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Bombardier Closes Sale of its Transportation business to Alstom

  • Net proceeds to Bombardier of ~$3.6 billion, including ~$600 million in Alstom shares
  • Proceeds strengthen liquidity and will allow the Company to begin debt paydown1; Pro-forma net debt as of December 31, 2020 ~$4.7 billion2 
  • Completes Bombardier’s repositioning as a pure-play business jet company

All amounts in this press release are in U.S. dollars unless otherwise indicated. Amounts in EUR in this press release are converted to USD at an exchange rate of 1.22, except for certain transaction cash proceeds fixed at an exchange rate of 1.17.

MONTREAL, Jan. 29, 2021 (GLOBE NEWSWIRE) — Bombardier (TSX: BBD.B) confirmed today the closing of the previously announced sale of its Transportation business to Alstom.

Total proceeds to the vendors after the deduction of debt-like items and transferred liabilities are $6.0 billion3. After deducting la Caisse de dépôt et placement du Québec equity position of $2.5 billion, transaction costs, and including the impact from closing adjustments and obligations related to achieving a minimum cash balance at Bombardier Transportation at the end of 2020, Bombardier expects net proceeds of approximately $3.6 billion. This amount includes $488 million of cash from the redemption of equity and a $125 million loan reimbursement by Transportation4, settled in conjunction with the transaction closing. Net proceeds also include approximately $600 million of Alstom shares (€500 million representing 11.5 million shares for a fixed subscription price of €43.465 per share), monetizable starting in late April 2021.

“With this transaction now complete, Bombardier begins an exciting new chapter focused exclusively on designing, building and servicing the world’s best business jets,” said Éric Martel, President and Chief Executive Officer, Bombardier Inc. “With an unmatched product portfolio, a world class customer services network and incredibly talented employees, we have a strong foundation to build upon as we use the proceeds from the transaction to begin addressing our balance sheet challenges through debt paydown.”

Proceeds from the transaction were lower than previous estimates as a result of Transportation’s lower than expected cash generation in the fourth quarter due in part to unfavorable market conditions, as well as disagreements between the parties as to certain adjustments which Bombardier intends to challenge.

Pro-forma net debt2 is approximately $4.7 billion, which includes long-term debt of $10.1 billion, net of $1.8 billion cash on hand at Bombardier Inc. (excluding Transportation) as of December 31, 2020, and the approximately $3.6 billion proceeds from the Transportation sale. The Company intends to deploy available proceeds from the sale of Transportation towards debt paydown and continues to evaluate the most efficient debt reduction strategies.

About Bombardier
Bombardier is a global leader in aviation, creating innovative and game-changing planes. Our products and services provide world-class experiences that set new standards in passenger comfort, energy efficiency, reliability and safety.

Headquartered in Montréal, Canada, Bombardier is present in more than 12 countries including its production/engineering sites and its customer support network. The Corporation supports a worldwide fleet of approximately 4,900 aircraft in-service with a wide variety of multinational corporations, charter and fractional ownership providers, governments and private individuals.

News and information is available at bombardier.com or follow us on Twitter @bombardierjets.

Bombardier is a trademark of Bombardier Inc. and its subsidiaries.

For Information
Jessica McDonald Patrick Ghoche
Advisor, Media Relations Vice President, Corporate Strategy and
and Public Affairs Investor Relations
Bombardier Inc. Bombardier Inc.
+1 514 861 9481 +1 514 861 5727
jessica.mcdonald@bombardier.com

1. See the forward-looking statements disclaimer at the end of this press release.
2. Non-GAAP financial measure. Pro-forma net debt is defined as Long-term debt of $10.1 billion less cash and cash equivalents at Bombardier Inc. (excluding Transportation) of $1.8 billion as of December 31, 2020 less net proceeds of approximately $3.6 billion from the sale of Bombardier Transportation, which includes approximately $600 million of Alstom shares. Non-GAAP financial measures are mainly derived from the consolidated financial statements but do not have standardized meanings prescribed by IFRS. The exclusion of certain items from non-GAAP performance measures does not imply that these items are necessarily non-recurring. Other entities in our industry may define the above measures differently than we do. In those cases, it may be difficult to compare the performance of those entities to ours based on these similarly-named non-GAAP measures.
3. Includes the amount paid by Alstom to redeem Bombardier and CDPQ’s capital injections of €400 million ($488 million) and €350 million ($427 million), respectively, in BT Holdco made in 2020 to support working capital.
4. Represents the redemption by Alstom of Bombardier’s share of the capital injection made in BT Holdco in 2020 amounting to €400 million ($488 million) and the pre-closing reimbursement by BT Holdco of the intercompany subordinated loan of €103 million ($125 million) made by Bombardier in 2019.
5. Because shares were issued by Alstom following the execution of the SPA, Bombardier’s share subscription price was adjusted from €47.50 per share to €43.46 per share in accordance with the previously agreed upon anti-dilution adjustment mechanism.

FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements, which may involve, but are not limited to: statements with respect to our objectives, anticipations and outlook or guidance in respect of various financial and global metrics and sources of contribution thereto, targets, goals, priorities, market and strategies, financial position, market position, capabilities, competitive strengths, credit ratings, beliefs, prospects, plans, expectations, anticipations, estimates and intentions; general economic and business outlook, prospects and trends of an industry; expected demand for products and services; growth strategy; product development, including projected design, characteristics, capacity or performance; expected or scheduled entry-into-service of products and services, orders, deliveries, testing, lead times, certifications and project execution in general; competitive position; expectations regarding revenue and backlog mix; the expected impact of the legislative and regulatory environment and legal proceedings; strength of capital profile and balance sheet, creditworthiness, available liquidities and capital resources and expected financial requirements; productivity enhancements, operational efficiencies and restructuring initiatives; expectations and objectives regarding debt repayments and refinancing of bank facilities and maturities; expectations regarding availability of government assistance programs, compliance with restrictive debt covenants; expectations regarding the declaration and payment of dividends on our preferred shares; intentions and objectives for our programs, assets and operations;  and the impact of the COVID-19 pandemic on the foregoing and the effectiveness of plans and measures we have implemented in response thereto. As it relates to the transaction discussed herein, this press release contains forward-looking statements with respect to the use of the proceeds from the sale of the Transportation business, the evaluation of debt reduction strategies and our intentions with respect to challenging the determination of proceeds.

Forward-looking statements can generally be identified by the use of forward-looking terminology such as “may”, “will”, “shall”, “can”, “expect”, “estimate”, “intend”, “anticipate”, “plan”, “foresee”, “believe”, “continue”, “maintain” or “align”, the negative of these terms, variations of them or similar terminology. Forward-looking statements are presented for the purpose of assisting investors and others in understanding certain key elements of our current objectives, strategic priorities, expectations, outlook and plans, and in obtaining a better understanding of our business and anticipated operating environment. Readers are cautioned that such information may not be appropriate for other purposes.

By their nature, forward-looking statements require management to make assumptions and are subject to important known and unknown risks and uncertainties, which may cause our actual results in future periods to differ materially from forecast results set forth in forward-looking statements. While management considers these assumptions to be reasonable and appropriate based on information currently available, there is risk that they may not be accurate. The assumptions underlying the forward-looking statements made in this press release in relation to the transaction discussed herein include the following material assumptions: the realization of the intended benefits therefrom (including intended use of proceeds) within the anticipated timeframe; our ability to retain key management and employees following completion of the transaction; our ability to satisfy our liabilities and meet our financial covenants and debt service obligations following completion of the transaction; our ability to access the capital markets as needed following completion of the transaction; and fulfillment by the other parties of their respective obligations, commitments and undertakings pursuant to transaction documentation. For additional information, including with respect to the other assumptions underlying the forward-looking statements made in this press release, refer to the assumptions below the Forward-looking statements in the MD&A of our financial report for the three-and nine-month periods ended September 30, 2020 and the Strategic Priorities and Guidance and forward-looking statements sections in the applicable reportable segment in the MD&A of our financial report for the fiscal year ended December 31, 2019. Given the impact of the changing circumstances surrounding the COVID-19 pandemic and the related response from Bombardier, governments (federal, provincial and municipal), regulatory authorities, businesses and customers, there is inherently more uncertainty associated with our assumptions as compared to prior periods.

With respect to the transaction discussed herein specifically, certain factors that could cause actual results to differ materially from those anticipated in the forward-looking statements include, but are not limited to: uncertainty regarding all or part of the intended benefits therefrom not being realized, or it is determined, necessary or required to direct all or part of the anticipated proceeds therefrom towards other uses than those identified in this press release the failure by the parties to fulfill their obligations, commitments and undertakings pursuant to transaction documentation; Bombardier being unable to satisfy its liabilities and meet its financial covenants and debt service obligations following completion of the transaction; the failure to retain our key management, personnel and clients following completion of the transaction and risks associated with the loss and replacement of key management and personnel; and the impact of the announcement of the transaction on our relationships with third parties, including potentially resulting in the loss of clients, employees, suppliers, business partners or other benefits and goodwill of the business.

Readers are cautioned that the foregoing list of factors that may affect the transaction discussed herein, future growth, results and performance is not exhaustive and undue reliance should not be placed on forward-looking statements. For more details, see the Risks and uncertainties sections in Other in the MD&A for the three- and nine- month period ended September 30, 2020 and in the MD&A of our financial report for the fiscal year ended December 31, 2019. Other risks and uncertainties not presently known to us or that we presently believe are not material could also cause actual results or events to differ materially from those expressed or implied in our forward-looking statements. The forward-looking statements set forth herein reflect management’s expectations as at the date of this press release and are subject to change after such date. Unless otherwise required by applicable securities laws, we expressly disclaim any intention, and assume no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. The forward-looking statements contained in this press release are expressly qualified by this cautionary statement.

January 30th to Mark the Second Annual World NTD Day

World NTD Day

A commitment to future generations. Three young girls in Sankura, Ethiopia, an area impacted by NTDs. Photo courtesy of Reaching the Last Mile.

  • Annual day designed to raise awareness and engage the general public in the urgent effort to #BeatNTDs
  • Following a year of unprecedented global health awareness due to the COVID-19 pandemic, the day aims to draw broader public awareness to the fight to end NTDs
  • The WHO Executive Board recommended support of World NTD Day, an important milestone in adding the day to the official global calendar
  • Inspired by the new WHO NTD Roadmap, the day will emphasize the critical need for partnerships and cross-industry collaboration to bring an end to this group of preventable diseases
  • More than 300 partner organizations from 55 countries to participate, helping to mobilize greater attention, action, and investment on priority issues in the countries and communities most directly affected by neglected tropical diseases (NTDs)
  • Building on the spirit of global collective action, more than 60 landmarks across 40 cities and 24 countries will be lit up on World NTD Day

ABU DHABI, United Arab Emirates, Jan. 29, 2021 (GLOBE NEWSWIRE) — On January 30th, global civil society advocates, community leaders, global health experts, and policymakers will unite to mark the second annual World NTD Day.

