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Adagio Therapeutics Announces ADG20 (adintrevimab) is the First Monoclonal Antibody to Meet Primary Endpoints with Statistical Significance Across Pre- and Post-exposure Prophylaxis and Treatment for COVID-19 and Plans to Seek U.S. Emergency Use Authorization

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.


GLOBENEWSWIRE (Distribution ID 8512575)

Adagio Therapeutics Summarizes ADG20 Neutralizing Activity Against SARS-CoV-2 Variants and Outlines Initiatives to Address Omicron

Recent Publications by Several Independent Laboratories Show ADG20 Has Neutralizing Activity with Potency Comparable to Other Antibodies that Retain Activity Against Omicron

Multiple Efforts Underway to Address Omicron and Potential Future SARS–CoV–2 Variants

WALTHAM, Mass., Jan. 12, 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 with pandemic potential, today summarized recent findings reported in three separate publications that show ADG20, its lead monoclonal antibody (mAb), has neutralization activity against the Omicron (B.1.1.529) variant of SARS–CoV–2, and outlined initiatives to address current and future SARS–CoV–2 variants of concern. Adagio is evaluating ADG20 in its global Phase 2/3 clinical trials for both the prevention and treatment of COVID–19. Adagio is engaging with the U.S. Food and Drug Administration (FDA) regarding potential protocol updates to its global Phase 2/3 clinical trials, including an increased dose of ADG20 for the potential prevention and treatment of COVID–19 resulting from the Omicron variant.

ADG20 Neutralizing Activity Against Omicron
Recently published in vitro studies examined the neutralization potencies of large panels of mAbs against the Omicron variant in both authentic and pseudovirus assays. Findings across all three studies show that among mAbs in late–stage clinical development or with Emergency Use Authorization (EUA), ADG20 is one of only a few mAbs that demonstrated neutralizing activity against Omicron. Across two distinct authentic neutralization assays against Omicron, the data show that ADG20 had an IC50, a measurement of neutralization potency, of approximately 0.4 to 1.1 g/mL, which is comparable with the two other active mAbs, sotrovimab and AZD7742.

"What is critical to assessing potential clinical effectiveness of SARS–CoV–2 mAbs is the neutralization potency by the mAb against a specific variant. While findings may show that ADG20 has reduced potency against Omicron when compared to its high potency against all other variants of concern, including Delta, the data support that ADG20 is among the few mAbs to demonstrate neutralizing activity against the Omicron variant and warrants its continued development," said Laura Walker, Ph.D., chief scientific officer and co–founder of Adagio.

These data add to previously reported in vitro data from a variety of preclinical studies that showed that ADG20 retains activity against other variants of concern including Alpha, Beta, Delta and Gamma, and that ADG20 retains neutralizing activity against a diverse panel of circulating SARS–CoV–2 variants, including the Lambda, Mu and Delta plus variants.

Clinical Trial Update to Address Omicron
Adagio is continuing evaluation of ADG20 in its EVADE and STAMP clinical trials. Adagio is engaging with the FDA on dosing strategy, including an increased dose of ADG20 and other protocol updates in light of the spread of the Omicron variant. Adagio is pausing the enrollment of new patients in the 300 mg dose arm in both clinical trials as the company updates its protocols. Follow–up and monitoring of patients previously administered ADG20 are continuing per the original protocols.

Additional Efforts to Address Omicron and Future Variants
In addition to its clinical trial updates, Adagio is pursuing multiple strategies to address both Omicron and potential future variants that may emerge. Leveraging its exclusive partnership with Adimab LLC, a global leader in antibody engineering, Adagio is exploring the potential to engineer ADG20 to further improve binding to the Omicron variant to enhance its neutralization potency against Omicron while retaining its broad neutralization against other SARS–CoV–2 variants of concern. In parallel, Adagio is assessing several hundred mAbs from its proprietary library of previously isolated SARS–CoV–2 antibodies for their neutralization potency against Omicron. Such an additional neutralizing mAb could be developed as a stand–alone product or as part of a combination approach. These efforts are underway, and the company anticipates preliminary findings from its research in the first quarter of 2022.

"SARS–CoV–2 is a quickly evolving virus, and at Adagio, we are committed to adapting just as quickly. It is abundantly clear that no single product will fully address the evolving nature of the COVID–19 pandemic, and that multiple preventative and therapeutic solutions are needed. Based on both in–house data and third–party findings, we are confident that ADG20 can be an important tool in the fight against this virus," added Tillman Gerngross, Ph.D., co–founder and chief executive officer of Adagio.

