September 20, 2021

Adagio Therapeutics Provides COVID-19 Antibody Program Updates as well as Business Highlights and Second Quarter 2021 Financial Results

New Data Supporting Potential of ADG20 for Both the Treatment and Prevention of COVID-19 to be Presented at IDWeek 2021

Patient Population in Global EVADE Phase 2/3 Clinical Trial of ADG20 Expanded following IDMC Assessment

$355.8 Million IPO Completed to Fund Continued Advancement of Portfolio of Antibody-based Solutions for Infectious Diseases with Pandemic Potential

WALTHAM, Mass., Sept. 20, 2021 (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 with pandemic potential, today reported updates on its lead COVID-19 antibody program, ADG20, as well as recent business highlights and second quarter 2021 financial results.

“Across the globe, COVID-19 continues to be a significant health crisis affecting nearly every age group. With the continued emergence of new variants, broadly neutralizing therapies that can be used for both the treatment and prevention of the disease are critical to address the current endemic as well as potential future outbreaks,” said Tillman Gerngross, Ph.D., co-founder and chief executive officer of Adagio. “Our team is working closely with our global CRO partners on the execution of our ongoing global clinical trials of ADG20, STAMP and EVADE, while also preparing for the anticipated worldwide commercialization of ADG20, if approved.

“ADG20 is a highly differentiated antibody that we are advancing through pivotal trials for both the treatment and prevention of COVID-19. We are pleased by the recent assessment of unblinded data by the IDMC for the EVADE trial, and their support of our plans to expand enrollment to include adolescents and pregnant or nursing women,” said Lynn Connolly, M.D., Ph.D., chief medical officer of Adagio. “To date, we have generated a compelling data package for ADG20 that includes broad neutralization of the original SARS-CoV-2 virus and the known variants of concerns in in vitro models as well as a favorable pharmacokinetic and tolerability profile in our Phase 1 trial. Further, at this year’s IDWeek, we will release additional data from our Phase 1 trial as well as details regarding our dose selection process for treatment and prevention, which we believe further support the important role this novel antibody can play in combatting the ongoing pandemic.”

ADG20 COVID-19 Program Highlights

New ADG20 Data to be Presented in Multiple Posters during IDWeek: At the IDWeek 2021 Virtual Conference, Adagio plans to present additional data highlighting the potential for ADG20 to provide protection from COVID-19 for up to one year based on its extended half-life in humans combined with its broad and potent neutralizing ability demonstrated in laboratory testing. In addition, the data support the evaluation of a 300mg dose, delivered as a single intramuscular injection, in the ongoing Phase 2/3 STAMP (treatment) and EVADE (prevention) global clinical trials. The data will be presented in multiple posters, which will be available to registered attendees on the virtual platform throughout the duration of the conference, being held from September 29 – October 3, 2021. The presentations include:
- 1086: A Whole-Body Quantitative System Pharmacology Physicologically-Based Pharmacokinetic (QSP/PBPK) Model that a priori Predicts Intramuscular (IM) Pharmacokinetics of ADG20: an Extended Half-life Monoclonal Antibody Being Developed for the Treatment and Prevention of Coronavirus Disease (COVID-19)
- 633: Preliminary Results from a Phase 1 Single Ascending-Dose Study Assessing Safety, Serum Viral Neutralizing Antibody Titers (sVNA), and Pharmacokinetic (PK) Profile of ADG20: an Extended Half-Life Monoclonal Antibody Being Developed for the Treatment and Prevention of Coronavirus Disease (COVID-19)
- 1089: Use of a Whole-Body Quantitative System Pharmacology Physiologically-Based Pharmacokinetic (QSP/PBPK) Model to Support Dose Selection of ADG20: an Extended Half-Life Monoclonal Antibody Being Developed for the Prevention of Coronavirus Disease (COVID-19)
- 1088: A Whole-Body Quantitative System Pharmacology Physiologically-Based Pharmacokinetic (QSP/PBPK) Model to Support Dose Selection of ADG20: an Extended Half-Life Monoclonal Antibody Being Developed for the Treatment of Coronavirus Disease (COVID-19)
Patient Population Expanded in EVADE following IDMC Data Assessment: The independent data monitoring committee (IDMC) for the EVADE Phase 2/3 trial of ADG20 for the prevention of COVID-19 recently provided a recommendation to expand Phase 3 trial enrollment to include adolescents 12 years and older and pregnant or nursing women, as well as a decrease in the protocol-specified, in-clinic post injection monitoring time. The IDMC’s recommendations were based on their review of unblinded safety and tolerability data through the Day 28 post-treatment visit from 200 participants enrolled in the Phase 2 lead-in portion of the trial.
Partnership with Biocon Biologics Expands the Reach of a Potent and Broadly Neutralizing COVID-19 Antibody Treatment to Patients in India and Select Emerging Markets: In the second quarter of 2021, Adagio partnered with Biocon Biologics Ltd. to combat the ongoing COVID-19 crisis in southern Asia. The partnership provides Biocon rights to manufacture and commercialize an antibody therapy based on ADG20 in India and additional select emerging markets based on the commercial manufacturing process developed for ADG20. As part of the agreement, Biocon will be granted access to data from Adagio’s Phase 2/3 clinical trials as well as its anticipated Emergency Use Authorization package and other regulatory submissions to support approval or emergency authorization in India and other select emerging markets.

