Full Press Release Details
Adagio Therapeutics Reports Second Quarter 2022 Financial Results and Business Highlights
$475 Million in Cash and Cash Equivalents to Support Operating Runway into Second Quarter of 2024
Integrated Discovery Platform Identifies Multiple New Candidates for COVID-19 Prevention and
Treatment with Plans to Enter Clinical Trials in the First Quarter of 2023
Waltham, MA August 15, 2022 Adagio
Therapeutics, Inc. (Nasdaq: ADGI), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases, today announced financial results and business highlights
for the second quarter ended June 30, 2022.
Adagio continues to leverage its proprietary discovery capabilities to create novel SARS-CoV-2 antibodies intended to overcome current and future viral variants resulting from the ongoing evolution of the SARS-CoV-2 virus. The company has engineered multiple antibodies that not only show activity against all known SARS-CoV-2
variants of concern to date, but which were also identified with the aim to better address future emerging variants. Adagio intends to initiate clinical development of select antibodies in the first quarter of 2023. In parallel, Adagio continues to
follow participants enrolled in its STAMP and EVADE Phase 3 clinical trials evaluating adintrevimab for the treatment and prevention of COVID-19. Adagio has inventory of adintrevimab at-the-ready as a potential EUA-ready candidate should adintrevimab-sensitive variants
We are pleased that our technology has yielded antibodies with the potential to counter future SARS-CoV-2 variants and look forward to advancing multiple candidates as rapidly as possible, said David Hering, Adagio s chief executive officer. Through the
achievement of the primary endpoints in our clinical trials with adintrevimab, and our in vitro studies that indicate its broadly neutralizing and potent activity, we have demonstrated our capabilities in the design and development of
clinically meaningful antibodies. Importantly, our integrated discovery engine continues to generate unique, broadly neutralizing, and potent mAb candidates for COVID-19 as we enhance our investment in our
pipeline of earlier-stage assets. With numerous antibodies identified, we intend to select multiple candidates to advance into the clinic in the first quarter of 2023. We look forward to sharing updates on the company and our long-term strategy, as
well as the progress across our programs and research.
Second Quarter 2022 Financial Results
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. The
company is advancing proprietary antibodies targeting distinct sites with activity against all SARS-CoV-2 variants of concern to date and plans to take a combination of
these antibodies into clinical trials in the first quarter of 2023. Beyond COVID-19, Adagio is leveraging its 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.
Note Regarding 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 (as
well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the future of the COVID-19 landscape including the expectation of continued evolution and emergence of new variants and subvariants; our ongoing research and clinical development plans; our plans to advance adintrevimab or other
early stage candidates as a potential prophylaxis and treatment option for COVID-19, including disease caused by most variants, as either a single or combination agent, including our intention to initiate
clinical development of certain antibodies in the first quarter of 2023; the potential for adintrevimab or any pipeline antibody or combination of antibodies to demonstrate activity against current or future predominant SARS-CoV-2 variant(s) in the U.S. and globally; the availability of adintrevimab supply; the anticipation of ongoing discussions with health authorities; the potential for an
emergency use authorization in the U.S. or other regulatory approval; our plans, technology and resources to develop therapeutic or preventative options for other infectious diseases, such as additional coronaviruses and influenza, in the U.S. and
globally; our belief in the potential to discover and develop pipeline candidates as potent and durable antibodies or combination of antibodies for COVID-19; the expectation that our existing cash and cash
equivalents will be sufficient to fund operating expenses into the second quarter of 2024; 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 or other pipeline candidates or combination of candidates 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; the uncertainties and timing of the regulatory approval process, including the outcome of our discussions with regulatory authorities concerning our clinical trials; whether adintrevimab or any other pipeline
candidate or combination of candidates is able to demonstrate activity against predominant SARS-CoV-2 variant(s) in the U.S. and globally; whether we are able to
successfully submit an emergency use authorization in the future, and the outcome of any such emergency use authorization submission; whether research and development efforts will improve efficacy of adintrevimab against predominant variants or
identify additional monoclonal antibodies or combination of antibodies for the prevention and treatment of COVID-19 and other infectious diseases; whether research and development efforts will identify and
result in safe and effective therapeutic or preventative options for other infectious diseases in the U.S. or globally and whether we have adequate funding to meet future operating expenses and capital expenditure requirements. 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 our Annual Report on Form 10-K for the year ended December 31, 2021 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, each 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 and available at www.sec.gov. 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 whether as a result of new information, future
events or otherwise, except as required under applicable law.