About ADG20
ADG20, an investigational monoclonal antibody targeting the spike protein of SARS–CoV–2 and related coronaviruses, is being evaluated in global clinical trials for the prevention and treatment of COVID–19, the disease caused by SARS–CoV–2. ADG20 was designed to possess high potency and broad neutralization activity against SARS–CoV–2 and additional clade 1 sarbecoviruses by targeting a highly conserved epitope in the receptor binding domain. ADG20 was further engineered to provide an extended half–life for durable protection. In vitro data from a variety of preclinical studies have shown that ADG20 retains neutralizing activity against all known SARS–CoV–2 variants of concern. In a Phase 1 trial, ADG20 was well–tolerated with no safety signals identified through a minimum of three months follow–up across all cohorts. ADG20 has not been approved for use in any country, and safety and efficacy have not yet been established.

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, including COVID–19 and influenza. 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 the potential for 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 to support the completion of clinical trials and initial commercial launch, ensuring the potential for broad accessibility to people around the world, if authorized or approved for use. 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 initiation, modification and completion of studies or trials and related preparatory work, including our plans to evaluate dosing regimens and other protocol updates in our clinical trials, the period during which the results of our clinical trials and other studies and research activities will become available, and our research and development programs; our ability to obtain and maintain regulatory approvals for our product candidates; our pursuit of other strategies to address the Omicron variant, including modification of clinical trial protocols; 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, clinical trials and financial position, unexpected safety or efficacy data observed during preclinical studies or clinical trials, the predictability of clinical success of ADG20 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. 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 Quarterly Report on Form 10–Q for the quarter ended September 30, 2021 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


GLOBENEWSWIRE (Distribution ID 8425948)

Adagio Therapeutics Reports Reduction in In Vitro Neutralizing Activity of ADG20 Against Omicron SARS-CoV-2 Variant

WALTHAM, Mass., Dec. 14, 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 provided an update following external in vitro analyses to evaluate neutralizing activity of ADG20 against the Omicron SARS–CoV–2 variant. The in vitro data generated through both authentic and pseudovirus testing of the Omicron variant show a greater than 300–fold reduction in neutralizing activity of ADG20 against Omicron. Additional analyses are ongoing, and the company plans to engage with regulatory and government agencies to assess the role ADG20 can play for the prevention and treatment of COVID–19, particularly as the industry's understanding of the epidemiology and impact of Omicron and potential new variants develops.

"Due to the highly conserved and immunorecessive nature of the epitope recognized by ADG20, we anticipated that ADG20 would retain neutralizing activity against Omicron, consistent with activity observed in in vitro models with all other known variants of concern," said Tillman Gerngross, Ph.D., chief executive officer of Adagio. "While the individual mutations present in the Omicron receptor binding domain were not associated with escape from ADG20 in the context of an original strain of the virus, new data show that the combination of mutations present in the Omicron spike protein led to a reduction in ADG20 neutralization that was not suggested by prior data. The continued prevalence of the Delta variant in the U.S. and other countries, evolution of SARS–CoV–2 variants and potential future coronaviruses means a multitude of therapies and approaches are needed. With an expert team committed to advancing antibody solutions that combat this unprecedented pandemic and a strong balance sheet, we're conducting additional analyses to assess the optimal path forward with ADG20 as both a prophylactic and treatment option for COVID–19."

ADG20 is an investigational monoclonal antibody (mAb) product candidate designed to provide broad and potent neutralizing activity against SARS–CoV–2, including variants of concern, for the prevention and treatment of COVID–19 with potential duration of protection for up to one year with a single injection. In previously disclosed in vitro studies, ADG20 retained activity against prior variants of concern including Alpha, Beta, Delta and Gamma. In addition, in vitro data demonstrated retained neutralizing activity of ADG20 against a diverse panel of circulating SARS–CoV–2 variants, including the Lambda, Mu and Delta plus variants. The safety and efficacy of ADG20 have not been established, and ADG20 is not authorized or approved for use in any country.

Adagio is currently evaluating ADG20 in global Phase 2/3 clinical trials for both the prevention and treatment of COVID–19. Based on the in vitro findings related to Omicron, Adagio plans to pause patient recruitment in its Phase 2/3 COVID–19 treatment trial at clinical sites in South Africa, where Omicron has emerged as the dominant variant. Adagio is evaluating next steps for its ADG20 program.

In vitro analyses were also conducted on ADG10, a second mAb in development, which showed minimal neutralizing activity against the Omicron variant in both authentic and pseudovirus neutralization assays.

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, including COVID–19 and influenza. 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 the potential for 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 to support the completion of clinical trials and initial commercial launch, ensuring the potential for broad accessibility to people around the world. 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 future program updates and the initiation, modification 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; the additional and ongoing analyses to evaluate the activity of ADG20 against the Omicron variant and the potential of ADG20 to play a role as both a prophylactic and a treatment option for COVID–19; the risk/benefit profile of our product candidates to patients; and the adequacy of our cash, cash equivalents and marketable securities. 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, clinical trials and financial position, unexpected safety or efficacy data observed during preclinical studies or clinical trials, 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. 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 Quarterly Report on Form 10–Q for the quarter ended September 30, 2021 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: Investor Contact:
Dan Budwick, 1AB Monique Allaire, THRUST Strategic Communications
Dan@1abmedia.com monique@thrustsc.com


