CORPORATE OVERVIEW
September 2023
© 2023 Invivyd, Inc. Invivyd and the Invivyd logo are trademarks of Invivyd, Inc. All trademarks in this presentation are the property of their respective owners.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are forward-looking statements. Words such as "may," "will," "should," "expect," "plan," "anticipate," "seek," "could," "intend," "target," "aim," "project," "designed to," "estimate," "believe," "predict," "potential" or "continue" or the negative of these terms or other similar expressions are intended to identify forward- looking statements, though not all forward-looking statements contain these identifying words. Forward-looking statements include statements concerning, among other things, our mission to rapidly deliver antibodies that protect vulnerable populations from viral threats; the future of the COVID-19 landscape; our expectations regarding the size of target patient populations and the potential market opportunity for our product candidates, as well as our market position; our beliefs regarding the clinical utility of anti-SARS-CoV-2 monoclonal antibodies (mAbs) and our product candidates; the potential of our platform-based approach to continuously discover and optimize mAb candidates that can perpetually protect the vulnerable from serious viral threats; the anticipated broad activity and prolonged utility of VYD222; our ongoing research and clinical development plans and the timing thereof, including with respect to VYD222; the possibility of a unique, rapid development pathway to potential emergency use authorization (EUA) in the U.S. for mAbs using immunobridging via serum neutralizing titers; the anticipated CANOPY clinical trial design, including our plans to use an immunobridging approach comparing data obtained in the CANOPY clinical trial to certain historical adintrevimab data; our expectation to rapidly generate clinical data in the CANOPY clinical trial for a potential VYD222 EUA submission, and the timing of anticipated initial primary endpoint data from the CANOPY clinical trial; our plans to generate a robust pipeline of product candidates which, if authorized or approved, could be used in prevention or treatment of serious viral diseases, starting with COVID-19 and expanding into influenza and other high-need indications; our belief that our existing cash resources will be sufficient to support operating runway into the fourth 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 timing and progress of our discovery, preclinical and clinical development activities; our ability to rapidly generate the clinical data needed from the CANOPY clinical trial to support a potential EUA submission for VYD222; clinical trial site activation or enrollment rates that are lower than expected; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the predictability of clinical success of VYD222 or other product candidates based on neutralizing activity in preclinical studies; the risk that results of preclinical studies or clinical trials may not be predictive of future results in connection with current or future clinical trials; variability of results in models used to predict activity against SARS- CoV-2 variants of concern; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; whether our platform-based approach enables us to continuously discover and optimize mAb candidates that can perpetually protect the vulnerable from serious viral threats; whether VYD222 or any other product candidate is able to demonstrate and sustain neutralizing activity against predominant SARS-CoV-2 variants, particularly in the face of viral evolution; whether we are able to successfully submit an EUA in the future, and the outcome of any such EUA submission; whether our research and development efforts will identify and result in safe and effective therapeutic options for infectious diseases other than COVID-19; 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 presentation are described under the heading "Risk Factors" in our most recent Annual Report on Form 10-K for the year ended December 31, 2022 filed with the Securities and Exchange Commission (SEC), and in our other filings with the SEC, and in our future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this presentation are made as of this date, and we undertake no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.
© 2023 Invivyd, Inc. Invivyd and the Invivyd logo are trademarks of Invivyd, Inc. All trademarks in this presentation are the property of their respective owners.
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INVIVYD IS ON A MISSION TO RAPIDLY DELIVER ANTIBODIES THAT PROTECT VULNERABLE POPULATIONS FROM VIRAL THREATS, STARTING WITH COVID-19
8-18M | Zero | Near-Term Opportunity |
immunocompromised people | authorized or approved | EUA pathway provides the |
in the U.S. alone who may not | monoclonal antibodies | opportunity to rapidly bring a |
adequately respond to | (mAbs) in the U.S. to | much needed therapeutic to |
COVID-19vaccination1-4 | prevent symptomatic | immunocompromised people |
COVID-19 |
References: 1. Harpaz JAMA 2016; 2. Patel Emerg Infect Dis 2020; 3. U.S. 2020 Census Bureau Data; 4. Lee BMJ 2022 | 3 |
MANY IMMUNOCOMPROMISED PEOPLE HAVE AN IMPAIRED RESPONSE TO VACCINES AND LESS PROTECTION AGAINST SEVERE COVID-19 OUTCOMES
Immunocompromised people are less likely to have detectable SARS- CoV-2 antibodies following vaccination than immunocompetent people
Seroconversion rates (detectable Abs) in immunocompromised people vs. immunocompetent controls after two COVID-19 vaccine doses1 [pre-Omicron]
Immunocompromised people generate less protection against severe outcomes than immunocompetent people after bivalent boosters
Vaccine effectiveness against COVID-19-associatedhospitalizations after bivalent booster compared with no vaccination2
Seroconversion rates (%)
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Immunocompetent | Immunocompromised | |||
98% | 98% | 98% |
74%
62%
43%
Haematological | Organ | Immune-Mediated |
cancers | Transplant | Inflammatory |
(Weighted average | (Weighted average | Disorders |
of 19 studies) | of 24 studies) | (Weighted average |
of 17 studies) |
Vaccine effectiveness (%)
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Immunocompetent | Immunocompromised | |||
62%
28% | 24% |
13% | |
7-59 days | 120-179 days |
post bivalent booster | post bivalent booster |
References: 1. Lee BMJ 2022 ; 2. Centers for Disease Control and Prevention, Estimates of Bivalent mRNA Vaccine Durability in Preventing COVID-19-Associated Hospitalization and Critical Illness Among Adults with and Without Immunocompromising Conditions - VISION Network, September 2022-April 2023; Abs, antibodies
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EVEN IN PRIMARILY IMMUNOCOMPETENT POPULATIONS, COVID-19 VACCINE EFFECTIVENESS (VE) HAS WANED
Monovalent boosters provided 90% VE against symptomatic Delta infection vs. 46% VE against symptomatic Omicron infection
VE against symptomatic COVID-19 in primarily immunocompetent1
Monovalent (BNT162b2) | ≥10 wks from monovalent booster |
(following two doses of monovalent vaccine) | |
Delta B.1.617.2 | 90% |
Omicron B.1.1.529 | 46% |
Bivalent boosters have shown 4-29% VE against infection with more recent Omicron variants
VE against SARS-CoV-2 infection in primarily immunocompetent2
Bivalent Booster | Up to 26 wks from |
bivalent booster | |
Omicron BA.4/5 dominant phase | 29% |
Omicron BQ dominant phase | 20% |
Omicron XBB dominant phase | 4% |
A mAb therapeutic that offers more robust protection against current variants would be an important
addition to the COVID-19 medicine cabinet, especially for vulnerable populations
References: 1. Andrews N Engl J Med 2022; 2. Shrestha Open Forum Infectious Diseases 2023
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Invivyd Inc. published this content on 11 September 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 11 September 2023 11:06:05 UTC.