Day: March 30, 2022

March 30, 2022

• New solution for interventional rooms offers patients a calming multi-sensory experience while staff prepare them for their procedure
• Ambient Experience with FlexVision display aims to help increases patient comfort, potentially improving interventional procedure workflows, outcomes, and productivity

Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced commercial availability of the company’s new solution for interventional rooms, Ambient Experience with FlexVision display, which will be showcased at the American College of Cardiology’s 71st Annual Scientific Session & Expo (ACC 2022), April 2-4, Washington, D.C., USA. Connecting to Philips Image Guided Therapy System – Azurion, it uses the system’s large display to offer patients a calming multi-sensory experience while staff prepare them for their procedure, prior to the display being used for the actual intervention. It also allows patients and interventional team members to adapt the room’s ambient lighting and sound to add to the overall feeling of calm, especially during the patient entry and preparation phases of procedures. Aimed at reducing patient anxiety during interventional procedures, Ambient Experience, leveraging FlexVision display, has the potential to improve the patient and staff experience, positively impact outcomes, and enhance workflows and productivity.

Anxiety in patients undergoing minimally-invasive image-guided therapy typically peaks immediately before the procedure is performed. As a result, sedative drugs and general anesthesia are commonly used in interventional rooms to ensure patients lie still during procedures. Mitigating the clinical atmosphere associated with typical interventional rooms by introducing positive elements that distract, inform, educate, and empower patients, Philips Ambient Experience aims to reduce patient anxiety to a level where interventionists can operate more productively and efficiently. For example, the solution could reduce the overall procedure time and, in some cases, reduce the costs associated with patient sedation or general anesthesia [1].

“One factor in our decision to use Philips’ solution is that along with the patient experience, it has been shown that you can use less anesthesia in some cases due to the relaxing and distracting factors of Ambient Experience. We wanted to set ourselves apart from other labs,” said Victor Hall, Vice President of the Heart and Vascular Institute, Baptist Health Care Pensacola, Florida, US.

“Interventional procedures can be challenging for patients, especially those who are anxious about the intervention and the outcome,” said Werner Satter, General Manager Ambient Experience at Philips. “With the addition of Ambient Experience connected to FlexVision display, which is part of Philips Image Guided Therapy System – Azurion, we address the atmosphere and mood of the room by offering active relaxation opportunities for patients and staff.”

In addition to the system’s library of pre-recorded themes, Ambient Experience also connects to media devices such as mobile phones and tablets, adding a powerful element of interactivity and choice so that patients and staff can enjoy an even more personalized experience. Single-touch control allows interventional room staff to switch between customized presets and optimal lighting and audio settings for each phase of a procedure.

Philips Ambient Experience applies evidence-based, human-focused innovation and design thinking to give patients and staff an engaging and pleasant experience, while also improving the efficiency of diagnostic and therapeutic procedures and building confidence in the services and reputation of healthcare facilities. Reduced patient anxiety contributes to better patient and staff experiences and potentially better patient outcomes, while improved efficiency contributes to lower cost of care, helping healthcare providers meet all four aspects of the Quadruple Aim.

Ambient Experience has a wide range of healthcare application areas. In the radiology department of Noah’s Ark Children’s Hospital for Wales (Cardiff, UK), where it provides an immersive interactive experience for children from the moment they arrive, a patient-satisfaction study showed that Philips Ambient Experience achieved high net promoter scores [2].

Join Philips in person at ACC 2022 to discover the latest innovations in cardiology from Philips.

[1] A fresh perspective from the interventional suite – research paper, Philips 2021.
[2] Results from case studies are not predictive of results in other cases. Results in other cases may vary.

For further information, please contact:

Joost Maltha
Philips Global Press Office
Tel: +31 6 10 55 8116
Email: joost.maltha@philips.com

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2021 sales of EUR 17.2 billion and employs approximately 78,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

Attachments

• Philips Ambient Experience and FlexVision display
• Philips Ambient Experience and FlexVision display for pediatric patients

TORONTO, March 30, 2022 (GLOBE NEWSWIRE) —

• Reported diluted earnings per share of $0.18
• Mutual fund net sales of $330 million for the quarter
• Announces increase in quarterly dividend from $0.09 to $0.10 per share

AGF Management Limited (AGF or the Company) (TSX: AGF.B) today announced financial results for the first quarter ended February 28, 2022.

AGF reported total assets under management and fee-earning assets¹ of $42.0 billion compared to $42.6 billion as at November 30, 2021 and $39.3 billion as at February 28, 2021.

“For the sixth consecutive quarter we are pleased to report positive mutual fund net sales while continuing to deliver strong risk-adjusted performance and maintaining a steadfast focus against our long-term strategy despite a volatile start to the year against the backdrop of rising interest rates and the financial fallout from the Russia-Ukraine war,” said Kevin McCreadie, Chief Executive Officer and Chief Investment Officer, AGF. “With these results, our strong balance sheet, and net cash, we are in the position to increase our quarterly dividend for the second year in a row.”

“We have spent considerable time over the past year planning and looking ahead to a post-pandemic future of work that will embrace flexibility as part of AGF’s new hybrid model,” added McCreadie. “We believe hybrid work will better support our workforce with a seamless in-office and home working environment that supports work-life balance, while encouraging greater collaboration to enable our best work as we continue to deliver for our clients, shareholders and our employees.”

AGF’s mutual fund gross sales were $989 million for the quarter compared to $1,042 million in the comparative period, while net sales were $330 million compared to $385 million in the comparative period. AGF’s sales have continued to outpace the industry. Year over year, retail mutual fund gross sales² declined slightly by 4% compared to an 8% decline for the industry³ and retail mutual fund net sales² declined by 12% compared to an 55% decline for the industry³.

