Full Press Release Details
Corporate Overview September 2024 2024 Invivyd, Inc. Invivy , Pemgar , and the Ribbon logos 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, PEMGARD (pemivibart) as a monoclonal antibody (mAb) for pre-exposure prophylaxis (PrEP) of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise; our plans, strategy and expectations related to
the launch and commercialization of PEMGARDA; the potential of our platform, including with respect to our mAb engineering capabilities, anticipated future immunobridging studies, and the potential commercial opportunity for our product candidates;
the company s general alignment with the U.S. Food and Drug Administration (FDA) on a repeatable immunobridging pathway to future potential Emergency Use Authorization (EUA) for serial, novel mAbs for the prevention and treatment of symptomatic
COVID-19, including the company s beliefs regarding the potential benefits, certain anticipated costs, and possible outcomes of utilizing such pathway; the company s EUA amendment request to the FDA
for PEMGARDA for COVID-19 treatment in certain immunocompromised patients; the company s expectation that, if authorized, PEMGARDA would represent the first and only mAb authorized in PrEP and treatment
of COVID-19 in certain immunocompromised patients; the potential of pemivibart for clinical protection from symptomatic COVID-19 based on the 180-day exploratory clinical efficacy data from the CANOPY clinical trial; the future of the COVID-19 landscape; our beliefs regarding the sufficiency of certain other COVID-19 therapies; our expectations about the potential market opportunity for mAbs, as well as our market position; our research and clinical development efforts, including statements regarding initiation or
completion of studies or trials, the time-frame during which results may become available, and the potential utility of generated data; our expectations regarding advancement of our pipeline and anticipated improved drug profiles; our expectations
regarding the biophysical properties and development of VYD2311; our beliefs regarding potential adjacent opportunities; our business strategies and objectives, and ability to execute on them; our future prospects; 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: how long the EUA granted by the FDA for PEMGARDA for COVID-19 PrEP in certain adults and adolescents with moderate-to-severe immune compromise will remain in effect and whether such EUA is
revoked or revised by the FDA; our ability to maintain and expand sales, marketing and distribution capabilities to successfully commercialize PEMGARDA; changes in expected or existing competition; the outcome of the company s EUA amendment
request for PEMGARDA for COVID-19 treatment in certain immunocompromised patients, and the timing thereof; our ability to effectively utilize an immunobridging pathway to potential EUA for serial, novel mAbs
for the prevention and treatment of COVID-19; whether we are able to successfully submit any future EUA request to the FDA, and the timing, scope and outcome of any such EUA request; uncertainties related to
the regulatory authorization or approval process, and available development and regulatory pathways for authorization or approval of the company s product candidates; changes in the regulatory environment; the timing, progress and results of
our discovery, preclinical and clinical development activities; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the ability to maintain a continued acceptable safety, tolerability and efficacy profile of
any product candidate following regulatory authorization or approval; the predictability of clinical success of our product candidates based on neutralizing activity in nonclinical studies; the risk that results of nonclinical studies or clinical
trials may not be predictive of future results, and interim data are subject to further analysis; our reliance on third parties with respect to virus assay creation and product candidate testing and with respect to our clinical trials; variability
of results in models used to predict activity against SARS-CoV-2 variants; potential variability in neutralizing activity of product candidates tested in different
assays, such as pseudovirus assays and authentic assays; whether pemivibart, VYD2311, or any other product candidate is able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; the complexities of manufacturing mAb therapies; our dependence on third parties to manufacture, label, package, store and distribute clinical
and commercial supplies of our product candidates; whether we are able to provide sufficient commercial supply of PEMGARDA to meet market demand; whether we can obtain and maintain third-party coverage and adequate reimbursement for PEMGARDA or any
other product candidate; whether we are able to achieve high potency and/or variation resistance with our future product pipeline; any legal proceedings or investigations relating to the company; our ability to continue as a going concern; 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 Annual Report on Form 10-K for the year ended December 31, 2023 and our Quarterly Report on Form
10-Q for the quarter ended June 30, 2024, each 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. 2
AGENDA What We Do How We Do It Where We Are What Comes Next 3
IT S 2024 AND YET Approximately every 8 MINUTES, a person in the U.S. DIES with COVID-19* COVID-19=coronavirus disease 2019. *Calculation based on provisional CDC data (from Oct 1, 2023 start date of RESP-NET,
through June 15, 2024, ~45,200 people in the U.S. died with COVID-19). Reference CDC. COVID Data Tracker. Accessed July 8, 2024.
