Omicron triples Canada’s COVID-19 infection count, study shows

Omicron triples Canada’s COVID-19 infection count, study shows




Omicron triples Canada’s COVID-19 infection count, study shows

TORONTO, May 19, 2022 (GLOBE NEWSWIRE) — Nearly 30 per cent of Canadian adults – 9 million people – were infected during the Omicron variant wave early in 2022, compared with just 10 per cent who had been infected in the previous four waves, according to a new study led by Toronto researchers.

Despite the high numbers of infections, the study also revealed that every dose of vaccine and previous infection boosted immune responses. Canadian adults with three vaccine doses and a past infection from COVID-19 had the highest protection.

The findings, published in a letter to the editor in The New England Journal of Medicine, fill a gap in understanding the scale of COVID-19’s spread during the fifth wave, as well as Canadians’ immunity to the virus, either through vaccination or natural infection. Provinces scaled back COVID-19 molecular diagnostic testing in December 2021, leaving policymakers and the public without reliable data to inform pandemic responses and to gauge community risk.

“The incidence of Omicron variants, which rose worldwide from December 2021 even among vaccinated people, is poorly understood. This study quantifies SARS-CoV-2 incidence during the initial Omicron wave among Canadian adults, and the contribution of prior infection and vaccination to age-specific active immunity,” said Dr. Prabhat Jha, principal investigator of the Action to Beat Coronavirus (Ab-C) study and director of the Centre for Global Health Research at St. Michael’s Hospital of Unity Health Toronto. Dr. Jha is also a professor of epidemiology at the University of Toronto’s Dalla Lana School of Public Health (DLSPH).

The study analyzed more than 5,000 blood samples representative of Canadian adults – members of the Angus Reid Forum, a public polling cohort – from January 15 to March 15, 2022. From those results, the researchers determined that an estimated 9 million of 29.7 million Canadian adults were newly infected during the Omicron wave. Of those infections, one million were among the country’s 2.3 million unvaccinated adult population – representing 40 per cent of all unvaccinated adults.

The Ab-C study is a collaboration among Unity Health Toronto, DLSPH, the Angus Reid Institute, and the Lunenfeld-Tanenbaum Research Institute at Sinai Health. It is funded by the Government of Canada through its COVID-19 Immunity Task Force (CITF). Ab-C has been tracking the pandemic in Canada with periodic polling about lived experience and blood sample collection since May 2020, and will continue as long as the COVID-19 pandemic continues to evolve.

“Canada has kept natural infection levels generally low – perhaps less than 10 per cent of the adult population prior to Omicron – in contrast to many parts of the United States and England. So Canada must rely on vaccination – especially three doses for the older population. However, the proportion of adults vaccinated with third doses is still lower than ideal,” added lead author Dr. Patrick Brown, a biostatistician at the Centre for Global Health Research and the University of Toronto.

“If we take into account the fact that pediatric surveys have estimated that the proportion of infections among children was as high or higher than it was among adults and that new subvariants of Omicron continue to infect Canadians in the ongoing sixth wave, there are now millions more infections to add to the Ab-C study’s total,” states Catherine Hankins, Co-Chair of the COVID-19 Immunity Task Force. “In short, a substantial portion of the Canadian population now has hybrid immunity – defined as a combination of a past COVID-19 infection along with between one and three doses of a COVID-19 vaccine.”

The Ab-C study has started surveying approximately 1,300 adults who were not infected from the initial Omicron variant (called BA.1/1.1) to determine whether they were infected by the latest Omicron variant (called BA.2) from March to June 2022.

“We owe a great debt of gratitude to the thousands of Canadians, drawn from every region who took the time to share specimens of their blood and complete related surveys. Their participation made this study possible,” said Dr. Angus Reid, chairman of the Angus Reid Institute.

About St. Michael’s Hospital

St. Michael’s Hospital provides compassionate care to all who enter its doors. The hospital also provides outstanding medical education to future health care professionals in more than 27 academic disciplines. Critical care and trauma, heart disease, neurosurgery, diabetes, cancer care, care of the homeless and global health are among the Hospital’s recognized areas of expertise. Through the Keenan Research Centre and the Li Ka Shing International Healthcare Education Centre, which make up the Li Ka Shing Knowledge Institute, research and education at St. Michael’s Hospital are recognized and make an impact around the world. Founded in 1892, the hospital is fully affiliated with the University of Toronto.

About Unity Health Toronto

Unity Health Toronto, comprised of Providence Healthcare, St. Joseph’s Health Centre and St. Michael’s Hospital, works to advance the health of everyone in our urban communities and beyond. Our health network serves patients, residents and clients across the full spectrum of care, spanning primary care, secondary community care, tertiary and quaternary care services to post-acute through rehabilitation, palliative care and long-term care, while investing in world-class research and education. For more information, visit www.unityhealth.to.

About the Dalla Lana School of Public Health

The Dalla Lana School of Public Health is a faculty of the University of Toronto, and Canada’s largest public health school. Our community is comprised of internationally recognized teachers, students, practitioners, policymakers and citizens. We create new knowledge; educate changemakers; advance practice and guide the way to better, more equitable outcomes in population health and health systems. Join us at the forefront of change in health!

About the Angus Reid Institute

The Angus Reid Institute (ARI) was founded by pollster & sociologist, Dr. Angus Reid to enhance and encourage a better understanding of issues and trends affecting the public policy in Canada. Since 2014 The Institute has carried out over 500 studies on a vast array of topics ranging from foreign policy to poverty reduction. In the health sector Institute research has helped shape the debate on pharmacare, examined waiting times for elective procedures and provided up to date information on gaps in primary care and mental health services. Strictly nonpartisan, ARI is funded by the Reid family and partnerships with other not for profits. ARI has the status of a registered charity in Canada.

About the COVID-19 Immunity Task Force

The Government of Canada established the COVID-19 Immunity Task Force (CITF) in late April 2020 to catalyze, support, fund, and harmonize research on SARS-CoV-2 immunity for federal, provincial, and territorial decision-makers in their efforts to protect Canadians and minimize the impact of the COVID-19. To date, the CITF has supported over 100 studies across Canada that are generating critical insights on the levels, trends, nature, and duration of immunity arising from SARS-CoV-2 infection and COVID-19 vaccination. The CITF is overseen by a Leadership Group of volunteers that includes leading scientists and policymakers from across Canada. The Task Force and its Secretariat work closely with a range of partners, including governments, public health agencies, institutions, health organizations, research teams, other task forces, engaging communities and stakeholders.