Created to galvanize the global health community and engage the general public in the urgent effort to end neglected tropical diseases, World NTD Day will bring together more than 300 partner organizations from 55 countries working across the diverse global health landscape to end NTDs.

The UAE has spearheaded diplomatic efforts to obtain official recognition of the day by The World Health Organization and has played a lead role in galvanizing partners and supporting the day. These efforts continue the UAE’s history and leadership in global disease elimination and are part of Reaching the Last Mile, portfolio of global health programs working towards disease elimination that is driven by the personal commitment of His Highness Sheikh Mohamed bin Zayed, Crown Prince of Abu Dhabi.

Thoko Pooley, Executive Director of Uniting to Combat NTDs, said: “2021 marks a crucial moment for the fight against NTDs. We are starting this decade of action motivated to deliver real change for the 1.7 billion people affected by neglected tropical diseases. It is a gross injustice that over a billion people continue to be affected by diseases we can prevent or treat. The World Health Organization’s new NTD Roadmap is a rallying cry that tells us that not only is beating NTDs possible, it’s possible within a decade.”

“COVID-19 has placed a huge strain on global health systems, but we refuse to let it beat us down. NTD programmes have already proven that they can adapt quickly, ensuring life-saving messages and treatments reaches the hardest to reach populations on our planet. We know that by protecting some of the most vulnerable communities from NTDs, we’re making the whole world more resilient to future pandemics.

“Uniting to Combat NTDs applauds His Highness Sheikh Mohamed bin Zayed, Crown Prince of Abu Dhabi, for his personal commitment to ending the neglect of neglected tropical diseases this World NTD Day.”

The critical need to end neglected tropical diseases (NTDs)
NTDs affect more than 1.7 billion people – often those living in extreme poverty, in remote communities, and without access to basic needs like clean water – and cost developing economies billions of dollars every year. Significant progress has been made since the landmark 2012 London Declaration on NTDs, which unified partners across sectors, countries and disease communities to push for greater investment and action on NTDs. Today, hundreds of millions of people no longer require treatment for NTDs and several countries have eliminated diseases that had been prevalent for thousands of years.

But despite this progress, challenges remain with one out of every five people in the world impacted by these preventable diseases. NTDs are responsible for thousands of preventable deaths each year and cause impairments that perpetuate the cycle of poverty by keeping millions of adults out of work and children out of school. The impact of NTDs on communities further intensified in the last year, with the outbreak of COVID-19. In fact, a recently published article in Infectious Diseases on Poverty Journal explained that the economic progress by treating NTDs in the last 20 years is close to being erased by the pandemic.

This year’s World NTD Day is drawing attention to the launch of the World Health Organization’s new roadmap to end NTDs. The WHO Roadmap is a guide for the global health community to create new, innovative cross-sector partnerships, to fill the gaps and strengthen countries’ capacity, and, ultimately, to make NTD interventions sustainable.

World NTD Day Activations
Building on the spirit of global collective action, more than 60 landmarks across 40 cities and 24 nations will be lit up on World NTD Day in an effort to remind people they cannot turn a blind eye to vulnerable health systems around the world. These well-known monuments span the globe with landmarks including The Great Wall of China, Leaning Tower of Pisa, Abu Dhabi’s Etihad Arena and Tokyo Tower.

Amplifying the critical messages of the day will be well-known personalities serving as Ambassadors to the day including Sharon Stone, Sabrina Elba, Avril Lavigne and Dikembe Mutombo.

In addition, the global community will be activated on social media via entertaining and informative videos, social media challenges and human stories from affected countries being shared by partner organizations. A series of virtual events was held in the week leading up to World NTD Day, featuring experts and frontline health workers exploring the intersections between NTDs and the broader global health space.

Support from The WHO
Recognizing that the annual celebration of the day provides a vital service to the world’s work to end NTDs, the World Health Organization’s Executive Board passed a decision on 23 January recommending that WHO officially support activities marking 30 January as World NTD Day, and inviting Member States and others to celebrate the day. The recommendation will be considered at the 74th World Health Assembly, taking place in May 2021.

More information may be found on the awareness day at https://worldntdday.org/.

About Reaching the Last Mile

Reaching the Last Mile (RLM) is a portfolio of global health programs working towards disease elimination that is driven by the personal commitment of His Highness Sheikh Mohamed bin Zayed, Crown Prince of Abu Dhabi. The Initiative provides treatment and preventative care in communities that lack access to quality health services, with a specific focus on reaching the last mile of disease elimination. RLM’s mission represents His Highness’s dedication to ending preventable diseases that affect the world’s poorest and most vulnerable communities and helping millions of children and adults live healthy, dignified lives. https://www.reachingthelastmile.com/, @RLMGlobalHealth

Uniting to Combat Neglected Tropical Diseases

Neglected tropical diseases (NTDs) are a group of debilitating infectious diseases that affect over 1.7 billion people around the world. They disable, disfigure and sometimes kill. Uniting to Combat NTDs is a collective of invested, interested and dedicated partners, including governments, donors, pharmaceutical companies, non-governmental organisations, academia and more. The partnership is committed to the fight to end the epidemic of NTDs.

