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

UN Chief: Climate Targets Not on Track

U.N. Secretary-General Antonio Guterres expressed concern Monday that the world is not on track to meet several urgent targets in the fight against climate change.

“Based on the present commitments of member states, the world is on a catastrophic pathway to 2.7-degrees [Celsius] of heating, instead of 1.5 we all agreed should be the limit,” Guterres told reporters. “Science tells us that anything above 1.5 degrees would be a disaster.”

To get to 1.5 degrees, the U.N. says wealthier nations need to step up with $100 billion a year between now and 2025.

Greenhouse gas emissions also need to be cut by nearly half by 2030 to enable nations to reach carbon neutrality by the 2050 target. This includes the difficult job of getting countries to phase out the use of polluting coal plants.

“Where I believe there is still a long way to go is in relation to the reduction of emissions,” Guterres said.

Nearly 80% of emissions are from G-20 countries.

Review conference

In November, nations will meet in Glasgow, Scotland, for a key climate conference to review progress on commitments since the 2015 Paris Climate Agreement.

On Monday, Guterres co-hosted with British Prime Minister Boris Johnson a small meeting of key countries for one of the final gatherings ahead of the conference. Guterres and Johnson have both raised alarms that the review conference, known as COP26, cannot fail and that ambitious commitments are needed.

“I think that Glasgow — COP26 — is a turning point for the world,” Johnson told reporters. “It is a moment when we have to grow up and take our responsibilities.”

The U.N. says half of the annual $100 billion in public climate financing needs to go to adaptation efforts in developing countries.

Guterres expressed concern that progress on this has not been sufficient. Although he did point to some movement, including new commitments from Sweden and Denmark on Monday.

“I believe that this 50% might gain traction, but we are still not yet there,” he said.

“It is the developing world that is bearing the brunt of catastrophic climate change in the form of hurricanes and fires and floods, and the real long-term economic damage that they face,” Johnson said. “And yet, it is the developed world that over 200 years has put the carbon in the atmosphere that is causing this acceleration of climate change. And so it really is up to us to help them.”

Climate action activists say it is not spending the money that is holding back accelerated progress.

“The pandemic has shown that countries can swiftly mobilize trillions of dollars to respond to an emergency — it is clearly a question of political will,” said Nafkote Dabi, Oxfam International’s Global Climate Policy lead. “Let’s be clear, we are in a climate emergency. It is wreaking havoc across the globe and requires the same decisiveness and urgency.”

Source: Voice of America

September 20, 2021

Journalists in Europe, US Face Harassment over Pandemic Coverage

When Italian reporter Francesco Giovannetti told protesters that he was covering them for the left-leaning daily La Repubblica, insults poured out with abandon.

It was August 30 in Rome, outside the Ministry of Public Education, and demonstrators were speaking out against Italy’s “green pass,” a COVID-19 measure requiring workers to show proof of vaccination, a negative COVID-19 test, or that they had recovered from the virus.

The verbal assault soon escalated into a physical one when one man, who moments earlier had threatened to kill Giovannetti, began to attack the journalist.

“He beat me in the face,” Giovannetti told VOA. “He landed four or five of these hits.”

The police soon intervened.

Attacked during protests

The attack occurred two days after Italian journalist Antonella Alba was harassed and assaulted while covering similar protests in Rome.

Neither journalist was seriously injured, but Giovannetti’s and Alba’s experiences underscore a broader danger for journalists who cover the pandemic in Europe and the United States.

Journalists have been harassed and attacked over reporting on COVID-19, especially when it comes to coverage of anti-masking campaigns, anti-vaccine campaigns and other forms of COVID-19 denialism.

“We are seen as propaganda right now,” Giovannetti said. “We are a target.”

Anti-media sentiment was on the rise before the pandemic, according to press freedom analysts. But it has intensified in part due to pressure from extremist and populist groups energized against public health mandates and vaccines, said Attila Mong, a correspondent in Berlin for the advocacy group Committee to Protect Journalists (CPJ).

Seen as the enemy

In trying to report about health safety, reporters are being viewed by some as the enemy.

“Most responsible media outlets follow scientific and public health instructions and advice, and they broadcast public health messages around mask wearing, about vaccination, about social distancing,” Mong told VOA. “Given this fact, people who oppose these measures perceive the media outlets as part of the government.”