About Sinai Health

Sinai Health is comprised of Mount Sinai Hospital, Hennick Bridgepoint Hospital, Lunenfeld-Tanenbaum Research Institute and its system partner Circle of Care. It delivers excellent care in hospital, community and home, focusing on the comprehensive needs of people. Sinai Health discovers and translates scientific breakthroughs, pushes boundaries for health solutions and educates future clinical and scientific leaders. Clinical areas of specialization include rehabilitation and complex continuing care, surgery and oncology, urgent and critical care, and women’s and infants’ health. Its Lunenfeld-Tanenbaum Research Institute ranks among the top ten biomedical research institutes in the world. Sinai Health is a full affiliate of the University of Toronto. www.sinaihealth.ca

Media contacts:

Jennifer Stranges, Unity Health Toronto; jennifer.stranges@unityhealth.to
Dr. Angus Reid, Angus Reid Institute; angus@angusreid.org
Rebecca Burns, COVID-19 Immunity Task Force; media@covid19immunitytaskforce.ca
Heidi Singer, Dalla Lana School of Public Health, University of Toronto; Heidi.Singer@utoronto.ca

The views expressed herein do not necessarily represent the views of the Public Health Agency of Canada.

Mainz Biomed & Dante Labs Announce Partnership for the Commercialization of ColoAlert in Europe and the United Arab Emirates (UAE)

Mainz Biomed & Dante Labs Announce Partnership for the Commercialization of ColoAlert in Europe and the United Arab Emirates (UAE)




Mainz Biomed & Dante Labs Announce Partnership for the Commercialization of ColoAlert in Europe and the United Arab Emirates (UAE)

  • Dante Labs is a Global Leader in Genomics and Precision Medicine
  • Mainz is Exclusively Focused on Developing Next Generation Diagnostics for the Early Detection of Cancer

BERKELEY, Calif. and MAINZ, Germany and NEW YORK, May 19, 2022 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer and Dante Labs, a global leader in genomics and precision medicine, announced today a partnership for the commercialization of ColoAlert in Italy and the United Arab Emirates (UAE). ColoAlert is Mainz’s flagship product, a highly efficacious and easy to use at-home detection test for colorectal cancer (CRC).

Dante Labs is a global leader in genome sequencing with a product development and commercial franchise focused on providing personalized preventive healthcare solutions by leveraging its robust databases and proprietary software platform to offer next-generation diagnostic tools direct to consumers and healthcare professionals. Inherent to Dante Lab’s business model is managing state-of-the-art genomic sequencing laboratories in multiple international regions, and operating a robust e-commerce platform.

“As a young company with the goal of bringing to market important diagnostic tools to help treat and prevent cancer indications, it’s an absolute pleasure to partner with an industry leader such as Dante Labs,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Our differentiated commercial plan of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility requires alliances with like-minded companies such as Dante Labs, who share our passion for forward-thinking diagnostic test development and marketing strategies.”

The partnership will first launch ColoAlert in Italy and UAE using Dante’s various established commercial channels. Samples will initially be processed at Mainz’s in-house facility and then Dante will purchase Mainz’s CE-IVD polymerase chain reaction (PCR) assay kits and transition all test processing to Dante’s wholly-owned automated genomic sequencing laboratories in Italy (Europe) and Dubai (UAE) to offer localized service and support.

“We are excited by the opportunity to align with Mainz and represent ColoAlert in these initial markets,” commented Andrea Riposati, Chief Executive Officer of Dante Labs. “Both the product and the Company mirror our mission to develop and market top-tier preventive health solutions and use new channels to make innovative tests available to more patients around the world. With the launch of our enhanced ecommerce platforms for advanced diagnostics, ColoAlert is an amazing product to deliver more personalized medicine.”

ColoAlert is currently marketed across Europe, and the partnership with Dante Labs marks the test’s initial launch in the Middle East. Mainz will continue to develop commercial and R&D partnerships with companies that lead the field of health screening with a particular focus on stool diagnostics.

About ColoAlert

ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy*. The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT) and is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVD marked (complying with EU safety, health and environmental requirements) and is transitioning to compliance with IVDR. The product is commercially available in a selection of countries in the European Union. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. Once approved in the U.S., the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.

*Dollinger MM et al. (2018)

About Colorectal Cancer

Colorectal cancer (CRC) is the second most lethal cancer in the U.S. and Europe, but also the most preventable with early detection providing survival rates above 90%. Annual testing costs per patient are minimal, especially when compared to late-stage treatments of CRC which cost patients an average of $38,469 per year. The American Cancer Society estimated that in 2021 there were approximately 149,500 new cases of colon and rectal cancer in the U.S. with 52,980 resulting in death. Recent FDA decisions suggest that screening with stool DNA tests such as ColoAlert in the U.S. should be conducted once every three years starting at age 45. Currently there are 112 million Americans aged 50+, a total that is expected to increase to 157 million within 10 years. Appropriately testing these U.S.-based 50+ populations every three years as prescribed equates to a U.S. market opportunity of approximately $3.7 Billion per year.

About Mainz Biomed N.V.

Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert, an accurate, non-invasive, and easy-to-use early detection diagnostic test for colorectal cancer. ColoAlert is currently marketed across Europe with FDA clinical study and submission process intended to be launched in the first half of 2022 for U.S. regulatory approval. Mainz Biomed’s product candidate portfolio includes PancAlert, an early-stage pancreatic cancer screening test based on Real-Time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples, and the GenoStick technology, a platform being developed to detect pathogens on a molecular genetic basis.

For more information please visit www.mainzbiomed.com

For media enquiries, please contact press@mainzbiomed.com

For investor enquiries, please contact ir@mainzbiomed.com

About Dante Labs

Dante Labs is a global genomic information company building and commercializing a new class of transformative health and longevity applications based on whole genome sequencing and AI. The Company uses its platform to deliver better patient outcomes from diagnostics to therapeutics with assets including one of the largest private genome databases with research consent, proprietary software designed to unleash the power of genomic data at scale and proprietary processes which enable an industrial approach to genomic sequencing.

Contact:

Laura D’Angelo
VP of Investor Relations
ir@dantelabs.com
+39 0862 191 0671
www.dantelabs.com

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its Prospectus filed on October 12, 2021 and amended on October 25, 2021 and November 1, 2021 as well as the Prospectus filed on January 21, 2022. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.

