Full Press Release Details
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, MA Nov. 15, 2021 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
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 continues to enroll patients in
its ongoing, global Phase 2/3 STAMP clinical trial evaluating ADG20 as a treatment for COVID-19.
Recent ADG20 Data Presentations at ISIRV-WHO and IDWeek2021
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
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.
Monique Allaire, THRUST Strategic Communications
ADAGIO THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
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
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 |