GLOBENEWSWIRE (Distribution ID 8411191)

Adagio Therapeutics Reports That None of the Mutations Present in SARS-CoV-2 Variant, Omicron, Are Associated with Escape from ADG20 Neutralization In Vitro

Additional in vitro studies to determine neutralization activity of ADG20 against Omicron are ongoing

ADG20 EUA submissions planned for prevention and treatment of COVID–19 in mid–2022

Inventory build continues in anticipation of EUA in second half of 2022, with 4 million doses available for distribution over the next two years

WALTHAM, Mass., Nov. 29, 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 provided information related to the potential of its lead SARS–CoV–2 antibody, ADG20, to address the Omicron SARS–CoV–2 variant, and other known variants of concern. ADG20 is an investigational monoclonal antibody (mAb) product candidate designed to provide broad and potent neutralizing activity against SARS–CoV–2, including variants of concern, for the prevention and treatment of COVID–19 with potential duration of protection for up to one year in a single injection.

"The continued global scale of the COVID–19 pandemic has led to increased levels of immune pressure on the virus, which is driving the emergence of variants containing mutations associated with escape from common classes of neutralizing antibodies induced by natural infection or vaccination. Unlike most antibodies currently available under EUA, ADG20 has been shown to target an epitope that is highly conserved among clade I sarbecoviruses and that is not readily targeted by the endogenous neutralizing antibody response," said Laura Walker, Ph.D., co–founder and chief scientific officer of Adagio. "Due to the highly conserved and immunorecessive nature of the epitope recognized by ADG20, we expect that ADG20 will retain activity against Omicron, as we have observed in in vitro models with all other variants of concern identified previously. Further, none of the mutations present in the spike protein of the Omicron variant have been associated with escape from ADG20 neutralization. ADG20 was engineered for potent and broadly neutralizing activity in anticipation of both the rapid antigenic evolution of SARS–CoV–2 and the emergence of future SARS–like viruses with pandemic potential."

"ADG20 was uniquely designed to combine breadth, potency and duration of protection against SARS–CoV–2 for up to one year in a single injection. We did this anticipating that SARS–CoV–2 would continue to evolve and potentially render some early therapies and vaccines obsolete," said Tillman Gerngross, Ph.D., co–founder and chief executive officer of Adagio. "Our global clinical trials are advancing with potential EUA submissions in mid–2022 for both prevention and treatment of COVID–19. We continue to engage with the FDA and other regulatory bodies and governmental agencies to discuss potential acceleration of development plans and the need for a portfolio of therapeutic solutions to combat the COVID–19 pandemic."

Given the significant potential health crisis resulting from the emergence of Omicron, Adagio is undertaking a number of activities to support ADG20's utility in addressing this newly emerged variant of concern, including:

  • Conducting in vitro studies to evaluate the expected binding and neutralizing activity of ADG20 against Omicron. Initial data from these studies is anticipated by the end of the year; and
  • Recruiting patients in Adagio's Phase 2/3 COVID–19 treatment trial, known as STAMP, across several clinical sites in South Africa (along with ongoing clinical trial efforts globally) in an effort to generate clinical data for ADG20 against infections due to the Omicron variant.

Based on the data being generated, Adagio plans to engage with health authorities and government agencies to accelerate development and supply of ADG20 to combat SARS–CoV–2 and its variants of concern.

ADG20 and Variants of Concern
The neutralizing antibody response induced by SARS–CoV–2 infection and vaccination is dominated by three classes of receptor binding domain (RBD)–directed antibodies (Class 1, Class 2 and Class 3), which often share common escape mutations. The newly emerged Omicron (B.1.1.529) variant identified in South Africa contains mutations associated with resistance to a large proportion of these commonly elicited antibodies, which may be due to immune pressure on these antigenic sites. Data for most antibodies available under EUA or in late–stage clinical development show they target one of these three dominant antigenic regions within the RBD.

In vitro studies have shown that ADG20 binds to a highly conserved epitope within the RBD that is not targeted by any of the common classes of neutralizing antibodies induced by SARS–CoV–2 infection and vaccination. Thus, unlike many other clinical–stage antibodies, which were isolated from COVID–19 patients and recognize epitopes that are also targeted by endogenous neutralizing antibodies, there is limited immune pressure on the ADG20 binding site. The ADG20 epitope has remained conserved in 99.99% of the nearly 4 million full length SARS–CoV–2 viral sequences deposited in the GISAID database as of October 15, 2021, and, as shown in in vitro studies, ADG20 retains activity against prior variants of concern including Alpha, Beta, Delta, and Gamma. For the Omicron variant, none of the mutations present in the spike protein are associated with escape from ADG20 neutralization. Based on published epitope mapping and structural studies, Adagio anticipates that ADG20 will retain neutralizing activity against the Omicron variant whereas other mAb products may lose substantial activity against this variant.