 

Mainz Biomed & Dante Labs Announce Partnership for the Commercialization of ColoAlert in Europe and the United Arab Emirates (UAE)

Mainz Biomed & Dante Labs Announce Partnership for the Commercialization of ColoAlert in Europe and the United Arab Emirates (UAE)




Mainz Biomed & Dante Labs Announce Partnership for the Commercialization of ColoAlert in Europe and the United Arab Emirates (UAE)

  • Dante Labs is a Global Leader in Genomics and Precision Medicine
  • Mainz is Exclusively Focused on Developing Next Generation Diagnostics for the Early Detection of Cancer

BERKELEY, Calif. and MAINZ, Germany and NEW YORK, May 19, 2022 (GLOBE NEWSWIRE) — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer and Dante Labs, a global leader in genomics and precision medicine, announced today a partnership for the commercialization of ColoAlert in Italy and the United Arab Emirates (UAE). ColoAlert is Mainz’s flagship product, a highly efficacious and easy to use at-home detection test for colorectal cancer (CRC).

Dante Labs is a global leader in genome sequencing with a product development and commercial franchise focused on providing personalized preventive healthcare solutions by leveraging its robust databases and proprietary software platform to offer next-generation diagnostic tools direct to consumers and healthcare professionals. Inherent to Dante Lab’s business model is managing state-of-the-art genomic sequencing laboratories in multiple international regions, and operating a robust e-commerce platform.

“As a young company with the goal of bringing to market important diagnostic tools to help treat and prevent cancer indications, it’s an absolute pleasure to partner with an industry leader such as Dante Labs,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Our differentiated commercial plan of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility requires alliances with like-minded companies such as Dante Labs, who share our passion for forward-thinking diagnostic test development and marketing strategies.”

The partnership will first launch ColoAlert in Italy and UAE using Dante’s various established commercial channels. Samples will initially be processed at Mainz’s in-house facility and then Dante will purchase Mainz’s CE-IVD polymerase chain reaction (PCR) assay kits and transition all test processing to Dante’s wholly-owned automated genomic sequencing laboratories in Italy (Europe) and Dubai (UAE) to offer localized service and support.

“We are excited by the opportunity to align with Mainz and represent ColoAlert in these initial markets,” commented Andrea Riposati, Chief Executive Officer of Dante Labs. “Both the product and the Company mirror our mission to develop and market top-tier preventive health solutions and use new channels to make innovative tests available to more patients around the world. With the launch of our enhanced ecommerce platforms for advanced diagnostics, ColoAlert is an amazing product to deliver more personalized medicine.”

ColoAlert is currently marketed across Europe, and the partnership with Dante Labs marks the test’s initial launch in the Middle East. Mainz will continue to develop commercial and R&D partnerships with companies that lead the field of health screening with a particular focus on stool diagnostics.

About ColoAlert

ColoAlert detects colorectal cancer (CRC) via a simple-to-administer test with a sensitivity and specificity nearly as high as the invasive colonoscopy*. The test utilizes proprietary methods to analyze cell DNA for specific tumor markers combined with the fecal immunochemical test (FIT) and is designed to detect tumor DNA and CRC cases in their earliest stages. The product is CE-IVD marked (complying with EU safety, health and environmental requirements) and is transitioning to compliance with IVDR. The product is commercially available in a selection of countries in the Europe Union. Mainz Biomed currently distributes ColoAlert through a number of clinical affiliates. Once approved in the U.S., the Company’s commercial strategy is to establish scalable distribution through a collaborative partner program with regional and national laboratory service providers across the country.

*Dollinger MM et al. (2018)

About Colorectal Cancer

Colorectal cancer (CRC) is the second most lethal cancer in the U.S. and Europe, but also the most preventable with early detection providing survival rates above 90%. Annual testing costs per patient are minimal, especially when compared to late-stage treatments of CRC which cost patients an average of $38,469 per year. The American Cancer Society estimated that in 2021 there were approximately 149,500 new cases of colon and rectal cancer in the U.S. with 52,980 resulting in death. Recent FDA decisions suggest that screening with stool DNA tests such as ColoAlert in the US should be conducted once every three years starting at age 45. Currently there are 112 million Americans aged 50+, a total that is expected to increase to 157 million within 10 years. Appropriately testing these US-based 50+ populations every three years as prescribed equates to a US market opportunity of approximately $3.7 Billion per year.

About Mainz Biomed N.V.

Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert, an accurate, non-invasive, and easy-to-use early detection diagnostic test for colorectal cancer. ColoAlert is currently marketed across Europe with FDA clinical study and submission process intended to be launched in the first half of 2022 for U.S. regulatory approval. Mainz Biomed’s product candidate portfolio includes PancAlert, an early-stage pancreatic cancer screening test based on Real-Time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples, and the GenoStick technology, a platform being developed to detect pathogens on a molecular genetic basis.

For more information please visit www.mainzbiomed.com

For media enquiries, please contact press@mainzbiomed.com

For investor enquiries, please contact ir@mainzbiomed.com

About Dante Labs
Dante Labs is a global genomic information company building and commercializing a new class of transformative health and longevity applications based on whole genome sequencing and AI. The Company uses its platform to deliver better patient outcomes from diagnostics to therapeutics with assets including one of the largest private genome databases with research consent, proprietary software designed to unleash the power of genomic data at scale and proprietary processes which enable an industrial approach to genomic sequencing.

Contact:

Laura D’Angelo
VP of Investor Relations
ir@dantelabs.com
+39 0862 191 0671
www.dantelabs.com

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its Prospectus filed on October 12, 2021 and amended on October 25, 2021 and November 1, 2021 as well as the Prospectus filed on January 21, 2022. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.

Chinook Therapeutics Presents Updated Data from BION-1301 Phase 1/2 Trial in Patients with IgA Nephropathy (IgAN) and from Atrasentan Preclinical Mechanism of Action Studies at the 59th European Renal Association (ERA) Congress 2022

Chinook Therapeutics Presents Updated Data from BION-1301 Phase 1/2 Trial in Patients with IgA Nephropathy (IgAN) and from Atrasentan Preclinical Mechanism of Action Studies at the 59th European Renal Association (ERA) Congress 2022




Chinook Therapeutics Presents Updated Data from BION-1301 Phase 1/2 Trial in Patients with IgA Nephropathy (IgAN) and from Atrasentan Preclinical Mechanism of Action Studies at the 59th European Renal Association (ERA) Congress 2022

  • All patients with IgAN in Cohort 1 have transitioned to subcutaneous (SC) dosing, and BION-1301 remains well-tolerated, with no serious adverse events (SAEs) and no treatment discontinuations due to adverse events (AEs)
  • BION-1301 continues to demonstrate rapid and sustained reductions in mechanistic biomarkers in patients with IgAN, including free APRIL, IgA and Gd-IgA1 levels
  • BION-1301 demonstrated ~50% proteinuria reduction in patients with IgAN after three to six months of treatment, with ~70% reductions observed in six patients at one year and in two patients at 1.5 years of treatment
  • Preclinical mechanistic data was presented, describing atrasentan’s effect to block mesangial cell injury and the pathogenic transcriptional networks driving IgAN progression in a model system
  • Chinook to host investor conference call and webcast on Friday, May 20th at 4:15 pm EDT with Dr. Muh Geot Wong, associate professor of nephrology at Concord Repatriation General Hospital at University of Sydney and Dr. Jonathan Barratt, Mayer Professor of Renal Medicine at University of Leicester

SEATTLE, May 18, 2022 (GLOBE NEWSWIRE) — Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, today announced three mini-oral presentations on the BION-1301 and atrasentan clinical programs at the 59th ERA Congress 2022 being held virtually and live in Paris, France.