“We continued to outperform the industry this quarter and this can be attributed to the diversity of our distribution strategy,” said Judy Goldring, President and Head of Global Distribution, AGF. “At AGF we are focused on building distribution channels that cater to our institutional clients, wealth advisory segments, and our strategic partners, including a focus on the mass affluent, a segment that is expected to grow over the next decade⁴.”

_{^{_______________________________
1} Fee-earning assets represents assets in which AGF has carried interest ownership and earns recurring fees but does not have ownership interest in the managers.
² Retail mutual fund gross and net sales are calculated as reported mutual fund gross and net sales less non-recurring institutional gross and net sales in excess of $5 million invested in our mutual funds.
³ Long-term funds.
⁴ Source: Household Balance Sheet Report – Canada 2021, Investor Economics.}

Key Business Highlights:

• March 2022 marked the two-year anniversary of the COVID-19 pandemic. After operating as a mostly virtual firm for two years, AGF’s offices have reopened, and employees are gradually increasing their time in the office with acknowledgement of a longer-term shift to a hybrid mix of in-office and at-home work environment.
• On February 14, AGF officially welcomed Ash Lawrence to the firm as Senior Vice-President, Head of Alternatives, and as a member of the Executive Management Team. As stated previously, Ash’s leadership and focus will allow AGF to build on its strong momentum and strategically deploy capital to effectively grow the firm’s private alternatives business.
• AGF Investments Inc. was recognized with FundGrade A+® Awards for AGF Global Select Fund, AGF U.S. Small-Mid Cap Fund, AGF Global Convertible Bond Fund and AGFiQ Global Multi-Sector Bond ETF.
• The firm continues to actively increase returns to shareholders through the use of its Normal Course Issuer Bid (NCIB). In addition, AGF’s Board of Directors has approved an 11% increase to the quarterly dividend for shareholders of record on April 8, 2022.

Financial Highlights:

• Management, advisory, administration fees and deferred sales charges were $114.1 million for the three months ended February 28, 2022, compared to $102.9 million in 2021. The increase in revenue is attributable to a 7.2% increase in assets under management.
• Selling, general and administrative costs were $49.3 million for the three months ended February 28, 2022, compared to $48.0 million in 2021. Excluding severance of $1.4 million incurred in the quarter, SG&A of $47.9 million remained flat compared to the prior year period.
• EBITDA before commissions for the three months ended February 28, 2022 was $40.0 million, compared to $26.8 million in the prior year comparative period.
• Net income for the three months ended February 28, 2022 was $12.9 million ($0.18 diluted EPS), compared to $5.6 million ($0.08 diluted EPS) in the prior year comparative period.

• EPS in the quarter of $0.18 reflects growth in top line revenue, which was partially offset in the period by higher deferred selling commissions.

	Three months ended
		February 28,				November 30,			February 28,
(in millions of Canadian dollars, except per share data)		2022				2021			2021
Income
Management, advisory, administration fees
and deferred sales charges	$	114.1			$	114.6		$	102.9
Share of profit (loss) of joint ventures		(0.6	)			0.1			0.8
Other income from fee-earning arrangements		0.8				0.8			–
Fair value adjustments and other income		10.6				6.4			3.6
Total Income	$	124.9			$	121.9		$	107.3
Selling, general and administrative		49.3				49.9			48.0
Deferred selling commissions		19.3				15.3			15.5
EBITDA before commissions1		40.0				35.5			26.8
EBITDA		20.7				20.2			11.3
Net income		12.9				13.8			5.6
Diluted earnings per share		0.18				0.19			0.08
Free cash flow1		13.3				12.5			10.5
Dividends per share		0.09				0.09			0.08

(end of period)	Three months ended
		February 28,			November 30,			February 28,
(in millions of Canadian dollars)		2022			2021			2021
Mutual fund assets under management (AUM)2	$	23,625		$	24,006		$	21,394
Institutional, sub-advisory and ETF accounts AUM		9,059			9,371			9,403
Private client AUM		7,102			7,077			6,300
Private alternatives AUM3,4		69			73			142
Total AUM3	$	39,855		$	40,527		$	37,239
Private alternatives fee-earning assets3,4		2,100			2,108			2,012
Total AUM and fee-earning assets4	$	41,955		$	42,635		$	39,251
Net mutual fund sales2		330			352			385
Average daily mutual fund AUM3		24,075			23,896			21,118

_{¹ EBITDA before commissions (earnings before interest, taxes, depreciation, amortization and deferred selling commissions), adjusted EBITDA before commissions, adjusted net income, adjusted diluted earnings per share and Free Cash Flow are not standardized measures prescribed by IFRS. The Company utilizes non-IFRS measures to assess our overall performance and facilitate a comparison of quarterly and full-year results from period to period. They allow us to assess our investment management business without the impact of non-operational items. These non-IFRS measures may not be comparable with similar measures presented by other companies. These non-IFRS measures and reconciliations to IFRS, where necessary, are included in the Management’s Discussion and Analysis available at www.agf.com.
² Mutual fund AUM includes retail AUM, pooled fund AUM and institutional client AUM invested in customized series offered within mutual funds.
³ Total AUM and Private alternatives AUM have been reclassified and restated to exclude co-investment AUM for comparative purposes.
⁴ Fee-earning assets represents assets in which AGF has carried interest ownership and earns recurring fees but does not have ownership interest in the managers.}

For further information and detailed financial statements for the first quarter ended February 28, 2022, including Management’s Discussion and Analysis, which contains discussions of non-IFRS measures, please refer to AGF’s website at www.agf.com under ‘About AGF’ and ‘Investor Relations’ and at www.sedar.com.

Conference Call

AGF will host a conference call to review its earnings results today at 11 a.m. ET.

The live audio webcast with supporting materials will be available in the Investor Relations section of AGF’s website at www.agf.com or at https://edge.media-server.com/mmc/p/6bqs4767. Alternatively, the call can be accessed toll-free in North America by dialing 1 (800) 708-4539 (Passcode #: 50285263).