An international rise in populist rhetoric contributes to this phenomenon, said Reporters Without Borders (RSF) spokesperson Pauline Adès-Mével. “It’s important to recall that some political leaders, such as (former U.S. President) Trump or (Brazil’s president Jair) Bolsonaro, declared the press the enemy of the people,” she told VOA. “Such populist declarations are extremely worrying.”

On August 28, Alba, who reports for Italian public broadcaster Rai News 24, was covering a Rome protest against Italy’s COVID-19 measures. Some of the protesters were affiliated with Forza Nuova – Italian for “New Force” – a far-right, ultra nationalist political party in Italy.

Alba said that demonstrators surrounded her, taunting her for wearing a mask, insulting her and calling the journalist a terrorist. One tried to take Alba’s phone, injuring her in the process.

“I was there to ask (demonstrators), ‘Why are you here?’” Alba told VOA. “My question was very simple, and I couldn’t find an answer that made sense.”

The most coherent explanation was that the green pass would restrict individual freedom. But Alba didn’t buy that. “This is a big contradiction,” Alba said. “If you want freedom, why are you treating me like this? Using violence is not freedom.”

“They wanted to be seen. They wanted to be heard. That’s why I was there, too, because a journalist reports for everybody,” she said.

COVID-19 deniers and anti-vaccination protesters stormed a newsroom of Slovenian public broadcaster RTV on September 3. And in early August, protesters tried to assault the offices of British public broadcaster BBC – but they had the wrong building.

Journalists in the U.S. haven’t been exempt.

The U.S. Press Freedom Tracker has counted at least 24 pandemic-related press freedom incidents over the past 18 months, including five in August alone.

Two reporters were assaulted while covering an anti-vaccination rally in Los Angeles on August 14. Four days later in Miami, WLRN reporter Danny Rivero was assaulted while covering a mask mandate protest.

Rivero told VOA he thinks that some of the protesters, including one who assaulted him, were members of the far-right group, Proud Boys. Some of the protesters were chanting about a conspiracy theory that someone was paying to have a mask mandate instituted, Rivero said.

Across the street, a group of pro-mask mandate demonstrators had gathered.

Rivero was interviewing and taking photos of some of the anti-mask mandate protesters. One of them became angry when Rivero took his photo; a group soon formed around Rivero, shoving him and attempting to take his camera, which was around his neck.

“There was a big guy with a big belly, and he just kept walking up toward me, closer and closer,” Rivero told VOA. “And he started bumping me with his belly, and pushing me back and saying, ‘Take off the freaking camera, or I’m going to smash your face in.’”

Rivero had reported in tense environments before, but the harassment hadn’t gone beyond verbal attacks. He was shocked that people would physically assault him for doing his job.

“I took 30 seconds just to catch my breath a little bit, and then I just went right back to work,” Rivero said. The police advised him against returning to that side of the protest to interview more people, but Rivero didn’t have any issues.

Suspicious of media

The pandemic fury comes at a time when more Americans are suspicious of the media.

A June study from the Reuters Institute for the Study of Journalism found 29% of people surveyed in the U.S. trust the news, placing the U.S. last out of 46 countries analyzed in the report.

The pandemic has provided people who were already wary of the media with the affirmation to double down, according to Kirstin McCudden, managing editor at the U.S. Press Freedom Tracker.

“If you were part of a group that didn’t trust the media to begin with, you can also blame them for the coronavirus coverage,” she told VOA.

“The blame rolls downhill toward journalists,” McCudden said, adding that the media find themselves at an “intersection of being responsible for the news and blamed for the news.”

WLRN reporter Rivero says he views the current environment “as a growing level of not just distrust but disdain for the work that we do.”

“They don’t want to hear things that might force them to question things and that might poke holes in things that they believe, one way or the other. They don’t like to hear that, so we become a target,” Rivero said.

CPJ’s Mong told VOA that news outlets, as well as politicians and authorities, are responsible for addressing this issue.

“Journalists themselves very often don’t come forward because they think it’s already part of their everyday lives,” Mong said. “It’s extremely important that even the slightest cases are investigated.”

For Italian journalist Alba, being assaulted has not deterred her.

“I am continuing to report,” she told VOA. “I’m not afraid.”

Source: Voice of America