“The additional data we presented today at ERA from the ongoing phase 1/2 study of BION-1301 further demonstrates its disease-modifying potential in IgAN by generating durable reductions in mechanistic biomarkers and corresponding impressive proteinuria reductions within three months of initiating treatment,” said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. “IgAN is a serious progressive disease for which there are limited treatment options, and the data from this trial will inform the design of a phase 3 trial of BION-1301 for patients with IgAN that we plan to initiate in 2023.”

MO212 – Updated Interim Results of a Phase 1/2 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Activity of BION-1301 in Patients with IgA Nephropathy

BION-1301 is a novel anti-APRIL monoclonal antibody currently in phase 1/2 clinical development for patients with IgAN. Blocking APRIL is a potentially disease-modifying approach to treating IgAN by reducing circulating levels of galactose-deficient IgA1 (Gd-IgA1).

Additional data was presented from Cohort 1 in Part 3 of the ongoing phase 1/2 multi-center trial (see www.clinicaltrials.gov, identifier NCT03945318) evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and initial clinical responses of open-label BION-1301 treatment in patients with IgAN. Patients in Cohort 1 initially received an intravenous (IV) dose of 450 mg of BION-1301 every two weeks. After at least 24 weeks of IV dosing, all Cohort 1 patients transitioned to SC therapy at 600 mg every two weeks for up to a total treatment duration of two years.

Key highlights from the mini oral presentation include the following:

  • Median baseline 24-hour urine protein excretion for the patients enrolled in Cohort 1 was 1.22 g/day, with a range of 0.74 – 6.47 g/day, representing a population of patients with IgAN at high risk of kidney disease progression.
  • All eight patients currently on trial have transitioned to SC administration with a mean SC treatment duration of 22 weeks (range five to 28 weeks).
  • As of the May 6, 2022 data cutoff, BION-1301 has been well-tolerated, with no serious adverse events or treatment discontinuations due to adverse events.
    • Three patients experienced mild (grade 1) treatment-related AEs, including one injection site reaction.
    • Four patients experienced mild (grade 1) infections, considered not related to treatment.
    • To date, no anti-drug antibodies have been observed in patients.
  • BION-1301 durably reduced serum IgA and IgM levels, and to a lesser extent, IgG levels in all patients.
    • BION-1301 demonstrated mean IgA and IgM reductions at steady-state of greater than 65%, while mean IgG levels were reduced by only 30-40%.
    • In one patient, IgG level fell below the study-defined threshold, necessitating protocol-mandated withholding of BION-1301. There have been no infections reported in this patient. The protocol did not include entry criteria for minimum IgG levels.
  • BION-1301 treatment resulted in steady-state reductions in Gd-IgA1 in the range of 70-80%, demonstrating depletion of the pathogenic IgA variant, and establishing the potentially disease-modifying mechanism of BION-1301 by directly targeting Hit 1 in the multi-hit pathogenesis of IgAN.
  • BION-1301 demonstrated a 48.8% geometric mean reduction in 24-hour urine protein creatinine ratio (UPCR) in all eight patients at six months of treatment, a 70.9% geometric mean reduction in 24-hour UPCR in six patients at one year of treatment and a 69.1% geometric mean reduction in 24-hour UPCR in two patients at 1.5 years of treatment (see figure below).

Cohort 2 in Part 3 of this study is currently enrolling additional patients with IgAN who are receiving a SC dose of 600 mg of BION-1301 every two weeks. Initial data from Cohort 2 is expected in the second half of 2022. Part 3 also includes the option for a third cohort of patients to receive a SC dose of BION-1301 at a dose and schedule to be determined based on data from Cohorts 1 and 2. Data generated from this phase 1/2 study will inform the design of a phase 3 trial of BION-1301 for patients with IgAN that Chinook plans to initiate in 2023.

BION-1301 treatment results in proteinuria reductions within 3 months, which are sustained and continue to decline through one year in patients with IgAN across a range of disease severity

MO264 – Selective Endothelin A Receptor Antagonist Atrasentan Attenuates Mesangial Cell Injury, Proteinuria and Intra-Renal Proliferative, Inflammatory and Fibrotic Transcriptional Networks in a Rat Model of Mesangioproliferative Glomerulonephritis (MPGN)

Mesangial cell activation is considered the initiating intra-renal event in the pathogenesis of IgAN and occurs in response to the deposition of pathogenic Gd-IgA1-containing immune complexes. Mesangial cell activation is characterized by increased cellular proliferation and overproduction of inflammatory cytokines and chemokines as well as extracellular matrix. This activation results in cellular crosstalk that leads to podocyte injury and proteinuria and ultimately to tubulointerstitial inflammation and fibrosis, resulting in kidney function loss. To assess the role of the endothelin A (ETA) receptor in mesangial cell activation, subsequent proteinuria and the transcriptional networks that drive disease progression, the effect of atrasentan was investigated in a rat model of mesangioproliferative glomerulonephritis (MPGN) as a surrogate for IgAN.

Induction of MPGN in rats was characterized by glomerular and tubulointerstitial injury histologically, marked proteinuria, and a transcriptional down‑regulation of metabolism gene networks and up-regulation of networks associated with proliferation, inflammation and fibrosis, consistent with the hallmark genesets dysregulated in the glomeruli of IgAN patients. Atrasentan treatment attenuated the mesangial cell response, glomerular injury and secondary tubulointerstitial injury observed histologically, and prevented proteinuria. Atrasentan down-regulated intra-renal proliferative, inflammatory and fibrotic transcriptional networks and restored metabolism networks, reversing hallmark gene set enrichments that are also observed in the glomerular transcriptome of IgAN patients. This study suggests an important role of the ETA receptor in mesangial cell activation, subsequent proteinuria and activation of pathogenic proliferative, inflammatory and fibrotic intra-renal transcriptional networks in MPGN. This further supports the therapeutic potential of atrasentan, a selective ETA receptor antagonist, to attenuate mesangial cell activation, proteinuria and pathogenic intra-renal signaling in MPGNs such as IgAN.