Previously disclosed in vitro data demonstrated retained neutralizing activity of ADG20 against a diverse panel of circulating SARS–CoV–2 variants, including the recently emerged Lambda, Mu and Delta plus variants. Notably, findings from these in vitro studies showed that ADG20 demonstrated potent neutralizing activity against all SARS–CoV–2 variants of concern tested, including those with reduced susceptibility to mAb products currently available under EUA or in late–stage development.

About ADG20
ADG20, an investigational monoclonal antibody targeting the spike protein of SARS–CoV–2 and related coronaviruses, is advancing through global clinical trials 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 activity against SARS–CoV–2 and additional clade 1 sarbecoviruses by targeting a highly conserved epitope in the receptor binding domain. ADG20 was further engineered to provide an extended half–life for durable protection. ADG20 has demonstrated potent neutralizing activity against the original SARS–CoV–2 virus, SARS–CoV–2 variants of concern Alpha, Beta, Delta, and Gamma, other SARS–CoV–2 variants to date, and additional SARS–like viruses in preclinical studies. ADG20 is administered in clinical trials by a single intramuscular injection. To date, ADG20 has been well–tolerated in a Phase 1 trial with no safety signals identified through a minimum of three months follow–up across all cohorts. ADG20 has not been approved for use in any country, and safety and efficacy have not yet been established.

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, including COVID–19 and influenza. 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 the potential for 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 to support the completion of clinical trials and initial commercial launch, ensuring the potential for broad accessibility to people around the world. 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 EUA submissions, initiation, modification 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; the expected neutralizing activity of ADG20 against the Omicron variant; our ability to obtain and maintain regulatory approvals for, our product candidates; our ability to identify patients, including in specific populations, with the diseases treated by our product candidates and to enroll these patients in our clinical trials; our expectations regarding the scope of any approved indication for ADG20; and the risk/benefit profile of our product candidates to patients; our manufacturing capabilities and strategy, including plans for doses available in the near future; 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, the impacts of the COVID–19 pandemic on our business, clinical trials and financial position, unexpected safety or efficacy data observed during preclinical studies or clinical trials, 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. 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 Quarterly Report on Form 10–Q for the quarter ended June 30, 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 September 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


GLOBENEWSWIRE (Distribution ID 8401774)

Adagio Therapeutics Provides Update for ADG20 COVID-19 Antibody Program and Reports Third Quarter 2021 Financial Results

FDA Feedback Supports Planned Emergency Use Authorization (EUA) Submission for ADG20 for Prevention of COVID–19; Interim Clinical Data Package from EVADE Prevention Trial to Support EUA Submission Expected in Second Quarter 2022

Enrollment Progressing in ADG20 STAMP Trial for Treatment of COVID–19; Planned Interim Efficacy Analysis Expected in Second Quarter 2022 to Support Potential EUA Submission

WALTHAM, Mass., Nov. 15, 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 provided an update on its lead COVID–19 antibody program, ADG20, and reported third quarter 2021 financial results. ADG20 is an investigational monoclonal antibody product candidate designed to provide broad and potent neutralizing activity against SARS–CoV–2, including variants of concern, for the prevention and treatment of COVID–19.

"ADG20 continues to be the only monoclonal antibody in late–stage development that has the potential to offer a unique combination of potency, breadth of neutralization across known SARS–CoV–2 variants of concern as well as additional SARS–like viruses with pandemic potential, and durable protection against COVID–19 for up to one year. Further, our single injection delivery avoids the inconveniences associated with IV administration or multiple injections," said Lynn Connolly, M.D., Ph.D., chief medical officer of Adagio. "The world continues to face a host of challenges in fully addressing the COVID–19 crisis. Alternatives or supplements to vaccines for the prevention of COVID–19 are needed for immunocompromised individuals and those who remain hesitant to receive a vaccine or to vaccinate their children. Certain patient populations may not be ideal candidates for emerging oral treatment options due to adherence concerns, comorbidities or possible drug interactions. Based on its combined attributes, ADG20 has the potential to be a differentiated alternative for the prevention and treatment of COVID–19 that may address the needs of these populations, and our commitment to its advancement is unwavering."

"We've made significant progress over the course of 2021, and 2022 is set to be a landmark year for Adagio as we prepare for potential EUA submissions for ADG20 for the prevention and treatment of COVID–19," said Tillman Gerngross, Ph.D., co–founder and chief executive officer of Adagio. "We recently received clear feedback from the FDA on a strategy to submit an EUA for ADG20 for the prevention of COVID–19, and have initiated efforts to expand our clinical program to additional patient subsets, including immunocompromised individuals and children. Our commercial–readiness efforts are well underway and with a strong balance sheet, we are ready to move quickly to enable access to individuals in need of COVID–19 prevention and treatment options, if authorization and/or approval is granted."

ADG20 COVID–19 Program Updates

Prevention
Adagio continues to enroll adult and adolescent participants in its ongoing, global Phase 3 EVADE clinical trial evaluating ADG20 as a prevention for COVID–19 in both the pre–exposure and recent exposure settings.