A complete archive of this discussion along with supporting materials will be available at the same webcast address within 24 hours of the end of the conference call.

About AGF Management Limited

Founded in 1957, AGF Management Limited (AGF) is an independent and globally diverse asset management firm. AGF brings a disciplined approach to delivering excellence in investment management through its fundamental, quantitative, alternative and high-net-worth businesses focused on providing an exceptional client experience. AGF’s suite of investment solutions extends globally to a wide range of clients, from financial advisors and individual investors to institutional investors including pension plans, corporate plans, sovereign wealth funds and endowments and foundations.

AGF has investment operations and client servicing teams on the ground in North America, Europe and Asia. With $42 billion in total assets under management and fee-earning assets, AGF serves more than 800,000 investors. AGF trades on the Toronto Stock Exchange under the symbol AGF.B.

AGF Management Limited shareholders, analysts and media, please contact:

Adrian Basaraba
Senior Vice-President and Chief Financial Officer
416-865-4203, InvestorRelations@agf.com

Courtney Learmont
Vice-President, Finance
647-253-6804, InvestorRelations@agf.com

Caution Regarding Forward-Looking Statements

This press release includes forward-looking statements about the Company, including its business operations, strategy and expected financial performance and condition. Forward-looking statements include statements that are predictive in nature, depend upon or refer to future events or conditions, or include words such as ‘expects,’ ‘estimates,’ ‘anticipates,’ ‘intends,’ ‘plans,’ ‘believes’ or negative versions thereof and similar expressions, or future or conditional verbs such as ‘may,’ ‘will,’ ‘should,’ ‘would’ and ‘could.’ In addition, any statement that may be made concerning future financial performance (including income, revenues, earnings or growth rates), ongoing business strategies or prospects, fund performance, and possible future action on our part, is also a forward-looking statement. Forward-looking statements are based on certain factors and assumptions, including expected growth, results of operations, business prospects, business performance and opportunities. While we consider these factors and assumptions to be reasonable based on information currently available, they may prove to be incorrect. Forward-looking statements are based on current expectations and projections about future events and are inherently subject to, among other things, risks, uncertainties and assumptions about our operations, economic factors and the financial services industry generally. They are not guarantees of future performance, and actual events and results could differ materially from those expressed or implied by forward-looking statements made by us due to, but not limited to, important risk factors such as level of assets under our management, volume of sales and redemptions of our investment products, performance of our investment funds and of our investment managers and advisors, client-driven asset allocation decisions, pipeline, competitive fee levels for investment management products and administration, and competitive dealer compensation levels and cost efficiency in our investment management operations, as well as general economic, political and market factors in North America and internationally, interest and foreign exchange rates, global equity and capital markets, business competition, taxation, changes in government regulations, unexpected judicial or regulatory proceedings, technological changes, cybersecurity, the possible effects of war or terrorist activities, outbreaks of disease or illness that affect local, national or international economies (such as COVID-19), natural disasters and disruptions to public infrastructure, such as transportation, communications, power or water supply or other catastrophic events, and our ability to complete strategic transactions and integrate acquisitions, and attract and retain key personnel. We caution that the foregoing list is not exhaustive. The reader is cautioned to consider these and other factors carefully and not place undue reliance on forward-looking statements. Other than specifically required by applicable laws, we are under no obligation (and expressly disclaim any such obligation) to update or alter the forward-looking statements, whether as a result of new information, future events or otherwise. For a more complete discussion of the risk factors that may impact actual results, please refer to the ‘Risk Factors and Management of Risk’ section of the 2021 Annual MD&A.

About the Fundata FundGrade A+ Rating

FundGrade A+® is used with permission from Fundata Canada Inc., all rights reserved. The annual FundGrade A+® Awards are presented by Fundata Canada Inc. to recognize the “best of the best” among Canadian investment funds. The FundGrade A+® calculation is supplemental to the monthly FundGrade ratings and is calculated at the end of each calendar year. The FundGrade rating system evaluates funds based on their risk-adjusted performance, measured by Sharpe Ratio, Sortino Ratio, and Information Ratio. The score for each ratio is calculated individually, covering all time periods from 2 to 10 years. The scores are then weighted equally in calculating a monthly FundGrade. The top 10% of funds earn an A Grade; the next 20% of funds earn a B Grade; the next 40% of funds earn a C Grade; the next 20% of funds receive a D Grade; and the lowest 10% of funds receive an E Grade. To be eligible, a fund must have received a FundGrade rating every month in the previous year. The FundGrade A+® uses a GPA-style calculation, where each monthly FundGrade from “A” to “E” receives a score from 4 to 0, respectively. A fund’s average score for the year determines its GPA. Any fund with a GPA of 3.5 or greater is awarded a FundGrade A+® Award. For more information, see www.FundGradeAwards.com. Although Fundata makes every effort to ensure the accuracy and reliability of the data contained herein, the accuracy is not guaranteed by Fundata.

AGF Global Select Fund won in the Global Equity CIFSC Category, out of 1127 funds. The FundGrade A+ start date was 1/31/2012 and the FundGrade A+ end date was 12/31/2021. AGF U.S. Small-Mid Cap Fund won in the U.S. Small/Mid Cap Equity CIFSC Category, out of 142 funds. The FundGrade A+ start date was 1/31/2012 and the FundGrade A+ end date was 12/31/2021. AGF Global Convertible Bond Fund won in the High Yield Fixed Income CIFSC Category, out of 242 funds. The FundGrade A+ start date was 1/31/2016 and the FundGrade A+ end date was 12/31/2021. AGFiQ Global Multi-Sector Bond ETF (QGB) won in the Global Fixed Income CIFSC Category, out of 251 funds. The FundGrade A+ start date was 1/31/2019 and the FundGrade A+ end date was 12/31/2021.