MO207 – A Phase 1/2, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults with IgA Nephropathy

A trial-in-progress overview for the ongoing phase 1/2 study of BION-1301 was delivered as a mini-oral presentation at the 59th ERA Congress 2022.

All three presentations can be found in the Scientific Publications section of Chinook’s website.

Live Conference Call and Webcast
Chinook will host a live conference call and webcast on Friday, May 20, 2022 at 4:15 pm EDT to discuss the presentations at the 59th ERA Congress 2022 and provide program updates. Members of the Chinook executive team will be joined by Dr. Muh Geot Wong, associate professor of nephrology at Concord Repatriation General Hospital at University of Sydney in Sydney, Australia and Dr. Jonathan Barratt, Mayer Professor of Renal Medicine at University of Leicester in Leicester, UK.

Conference Call and Webcast Details
To access the call, please dial (844) 309-0604 (domestic) or (574) 990-9932 (international) and provide the Conference ID 9428716 to the operator.

To access the live webcast and subsequent archived recording of this and other company presentations, please visit the Investors section of Chinook’s website. The archived webcast will remain available for replay on Chinook’s website for 90 days.

About Chinook Therapeutics, Inc.
Chinook Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing precision medicines for kidney diseases. Chinook’s product candidates are being investigated in rare, severe chronic kidney disorders with opportunities for well-defined clinical pathways. Chinook’s lead program is atrasentan, a phase 3 endothelin receptor antagonist for the treatment of IgA nephropathy and other proteinuric glomerular diseases. BION-1301, an anti-APRIL monoclonal antibody is being evaluated in a phase 1/2 trial for IgA nephropathy. CHK-336, an oral small molecule LDHA inhibitor for the treatment of hyperoxalurias, is being evaluated in a phase 1 healthy volunteer trial. In addition, Chinook is advancing research programs for other rare, severe chronic kidney diseases. Chinook is building its pipeline by leveraging insights in kidney single cell RNA sequencing, human-derived organoids and new translational models, to discover and develop therapeutics with differentiating mechanisms of action against key kidney disease pathways. To learn more, visit www.chinooktx.com.

Cautionary Note on Forward-Looking Statements
Certain of the statements made in this press release are forward looking, including those relating to Chinook’s business, future operations, advancement of its product candidates and product pipeline, clinical development of its product candidates, including expectations regarding timing of results of clinical trials and the readthrough to topline data. In some cases, you can identify these statements by forward-looking words such as “may,” “will,” “continue,” “anticipate,” “intend,” “could,” “project,” “expect” or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, including initiation of clinical trials of our existing product candidates or those developed as part of the Evotec collaboration, whether results of early clinical trials, such as those described above for BION-1301, or preclinical studies will be indicative of the results of future trials, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that may be more advanced or have greater resources than we do, our ability to obtain and adequately protect intellectual property rights for our product candidates and the effects of COVID-19 on our clinical programs and business operations. Many of these risks are described in greater detail in our filings with the SEC. Any forward-looking statements in this press release speak only as of the date of this press release. Chinook assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

A graphic accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d22e4a92-4941-4d36-be8b-a0d62dc557e7

CONTACT: Contact:
Noopur Liffick
Vice President, Investor Relations & Corporate Communications
investors@chinooktx.com
media@chinooktx.com

ObsEva Announces Appointment of Annette Clancy as Chair of the Board of Directors

ObsEva Announces Appointment of Annette Clancy as Chair of the Board of Directors




ObsEva Announces Appointment of Annette Clancy as Chair of the Board of Directors

GENEVA, Switzerland May 19, 2022 – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies for women’s health, today announced the appointment of Annette Clancy as Chair of the Board of Directors at the Company’s Annual General Meeting on May 18, 2022. Ms. Clancy has served as a member of ObsEva’s Board of Directors since 2013 and was previously Chair from November 2013 to December 2016. Ms. Clancy succeeds Dr. Frank Verwiel, who had decided to step down from the role of Chair and retire from the Board of Directors, effective following the conclusion of the Annual General Meeting.

“We could not be more pleased, or fortunate, to have Annette return to the Chair position as we prepare for our first approvals and transition to a commercial stage company,” said Brian O’Callaghan, CEO of ObsEva. “Annette’s contributions to ObsEva are undisputed and her distinguished career spanning research and development, commercialization, and business development constitute the ideal skill set to position ObsEva for success in this next stage of growth. I would also like to sincerely thank Frank for his years of Board contribution. The tremendous progress across the pipeline, which positions ObsEva for upcoming milestones, is a testament to Frank’s Board leadership. We wish him success in his future pursuits.”

Ms. Clancy has over 30 years’ experience in the pharmaceutical industry, including fifteen years in business development at GlaxoSmithKline (GSK) where she was most recently Head of Transactions and Alliance Management, responsible for innovative deals ranging from early drug discovery partnerships to global commercial alliances, and mergers and acquisitions. Since her retirement from GSK in 2008, Ms. Clancy has advised venture capital health groups in the United States and Europe, namely as an Operational Investor for Jeito Capital and previously a Senior Advisor to Frazier Healthcare Ventures. Ms. Clancy has extensive Board experience and in addition to her role with ObsEva, she is Chair of the privately held French company, Enyo SA, and a non-Executive Director of the Swedish public company, Sobi. Prior to Ms. Clancy’s time in business development, she held a number of positions in clinical research, research and development project management, and commercialization. Ms. Clancy holds a BSc (Hons) Pharmacology from Bath University (UK) and a series of American Management Association diplomas (finance/marketing).

Ms. Clancy commented, “I’m honored to be reprising the role of Chair at ObsEva at this pivotal time and building on the momentum created by Frank and the executive team as ObsEva prepares for commercial launch. My dedication to ObsEva and conviction in its prospects is long-standing, and I am excited to be presiding over this potentially transformational period as we pursue our first approvals and seek to change the treatment paradigm for women with uterine fibroids and other underserved conditions.”

Dr. Verwiel commented, “It is a privilege to have been part of the exceptional team at ObsEva over the past six years, and I take great pride in all that we have accomplished together. I look forward to following ObsEva’s continued achievement as the company nears prospective approval of linzagolix and pursues its vision of delivering life-changing therapies to address the most challenging unmet needs facing women.”

About ObsEva

ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s health. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on new therapies for the treatment of uterine fibroids, endometriosis, and preterm labor. ObsEva is listed on the Nasdaq Global Select Market and is traded under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is traded under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com.

