1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Valuation
Discussion
Symbol
ADGI
Event Date
2021-08-06
Sector
Health Care
Subsector
Biotechnology
Offer Range
$17.00-$17.00
Shares Offered
18.2M
111.25M
$1.8B
16.4%
Implied Upside vs Midpoint
Description
We are a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential. We are developing our lead product candidate, ADG20, for the treatment and prevention of coronavirus disease 2019, or COVID-19, the disease caused by the virus SARS-CoV-2 and its variants. COVID-19 has caused the current global pandemic that remains a significant global health crisis and has resulted in millions of deaths and lasting health problems in many survivors. We believe that COVID-19 will become an endemic disease requiring a variety of effective, safe and convenient treatment and prevention options for years to come. We aim to address COVID-19 and future potential viral outbreaks by building a portfolio of antibodies with broadly neutralizing activity against multiple members of the coronavirus family or additional viruses with pandemic potential. Our portfolio of antibodies was discovered by Adimab, LLC, or Adimab, an industry leader in translating target hypotheses into therapeutically relevant antibodies with their proprietary platform, which has resulted in more than 385 antibody discovery programs, over 40 of which have advanced into clinical trials. ADG20 is designed to be a potent, long-acting and broadly neutralizing antibody for both the treatment and prevention of COVID-19 as either a single or combination agent. Unlike other antibody-based therapies specifically targeting SARS-CoV-2, ADG20 has demonstrated in non-clinical studies an ability to neutralize SARS-CoV-2, including variants of concern, as well as a broad range of SARS-like viruses with neutralization potency at IC50 (half maximal inhibitory concentrations) of approximately 0.01 mcg/mL or less in live-virus cellular assays. We believe this demonstrated in vitro neutralization activity will translate into the ability to conveniently deliver ADG20 as a single intramuscular, or IM, injection. We believe these and other attributes of ADG20 differentiate it from other antibodies that are either available under Emergency Use Authorization, or EUA, or in development to address COVID-19. We have completed enrollment in our first-in-human Phase 1 clinical trial of ADG20. Interim data demonstrated that ADG20 was well tolerated and displayed a pharmacokinetic profile consistent with an extended half-life monoclonal antibody, or mAb. Serum virus neutralizing antibody titers measured the day following administration of ADG20 were similar to or exceeded peak serum neutralizing antibody titers generated after two doses of mRNA or adenovirus-based COVID-19 vaccines. Based on these data, we are conducting two separate Phase 2/3 clinical trials: our STAMP trial to evaluate ADG20 for the treatment of COVID-19 and our EVADE trial to evaluate ADG20 for the prevention of COVID-19. Additionally, our portfolio includes multiple broadly neutralizing antibodies, including ADG10, for potential use with ADG20 as a combination therapy for the treatment and prevention of COVID-19 and future coronavirus outbreaks. Over the past 20 years, three pathogenic novel coronaviruses have spilled over into the human population from animal reservoirs to cause outbreaks of deadly pneumonia, including COVID-19, severe acute respiratory syndrome, or SARS, and Middle East respiratory syndrome, or MERS. Most recently, SARS-CoV-2 has given rise to a global pandemic that swept rapidly throughout the world in 2020. Of significant current concern is the emergence of a number of SARS-CoV-2 variants with increased transmissibility and/or the ability to evade neutralizing antibodies. In addition to the emergence of these variants, there are multiple factors that we believe contribute to the likelihood of COVID-19 becoming an endemic threat, including (1) uneven global rollout of vaccinations; (2) ongoing vaccine hesitancy; (3) unknown duration of immunity and efficacy against current and future viral variants conferred by currently available vaccines; (4) uncertain impact of vaccines on transmission; and (5) variable implementation of virus mitigation efforts, such as wearing masks and social distancing. As a result, our epidemiological modeling has suggested that as much as 50% of the global population may be susceptible to SARS-CoV-2 infection within three years. We also believe that future pandemics similar to the COVID-19 pandemic are likely because, in many parts of the world, humans live in close proximity to animal species harboring SARS-like viruses that are capable of infecting humans. In response to the ongoing pandemic, multiple agents have been discovered, developed and authorized at an unprecedented speed to address COVID-19. Several vaccines have been authorized for the prevention of COVID-19 under public health emergency guidelines both in the United States and abroad. In addition, some mAb therapies, either as a monotherapy or a combination cocktail, have been granted an EUA in the United States and India and are available for use as unauthorized products in certain EU member states for the treatment of mild to moderate COVID-19 in patients at high risk of disease progression. However, we believe additional solutions are required. The recent emergence of SARS-CoV-2 variants has attenuated in vitro neutralization activity of certain currently available mAbs. For example, the U.S. Food and Drug Administration, or the FDA, recently revoked the EUA for one of these mAbs due to its lack of in vitro activity against key variants of concern as a single agent and distribution of a second agent, bamlanvimab/etesevimab, has been paused in the United States due to data showing increased prevalence of two variants resistant to this product, the Gamma (P.1) and Beta (B.1.351) variants. Consistent with in vitro data showing more pronounced loss of neutralization activity for casirivimab and bamlanivimab/etesevimab against the Gamma variant compared to the Alpha variant, preliminary real-world use data from Italy suggest lower clinical efficacy for casirivimab/imdevimab and bamlanivimab/etesevimab against infections due to the Gamma variant. In addition, the use of currently available mAbs for the treatment of COVID-19 has been limited by the inconvenience of their intravenous, or IV, administration, which requires specialized facilities that are properly equipped to accommodate IV infusions in actively infected patients and may lead to a delay in administration. Additional factors that have limited use of mAbs include lack of awareness and education on appropriate use as well as perceived difficulty accessing treatment. We anticipate that these same limitations will apply to any IV-administered mAbs that may be authorized or approved for the prevention of COVID-19. Furthermore, in the setting of prevention, mAbs without sufficiently long half-lives will likely require frequent and periodic administration in order to achieve long-lasting protection. --- We were incorporated under the laws of the State of Delaware in June of 2020. Our principal executive offices are located at 303 Wyman Street, Suite 300, Waltham, MA 02451 and our telephone number is (781) 819-0080. Our website address is www.adagiotx.com.
Invivyd, Inc. annual income statement and balance sheet, FY 2021 to FY 2025, as reported in SEC filings.
| Metric | FY 2021 | FY 2022 | FY 2024 | FY 2025 |
|---|---|---|---|---|
| Revenue | — | — | $25.4M | $53.4M |
| Operating income | ($227M) | ($248M) | ($177M) | ($55.6M) |
| Net income | ($227M) | ($241M) | ($170M) | ($52.5M) |
| Metric | FY 2021 | FY 2022 | FY 2024 | FY 2025 |
|---|---|---|---|---|
| Total assets | $620M | $383M | $130M | $277M |
| Total liabilities | $62.1M | $27.2M | $62.0M | $35.3M |
| Total equity | $558M | $356M | $67.5M | $242M |
| Cash & equivalents | $542M | $92.1M | $69.3M | $227M |