  • Adagio has received feedback from the U.S. Food and Drug Administration (FDA) on a data package needed and a pathway for an EUA submission for the pre–exposure prevention of COVID–19
  • Adagio anticipates that the data package to support an EUA for ADG20 will be available in the second quarter of 2022 followed by expected submission to the FDA in the third quarter of 2022
  • Adagio plans to add a new cohort in EVADE to evaluate ADG20 as a preventative option in immunocompromised individuals, with enrollment expected to begin in the first quarter of 2022
  • Adagio also plans to initiate a trial evaluating ADG20 as a vaccine supplement
  • Following discussion with the FDA, Adagio has aligned on a plan to evaluate ADG20 as a preventative option in the pediatric population, with a trial in individuals between two and 11 years of age expected to be initiated by mid–year 2022

Treatment
Adagio continues to enroll patients in its ongoing, global Phase 2/3 STAMP clinical trial evaluating ADG20 as a treatment for COVID–19.

  • Adagio is planning to modify the trial design in order to expand the at–risk patient population eligible for enrollment in STAMP
  • Based on current enrollment, Adagio anticipates reaching the Phase 2 independent data monitoring committee evaluation in the first quarter of 2022 and the interim efficacy analysis in the second quarter of 2022 to potentially support a subsequent EUA submission

Recent ADG20 Data Presentations at ISIRV–WHO and IDWeek2021

  • New in vitro data demonstrated retained neutralizing activity of ADG20 against a diverse panel of circulating SARS–CoV–2 variants, including the newly emerged Lambda, Mu and Delta plus variants. Notably, findings showed that ADG20 demonstrated potent neutralizing activity against all SARS–CoV–2 variants of concern tested, including those with reduced susceptibility to mAb products currently available under EUA or in late–stage development.
  • Data from a six–month evaluation in Adagio's Phase 1 healthy volunteer trial of ADG20 confirmed the extended half–life of ADG20, which approached 100 days based on data from the 300 mg intramuscular dose that was given as a single injection. In addition, an exploratory analysis showed that 50% serum virus neutralization titers at six months after a 300 mg intramuscular dose of ADG20 were similar to observed peak titers with the mRNA–1273 vaccine and exceeded those achieved with the AZD1222 vaccine series. ADG20 was well–tolerated with no study drug–related adverse events (AEs), serious AEs, or injection–site or hypersensitivity reactions reported through a minimum of three months follow–up across all cohorts.
  • To support dose selection for Adagio's global Phase 2/3 STAMP and EVADE clinical trials, the company modified an existing quantitative systems pharmacology whole–body physiologically–based pharmacokinetic (QSP/PBPK) model to better characterize the PK of extended half–life mAbs in serum and key sites of viral replication in the respiratory tract. Adagio's model adequately a priori predicted the observed ADG20 serum PK in non–human primates (NHPs) and humans. The model was further optimized based on data from Adagio's Phase 1 clinical trial and then applied for dose selection for STAMP and EVADE, ultimately informing selection of the 300 mg intramuscular dose for the trials.

Intellectual Property

On October 29, 2021, the United States Patent and Trademark Office mailed a notice of allowance to the company for a patent application that will provide patent protection for ADG20 in the U.S.

Third Quarter 2021 Financial Results

  • As of September 30, 2021, Adagio had cash, cash equivalents and marketable securities of $666.3 million, which are expected to support the company's current operating plans into 2023.
  • Research & development expenses including in–process research and development for the third quarter of 2021 were $49.4 million.
  • Selling, general & administrative expenses for the third quarter of 2021 were $11.1 million.
  • Net loss for the third quarter was $60.4 million, or $0.98 per share.

About ADG20
ADG20, an investigational monoclonal antibody targeting the spike protein of SARS–CoV–2 and related coronaviruses, is advancing through global clinical trials 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 activity against SARS–CoV–2 and additional clade 1 sarbecoviruses by targeting a highly conserved epitope in the receptor binding domain. ADG20 was further engineered to provide an extended half–life for durable protection. ADG20 has demonstrated potent neutralizing activity against the original SARS–CoV–2 virus, all known SARS–CoV–2 variants of concern and additional SARS–like viruses in preclinical studies. ADG20 is administered in clinical trials by a single intramuscular injection. To date, ADG20 has been well–tolerated in a Phase 1 trial with no safety signals identified through a minimum of three months follow–up across all cohorts. ADG20 has not been approved for use in any country, and safety and efficacy have not yet been established.