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “anticipate”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “might”, “ongoing”, “objective”, “plan”, “potential”, “predict”, “should”, “will”, “would”, or the negative of these and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the potential approval of linzagolix by regulatory authorities, including the European Commission and the U.S. Food and Drug Administration (FDA), and the timing of such approval and subsequent transition of ObsEva to a commercial-stage company, the timing or results of interactions with regulatory authorities, clinical development of ObsEva’s product candidates, including the timing, advancement of, and potential therapeutic benefits of such product candidates, including linzagolix, the potential for linzagolix and other product candidates to be commercially competitive, the success of the Company’s partnerships with third parties, expectations regarding regulatory and development milestones and ObsEva’s ability to obtain and maintain regulatory approvals for its product candidates. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and clinical development, including the risk that the results of earlier clinical trials may not be predictive of the results of later stage clinical trials, related interactions with regulators, including interactions with the European Medicines Agency during the marketing authorization application process and with the FDA during the New Drug Application process for linzagolix, ObsEva’s reliance on third parties over which it may not always have full control, and the capabilities of such third parties, the impact of the ongoing novel coronavirus outbreak and other geopolitical events, and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2021 filed with Securities and Exchange Commission (SEC) on March 10, 2022, in the Report on Form 6-K filed with the SEC on May 17, 2022 and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at www.ObsEva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and, except as required by law, ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

For further information, please contact:

CEO Office contact
Shauna Dillon
shauna.dillon@obseva.ch
+41 22 552 1550

Investor Contact
Katja Bührer
Katja.buhrer@obseva.com

+1 (917) 969-3438

Attachment

Addex Announces Participation in the H.C. Wainwright Global Investment Conference

Addex Announces Participation in the H.C. Wainwright Global Investment Conference




Addex Announces Participation in the H.C. Wainwright Global Investment Conference

Geneva, Switzerland, May 19, 2022 Addex Therapeutics Ltd (SIX: ADXN, Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, announced today that CEO, Tim Dyer, will be virtually attending the H.C. Wainwright Global Investment Conference taking place May 23 – 26, 2022.

Mr. Dyer has also submitted a pre-recorded video presentation to the conference, in which he provides a corporate update and discusses recent developments at Addex. The presentation will be available for viewing on-demand by registered participants.

Mr. Dyer will be available for virtual one-on-one meetings throughout the conference. For more information or to schedule a one-on-one meeting with management, please contact IR@addexpharma.com.

About Addex Therapeutics:
Addex Therapeutics is a clinical-stage pharmaceutical company focused on the development and commercialization of an emerging class of novel orally available small molecule drugs known as allosteric modulators for neurological disorders. Allosteric modulators offer several potential advantages over conventional non-allosteric molecules and may offer an improved therapeutic approach to conventional “orthosteric” small molecule or biological drugs. Addex’s allosteric modulator drug discovery platform targets receptors and other proteins that are recognized as essential for therapeutic intervention. Addex’s lead drug candidate, dipraglurant (mGlu5 negative allosteric modulator or NAM), is in a pivotal registration clinical trial for Parkinson’s disease levodopa induced dyskinesia (PD-LID) and a Phase 2 clinical study is underway for the treatment of blepharospasm, a form of dystonia. Addex’s third clinical program, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with Janssen Pharmaceuticals, Inc., is in a Phase 2a proof of concept clinical trial for the treatment of epilepsy. Indivior PLC has licensed Addex’s GABAB PAM program for the development of drug candidates with a focus in substance use disorder. Preclinical programs include GABAB PAM for CMT1A, mGlu7 NAM for PTSD, mGlu2 NAM for mild neurocognitive disorders, M4 PAM for psychotic disorders, mGlu4 PAM for Parkinson’s disease and mGlu3 PAM for neurodegenerative disorders. Addex shares are listed on the SIX Swiss Exchange and American Depositary Shares representing its shares are listed on the NASDAQ Capital Market, and trade under the ticker symbol “ADXN” on each exchange.

Contacts:

Tim Dyer
Chief Executive Officer
Telephone: +41 22 884 15 55        
PR@addextherapeutics.com
Mike Sinclair
Partner, Halsin Partners
+44 (0)20 7318 2955
msinclair@halsin.com
James Carbonara
Hayden IR
(646)-755-7412
james@haydenir.com

Addex Forward Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including in respect of the progress of clinical trials and preclinical studies. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release, are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, uncertainties related to market conditions. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Addex Therapeutics’ Annual Report on Form 20-F for the year ended December 31, 2021, as filed with the SEC on March 10, 2022, the final prospectus supplement and accompanying prospectus and other filings that Addex Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release represent Addex Therapeutics’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Addex Therapeutics explicitly disclaims any obligation to update any forward-looking statements.

ObsEva SA Announces that Shareholders Approved all Board Proposals at its 2022 Annual General Meeting held on May 18, 2022

ObsEva SA Announces that Shareholders Approved all Board Proposals at its 2022 Annual General Meeting held on May 18, 2022




ObsEva SA Announces that Shareholders Approved all Board Proposals at its 2022 Annual General Meeting held on May 18, 2022

Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange

Geneva, Switzerland – May 19, 2022 – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies for women’s health, today announced that shareholders approved all Board proposals at its 2022 Annual General Meeting held on May 18, 2022.

The approved items are as follows:

  1. Shareholders approved the Annual Report, the Statutory Financial Statements and the Consolidated Financial Statements for Fiscal Year 2021
  2. Shareholders granted discharge to the Members of the Board of Directors and to the Executive Committee for year 2021
  3. Shareholders approved the proposed appropriation of the Financial Results for year 2021
  4. Shareholders approved the proposed elections to the Board of Directors and election of the Chairperson of the Board of Directors
  5. Shareholders approved the proposed elections to the Compensation Committee
  6. Shareholders approved the re-election of PricewaterhouseCoopers SA as ObsEva SA’s Auditors and Independent Registered Public Accounting Firm
  7. Shareholders approved the re-election of Perréard de Boccard SA as Independent Representative
  8. Shareholders approved the proposed compensation of the Board of Directors and the Executive Committee
  9. Shareholders approved the proposed increase of ObsEva SA’s Authorized Share Capital
  10. Shareholders approved the proposed increase of ObsEva SA’s Conditional Share Capital for Financing Purposes
  11. Shareholders approved the proposed increase of ObsEva SA’s Conditional Share Capital for Equity Plans
  12. Shareholders approved the proposed change to ObsEva SA’s Equity Incentive Plan
  13. Shareholders approved the Issuance of Conversion Shares and Warrant Shares under Securities Purchase Agreement

For a detailed agenda, including items submitted to shareholders’ vote and related proposals of the Board of Directors, please refer to the full invitation, which may be found in the Investors / General Meetings section of the company’s website www.ObsEva.com.

To access the general meetings section of the Company’s website, please click here.