Recent Business Highlights

David Hering, Global COVID-19 Vaccine Expert, Appointed as Chief Operating Officer: Adagio recently appointed David Hering as the company’s chief operating officer. Mr. Hering joins Adagio from Pfizer, where he most recently served as the global mRNA business lead, a business specifically created to manage global COVID-19 efforts as well as future vaccines utilizing mRNA technology, and led the launch of the first-ever COVID-19 vaccine in the United States. Prior to his most recent role at Pfizer, Mr. Hering was president, North America at Pfizer, where he led a 700-person organization across a portfolio of vaccine products for COVID-19 and meningococcal and pneumococcal diseases.
$355.8 Million Initial Public Offering (IPO) Successfully Completed: In August 2021, Adagio sold 20,930,000 shares of common stock, including the full exercise of the underwriters’ option to purchase an additional 2,730,000 shares of common stock at a public offering price of $17.00 per share. The gross proceeds of the offering, before underwriting discounts and commissions and other offering expenses payable by Adagio, were approximately $355.8 million.
Collaboration with Scripps: Adagio entered into an exclusive research agreement with The Scripps Research Institute to identify broadly protective vaccine candidates for the prevention of influenza and beta coronaviruses.
Board of Directors Expanded with Industry Leaders to Support Future Growth: Adagio recently announced appointments of three industry veterans and area experts to its board of directors:
- Tom Heyman, former president of the Johnson & Johnson Development Corporation (JJDC);
- Anand Shah, M.D., former deputy commissioner for medical and scientific affairs at the U.S. Food and Drug Administration (FDA); and
- Michael S. Wyzga, president of MSW Consulting, Inc. and former CFO of Genzyme

Second Quarter 2021 Financial Results

As of June 30, 2021, Adagio had cash, cash equivalents and marketable securities of $392.5 million, which includes net proceeds from its Series C financing completed in April. Pro forma cash, cash equivalents and marketable securities as of June 30, 2021 is $719.6 million after giving effect to our initial public offering which closed on August 10, 2021.
Research & development expenses including in-process research and development for the second quarter of 2021 were $37.6 million.
Selling, general & administrative expenses for the second quarter of 2021 were $7.1 million.
Net Loss for the second quarter was $44.7 million, or $0.18 per share.

About ADG20
ADG20, a monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses, is being developed for the prevention and treatment of COVID-19, the disease caused by SARS-CoV-2. ADG20 was designed and engineered to possess high potency and broad neutralization against SARS-CoV-2 and additional clade 1 sarbecoviruses, by targeting a highly conserved epitope in the receptor binding domain. ADG20 displays potent neutralizing activity against the original SARS-CoV-2 strain as well as all known variants of concern. ADG20 has the potential to impact viral replication and subsequent disease through multiple mechanisms of action, including direct blocking of viral entry into the host cell (neutralization) and elimination of infected host cells through Fc-mediated innate immune effector activity. ADG20 is administered by a single intramuscular injection, and was engineered to have a long half-life, with a goal of providing both rapid and durable protection. Adagio is advancing ADG20 through multiple clinical trials on a global basis.

About Adagio Therapeutics

Adagio (Nasdaq: ADGI) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential. The company’s portfolio of antibodies has been optimized using Adimab’s industry-leading antibody engineering capabilities and is designed to provide patients and clinicians with a powerful combination of potency, breadth, durable protection (via half-life extension), manufacturability and affordability. Adagio’s portfolio of SARS-CoV-2 antibodies includes multiple, non-competing broadly neutralizing antibodies with distinct binding epitopes, led by ADG20. Adagio has secured manufacturing capacity for the production of ADG20 with third-party contract manufacturers through the completion of clinical trials and, if approved by regulatory authorities, through initial commercial launch. 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,” “expects,” “intends,” “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 ADG20, including the timing of our planned IND submissions, initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; our ability to obtain and maintain regulatory approvals for, our product candidates; our ability to identify patients with the diseases treated by our product candidates and to enroll these patients in our clinical trials; our manufacturing capabilities and strategy; and our ability to successfully commercialize our product candidates. 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, those risks described under the heading “Risk Factors” in Adagio’s prospectus filed with the Securities and Exchange Commission (“SEC”) on August 6, 2021 and in Adagio’s future reports to be filed with the SEC, including Adagio’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. 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.