SAN FRANCISCO, March 30, 2022 (GLOBE NEWSWIRE) — Zenput announced today that more than 5,000 franchise and company-owned Taco Bell restaurants are now using the company’s operations execution platform to support compliance against food safety protocols and brand standards.

Embracing the move away from pen and paper tracking and towards the digitization of a range of procedures and food safety protocols, the corporate team joined several of its franchisees in rolling out Zenput to its 480 company-owned restaurants.

Restaurant general managers and Taco Bell team members use Zenput on tablets to complete tasks throughout the day, including daily food safety checklists, sanitization procedures, manager daily walks, audits, new product roll-outs, and a range of other work to ensure brand standards are met. Area coaches then access Zenput from anywhere through an app on their phones to make sure work is being performed correctly and to focus their attention where it’s needed most.

“For leading operators like Taco Bell, success depends on maintaining standards and ensuring positive and safe guest experiences,” said Vladik Rikhter, CEO of Zenput. “Having Taco Bell corporate and select Taco Bell franchisees using Zenput not only strengthens that relationship, it compounds the benefits of the platform – to work separately yet together in their goal to continually improve operations.”

About Zenput

Zenput is how top operators elevate team execution in every store. Multi-unit operators such as Chipotle, P.F. Chang’s, Domino’s, Global Partners, and Smart & Final use the platform to roll out and enforce compliance against operating procedures, food safety protocols, and other key initiatives. Supporting 60,000 locations in over 100 countries, automation gives field and store employees hours back each day, and execs know exactly what’s happening on the ground, from anywhere. For more information, visit zenput.com.

For more information, contact David Karel at (800) 537-0227, or email hello@zenput.com.

Risk of symptomatic COVID-19 was reduced by 71% compared to placebo in pre-exposure prophylaxis and 75% compared to placebo in post-exposure prophylaxis

Risk of hospitalization or death in participants with mild to moderate COVID-19 was reduced by 66% compared to placebo in the primary efficacy analysis population and by 77% compared to placebo in participants who received treatment within three days of symptom onset

Full year and fourth quarter 2021 financial results reported; $591 million in cash and investments expected to be sufficient to fund operations into second half of 2024

WALTHAM, Mass., March 30, 2022 (GLOBE NEWSWIRE) — Adagio Therapeutics, Inc. (Nasdaq: ADGI), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases, reported that the primary endpoints were met with statistical significance for all three indications in the company’s ongoing global Phase 2/3 clinical trials evaluating its investigational drug adintrevimab (ADG20) as a pre-and-post-exposure prophylaxis (EVADE) and treatment (STAMP) for COVID-19. EVADE and STAMP were primarily conducted during a time when pre-Omicron SARS-CoV-2 variants were dominant. Following the emergence of the Omicron variant, in a pre-specified exploratory analysis in a subset of the pre-exposure cohort, a clinically meaningful reduction in cases of symptomatic COVID-19 was observed with adintrevimab compared to placebo. Across both trials, a single intramuscular (IM) administration of adintrevimab at the 300mg dose had a similar safety profile to that of placebo. Based on these data, Adagio plans to engage with the U.S. Food and Drug Administration (FDA) and to submit an Emergency Use Authorization (EUA) application in the second quarter of 2022 for adintrevimab for both the prevention and treatment of COVID-19.

In addition, Adagio provided an update on its ongoing Phase 1 study evaluating adintrevimab at higher doses and on research activities related to adintrevimab re-engineering and the identification of new antibodies to potentially address COVID-19 and other viruses.

“COVID-19 continues to pose significant challenges globally as waning immunity combined with the emergence of resistant variants has led to ongoing waves of disease. We believe that a suite of options – spanning prophylaxis and treatment – is needed to effectively address this virus as it continues to evolve, and these data give us confidence in the potential role adintrevimab can play in physicians’ arsenals,” said David Hering, MBA, interim chief executive officer and chief operating officer of Adagio. “Based on the data from both EVADE and STAMP, including the impacts observed in preliminary analyses from participants enrolled after the emergence of the Omicron variant, our team is initiating discussions with the FDA and preparing an EUA submission for adintrevimab. With more than one million doses of adintrevimab secured for 2022 and a solid financial position expected to take us into the second half of 2024, we are optimistic about the road ahead and the impact adintrevimab could have for the many people around the globe, particularly those at high risk with co-morbidities, who continue to need options.”

Michael Ison, M.D., M.S., professor of Medicine in the Division of Infectious Diseases and of Surgery in the Division of Organ Transplantation, Northwestern University Feinberg School of Medicine, added, “the compelling data generated on adintrevimab in both of Adagio’s clinical trials represent an important step toward further addressing the continuation of the COVID-19 pandemic. I am particularly encouraged by the consistent treatment effect observed across all three clinical settings and patient subpopulations, and the favorable safety profile, with just a single dose and convenient IM delivery for all patients. The risk-reduction in the post-exposure prophylaxis setting regardless of serostatus translates to real-world use when clinicians might not know the vaccination or prior infection status of their patients. In the STAMP trial, adintrevimab showed prevention of hospitalization and death in the face of the ‘highest-risk’ variant (Delta) to-date.”

EVADE Preliminary Data
EVADE is a global, multi-center, double-blind, placebo-controlled Phase 2/3 clinical trial evaluating adintrevimab at the 300mg IM dose in two independent cohorts for the prevention of COVID-19. The study includes a pre-exposure prophylaxis (PrEP) cohort and a post-exposure prophylaxis (PEP) cohort. The study population is comprised of adults and adolescents at risk of SARS-CoV-2 infection due to reported recent exposure or whose circumstances placed them at increased risk of acquiring SARS-CoV-2 infection and developing symptomatic COVID-19.

