained in this communication may be considered forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, Section 21 of the Securities Exchange Act of 1934, as amended, and applicable Canadian securities laws. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," should, would, expect, anticipate, plan, likely, believe, estimate, project, intend, and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to significant risks and uncertainties, many of which are beyond the control of Li-Cycle and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: (i) the possibility that the anticipated benefits and/or the anticipated tax treatment of the recently completed transaction between the Company and Peridot Acquisition Corp. (the transaction) will not be realized; (ii) the risk that stockholder litigation in connection with the transaction or other settlements or investigations may result in significant costs of defense, indemnification and liability; (iii) changes in general economic and/or industry specific conditions; (iv) possible disruptions from the transaction that could harm Li-Cycles business; (v) the ability of Li-Cycle to retain, attract and hire key personnel; (vi) potential adverse reactions or changes to relationships with customers, employees, suppliers or other parties; (vii) legislative, regulatory and economic developments; (viii) unpredictability and severity of catastrophic events, including, but not limited to, acts of terrorism, outbreak of war or hostilities and any epidemic, pandemic or disease outbreak (including COVID-19), as well as managements response to any of the aforementioned factors; and (ix) the ability of Li-Cycle to maintain the listing of the Companys common shares or warrants on The New York Stock Exchange, and (x) other risk factors as detailed from time to time in Li-Cycles reports and other documents filed with the U.S. Securities and Exchange Commission (SEC) and securities regulatory authorities in Canada, including, without limitation, the Companys final prospectus dated August 10, 2021 filed with the Ontario Securities Commission in Canada and the Form 20-F filed with the SEC. The foregoing list of important factors is not exclusive. You should not place undue reliance upon any forward-looking statements, which speak only as of the date made. Except as required by applicable law, Li-Cycle does not undertake any obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

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