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, including COVID–19 and influenza. 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 the potential for 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 to support the completion of clinical trials and initial commercial launch, ensuring the potential for broad accessibility to people around the world. 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 EUA submissions, initiation, modification 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, including in specific populations, with the diseases treated by our product candidates and to enroll these patients in our clinical trials; our expectations regarding the scope of any approved indication for ADG20; and the benefits of our product candidates to patients; 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, the impacts of the COVID–19 pandemic on our business, clinical trials and financial position, unexpected safety or efficacy data observed during preclinical studies or clinical trials, 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. 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 Quarterly Report on Form 10–Q for the quarter ended June 30, 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 September 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)

September 30,
2021		 December 31,
2020
Assets
Current assets:
Cash and cash equivalents $ 478,269 $ 114,988
Marketable securities 188,053 ""
Prepaid expenses and other current assets 13,833 2,394
Total current assets 680,155 117,382
Other non–current assets 6,115 ""
Total assets $ 686,270 $ 117,382
Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit)
Current liabilities:
Accounts payable $ 17,564 $ 8,153
Accrued expenses 35,485 4,919
Total current liabilities 53,049 13,072
Early–exercise liability 8 11
Total liabilities 53,057 13,083
Commitments and contingencies
Convertible preferred stock (Series A, B and C) $0.0001 par value; no shares authorized, issued and outstanding at September 30, 2021; 12,647,934 shares authorized, issued and outstanding at December 31, 2020; aggregate liquidation preference of $0 and $169,900 at September 30, 2021 and December 31, 2020, respectively "" 169,548
Stockholders' equity (deficit):
Preferred stock:
Undesignated preferred stock, $0.0001 par value; 10,000,000 shares authorized at September 30, 2021; no shares authorized at December 31, 2020; no shares issued and outstanding at September 30, 2021 and December 31, 2020 "" ""
Common stock, $0.0001 par value; 1,000,000,000 shares authorized at September 30, 2021; 150,000,000 shares authorized at December 31, 2020; 111,251,660 shares issued and outstanding at September 30, 2021; 28,193,240 shares issued and 5,593,240 shares outstanding at December 31, 2020 5 1
Treasury stock, at cost; no shares and 22,600,000 shares at September 30, 2021 and December 31, 2020, respectively "" (85 )
Additional paid–in capital 842,272 154
Accumulated other comprehensive income 3 ""
Accumulated deficit (209,067 ) (65,319 )
Total stockholders' equity (deficit) 633,213 (65,249 )
Total liabilities, convertible preferred stock and stockholders' equity (deficit) $ 686,270 $ 117,382


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

Three Months
Ended
September 30,		 Three Months
Ended
September 30,		 Nine Months
Ended
September 30,		 Period from
June 3, 2020
(Inception) to
September 30,
2021 2020 2021 2020
Operating expenses:
Research and development(1) $ 45,366 $ 7,251 $ 114,465 $ 7,299
Acquired in–process research and development(2) 4,000 39,915 7,500 39,915
Selling, general and administrative 11,052 842 21,853 892
Total operating expenses 60,418 48,008 143,818 48,106
Loss from operations (60,418 ) (48,008 ) (143,818 ) (48,106 )
Other income (expense):
Interest income 48 "" 80 ""
Other expense (5 ) "" (10 ) ""
Total other income (expense), net 43 "" 70 ""
Net loss (60,375 ) (48,008 ) (143,748 ) (48,106 )
Other comprehensive income (loss)
Unrealized gain on available–for–sale securities, net of tax 3 "" 3 ""
Comprehensive loss $ (60,372 ) $ (48,008 ) $ (143,745 ) $ (48,106 )
Net loss per share attributable to common stockholders, basic and diluted $ (0.98 ) $ (25.98 ) $ (7.06 ) $ (7.55 )
Weighted–average common shares outstanding, basic and diluted 61,297,086 1,847,826 20,346,771 6,375,000

(1) Includes related–party amounts of $1,826 and $2,261 for the three and nine months ended September 30, 2021, respectively, and $291 for both the three months ended September 30, 2020 and for the period from June 3, 2020 (inception) to September 30, 2020.
(2) Includes related–party amounts of $4,000 and $7,500 for the three and nine months ended September 30, 2021, respectively, and $39,915 for both the three months ended September 30, 2020 and for the period from June 3, 2020 (inception) to September 30, 2020.


GLOBENEWSWIRE (Distribution ID 8393495)

Adagio Therapeutics Announces New In Vitro Data Highlighting Broad and Potent Neutralization of ADG20 Against All Known SARS-CoV-2 Variants

WALTHAM, Mass., Oct. 19, 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 announced new in vitro data demonstrating retained neutralizing activity of its monoclonal antibody (mAb), ADG20, against a diverse panel of circulating SARS–CoV–2 variants, including the newly emerged Lambda and Mu variants. Notably, findings show that ADG20 demonstrated potent in vitro neutralizing activity against all SARS–CoV–2 variants of concern tested, including those with reduced susceptibility to mAb products currently available under Emergency Use Authorization (EUA) or in late–stage development. These data will be presented during a poster session at the 2021 ISIRV–WHO Virtual Conference, which is being held October 19–21, 2021. In addition, Adagio will present an encore poster highlighting recently announced data from the company's ongoing Phase 1 trial of ADG20 in healthy participants.