In the primary efficacy analysis of the PrEP cohort, adintrevimab was associated with a lower incidence of symptomatic COVID-19 compared with placebo through month three or the emergence of Omicron, whichever was earlier (12/730, 1.6% vs. 40/703, 5.7%, respectively). The standardized risk difference was -4.0% (95% CI –6.0, -2.1; p <0.0001), demonstrating a 71% relative risk reduction in favor of adintrevimab through three months. There were five (0.7%) COVID-19 related hospitalizations in the placebo group compared to none in the adintrevimab group. In a pre-specified exploratory analysis of the PrEP cohort, which included 402 participants (196 and 206 in the adintrevimab and placebo groups, respectively) following the emergence of Omicron (BA.1), a clinically meaningful reduction in cases of symptomatic COVID-19 was observed with adintrevimab, as compared to placebo. Adintrevimab was associated with a relative risk reduction of 59% and 47% with a median follow-up duration of 56 and 77 days, respectively (nominal p <0.05).

In the primary efficacy analysis in the PEP cohort, adintrevimab met statistical significance and was associated with a lower incidence of symptomatic COVID-19 through day 28 compared with placebo (3/173, 1.7% vs. 12/175, 6.9%, respectively). The standardized risk difference was -4.9% (95% CI: -8.8, -1.0; p=0.0135), demonstrating a 75% relative risk reduction in favor of adintrevimab through 28 days. There were two (1.1%) COVID-19 related hospitalizations in the placebo group compared to none in the adintrevimab group.

In the EVADE cohorts across 1,239 adintrevimab-treated participants with a median range of follow up of 140 days for the PrEP cohort and 126 days for the PEP cohort as of the March 2, 2022, data cut off, the safety profile was similar to that of placebo. The incidence of adverse events (AEs), including serious adverse events (SAEs), was similar between adintrevimab and placebo groups. No study drug related SAEs, including deaths, were reported. The most frequently reported AEs were injection-site reactions, the majority of which were mild or moderate in severity and occurred with similar frequency in both groups.

STAMP Preliminary Data
STAMP is a global, multi-center, double-blind, placebo-controlled Phase 2/3 clinical trial evaluating adintrevimab at the 300mg IM dose in patients with mild to moderate COVID-19 who are at high risk for disease progression. Adintrevimab was associated with a statistically significant lower incidence of COVID-19 related hospitalization or all cause death through day 29 compared with placebo (8/169, 4.7% vs. 23/167, 13.8%), with a standardized risk difference of -8.6% (95% CI: -14.65, -2.57; p=0.0052), demonstrating a 66% relative risk reduction in favor of adintrevimab. There was one death (0.6%) in the adintrevimab group, compared with six deaths (3.6%) in the placebo group through day 29. In patients treated within three days of symptom onset (adintrevimab n=91, placebo n=85), adintrevimab reduced the risk of COVID-19 hospitalization or death from any cause by 77% compared to placebo. STAMP enrolled 63 participants (29 in the adintrevimab group and 34 in the placebo group) with COVID-19 infection with the Omicron SARS-CoV-2 variant. There were two events of COVID-19 related hospitalization and no deaths through day 29 among the patients with the Omicron variant, and both events of hospitalization occurred in the placebo group.

In STAMP, across 192 adintrevimab-treated participants with a median follow up of 73 days in the adintrevimab group as of the February 2, 2022, data cut off, the incidence of AEs, including SAEs, was lower in the adintrevimab group. No study drug related SAEs, including deaths, were reported. The most frequently reported AEs were injection-site reactions, all of which were mild or moderate in severity and occurred with similar frequency in both groups.

“On behalf of the entire Adagio team, I’d like to thank the numerous investigators, clinical teams and, most importantly, the patients, families and caregivers for their participation in our clinical trials. We are encouraged by the data and look forward to submitting an EUA and discussing these results with the FDA and other regulatory authorities. Further, we are continuing our research efforts to improve adintrevimab activity against Omicron and identify antibodies targeting novel domains, which will provide potential additional product candidates to take into clinical development. Collectively, these efforts showcase the ability of our platform and expertise to discover, design and engineer novel antibodies, and execute global clinical trials, to potentially address infectious diseases,” said Ellie Hershberger, Pharm.D., chief development officer of Adagio.

Additional Development and Research Updates
Adagio continues to leverage its platform and expertise by conducting numerous efforts to address COVID-19, other coronaviruses, influenza and other infectious diseases, including:

• Advancing a Phase 1 trial in healthy volunteers to evaluate pharmacokinetics and safety of additional higher doses of adintrevimab to supplement the data generated to date, which has evaluated doses up to 600mg IM. Preliminary safety data through two weeks post-dosing suggest a favorable safety profile at the 1200mg dose administered with IM injection or intravenously (IV).
• Ongoing efforts to modify adintrevimab to improve binding to the Omicron subvariants (BA.1 and BA.2) in order to enhance neutralization potency while retaining the broad neutralization observed in vitro against other SARS-CoV-2 variants of concern. Re-engineered variants of ADG20 show over 100-fold improvement in binding and up to 40-fold enhanced neutralizing activity against the Omicron BA.1 variant while maintaining activity against all other variants of concern tested to date.
• Ongoing discovery efforts to assess additional monoclonal antibodies from the company’s proprietary library of previously isolated SARS-CoV-2 antibodies for neutralization breadth and potency, which could be developed as a standalone treatment or combination therapy. Novel antibodies isolated from Omicron breakthrough infection donors have displayed in vitro activity against the 2003 SARS virus and all SARS-CoV-2 variants of concern tested to date, including the BA.1 and BA.2 variants.
• Continuing discovery efforts to identify novel, broadly neutralizing antibodies that target epitopes both within and outside the receptor binding domain of SARS-CoV-2 and pan betacoronavirus neutralizing antibodies.