Media Contacts

Reaching the Last Mile, U.S.
Colleen McMillen
colleen.mcmillen@gmail.com
+1 917 344 9360

Reaching the Last Mile, Abu Dhabi
Sami Haddad
shaddad87@gmail.com
+971 56 865 9756

Uniting to Combat Neglected Tropical Diseases

Kirsten Walkom
kirsten@unitingtocombatntds.org
+44 7542013310

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8a257b37-b2d5-4638-ac01-f04d771f9437

Lung Cancer Care and Research Not Immune to Socioeconomic, Ethnic, Racial, and Gender-related Factors that Create Disparities

Press Briefing at IASLC World Conference on Lung Cancer 2020 Singapore

SINGAPORE, Jan. 28, 2021 (GLOBE NEWSWIRE) — Several leading international lung cancer researchers at a press today presented compelling new data revealing that factors of race, gender, sexual orientation and income continue to be significant barriers to those living with lung cancer. The press briefing is part of the IASLC’s World Conference on Lung Cancer 2020 Singapore.

(Note: you may access a recording of the press briefing at this link: https://vimeo.com/505823998/d5260e13a9)

The press briefing was moderated by IASLC Communications Committee Chair Dr. Anne-Marie Baird, senior research fellow at Trinity College in Dublin and president of Lung Cancer Europe (LuCE), a nonprofit that aims to provide a voice for people impacted by lung cancer in Europe. Patient Research Advocate Jill Feldman, co-founder of the patient advocacy group, The EGFR Resisters, will contribute insights from the advocacy community’s perspective.

Earlier this year, Ms. Feldman co-authored an article for IASLC Lung Cancer News, in which it was noted that, “[c]ontemporaneously, the COVID-19 pandemic has exposed the already existing health inequities in underserved populations [in the United States]. It is well documented that Black patients, Indigenous People, patients of Pacific island descent, and Hispanic patients are 3.7 times, 3.5 times, 3.1 times, and 2.8 times, respectively, more like to succumb to COVID-19, than White patients.(1) These disparities cannot be explained by differences in income alone.(2) It is, therefore, very likely that the pandemic will only exacerbate lung cancer health care delivery gaps in these already disenfranchised communities.”

Among Patients with Lung Cancer, Gender Disparities Exist in Virtually Every Country

Dr. Yanting Zhang, of the Department of Medical Statistics and Epidemiology at the School of Public Health, Sun Yat-sen University, Guangzhou, Guangdong Province, China, examined geographic patterns and temporal trends in lung cancer incidence from 1978 to 2012 for 43 countries across five continents (Abstract 3090).

“We sought to evaluate the effects of a birth cohort and period of time on temporal trends to better identify populations at increased risk of lung cancer and to provide clues for understanding the causal factors underlying the changing trends,” he said.

Sex disparities were noted in almost all countries, with the male-to-female rate ratios exceeding 5.0 in five countries (Belarus, Turkey, Lithuania, Bulgaria, and Estonia) and ranging from 2.0 to 5.0 in 22 countries for rates of incidence of lung cancer. During 1978-2012, 19 countries showed significantly favorable trends among men, with the largest decline in incidence rates occurring in Bahrain (AAPC = -6.9 %), while 26 countries showed significantly unfavorable trends among women, with AAPCs ranging from 0.9% to 5.2 %.

“The disparity in both incidence rates and trends of a birth-cohort effect between the sexes may reflect sex differences in underlying risk factors and pathogenesis. Further etiologic research will be required to identify reasons for the elevated incidence of lung cancer among [women],” Dr. Zhang reported.

Gender and Never-Smokers Study from Women’s Health Initiative

The stigma of lung cancer is strong and pervasive, and one that the lung cancer community has worked hard to counter.  Research presented today by Dr. Sitapriya Moorthi from Dr. Alice Berger’s lab at the Fred Hutchinson Cancer Research Center, Seattle showed that if those never-smokers with lung cancer were considered as having a separate disease, it would be the seventh largest category of cancer deaths (Featured Poster, FP12.12).  Currently, 24% of lung cancer cases in women and 17% of lung cancer cases in men are in individuals who have never smoked, the majority of which are adenocarcinomas.

Lung cancer cases in never-smokers are more common among women and are three- to four-fold more common among Asian women, Dr. Moorthi stated. “Despite this, the majority of tumor genome-wide sequencing efforts in lung cancer have been focused on patient cohorts with a smoking history,” she said.

Through a unique collaboration with the Women’s Health Initiative (WHI) and Dr. Garnet Anderson, Dr. Moorthi performed exome-sequencing on this cohort and describes here novel mutations, structural variants and copy number alterations in this cohort.

“Mutational analysis of our lung cancer never smokers cohort revealed that, in general, LCNS have a lower tumor mutational burden compared to their control cohort with a history of smoking. Additionally, we find that this cohort has mutations that have been previously reported in studies in never-smoker patients with lung cancer. However, the existence of novel mutations and structural alterations may offer a unique opportunity for future target identification and therapeutic intervention,” she reported.

The LGBTQ+ Community and Lung Cancer Disparities

Research presented at the World Conference by Dr. Yannan Li, of the Department of Medicine at the Icahn School of Medicine at Mount Sinai, reported potential worse cancer survival outcomes in the lesbian, gay, bisexual, transgender (LGBTQ), and queer population.

Previous studies have shown the LGBT population have increased smoking prevalence, predisposing this group to higher cancer risks, especially for lung cancer, along with worse survival.