"These new variant data further underscore the potential of ADG20 to address the ongoing COVID–19 pandemic, as well as possible future outbreaks caused by other SARS–like viruses," said Laura Walker, Ph.D., co–founder and chief scientific officer of Adagio. "We have intentionally designed this mAb to have both broad and potent neutralizing activity as well as a half–life that extends its potential window of protection, critical features that may set it apart from other therapies available under EUA or in development today. With global Phase 2/3 prevention and treatment trials ongoing, we look forward to continuing our evaluation of ADG20 to assess the meaningful role it could potentially play in the arsenal of COVID–19 treatment options. Given as a single, intramuscular injection in clinical trials, ADG20 has been designed to offer protection for up to a year in the prevention setting and is being explored as a treatment for high–risk patients and/or as a vaccine supplement, including for immunocompromised individuals."

In addition to the Phase 1 healthy participant trial, Adagio is advancing two ongoing global Phase 2/3 trials with ADG20, a treatment trial (STAMP) and a prevention trial (EVADE). The company anticipates submitting an EUA application to the U.S. Food and Drug Administration for ADG20 in the first quarter of 2022.

Presentation Details
Poster Title: (130) Broad and Potent In Vitro Neutralization of SARS–CoV–2 Variants by ADG20, a Half–Life Extended Monoclonal Antibody in Development for the Prevention and Treatment of COVID–19

Poster Title: (131) Evaluating the Safety, Tolerability, and Pharmacokinetics of ADG20, a Half–Life""Extended Monoclonal Antibody (mAb) in Development for the Prevention and Treatment of COVID–19: a Preliminary Analysis of a Randomized Phase 1 Study

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 in vivo 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 to support the completion of clinical trials and initial commercial launch, ensuring broad accessibility to people around the world. 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 EUA application, 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 Quarterly Report on Form 10–Q for the quarter ended June 30, 2021 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


GLOBENEWSWIRE (Distribution ID 8375129)

Adagio Therapeutics Announces New Data Highlighting the Potential of ADG20 for Treatment and Prevention of COVID-19

ADG20 Continues to be Well Tolerated in Healthy Volunteers with Prolonged Half–Life and Serum Virus Neutralization Activity Observed out to Six Months in Ongoing Phase 1 Study

Data from Quantitative Systems Pharmacology/Whole–Body Physiologically Based Pharmacokinetic Modeling Support Evaluation of 300 mg Intramuscular Dose of ADG20 Given as a Single Intramuscular Injection in Ongoing Phase 2/3 Studies

Data to be Presented During IDWeek 2021 and 19th Annual Discovery on Target Conference

WALTHAM, Mass., Sept. 29, 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 announced new data from the company's COVID–19 antibody program. Updated, six–month data from its ongoing Phase 1 study of ADG20 in healthy participants and data validating the selection of the 300 mg intramuscular (IM) dose given as a single injection that is being evaluated in the company's ongoing global Phase 2/3 treatment (STAMP) and prevention (EVADE) clinical trials will be presented during four poster sessions at the Infectious Disease Society of America's IDWeek 2021, being held from Sept. 29 "" Oct. 3, 2021. In addition, Adagio's chief scientific officer, Laura Walker, Ph.D., will present a subset of the ADG20 Phase 1 data as well as background on the identification and optimization of this differentiated antibody clinical candidate in an oral presentation at the 19th Annual Discovery on Target Conference on Sept. 30, 2021.

"The continued strength of the safety and pharmacokinetic data from our Phase 1 study is encouraging and further underscores the potential impact an antibody like ADG20 "" which was designed to be potent, broadly neutralizing and delivered as a single IM injection "" could have on people with or at risk of COVID–19," said Lynn Connolly, M.D., Ph.D., chief medical officer of Adagio. "These Phase 1 data combined with our dose selection strategy, which relied on our innovative modeling approach, have allowed us to initiate and advance our pivotal trials of ADG20 in the treatment and prevention of COVID–19. We anticipate these data will support an Emergency Use Authorization (EUA) application in the first quarter of 2022, which could enable us to bring an important treatment option to patients."

Phase 1 Trial Update
Adagio is evaluating ADG20 in a Phase 1 randomized, double–blind, placebo–controlled single ascending–dose study to assess safety and tolerability, pharmacokinetics (PK), immunogenicity, and serum virus neutralizing activity of ADG20 ex vivo against SARS–CoV–2. Data from a six–month evaluation timepoint confirmed the extended half–life of ADG20, which approached 100 days based on data from the 300 mg IM dose that was given as a single injection. In addition, 50% serum virus neutralization titers at six months after a 300 mg IM dose of ADG20 were similar to observed peak titers with the mRNA–1273 vaccine and exceeded those achieved with the AZD1222 vaccine series. Importantly, ADG20 was well tolerated with no study drug–related adverse events (AEs), serious AEs, or injection–site or hypersensitivity reactions reported through a minimum of three months follow–up across all cohorts. Participants will continue to be followed through 12 months to assess safety and tolerability, PK, immunogenicity and serum virus neutralizing activity.