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

(In thousands, except share and per share amounts)

	June 30, 2021			December 31, 2020
Assets
Current assets:
Cash and cash equivalents⁽¹⁾	$	392,509		$	114,988
Prepaid expenses and other current assets		3,550			2,394
Total current assets		396,059			117,382
Deferred offering costs		1,933			—
Total assets	$	397,992		$	117,382
Liabilities, Convertible Preferred Stock and Stockholders’ Deficit
Current liabilities:
Accounts payable	$	10,716		$	8,153
Accrued expenses		27,181			4,919
Total current liabilities		37,897			13,072
Early-exercise liability		8			11
Total liabilities		37,905			13,083
Commitments and contingencies
Convertible preferred stock (Series A, B and C) $0.0001 par value; 16,944,484 shares authorized, issued and outstanding at June 30, 2021; 12,647,934 shares authorized, issued and outstanding at December 31, 2020; aggregate liquidation preference of $505,399 and $169,900 at June 30, 2021 and December 31, 2020, respectively		504,711			169,548
Stockholders’ deficit:
Common stock, $0.0001 par value; 150,000,000 shares authorized at June 30, 2021 and December 31, 2020; 5,599,240 shares issued and outstanding at June 30, 2021; 28,193,240 shares issued and 5,593,240 shares outstanding at December 31, 2020		1			1
Treasury stock, at cost; 0 shares and 22,600,000 shares at June 30, 2021 and December 31, 2020, respectively		—			(85	)
Additional paid-in capital		4,067			154
Accumulated deficit		(148,692	)		(65,319	)
Total stockholders’ deficit		(144,624	)		(65,249	)
Total liabilities, convertible preferred stock and stockholders’ deficit	$	397,992		$	117,382

(1) Pro forma cash, cash equivalents and marketable securities as of June 30, 2021 is $719.6 million after giving effect to our issuance and sale of 20,930,000 shares of our common stock in our initial public offering at the price of $17.00 per share after deducting underwriting discounts, commissions and estimated offering costs which closed on August 10, 2021.

ADAGIO THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(UNAUDITED)

(In thousands, except share and per share amounts)

	Three Months Ended June 30,			Six Months Ended June 30,			Period from June 3, 2020 (Inception) to June 30,
	2021			2021			2020 ⁽³⁾
Operating expenses:
Research and development⁽¹⁾	$	35,067		$	69,204		$	48
Acquired in-process research and development⁽²⁾		2,500			3,500			—
Selling, general and administrative		7,124			10,695			50
Total operating expenses		44,691			83,399			98
Loss from operations		(44,691	)		(83,399	)		(98	)
Other income (expense):
Interest income		23			32			—
Other expense		(5	)		(6	)		—
Total other income (expense), net		18			26			—
Net loss and comprehensive loss	$	(44,673	)	$	(83,373	)	$	(98	)
Net loss per share attributable to common stockholders, basic and diluted	$	(0.18	)	$	(0.66	)	$	—
Weighted-average common shares outstanding, basic and diluted		249,769			125,574			21,250,000

(1) Includes related-party amounts of $247 for the three months ended June 30, 2021, $435 for the six months ended June 30, 2021 and $0 for the period from June 3, 2020 (inception) to June 30, 2020.
(2) Includes related-party amounts of $2,500 for the three months ended June 30, 2021, $3,500 for the six months ended June 30, 2021 and $0 for the period from June 3, 2020 (inception) to June 30, 2020.
(3) The results for the period from June 3, 2020 (inception) to June 30, 2020 are the same for the three and six months ended June 30, 2020.

September 20, 2021

Australia Warned Dementia Cases Will Double Within 40 Years

Within 40 years, more than 800,000 Australians — twice as many as now — will be living with dementia, unless a cure is found, according to a new government-sponsored report.

Dementia is the second leading cause of death in Australia.

A new study by the Australian Institute of Health and Welfare, a government agency, has forecast that 1.1 million Australians will live with dementia by 2058, unless major new treatments are discovered.

Dementia is a broad term for a number of conditions that impair the functions of the brain.

In 2019, $2.1 billion was spent in Australia on residential and community-based services, and hospital care for dementia patients, two-thirds of whom are women.