To access the AGM 2022 section of the general meetings section directly, please click here.

To access the full invitation to the AGM 2022 directly, please click here.


About ObsEva
ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s health. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on new therapies for the treatment of uterine fibroids, endometriosis, and preterm labor. ObsEva is listed on the Nasdaq Global Select Market and is traded under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is traded under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com.

For further information, please contact:

CEO Office Contact:

Shauna Dillon

Shauna.dillon@obseva.ch

+41 22 552 1550

Investor Contact:

Katja Bührer

Katja.buhrer@obseva.com

+1 (917) 969-3438

Attachment

EMA Accepts Filing of Marketing Authorization Application for Valneva’s Inactivated COVID-19 Vaccine Candidate

EMA Accepts Filing of Marketing Authorization Application for Valneva’s Inactivated COVID-19 Vaccine Candidate




EMA Accepts Filing of Marketing Authorization Application for Valneva’s Inactivated COVID-19 Vaccine Candidate

Saint Herblain (France), May 19, 2022Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today confirmed that the European Medicines Agency (“EMA”) has accepted the filing of a marketing authorization application (MAA) for Valneva’s inactivated, whole-virus COVID-19 vaccine candidate, VLA2001. Acceptance of the MAA means VLA2001 is advancing from the rolling review process and beginning the formal review process by the EMA’s Committee for Human Medicinal Products (CHMP). If the CHMP accepts Valneva’s conditional marketing authorization application, the Company confirms it would expect to receive a positive CHMP opinion in June 2022.

If positive opinion is given by the CHMP, the European Commission (EC) will review the recommendation and provide a final decision on the MAA. If granted by the EC, the centralized marketing authorization would be valid in all European Union Member States as well as in Iceland, Liechtenstein, and Norway.

Thomas Lingelbach, Chief Executive Officer of Valneva, commented, “The EMA’s acceptance of the filing for VLA2001 is an important step toward product approval. We remain fully committed and dedicated to working jointly with the regulators, the European members states and the European Commission toward making a more traditional and established COVID-19 vaccine technology available to people in Europe.”

About VLA2001
VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. It is intended for active immunization of at-risk populations to prevent carriage and symptomatic infection with COVID-19 during the pandemic and for routine vaccination including addressing new variants. VLA2001 may also be suited for boosting, as repeat booster vaccinations have been shown to work well with whole virus inactivated vaccines. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the immune response towards Th1. CpG 1018 adjuvant, supplied by Dynavax Technologies Corporation (Nasdaq: DVAX), is a component of the US FDA- and EMA-approved HEPLISAV-B® vaccine. VLA2001’s manufacturing process, which has already been upscaled to final industrial scale, includes chemical inactivation to preserve the native structure of the S-protein. VLA2001 is expected to conform with standard cold chain requirements (2 to 8 degrees Celsius).

About Valneva SE
Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. The Company takes a highly specialized and targeted approach to vaccine development and then applies its deep understanding of vaccine science to develop prophylactic vaccines addressing these diseases. Valneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

Media & Investor Contacts
Laëtitia Bachelot-Fontaine
VP Global Communications & European Investor Relations
M +33 (0)6 4516 7099
laetitia.bachelot-fontaine@valneva.com        
 

Joshua Drumm, Ph.D.
VP Global Investor Relations
M +001 917 815 4520
joshua.drumm@valneva.com

Forward-Looking Statements
This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, design, data read-outs, anticipated results and completion of clinical trials of VLA2001 and with respect to possible regulatory approval of VLA2001. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of future results. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, the ability to obtain or maintain patent or other proprietary intellectual property protection and the impact of the COVID-19 pandemic. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in this press release as of the date hereof and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Attachment

IBA Business Update – First Quarter 2022

IBA Business Update – First Quarter 2022




IBA Business Update – First Quarter 2022

Louvain-La-Neuve, Belgium, 19 May 2022 – IBA (Ion Beam Applications S.A., EURONEXT), the world leader in particle accelerator technology, today announces its business update for the first quarter ending 31 March 2022.

Group Overview

  • Strong balance sheet maintained with EUR 113 million net cash position 
  • Business operations continue to be solid, with good performance across all business units
  • Backlog remains high at EUR 1.2 billion and new tenders continue to progress internationally with active discussions ongoing
  • Solid order intake with one Proteus®ONE1 and three Other Accelerators systems sold in the period with nine additional Other Accelerators systems sold and the first proton therapy order received from CGN Medical Technologies post-period end
  • Expansion of Dosimetry offering with the acquisition of quality assurance (QA) company, Modus Medical Devices, post-period end  

Olivier Legrain, Chief Executive Officer of IBA commented: “IBA’s strong performance has continued into the first quarter of 2022, with good momentum across all business lines on an international scale. Against the backdrop of ongoing global economic and geopolitical challenges, our active pipeline, increasing recurring revenue stream and excellent balance sheet ensure that we are in a robust position to weather any uncertainty.”

Proton Therapy

  • 23 projects ongoing, with eight Proteus®PLUS2 and 15 Proteus®ONE systems in progress
  • Strong pipeline continues across all geographies
  • One new service contract in the quarter and a further post-period, with a total of 41 service contracts now generating recurring revenues globally
  • One Proteus®ONE proton therapy solution contract signed
  • Partnership with global engineering company, Tractebel, to support IBA’s customers with proton therapy design and construction projects
  • Post-period end, IBA received its first order from CGN Medical Technologies for a Proteus®PLUS proton therapy system to be installed in Yangzhou, China
  • Research collaboration with University Medical Center Groningen (UMCG) for the development of a new FLASH irradiation protocol for the treatment of early-stage breast cancer
  • Ongoing expansion of Campus, the world’s first online proton therapy platform

Other Accelerators (RadioPharma, Industrial)

  • Other Accelerators continued to perform strongly in the first quarter with three systems sold in the period and an additional nine sold post-period end
  • Launch of a new low energy compact cyclotron, the Cyclone® KEY, improving access to diagnosis solutions in emerging market countries with in-house isotope production in hospitals
  • Increasing demand for Rhodotron® for medical sterilization, with this part of the business performing particularly well

Dosimetry

  • Very strong order intake with backlog remaining at a record high
  • Collaborative agreement with Elekta to optimize quality assurance (QA) solutions of radiation therapy departments and clinics using Elekta’s treatment delivery systems
  • Acquisition of Modus Medical Devices, specializing in phantoms for QA for radiation therapy, expanding the business unit’s service offering

Outlook
IBA has continued to perform well across all business lines in the first quarter of 2022. Our pipeline remains highly active, particularly in the US and Asia, and, coupled with our growing recurring revenue stream, provides significant visibility on future sales. Alongside this, our balance sheet remains very strong, giving us optionality to support long-term growth.