Dr. Li and her research colleagues conducted a cross-sectional study using the 2018 Behavioral Risk Factor Surveillance System (BRFSS) survey data (Poster P09.19). They used a weighted estimation method for the cancer survivorship model using data from seven states regarding demographics, health risks, health care access, and cancer survival outcomes.

Of the 44,348 sample participants in the study, 1,439 self-identified as LGBT. In terms of healthcare access, 33.5% of transgender individuals did not have healthcare insurance coverage vs. 3.4% of those who identified as gay/lesbian (p < 0.0001). Meanwhile, 35% of people identifying as bisexual reported having two or more types of cancer vs.4.3% for the gay/lesbian group (p < 0.0001).

Dr. Li urged future policymakers to focus on expanding healthcare insurance coverage, promoting physical and mental wellbeing regarding cancer status, re-evaluating cancer pain management approaches, and improving programs for tobacco and alcohol control, to adapt to the needs of the LGBT population.

Another study, also using the 2018 BRFSS survey data, focused on people aged 55 to 79 years who identified as LGBT and examined lung cancer screening access.

There are no previous data on lung cancer screening in the LGBT population, according to Dr. Hui Xie, of the University of Wisconsin-Milwaukee’s Zilber School of Public Health, Milwaukee (Abstract 3133). With higher smoking rates and other outstanding risk factors in this population, Dr. Xie and colleagues examined the social determinants regarding receipt of lung cancer screening and explored potential solutions to eliminate health disparities in lung cancer

Dr. Xie’s team identified a total of 14.37% of U.S. individuals aged 55 to 79 years old who had no personal history of lung cancer and who were eligible for lung cancer screening. Among this group, approximately 22.85% underwent screening in the past 12 months.

Respondents who were assigned males at birth, or gay/lesbians (OR: 5.30; 95% CI: 1.32-21.36; p = 0.019), in fair/poor general health (OR: 4.16; 95% CI: 1.41-12.26; p = 0.010), and had no medical cost burden (OR: 9.37; 95% CI: 2.26-38.83; p = 0.002) were significantly associated with greater odds of receiving lung cancer screening.

However, those who identified as bisexual (OR: 0.13; 95% CI: 0.20-0.96; p = 0.045) and heavy drinkers (OR: 0.13; 95% CI: 0.02-0.75; p = 0.023) were associated with decreased odds of receiving screening. Respondents who were assigned female at birth, in fair/poor general health (OR: 4.26; 95% CI: 1.15-15.73; p = 0.030) and had no medical cost burden (OR: 17.00; 95% CI: 2.44-118.23; p = 0.004) were significantly associated with greater odds of receiving screening.

“Our findings point to the potential sex-related and sexual-identity disparities regarding use of lung cancer screening among U.S. respondents aged between 55 and 79 years old, using BRFSS data from 2018,” Dr. Xie said. She recommends targeted educational programs are needed to address the economic burden and increase awareness for the uptake of lung cancer screening among bisexual populations, especially among those who were assigned male at birth.

New Lung Cancer Screening Guidelines May Not Improve Disparities

Public health screening for lung cancer should aim to reduce disparities in mortality rates between racial and ethnic groups.  However, proposed United States Preventive Services Task Force (USPSTF) Draft 2020 guidelines may inadvertently increase racial and ethnic disparities compared with the 2013 guidelines, according to research presented during the World Conference by Dr. Rebecca Landy, of the Division of Cancer Epidemiology and Genetics at the National Cancer Institute, part of the National Institutes of Health, Bethesda, MD (Abstract 3564). Landy published her research on January 5th in the Journal of the National Cancer Institute.

The draft USPSTF 2020 recommends annual lung cancer screening for individuals aged 50 to 80 who currently smoke or quit in the last 15 years, and who have a smoking history equivalent to at least one pack of cigarettes per day for 20 years or more. This expanded the age range and smoking history requirement compared to the current (2013) USPSTF recommendations, to “partially ameliorate racial disparities in screening eligibility”. Neither set of recommendations considered the higher risk of lung cancer and younger ages at diagnosis among African Americans, despite smoking less than whites.

Dr. Landy and colleagues found that draft USPSTF 2020 guidelines increase eligibility for all races/ethnicities by similar levels (97% for whites vs 78% for minorities).  Their empirical modeling showed the draft guidelines inadvertently increased racial/ethnic disparities in screening-prevented deaths or increased life-expectancy for each minority group.  The researchers suggested broadening the eligibility criteria to additionally select individuals who would benefit most under the Life-Years From Screening-CT (LYFS-CT) model, which calculates the gain in life expectancy for an individual if they undergo screening.  They showed that augmenting USPSTF criteria to include these high benefit people selected significantly more African-Americans than whites (22% vs 9%), and thus could reduce or even eliminate disparities between whites and African Americans.

This study highlighted the importance of developing eligibility criteria that identify individuals who benefit most from screening, regardless of race/ethnicity. Using prediction models such as the LYFS-CT models could reduce racial/ethnic disparities in screening eligibility.

Progress Before COVID-19

Dr. Brendon Stiles, of Weill Cornell Medicine, New York-Presbyterian Hospital, New York City, reported that that short-term mortality and hospital readmission decreased in the years between 2004 and 2014, and that short-term survival improved in low-income patients. In addition to later year of diagnosis, treatment at academic centers, surgical treatment, and having private insurance each seem to improve outcomes in economically disadvantaged patients (Poster P08.04).