Full Year and Fourth Quarter 2021 Financial Results

• Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities were $591.4 million as of December 31, 2021. Based on current operating plans, Adagio expects its existing cash, cash equivalents and marketable securities will enable the company to fund its operating expenses and capital expenditure requirements into the second half of 2024.
• R&D Expenses: Research and development (R&D) expenses, including in-process research and development expenses, were $68.4 million for the quarter ended December 31, 2021, and $190.4 million for the year ended December 31, 2021.
• SG&A Expenses: Selling, general and administrative (SG&A) expenses were $14.7 million for the quarter ended December 31, 2021, and $36.5 million for the year ended December 31, 2021.
• Net Loss: Net loss was $83.0 million, or $0.77 basic and diluted net loss per share, for the quarter ended December 31, 2021, and $226.8 million, or $5.32 basic and diluted net loss per share, for the year ended December 31, 2021.

About Adintrevimab
Adintrevimab (ADG20), Adagio’s lead product candidate, is designed to be a potent, broadly neutralizing antibody for both the prevention and treatment of COVID-19, including disease caused by most variants, as either a single or combination agent. Adintrevimab is being assessed in two separate Phase 2/3 clinical trials: the EVADE trial for the prevention of COVID-19 in both the post-exposure and pre-exposure settings, and the STAMP trial for the treatment of COVID-19. Preliminary data from these trials demonstrated that in the pre-Omicron population, adintrevimab met the primary endpoints across all three indications, demonstrating statistically significant and clinically meaningful efficacy. Across each of the trials, intramuscular (IM) administration of adintrevimab at the 300mg dose had a similar safety profile to that of placebo. Adintrevimab is also being evaluated in a Phase 1 study to evaluate safety and pharmacokinetics at higher doses, and as of an interim data cut, no study drug related adverse events, serious adverse events, injection-site reactions or hypersensitivity reactions were reported across all dose levels evaluated. Adintrevimab is an investigational monoclonal antibody that is not approved for use in any country. The safety and efficacy of adintrevimab have not been established.

About Adagio Therapeutics
Adagio (Nasdaq: ADGI) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of differentiated products for the prevention and treatment of infectious diseases. The company is developing its lead product candidate, adintrevimab, for the prevention and treatment of COVID-19, the disease caused by the virus SARS-CoV-2 and its variants. Beyond COVID-19, Adagio is leveraging robust antibody discovery and development capabilities that have enabled expedited advancement of adintrevimab into clinical trials to develop therapeutic or preventative options for other infectious diseases, such as additional coronaviruses and influenza. Adintrevimab is an investigational monoclonal antibody that is not approved for use in any country. The safety and efficacy of adintrevimab have not been established. For more information, please visit www.adagiotx.com.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could”, “expects,” “intends,” “potential”, “projects,” and “future” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the timing, progress and results of our preclinical studies and clinical trials of adintrevimab, the review and analysis of data from our ongoing trials and the timing thereof, the initiation, modification and completion of studies or trials and related preparatory work, and our research and development programs; our plans related to engaging with regulatory authorities, including the timing of any regulatory submissions or applications; our pursuit of other strategies to broaden our portfolio of SARS-CoV-2 mAbs to address other SARS-CoV-2 variants of concern, including the Delta and Omicron variants; our discovery efforts to identify novel broadly neutralizing antibodies that target distinct epitopes both within and outside the receptor binding domain of SARS-CoV-2 and other beta coronaviruses; our expected cash runway; and other statements that are not historical fact. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation, the impacts of the COVID-19 pandemic on our business and those of our collaborators, our clinical trials and our financial position, unexpected safety or efficacy data observed during preclinical studies or clinical trials, the predictability of clinical success of adintrevimab based on neutralizing activity in pre-clinical studies, variability of results in models used to predict activity against SARS-CoV-2 variants of concern, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, and the uncertainties and timing of the regulatory approval process, including the outcome of our discussions with regulatory authorities concerning our Phase 2/3 clinical trials and the result of any emergency use application submission. Other factors that may cause our actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in Adagio’s Form 10-Q for the quarter ended September 30, 2021 filed with the Securities and Exchange Commission (the “SEC”), and in our other filings with the SEC, and in Adagio’s future reports to be filed with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic.  Forward-looking statements contained in this press release are made as of this date, and Adagio undertakes no duty to update such information except as required under applicable law.

Contacts
Media Contact:
Dan Budwick, 1AB
dan@1abmedia.com

Investor Contact:
Monique Allaire, THRUST Strategic Communications
monique@thrustsc.com

ADAGIO THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except share and per share amounts)

		December 31,
			2021				2020
Assets
Current assets:
Cash and cash equivalents		$	542,224			$	114,988
Marketable securities			49,194				—
Prepaid expenses and other current assets			25,293				2,394
Total current assets			616,711				117,382
Property and equipment, net			83				—
Other non-current assets			3,297				—
Total assets		$	620,091			$	117,382
Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable		$	5,783			$	8,153
Accrued expenses			56,277				4,919
Total current liabilities			62,060				13,072
Early-exercise liability			6				11
Other non-current liabilities			6				—
Total liabilities			62,072				13,083
Commitments and contingencies
Convertible preferred stock (Series A, B and C), $0.0001 par value; no shares authorized, issued and outstanding at December 31, 2021; 12,647,934 shares authorized, issued and outstanding at December 31, 2020; aggregate liquidation preference of $0 and $169,900 at December 31, 2021 and December 31, 2020, respectively			—				169,548
Stockholders’ equity (deficit):
Preferred stock (undesignated), $0.0001 par value; 10,000,000 shares authorized and no shares issued and outstanding at December 31 2021; no shares authorized, issued and outstanding at December 31, 2020			—				—
Common stock, $0.0001 par value; 1,000,000,000 shares authorized, 111,251,660 shares issued and 110,782,909 shares outstanding at December 31, 2021; 150,000,000 shares authorized, 28,193,240 shares issued and 5,593,240 shares outstanding as of December 31, 2020			11				1
Treasury stock, at cost; 468,751 shares and 22,600,000 shares at December 31, 2021 and December 31, 2020, respectively			—				(85	)
Additional paid-in capital			850,125				154
Accumulated other comprehensive loss			(8	)			—
Accumulated deficit			(292,109	)			(65,319	)
Total stockholders’ equity (deficit)			558,019				(65,249	)
Total liabilities, convertible preferred stock and stockholders’ equity (deficit)		$	620,091			$	117,382