We have seen a modest impact from the ongoing conflict in Ukraine and its effect on the global supply chain and transportation. Although it is difficult to predict the impact of the conflict on IBA’s performance for the rest of the year, the associated disruptions and delays are currently manageable and we continue to work to monitor and mitigate our risks.

Financial calendar
Half year Results                                                       31 August 2022
Business Update Q3 2022                                        17 November 2022

About IBA
IBA (Ion Beam Applications S.A.) is the world leader in particle accelerator technology. The company is the leading supplier of equipment and services in the field of proton therapy, considered to be the most advanced form of radiation therapy available today. IBA is also a leading player in the fields of industrial sterilization, radiopharmaceuticals and dosimetry. The company, based in Louvain-la-Neuve, Belgium, employs approximately 1,600 people worldwide. IBA is a certified B Corporation (B Corp) meeting the highest standards of verified social and environmental performance.

IBA is listed on the pan-European stock exchange EURONEXT (IBA: Reuters IBAB.BR and Bloomberg IBAB.BB).

More information can be found at: www.iba-worldwide.com

For further information, please contact:

IBA
Soumya Chandramouli
Chief Financial Officer
+32 10 475 890
Investorrelations@iba-group.com

Olivier Lechien
Corporate Communication Director
+32 10 475 890
communication@iba-group.com

For media and investor enquiries:
Consilium Strategic Communications
Amber Fennell, Angela Gray, Lucy Featherstone
+44 (0) 20 3709 5700
IBA@consilium-comms.com


1 Proteus®ONE is a brand name of Proteus®235

2 Proteus®PLUS is a brand name of Proteus®235

Attachment

Premier Health Reports FY2022 Second Quarter Results

Premier Health Reports FY2022 Second Quarter Results




Premier Health Reports FY2022 Second Quarter Results

MONTRÉAL, May 18, 2022 (GLOBE NEWSWIRE) — Premier Health of America Inc. (TSXV: PHA) (the “Corporation”), a leading Canadian Healthtech company, announces it has filed its Condensed Interim Consolidated Financial Statements and Management Discussion and Analysis for its second quarter ended March 31, 2022.

Summary

  • The Corporation had revenues of $17.6M for the 3-month period compared to $17.0M for the same period in FY2021, representing a 3.4% increase mainly attributable to organic growth over the period.
  • The 24.7% gross margin for the quarter was close to the Corporation’s 25% target.
  • EBITDA(1) for the quarter was $0.5M compared to $1.6M for the same period in FY2021.
  • Net income was -$0.8M compared to $0.3M for the same period in FY2021.

“We invested in our capacity to manage a wider geographical footprint” Said Martin Legault, CEO of Premier Health. “We believe these investments made upstream of contemplated acquisitions will facilitate integration and leverage operations in other provinces.”

Second Quarter 2022 Results Highlights

  March 31, 2022
(3 months)
March 31, 2021
(3 months)
March 31, 2022
(6 months)
March 31, 2021
(6 months)
Revenues $17,583,869   $17,003,358 $35,999,588   $30,363,667
From last period +3.4%     +18.6%    
Gross margin $4,335,299   $4,110,981 $8,755,848   $7,348,473
From last period +5.5%     +19.2%    
EBITDA (1) $466,798   $1,582,256 $1,952,448   $2,900,975
From last period 70.5%     -32.7%    
Net Income -$770,594   $338,508 -$459,305   $772,452
  -327.6%     -159.5%    

(1) Adjusted EBITDA before non-recurring items

Business Highlights

  • The Corporation provided 227,748 hours of services during the quarter.
  • Revenues were slightly below budget due to Omicron variant related absenteeism and a variation in Premier Soin’s unit business mix.
  • EBITDA was impacted by an increase in administrative expenses including an increase in management and technology expenses, higher than expected transport division maintenance costs, and acquisition expenses related to Canadian Health Care Agency.
  • The Corporation completed the acquisition of Canadian Health Care Agency on April 19 which is expected to add approximately $24M in annual turnover going forward.

Healthcare workforce solutions

During the second quarter, our Premier Soin business unit experienced a revenue contraction of 8% while Code Bleu’s business unit revenue remained stable. The two subsidiaries offer similar services across the province of Quebec with different pricing strategy and resource profiles that sometimes lead to positive or negative revenue generation discrepancies. The decrease in revenue at Premier Soin was mainly caused by a lower demand for longer term replacement periods and a higher demand for short-term daily shifts. This business mix often results in a higher turnover rate and, by extension, a higher risk of not being able to fulfill every request for resources on short notice due to personnel availability. We believe this temporary impact is related to an adjustment period in the receding pandemic. We already experienced a shift from this situation in April but still expect a certain level of volatility in the near future. The Nordik business unit continued its organic growth steadily during the quarter with an increased deployment of resources in Northern Ontario, Northern Quebec, and James Bay. During the quarter, Premier Soin Nordik signed contractual arrangements with 6 additional hospitals. This follows the five contracts that were signed earlier in the first quarter in Northern Ontario.

Non-ambulatory transport services

The Corporation is still experimenting supply chain issues, which resulted in new vehicle deliveries being further postponed. The first 3 new transport units which delivery was postponed to March 2022 are now scheduled to be delivered only at the end of the third quarter. This resulted in higher-than-expected maintenance costs that are impacting EBTDA margins and net income.

About Premier Health

Premier Health is a leading Canadian Healthtech company that provides a comprehensive range of outsourced services solutions for healthcare needs to governments, corporations, and individuals. Premier Health uses its proprietary PSweb platform to lead the healthcare services sector digital transformation to provide patients with faster, cheaper and more accessible care services.

Non-GAAP Measures

Earnings before interest, taxes, depreciation and amortization (“EBITDA”), is calculated as the net profit (loss), before non-recurring items excluding acquisition and transaction costs, non-cash expenses (including loss from disposal of assets, impairments, amortization and depreciation), interest expense, net of interest income and income tax expense.

For Further Information Please Contact:

Mr. Jean-Robert Pronovost
Vice-President, Corporate Development
Premier Health of America Inc.
jrpronovost@premierhealth.ca / 1 800 231 9916

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION:

This press release contains forward-looking information based on current expectations. Statements about the date of trading of the Corporation’s common shares on the Exchange and final regulatory approvals, among others, are forward-looking information. These statements should not be read as guarantees of future performance or results. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. The Corporation assumes no responsibility to update or revise forward-looking information to reflect new events or circumstances unless required by law. These factors and others are more fully discussed in the filings of the Corporation with Canadian securities regulatory authorities available at www.sedar.com.