Dr. Stiles and his co-researchers identified 242,757 patients from the National Cancer Database that featured the following demographic breakdown:

  • 47,437 patients (49.7% female) were in the lowest income quartile, with a median age of 69 years
  • Approximately 23% of patients were Black
  • 65% were from metropolitan areas
  • Most patients were clinical stage I (75%), with adenocarcinoma (43%) the most common histology

“Patients with the lowest income may be slower to seek treatment, are more likely to be undertreated, and have historically had worse survival for early-stage NSCLC,” Dr.Stiles reported.  “We sought to determine whether early-stage NSCLC outcomes have improved over time in low-income patients, and I can report that progress has been made.”

Stiles also reported that treatment at academic centers, surgical treatment, and having private insurance each seem to improve outcomes in economically disadvantaged patients.

About the IASLC:
The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated solely to the study of lung cancer and other thoracic malignancies. Founded in 1974, the association’s membership includes nearly 7,500 lung cancer specialists across all disciplines in over 100 countries, forming a global network working together to conquer lung and thoracic cancers worldwide. The association also publishes the Journal of Thoracic Oncology, the primary educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancies. Visit www.iaslc.org for more information.

About the WCLC:
The WCLC is the world’s largest meeting dedicated to lung cancer and other thoracic malignancies, attracting more than 7,000 researchers, physicians and specialists from more than 100 countries. The goal is to increase awareness, collaboration and understanding of lung cancer, and to help participants implement the latest developments across the globe. The conference will cover a wide range of disciplines and unveil several research studies and clinical trial results. For more information, visit wclc2020.iaslc.org.

Chris Martin CMartin@DavidJamesGroup.com | 630-670-2745

Malaysia’s Ho Wah Genting Berhad Advises Guardion Health Sciences That It Has received Regulatory Product Registration Approval for Second Immune Support Dietary Supplement Designed and Produced by Guardion Health Sciences

SAN DIEGO, Jan. 28, 2021 (GLOBE NEWSWIRE) — Guardion Health Sciences, Inc. (Nasdaq: GHSI) (“Guardion” or the “Company”), a specialty health sciences company that develops clinically supported nutrition, medical foods, nutraceuticals and medical devices, with a focus in the ocular health marketplace, announced that its exclusive distributor in Malaysia, Ho Wah Genting Berhad (HWGB), has advised Guardion that Astramern Astra H (formerly Astramern Nutra H), an immune support dietary supplement designed and produced by the Company, has been granted product registration approval by the Malaysian National Pharmaceutical Regulatory Agency (“NPRA”).

The product registration, which is valid for five years and is renewable, is an important step toward commercialization by HWGB. Astramern Astra H comes in capsule form and contains specifically formulated herbs that are believed to help boost the body’s immune system.

This product registration approval is the second such approval received by HWGB using a Guardion-developed product. In August 2020, the Company announced the product registration approval of the vitamin formulation Astramern Nutra V. Previously, in early 2020, HWGB had entered into a Manufacturing and Supply Agreement for Guardion to design and manufacture both immune support dietary supplements, which are to be packaged together for sale by HWGB in Malaysia. HWGB’s healthcare subsidiary, Astramern Sdn Bhd, has an exclusive license to use and distribute these products in certain territories. Guardion fulfilled HWGB’s initial product order of $890,000 in June 2020.

“We have been advised that this product registration will allow HWGB to package both the Nutra V and Astra H products together to provide a more complete immune support product offering to its customers. Importantly, this development helps to expand Guardion’s presence in the Asian nutraceutical market,” said Bret Scholtes, President and CEO of Guardion. “A key part of our strategy includes expansion into foreign markets, either through licensing, supply and distribution agreements, or direct marketing opportunities. Additionally, this relationship with HWGB is important, as it allows the Company to develop new products that widen our scope in terms of health applications. We are very pleased to have a leading role in expanding into immune support in the Asian markets and anticipate a continued expansion of our product offerings that are supported by verified science and superior product development.”

About Guardion Health Sciences

Guardion is a specialty health sciences company that develops clinically supported nutrition, medical foods, nutraceuticals and medical devices, with a focus in the ocular health marketplace. Located in San Diego, California, the Company combines targeted nutrition with innovative, evidence-based diagnostic technology. Guardion boasts impressive Scientific and Medical Advisory Boards. Information and risk factors with respect to Guardion and its business, including its ability to successfully develop and commercialize its proprietary products and technologies, may be obtained in the Company’s filings with the SEC at www.sec.gov.

Forward-Looking Statement Disclaimer

With the exception of the historical information contained in this news release, the matters described herein may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. These statements involve unknown risks and uncertainties that may individually or materially impact the matters discussed herein for a variety of reasons that are outside the control of the Company, including, but are not limited to, the Company’s ability to raise sufficient financing to implement its business plan, the integration of a new management team, the impact of the COVID-19 pandemic on the Company’s business, operations and the economy in general, the Company’s ability to successfully develop and commercialize its proprietary products and technologies, and the Company’s ability to maintain compliance with Nasdaq’s listing requirements. Readers are cautioned not to place undue reliance on these forward-looking statements, as actual results could differ materially from those described in the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”), which are available at the SEC’s website (www.sec.gov). The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Relations Contact:
CORE IR
Scott Arnold
516-222-2560
scotta@coreir.com

Media Relations Contact:
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
julesa@coreir.com

Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial

First to Demonstrate Clinical Efficacy Against COVID-19 and Both UK and South Africa Variants

  • Strong efficacy in Phase 3 UK trial with over 50% of cases attributable to the now-predominant UK variant and the remainder attributable to COVID-19 virus
  • Clinical efficacy demonstrated in Phase 2b South Africa trial with over 90% of sequenced cases attributable to prevalent South Africa escape variant
  • Company to host investor conference call today at 4:30pm ET

GAITHERSBURG, Md., Jan. 28, 2021 (GLOBE NEWSWIRE) — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3%, in its Phase 3 clinical trial conducted in the United Kingdom (UK). The study assessed efficacy during a period with high transmission and with a new UK variant strain of the virus emerging and circulating widely. It was conducted in partnership with the UK Government’s Vaccines Taskforce. Novavax also announced successful results of its Phase 2b study conducted in South Africa.