ADAGIO THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(In thousands, except share and per share amounts)

		Year Ended December 31, 2021				Period from June 3, 2020 (Inception) to December 31, 2020
Operating expenses:
Research and development(1)		$	182,891			$	21,992
Acquired in-process research and development(2)			7,500				40,125
Selling, general and administrative			36,517				3,210
Total operating expenses			226,908				65,327
Loss from operations			(226,908	)			(65,327	)
Other income (expense):
Other income (expense), net			118				8
Total other income (expense), net			118				8
Net loss			(226,790	)			(65,319	)
Other comprehensive income (loss):
Unrealized loss on available-for-sale securities, net of tax			(8	)			—
Comprehensive loss		$	(226,798	)		$	(65,319	)
Net loss per share attributable to common stockholders, basic and diluted		$	(5.32	)		$	(18.10	)
Weighted-average common shares outstanding, basic and diluted			42,621,265				3,608,491

(1)  Includes related-party amounts of $4,150 for the year ended December 31, 2021 and $595 for the period from June 3, 2020 (inception) to December 31, 2020.
(2)  Includes related-party amounts of $7,500 for the year ended December 31, 2021 and $39,915 for the period from June 3, 2020 (inception) to December 31, 2020.

LTO Network announces that through its collaboration with integrator Sphereon, it will host the world’s next generation of eClinical data. Triall will integrate its blockchain APIs with the eClinical solutions of CDS, realizing the world’s first end-to-end eClinical platform powered by blockchain.

AMSTERDAM, March 30, 2022 (GLOBE NEWSWIRE) — LTO Network further solidifies its position as a key blockchain infrastructure provider to the clinical trial software (eClinical) space through its partnership with blockchain-integrated eClinical platform Triall and Self-Sovereign Identity specialist Sphereon. This is made possible by the recent partnership between Triall and Crucial Data Solutions (CDS), a leading eClinical solution provider whose software has been used by over 7,000 clinical trials worldwide.

Triall will integrate its blockchain APIs with the eClinical solutions of CDS, realizing the world’s first end-to-end eClinical platform powered by blockchain. The platform covers all core clinical trial functions (e.g., eTMF, EDC, CTMS, RTSM, eConsent, Medical Coding, Wearable integration, etc.) to radically advance data integrity, auditability, and interoperability in the global clinical trials industry.

The landmark partnership is a major leap forward for Triall as it enables the company to innovate on top of a validated eClinical platform that is trusted by thousands of industry professionals globally. It also has wild implications for LTO as Triall’s new eClinical product range will anchor data on the blockchain servers of the LTO Network, thereby generating verifiable proof of clinical trial data, documents, and processes.

It further cements LTO Network as a leading provider of blockchain services for critical business and enterprise solutions due to the company’s experience and capabilities with adhering to regulatory frameworks and maintaining privacy through its “hybrid architecture” that allows privacy to be maintained whilst offering the decentralized power and transparency of blockchain technology.  Its privacy and GDPR-friendly network has played host to world-leading organizations and government bodies such as the United Nations, Dutch Government, and IBM.

“Of course, we are excited by the prospect of a record number of transactions on our network through this partnership, but we are more enthusiastic about the fact that we are proving again and again that our network is a leading choice for the world’s most important data. This partnership would not have been possible without the hard work of Sphereon, who developed the integration of LTO Network and Triall’s eTMF suite,” said Rick Schmitz, CEO of LTO Network.

“Clinical trials have become increasingly digital, data-driven, and decentralized. This underlines the need for an end-to-end eClinical platform that unifies and secures all essential trial activities and processes. We have found the ideal partner in CDS and are very excited to continue our journey together,” said Hadil Es-Sbai, CEO at Triall.

“Blockchain technology has the ability to make the world a better place. This partnership takes a firm step towards that vision and we are excited to be part of this journey on the LTO Network,” said Shawn Naderi, CMO of LTO Network.

About LTO Network

The LTO Network team is on a mission to create and maintain a fully decentralized and highly efficient blockchain infrastructure, directly applicable and aimed at creating value for organizations. LTO Network can be used by any company with a need for a production-ready blockchain that allows for digital verification of digital assets and enabling collaboration through the use of decentralized workflows.

About Triall

Triall brings Web 3.0 to medical research by creating a digital ecosystem of blockchain-integrated software solutions that secure and streamline the development of new vaccines and therapeutics during clinical trials. Triall’s solutions make clinical trials tamper-resistant and enable secure and efficient integrations between the many isolated systems and parties involved in clinical trial processes. Triall’s software is created by clinical trial professionals to ensure optimal user experience, solving actual industry pain points.

Stay up to date with LTO Network –

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Media Contacts:

LTO Network – Press & Media Relations
press@ltonetwork.com

Triall – Press & Media Relations
press@triall.io

This content was issued through the press release distribution service at Newswire.com.

CELEBRATING THE DELIVERY OF VISTAJET’S 10th,
AND BOMBARDIER’S 100th, GLOBAL 7500 BUSINESS JET IN ANOTHER MILESTONE FOR THE INDUSTRY FLAGSHIP

VistaJet now owns 10% of the world’s Global 7500 fleet

• A milestone moment: VistaJet now offers a fleet of 10 Global 7500 business jets following Bombardier’s 100^th delivery of the aircraft;
• VistaJet continues to expand its fleet globally, and now manages 10% of all the world’s Global 7500 aircraft;
• Celebration marks the strong relationship between two pillars of business aviation who are providing unparalleled aircraft to a growing client base;
• Bombardier’s Global 7500 expands VistaJet’s ultra-long haul fleet and reinforces its confidence in the outlook for business jet travel in 2022 and beyond.