The release of the Australian Institute of Health and Welfare study has coincided with a new awareness campaign by Dementia Australia, a non-profit organization.

Its chief executive, Maree McCabe, says exercise and a sensible diet can offer protection against several types of dementia.

“The main type is Alzheimer’s disease but there are about 100 different types and about 60% of people with dementia have Alzheimer’s disease. But there’s types such as frontotemporal dementia, dementia with lewy bodies, vascular dementia, just to name a few. We can definitely reduce our risk of developing dementia by ensuring that we eat well, that we exercise our body and our brain,” McCabe said.

The World Health Organization has said there are currently more than 55 million people living with dementia globally.

Almost 10 million new cases are diagnosed every year. About a quarter of those are detected in China, the world’s most populous country.

It is estimated that 10 million people currently suffer from the degenerative brain disorder in China. As its population ages, that number is forecast to rise to 40 million by 2050, according to a study by the London School of Hygiene and Tropical Medicine.

The study warned that the annual economic costs to China from dementia could reach $1 trillion in medical expenses and lost productivity as caregivers leave the workforce.

Dementia support groups warn that worldwide, both patients and caregivers face discrimination because of a lack of understanding about the disease that currently has no cure.

Source: Voice of America

September 20, 2021

Pfizer-BioNTech Say Their COVID Vaccine Safe, Effective for 5- to-11-Year-Olds

The Pfizer and BioNTech drug companies said Monday that lower dose shots of their two-dose COVID-19 vaccine are safe and effective for five-to-11-year-old children.

The U.S. company and its German partner BioNTech said trials showed the vaccine was well-tolerated and robust, neutralizing antibody responses at the lower dose levels necessary in younger children.

Pfizer said it plans to soon seek U.S., British and European Union authorization for use of the vaccine for the younger age group, which could greatly expand the scope of the U.S. vaccination effort. About 28 million U.S. children fall into the affected age range, although millions of adults have themselves declined to get the jab.

The U.S. Centers for Disease Control and Prevention says that more than 181 million people have been fully vaccinated in the country, but 70 million others 12 and older have so far, for one reason or another, not been inoculated.

Pfizer said it studied a lower dose — a third of the adult strength — in tests involving more than 2,200 kindergartners and elementary school students, two-thirds of whom were given the vaccine and a third saltwater shots. The company said the children developed antibody levels that were just as strong as exhibited by teenagers and young adults.

With children now back in school, and the delta variant spreading throughout the U.S., parents in many communities have been anxious for government health officials to approve the vaccine for their children.

Children are at lower risk than older people of severe illness or death from COVID-19, the disease caused by the coronavirus, but more than 5 million children in the U.S. have tested positive for COVID-19 and at least 460 have died, according to the American Academy of Pediatrics.

Dr. William Gruber, a pediatrician and Pfizer senior vice president, told The Associated Press that by the end of the month, the company would apply for emergency use of the vaccine for five-to-11-year-olds in the U.S. and shortly thereafter in Britain and Europe.

The U.S. Food and Drug Administration said it would then evaluate Pfizer’s data, a process that could take a few weeks.

U.S. vaccine maker Moderna also is studying its shots for young children. Both Pfizer and Moderna are studying use of the vaccine for children as young as six months old, with results expected later this year.

In Britain, the COVID-19 vaccination campaign for children between the ages of 12 and 15 began Monday at schools around the country.

Meanwhile, some private hospitals in Kolkata, India, bracing for a possible surge in pediatric COVID-19 cases, have enhanced their facilities and provided additional training for health care professionals.

A new study published by the CDC revealed that roughly one in three people who has tested positive for COVID-19 still reported symptoms several weeks after the fact.

The CDC reported that rates were even higher in women, Black people, those older than 40, and those with preexisting conditions. The CDC describes people with “long COVID” as experiencing symptoms more than one month after a positive test result.

The U.S. has more COVID-19 cases than any other country, according to the Johns Hopkins Coronavirus Resource Center, with more than 42 million infections. Around the world, there have been more than 228 million cases and 4.7 million deaths, according to the data.

Singapore reported more than 1,000 new cases Sunday, the highest rate for the country since April 2020. Even with 80% of its population fully vaccinated against the coronavirus, Singapore has paused further reopening.

Source: Voice of America

September 20, 2021

Uganda Launches the Third Edition of the National Guidelines for Integrated Diseases Surveillance and Response

Kampala 20th September 2021:- Uganda launched the Third Edition of the National Guidelines for Integrated Diseases Surveillance and Response (IDSR) at Golden Tulip Hotel in Kampala. The third edition highlights new methods of disease detection, reporting, and provision of real-time surveillance data using new technologies and platforms.