“With today’s results from our UK Phase 3 and South Africa Phase 2b clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2 and 3 trials involving over 20,000 participants. In addition, our PREVENT-19 US and Mexico clinical trial has randomized over 16,000 participants toward our enrollment goal of 30,000. NVX-CoV2373 is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging UK and South Africa variants,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “NVX-CoV2373 has the potential to play an important role in solving this global public health crisis. We look forward to continuing to work with our partners, collaborators, investigators and regulators around the world to make the vaccine available as quickly as possible.”

NVX-CoV2373 contains a full-length, prefusion spike protein made using Novavax’ recombinant nanoparticle technology and the company’s proprietary saponin-based Matrix-M™ adjuvant. The purified protein is encoded by the genetic sequence of the SARS-CoV-2 spike (S) protein and is produced in insect cells. It can neither cause COVID-19 nor can it replicate, is stable at 2°C to 8°C (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.

UK Phase 3 Results: 89.3% Efficacy

The study enrolled more than 15,000 participants between 18-84 years of age, including 27% over the age of 65. The primary endpoint of the UK Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.

The first interim analysis is based on 62 cases, of which 56 cases of COVID-19 were observed in the placebo group versus 6 cases observed in the NVX-CoV2373 group, resulting in a point estimate of vaccine efficacy of 89.3% (95% CI: 75.2 – 95.4). Of the 62 cases, 61 were mild or moderate, and 1 was severe (in placebo group).

Preliminary analysis indicates that the UK variant strain that was increasingly prevalent was detected in over 50% of the PCR-confirmed symptomatic cases (32 UK variant, 24 non-variant, 6 unknown). Based on PCR performed on strains from 56 of the 62 cases, efficacy by strain was calculated to be 95.6% against the original COVID-19 strain and 85.6% against the UK variant strain [post hoc].

The interim analysis included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups.

“These are spectacular results, and we are very pleased to have helped Novavax with the development of this vaccine. The efficacy shown against the emerging variants is also extremely encouraging. This is an incredible achievement that will ensure we can protect individuals in the UK and the rest of the world from this virus,” said Clive Dix, Chair, UK Vaccine Taskforce.

Novavax expects to share further details of the UK trial results as additional data become available. Additional analysis on both trials is ongoing and will be shared via prepublication servers as well as submitted to a peer-reviewed journal for publication. The company initiated a rolling submission to the United Kingdom’s regulatory agency, the MHRA, in mid-January.

South Africa Results:   Approximately 90% of COVID-19 cases attributed to South Africa escape variant

In the South Africa Phase 2b clinical trial, 60% efficacy (95% CI: 19.9 – 80.1) for the prevention of mild, moderate and severe COVID-19 disease was observed in the 94% of the study population that was HIV-negative. Twenty-nine cases were observed in the placebo group and 15 in the vaccine group. One severe case occurred in the placebo group and all other cases were mild or moderate. The clinical trial also achieved its primary efficacy endpoint in the overall trial population, including HIV-positive and HIV-negative subjects (efficacy of 49.4%; 95% CI: 6.1 – 72.8).

This study enrolled over 4,400 patients beginning in August 2020, with COVID-19 cases counted from September through mid-January. During this time, the triple mutant variant, which contains three critical mutations in the receptor binding domain (RBD) and multiple mutations outside the RBD, was widely circulating in South Africa. Preliminary sequencing data is available for 27 of 44 COVID-19 events; of these, 92.6% (25 out of 27 cases) were the South Africa escape variant.

Importantly in this trial, approximately 1/3 of the patients enrolled (but not included in the primary analyses described above) were seropositive, demonstrating prior COVID-19 infection at baseline. Based on temporal epidemiology data in the region, the pre-trial infections are thought to have been caused by the original COVID-19 strain (i.e., non-variant), while the subsequent infections during the study were largely variant virus. These data suggest that prior infection with COVID-19 may not completely protect against subsequent infection by the South Africa escape variant, however, vaccination with NVX-CoV2373 provided significant protection.

“The 60% reduced risk against COVID-19 illness in vaccinated individuals in South Africans underscores the value of this vaccine to prevent illness from the highly worrisome variant currently circulating in South Africa, and which is spreading globally. This is the first COVID-19 vaccine for which we now have objective evidence that it protects against the variant dominating in South Africa,” says Professor Shabir Maddi, Executive Director of the Vaccines and Infectious Diseases Analytics Research Unit (VIDA) at Wits, and principal investigator in the Novavax COVID-19 vaccine trial in South Africa. “I am encouraged to see that Novavax plans to immediately begin clinical development on a vaccine specifically targeted to the variant, which together with the current vaccine is likely to form the cornerstone of the fight against COVID-19.”

Novavax initiated development of new constructs against the emerging strains in early January and expects to select ideal candidates for a booster and/or combination bivalent vaccine for the new strains in the coming days. The company plans to initiate clinical testing of these new vaccines in the second quarter of this year.