Montréal, March 30, 2022: VistaJet, the first and only global business aviation company, and leading aircraft manufacturer, Bombardier, celebrated a milestone delivery of the industry flagship Global 7500 aircraft.

The celebration, taking place at Bombardier’s Laurent Beaudoin Completion Centre in Montréal on March 29, marks Bombardier’s 100th delivery of the ultra-long-range smooth-flying jet, and VistaJet’s 10th, making it the largest operator of Global 7500 aircraft in the world. The event underscores the long-time relationship between the two brands and demonstrates the success of this unparalleled business jet. VistaJet plans to welcome up to a total of 17 Global 7500 aircraft into its fleet by the end of 2022.

Thomas Flohr, VistaJet’s Founder and Chairman comments: “We are extremely proud of this landmark moment with Bombardier, as we grow our Global 7500 fleet and meet the growing demand for ultra-long-range solutions. VistaJet is committed to a sustainable aviation future and supporting the global business industry with this expansion. Our enhanced product offering onboard the Global 7500 also guarantees that our clients, whether business or leisure travelers, are given the best and most seamless flying experience. We look forward to welcoming more Members and supporting the business world as our growing fleet of Global 7500 aircraft opens a new era for long-haul private travel.”

Éric Martel, Bombardier’s President and Chief Executive Officer adds: “I am thrilled to celebrate the 100th delivery of the Global 7500 aircraft with our valued customer, VistaJet. VistaJet recognized early on that this aircraft would transform the business jet industry, and the enormous success of Bombardier’s Global 7500 in transforming the private aviation industry. I would like to thank our teams in Montréal, Toronto and Wichita for designing, building and testing this amazing feat of technology. It’s thanks to their talent and dedication that this aircraft has raised the bar for excellence in this sector.”

With an industry-leading range of over 7,700nm, the Bombardier Global 7500 aircraft opens up global access in long haul private travel. VistaJet’s unparalleled network gives the Global 7500 business jet the space to operate at its peak and opens an extended world of non-stop possibilities for its Members. With VistaJet, passengers can travel long-haul on the Global 7500 to 187 countries worldwide, unlocking access to 96% of the world and some of the most hard-to-reach areas in a single flight

VistaJet’s Global 7500 fleet has already completed a number of incredible non-stop flights, including São Paulo to the Maldives (15 hours 43 minutes flight time), Los Angeles to Hong Kong (14 hours 50 minutes), St Maarten to the Seychelles (14 hours 45 minutes), Phuket to Vancouver (13 hours 50 minutes), Liège to Jakarta (13 hours 30 minutes), Honolulu to Helsinki (13 hours 30 minutes) and many from the Middle East — including Abu Dhabi to Washington DC (13 hours 50 minutes), Abu Dhabi to Sydney (13 hours 30 minute flight time) and Abu Dhabi to New York (13 hours 10 minutes).

Bombardier’s Global 7500 aircraft is the first business jet with an Environmental Product Declaration, offering complete transparency on its performance. It flies at a higher altitude (up to 51,000ft) than commercial jets, where the air is thinner, thus allowing the aircraft to fly faster while burning less fuel. This aligns with VistaJet’s commitment to become the first carbon neutral business aviation company by 2025.

To virtually experience the Global 7500 business jet click here.

Press enquiries

Jennifer Farquhar | VistaJet | press@vistajet.com
Anna Cristofaro | Bombardier | anna.cristofaro@aero.bombardier.com

About VistaJet 

VistaJet is the first and only global business aviation company. On its fleet of over 80 silver and red business jets, VistaJet has flown corporations, governments and private clients to 187 countries, covering 96% of the world.
Founded in 2004, the company pioneered an innovative business model where customers have access to an entire fleet whilst paying only for the hours they fly, free of the responsibilities and asset risks linked to aircraft ownership. VistaJet’s signature Program membership offers customers a bespoke subscription of flight hours on its fleet of mid and long-range jets, to fly them anytime, anywhere.
VistaJet is part of Vista Global Holding (Vista) — the world’s first private aviation ecosystem, integrating a unique portfolio of companies offering asset-light solutions to cover all key aspects of business aviation.

More VistaJet information and news at vistajet.com

About Bombardier
Bombardier is a global leader in aviation, focused on designing, manufacturing and servicing the world’s most exceptional business jets. Bombardier’s Challenger and Global aircraft families are renowned for their cutting-edge innovation, cabin design, performance and reliability. Bombardier has a worldwide fleet of approximately 5,000 aircraft in service with a wide variety of multinational corporations, charter and fractional ownership providers, governments and private individuals. Bombardier aircraft are also trusted around the world in special-mission roles.
Headquartered in Montréal, Québec, Bombardier operates aerostructure, assembly and completion facilities in Canada, the United States and Mexico. The company’s robust customer support network includes facilities in strategic locations in the United States and Canada, as well as in the United Kingdom, Germany, France, Switzerland, Italy, Austria, the UAE, Singapore, China and an Australian facility opening in 2022.

For corporate news and information, including Bombardier’s Environmental, Social and Governance report, visit bombardier.com. Learn more about Bombardier’s industry-leading products and customer service network at businessaircraft.bombardier.com. Follow us on Twitter @Bombardier.

Bombardier, Global and Global 7500 are registered or unregistered trademarks of Bombardier Inc. or its subsidiaries.

VistaJet Limited is a European air carrier that operates 9H registered aircraft under its Maltese Air Operator Certificate No. MT-17 and is incorporated in Malta under Company Number C 55231. VistaJet US Inc. is an Air Charter Broker that does not operate aircraft. VistaJet and its subsidiaries are not U.S. direct carriers. VistaJet-owned and U.S. registered aircraft are operated by properly licensed U.S. air carriers, including XOJET Aviation LLC. 

Attachment

• VistaJet x Bombardier