This press release contains hyperlinks to information that is not deemed to be incorporated
by reference in this press release.
Tony Berry, Evoke Canale
Chris Brinzey, ICR Westwicke
ADAGIO THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
thousands, except share and per share amounts)
| June 30, 2022 | December 31, 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 474,885 | $ | 542,224 | ||||
| Marketable securities | 49,194 | |||||||
| Prepaid expenses and other current assets | 6,476 | 25,293 | ||||||
| Total current assets | 481,361 | 616,711 | ||||||
| Property and equipment, net | 91 | 83 | ||||||
| Operating lease right-of-use assets | 2,861 | |||||||
| Other non-current assets | 299 | 3,297 | ||||||
| Total assets | $ | 484,612 | $ | 620,091 | ||||
| Liabilities, Convertible Preferred Stock and Stockholders Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 14,232 | $ | 5,783 | ||||
| Accrued expenses | 52,624 | 56,277 | ||||||
| Operating lease liabilities, current | 969 | |||||||
| Other current liabilities | 58 | |||||||
| Total current liabilities | 67,883 | 62,060 | ||||||
| Early-exercise liability | 1 | 6 | ||||||
| Operating lease liabilities, non-current | 1,889 | |||||||
| Other non-current liability | 6 | |||||||
| Total liabilities | 69,773 | 62,072 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity (deficit): | ||||||||
| Preferred stock (undesignated), $0.0001 par value; 10,000,000 shares authorized and no shares issued and outstanding at June 30, 2022 and December 31, 2021 | ||||||||
| Common stock, $0.0001 par value; 1,000,000,000 shares authorized, 109,773,173 shares issued and 108,780,525 shares outstanding at June 30, 2022; 1,000,000,000 shares authorized, 111,251,660 shares issued and 110,782,909 shares outstanding at December 31, 2021 | 11 | 11 | ||||||
| Treasury stock, at cost; 992,648 shares and 468,751 shares at June 30, 2022 and December 31, 2021, respectively | ||||||||
| Additional paid-in capital | 858,593 | 850,125 | ||||||
| Accumulated other comprehensive loss | (8 | ) | ||||||
| Accumulated deficit | (443,765 | ) | (292,109 | ) | ||||
| Total stockholders equity (deficit) | 414,839 | 558,019 | ||||||
| Total liabilities, convertible preferred stock and stockholders equity (deficit) | $ | 484,612 | $ | 620,091 |
ADAGIO THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
thousands, except share and per share amounts)
| Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development (1) | $ | 37,129 | $ | 35,067 | $ | 129,164 | $ | 69,204 | ||||||||
| Acquired in-process research and development (2) | 2,500 | 3,500 | ||||||||||||||
| Selling, general and administrative | 14,620 | 7,124 | 23,324 | 10,695 | ||||||||||||
| Total operating expenses | 51,749 | 44,691 | 152,488 | 83,399 | ||||||||||||
| Loss from operations | (51,749 | ) | (44,691 | ) | (152,488 | ) | (83,399 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Other income (expense), net | 759 | 18 | 832 | 26 | ||||||||||||
| Total other income (expense), net | 759 | 18 | 832 | 26 | ||||||||||||
| Net loss | (50,990 | ) | (44,673 | ) | (151,656 | ) | (83,373 | ) | ||||||||
| Other comprehensive income (loss) | ||||||||||||||||
| Unrealized gain on available-for-sale securities, net of tax | 8 | |||||||||||||||
| Comprehensive loss | $ | (50,990 | ) | $ | (44,673 | ) | $ | (151,648 | ) | $ | (83,373 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.47 | ) | $ | (178.86 | ) | $ | (1.40 | ) | $ | (663.94 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 108,166,890 | 249,769 | 108,019,051 | 125,574 |