“A primary benefit of our adjuvanted platform is that it uses a very small amount of antigen, enabling the rapid creation and large-scale production of combination vaccine candidates that could potentially address multiple circulating strains of COVID-19,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “Combined with the safety profile that has been observed in our studies to-date with our COVID-19 vaccine, as well as prior studies in influenza, we are optimistic about our ability to rapidly adapt to evolving conditions.”

The Coalition for Epidemic Preparedness Innovations (CEPI) funded the manufacturing of doses of NVX-CoV2373 for this Phase 2b clinical trial, which was supported in part by a $15 million grant from the Bill & Melinda Gates Foundation.

Significant progress on PREVENT-19 Clinical Trial in US and Mexico

To date, PREVENT-19 has randomized over 16,000 participants and expects to complete our targeted enrollment of 30,000 patients in the first half of February.  PREVENT-19 is being conducted with support from the U.S. government partnership formerly known as Operation Warp Speed, which includes the Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at HHS. BARDA is also providing up to $1.75 billion under a Department of Defense agreement.

PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial | COVID-19) is a Phase 3, randomized, placebo-controlled, observer-blinded study in the US and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in up to 30,000 subjects 18 years of age and older compared with placebo. The trial design has been harmonized to align with other Phase 3 trials conducted under the auspices of Operation Warp Speed, including the use of a single external independent Data and Safety Monitoring Board to evaluate safety and conduct an unblinded review when predetermined interim analysis events are reached.

The trial’s primary endpoint is the prevention of PCR-confirmed, symptomatic COVID-19. The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints will be assessed at least seven days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2.

Conference Call

Novavax will host a conference call today at 4:30pm ET. The dial-in numbers for the conference call are (877) 212-6076 (Domestic) or (707) 287-9331 (International), passcode 7470222. A replay of the conference call will be available starting at 7:30 p.m. ET on January 28, 2021 until 7:30 p.m. ET on February 4, 2021. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 7470222.

A webcast of the conference call can also be accessed on the Novavax website at novavax.com/events. A replay of the webcast will be available on the Novavax website until April 28, 2021.

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax’ patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. Over 37,000 participants have participated to date across four different clinical studies in five countries. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that completed enrollment in November and the PREVENT-19 trial in the U.S. and Mexico that began in December.

About Matrix-M™

Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

Novavax Forward Looking Statements

Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading “Risk Factors” in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:         

Investors
Novavax, Inc.
Erika (Trahan) Schultz
ir@novavax.com
240-268-2022

Solebury Trout
Jennifer Porcelli
jporcelli@soleburytrout.com
617-974-8659

Media
Edna Kaplan
media@novavax.com 
617-974-8659

FT Ministry mulls setting up Mayor Incorporated

The Federal Territories Ministry will consider establishing Mayor Incorporated to facilitate the implementation and development of projects around the capital, said its Minister, Tan Sri Annuar Musa.

He said the body would administer and manage assets and investments owned by the Kuala Lumpur City Hall (DBKL) in carrying out business-related activities.

He said several acts needed to be introduced and amended, among others, to overcome legal constraints for that purpose.

“DBKL can create (Mayor Incorporated) just like the MB Incorporated established in several states.

“This is to enable the Mayor (of Kuala Lumpur) to carry out joint venture projects in an ordinary manner and, thus, speed up the urban renewal process,” he said in a talk show programme hosted by the ministry that was streamed live on Facebook today.

The talk show programme was held in conjunction with the virtual launch of the Kuala Lumpur Urban Renewal Guidebook by Annuar.

Commenting on the Implementation of Kuala Lumpur Urban Renewal programme, Annuar said a total of 30 areas had been identified for redevelopment, among them being the Sri Negeri Sembilan Public Housing (PA) and Sri Labuan People’s Housing Project (PPR).

He said this was to ensure a better quality of life among city folks by allowing them to live in bigger, more relevant and comfortable residences.

“Through this, they will also own new residences that will have better asset values in the future without additional cost,” he said.

Annuar said the government also offered several incentives to encourage the involvement of the private sector in the project, which has been proven to benefit the community as seen from its implementation at the Kerinchi Residence.

Source: BERNAMA News Agency

MACC studies proposal by TI-M to curb corruption

The Malaysian Anti-Corruption Commission (MACC) will scrutinise and study the proposal submitted by Transparency International Malaysia (TI-M) in efforts to combat corruption.

MACC, in a statement today, said the bid would involve any proposal linked to or under the jurisdiction of the agency so as to contribute to a better score for Malaysia in the future.

“MACC takes cognisance of the position and score of Malaysia in the 2020 Corruption Perception Index (CPI) as announced by TI-M yesterday,” said the statement.

The MACC also lauded the positive feedback on the 2020 CPI relating to the National Anti-Corruption Plan (NACP), enforcement of Section 17A of the MACC Act and investigation of high-profile cases currently underway.

The media yesterday reported that Malaysia dropped six rungs to 57th spot out of 180 countries in the Transparency International (TI) CPI for 2020.

TI-M president Dr Muhammad Mohan, among others, suggested that the Perikatan Nasional speed up institutional reforms, such as making the MACC more independent, tabling the Independent Police Complaints and Misconduct Commission (IPCMC) Bill instead of the Independent Police Conduct Commission (IPCC) Bill.

In addition, Dr Muhammad also suggested the enactment of a law on financing political funds to curb money politics and restoring political democracy.

Source: BERNAMA News Agency