The platforms include event-based disease surveillance, community-based surveillance, one health approach, cross-border surveillance, and electronic IDSR to improve disease surveillance in Uganda at all levels.

The third edition of the IDSR guidelines is meant to upgrade the existing standards of the national disease surveillance system. It seeks to sustain the gains and progress made towards achieving an efficient surveillance system.

The launch also looked at strengthening the commitment of stakeholders to IDSR and enhance ownership of the strategy for prevention and control of diseases and events.

A national rollout plan will also be implemented and will incorporate the national agenda for establishing the core capacity requirements for the International Health Regulations (IHR 2005) and Uganda’s contribution to Global Health Security Agenda (GHSA) especially in containing the different public health events.

The launch was officiated by the State Minister of Health in Charge of General Duties, Hon. Anifa Bangirana Kawooya, who commended stakeholders for the support in finalizing the document but especially WHO for providing the much-needed leadership to produce the IDSR guidelines.

“We are working in tricky times when a disease in one country can easily cross to another, therefore with these guidelines in place, we should equip our systems to detect and respond to diseases effectively,” she said.

The World Health Organization (WHO) Representative to Uganda, Dr. Yonas Tegegn Woldemariam, noted that IDSR is a cost-effective public health method.

“Africa is challenged by recurrent disease outbreaks. These guidelines provide an opportunity to build resilient systems and contribute to attaining the SDGs. COVID-19 has taught us enough about building resilience and preparation for disease outbreaks and we ought to do that,” he said.

He further added that picking lessons from the COVID-19 pandemic, “prompt detection and response are very critical during outbreaks”.

Dr. Yonas further committed WHO’s support to the government in implementing the IDSR guidelines.

The launch was attended by officials from various Ministries and Departments in the Government of Uganda, WHO, AFENET, Center for Disease Control, Africa CDC, Infectious Disease Institute, and the Baylor Foundation.

Source: World Health Organization. Africa

September 20, 2021

MINISTER TÉTE ANTÓNIO CONSIDERS ANGOLA-US PARTNERSHIP PROSPEROUS

Washington – The minister of Foreign Affairs, Téte António, this Sunday, in Washington, considered the strategic partnership between Angola and the United States of America healthy.

“We have had meetings and conversations at various levels. The partnership is a healthy one and I think that this is the assessment that the United States of America has also made”, said the head of the Angolan diplomacy, as part of the visit to Washington by the President of the Republic, João Lourenço.

Minister Téte António said that there is cooperation between Angola and the United States of America in various domains, so obviously the presence of some Angolan ministers in Washington, as part of the presidential delegation aim at dealing with aspects related to economic diplomacy.

In his view, all the components that characterize strategic cooperation are on the right path in relation to the US.

Strategic cooperation between Angola and the United States was signed in 2010.

The minister considered as the “highest point” of the Angolan President’s visit to Washington the participation in the Annual Gala of the International Conservation Caucas Foundation (ICCF), in which he will be awarded for his leadership in environmental conservation.

“The United States of America has shown a lot of interest in the work that Angola has been doing in this area”, he underlined, recalling the recent visit of US congressmen to Angola, particularly to the Okovango project.

He also said that the prize to be awarded to João Lourenço is a deserved recognition of his initiatives, which should make Angola feel proud.

Regarding the participation of the Head of State in the general debate of the 76th session of the General Assembly of the United Nations, Téte António said that Angola will reiterate its defense of peaceful resolution of conflicts, among other issues of a multilateral nature.

Source: Angola Press News Agency

September 20, 2021

NIMI A SIMBI ELECTED PRESIDENT OF FNLA PARTY

Luanda – The delegates to the fifth congress of the historical party FNLA, on Sunday, in Luanda, elected Nimi a Simbi as party president, with 297 votes.

In second place ended up the outgoing president, Lucas Ngonda, with 276 votes, while Fernando Pedro Gomes was the third most voted candidate.

Five candidates ran for office, namely Lucas Benghy Ngonda, Nimi a Simbi, Fernando Pedro Gomes, Tristão Ernesto and Carlito Roberto, in a congress that took place under the motto of the reunification and harmonization of the party, several participants.

The congress, attended by 1,459 delegates, took place under the motto “FNLA united in diversity, we will win”.

The voting process was preceded by the presentation to the delegates of the action programmes of each candidate.

In addition to the election of the president of the party and its Central Committee, the party also approved, during the event, the electoral strategy for the 2022 general elections, as well as the report of accounts of the outgoing Central Committee.

Source: Angola Press News Agency