Phase 1 Poster Information: (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)

Dose Selection Strategy
To support dose selection for Adagio's global Phase 2/3 STAMP and EVADE clinical trials, the company modified an existing quantitative systems pharmacology whole–body physiologically–based pharmacokinetic (QSP/PBPK) model to better characterize the PK of extended half–life monoclonal antibodies in serum and key sites of viral replication in the respiratory tract. Adagio's model adequately a priori predicted the observed ADG20 serum PK in non–human primates (NHPs) and humans. The model was further optimized based on data from Adagio's Phase 1 clinical trial and then applied for dose selection for STAMP and EVADE.

For the STAMP treatment trial, data compiled to date suggest that the 300 mg IM regimen has a projected ability to rapidly achieve and maintain target concentrations at key tissue sites of viral replication, including the ability to attain near complete (> 90%) and durable (> 28–day) SARS–CoV–2 receptor occupancy across a range of baseline viral loads. Further, for the EVADE prevention trial, data compiled to date suggest the 300 mg IM regimen has a projected ability to rapidly exceed target serum concentrations in the majority of simulated patients and to maintain potentially effective concentrations for up to 12 months.

Dose Selection Poster Information

  • (1086) A Whole–Body Quantitative System Pharmacology Physiologically–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)
  • (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)

The STAMP and EVADE clinical trials are currently ongoing and enrolling patients globally. For more information, please visit clincialtrials.gov.

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 to support the completion of clinical trials and 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 EUA application, 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


GLOBENEWSWIRE (Distribution ID 8334244)

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.


GLOBENEWSWIRE (Distribution ID 8328556)

Adagio Therapeutics Announces Expansion of Patient Population in Global Phase 2/3 Clinical Trial of ADG20 for the Prevention of COVID-19

WALTHAM, Mass., Sept. 10, 2021 (GLOBE NEWSWIRE) — Adagio Therapeutics, Inc., a clinical–stage biopharmaceutical company focused on the discovery, development and commercialization of antibody–based solutions for infectious diseases with pandemic potential, today announced that the independent data monitoring committee (IDMC) for the EVADE Phase 2/3 trial of ADG20 for the prevention of COVID–19 has provided a recommendation to expand Phase 3 trial enrollment to include adolescents and pregnant or nursing women, as well as to decrease the protocol–specified, post injection monitoring time. The IDMC's assessments are based on their review of unblinded safety and tolerability data from 200 participants enrolled in the Phase 2 lead–in portion of the trial. Adagio remains blinded to the data and plans to implement the IDMC recommendations for the Phase 3 portion of the trial. EVADE is being conducted globally, including in regions where there is a high prevalence of SARS–CoV–2 variants of concern, to evaluate the ability of a single, intramuscular dose of ADG20 to prevent COVID–19 in both pre– and post–exposure settings.

"Given the urgent need for additional treatment and preventative options for COVID–19, particularly in vulnerable populations, we are pleased that an independent assessment of the safety data from the lead–in portion of EVADE supported inclusion of adolescents and pregnant or nursing women in the next phase of the study," said Lynn Connolly, M.D., Ph.D., chief medical officer of Adagio. "Based on the potent and broad activity of ADG20 in non–clinical studies, as well as its extended half–life and ease of administration, we believe this antibody has the potential to become a preferred prophylactic option for COVID–19, particularly for vulnerable groups such as children and the immunocompromised, for whom there are currently limited or no available options."

The EVADE trial is a global, multi–center, double–blind, placebo–controlled clinical trial evaluating ADG20 in two independent cohorts. The first cohort (post–exposure prophylaxis) is designed to assess the safety and efficacy of ADG20 compared to placebo for the prevention of COVID–19 after exposure to an individual with laboratory confirmed SARS–CoV–2 infection. The second cohort (pre–exposure prophylaxis) is designed to assess the efficacy and safety of ADG20 compared to placebo in individuals who are at increased risk for SARS–CoV–2 infection due to occupational, housing or recreational situations, and in individuals who are at increased risk of poor vaccine response, including individuals with compromised immune systems or other co–morbidities. The primary efficacy endpoint in both cohorts is the prevention of laboratory confirmed, symptomatic COVID–19. For more information on the EVADE trial, please visit https://clinicaltrials.gov/ct2/show/NCT04859517.

The clinical development program for ADG20 includes two additional trials: the ongoing Phase 1 clinical trial of ADG20 in healthy volunteers and the ongoing STAMP trial evaluating ADG20 as a treatment for high–risk individuals with mild or moderate COVID–19 (see clinicaltrials.gov).

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 formulated at high concentrations, enabling intramuscular administration, 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 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.

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

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


GLOBENEWSWIRE (Distribution ID 8323570)