SO, WHILE YOU WERE Getting ready in Having lunch Watching a Sleeping the morning with your colleague
movie on Netflix 15 minutes 60 minutes 2 hours 8 hours 2 7 14 56 PEOPLE IN THE U.S. DIED WITH COVID-19 COVID-19=coronavirus disease 2019. Calculation based on
provisional CDC data (from Oct 1, 2023 start date of RESP-NET, through June 15, 2024, ~45,200 people in the U.S. died with COVID-19). Reference CDC. COVID Data
Tracker. Accessed July 8, 2024. https://covid.cdc.gov/covid-data-tracker/#trends_weeklydeaths_select_00
MOREOVER, COVID-19 PLAYS NEVERENDING ROULETTE WITH OUR OVERALL HEALTH
Cumulative Incidence of Post-acute Sequelae ( Long COVID ) of COVID-19 Infection1 3.5% to 7.8% chance of developing Long COVID1 Reinfection may be the norm2* COVID-19=coronavirus disease 2019; PCR=polymerase chain reaction; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2. *COVID-19 reinfection defined as a positive SARS-CoV-2 PCR or antigen test that occurred 60 or more days after a COVID-19 infection index date. The date of the test was considered the first COVID-19 reinfection index date. Subsequent reinfections were defined as a new positive SARS-CoV-2 PCR or antigen test that occurred 60 or more days after each reinfection index date. References: 1. Xie Y, et al. N Engl J Med. Published online July 17, 2024.
doi:10.1056/NEJMoa2403211. 2. Hadley E, et al. Commun Med. 2024; doi: 10.1038/s43856-024-00539-2. 6
COVID-19 IS THE MOST DAMAGING AND DEADLY OF PREVALENT RESPIRATORY
VIRUSES COVID-19 is the leading cause of hospitalizations and death from respiratory viruses in the U.S. (2023-2024 data)* Hospitalizations1* Deaths* COVID-19 460,000
45,2002 INFLUENZA 272,000 9,9003 RSV 179,000 ~6,000 10,0004 COVID-19=coronavirus disease 2019; RSV=respiratory syncytial virus. *From Oct 1, 2023, through June 15, 2024; hospitalizations for
all 3 viruses calculated based on 334.9 million US Census Bureau estimate of US population size and CDC reported rates of hospitalizations. RSV death data are an estimate from the CDC prior to the
COVID-19 pandemic. Estimate in adults aged 65 years prior to the COVID-19 pandemic. Mortality data for the 2023-2024 season are not currently available.
References: 1. CDC. RESP-NET. Accessed July 8, 2024. https://www.cdc.gov/resp-net/dashboard/?CDC 2. CDC. COVID Data Tracker. Accessed July 8, 2024.
https://covid.cdc.gov/covid-data-tracker/#trends_weeklydeaths_select_00 3. CDC. FluView. Accessed July 8, 2024. https://gis.cdc.gov/grasp/fluview/mortality.html 4. CDC. Readout of Advisory Committee on Immunization Practices Meeting Held
June 26 28, 2024. Accessed July 8, 2024. https://www.cdc.gov/media/releases/2024/s-0627-immunization-practices-meeting.html 7
THE VIRUS WILL NEVER GO AWAY 2021 2022 2023 2024 June July 11, 2, 2021 August 31, 2022
January 10, 2024 July 2, 2021 December 22, 2023 June 19, 2024 August 12, 2021 December 22, 2023 January 23, 2024 EVERY YEAR, THE SAME STORY: COVID-19 IS IN NONSTOP EVOLUTION COVID-19=coronavirus disease 2019. All trademarks and logos displayed are the property of their respective owners. Their use here is for identification purposes only and does not constitute endorsement or
COVID-19 BURDEN RESTS DISPROPORTIONATELY ON THE IMMUNOCOMPROMISED
Updated INFORM study data from England (1H 2023) found that in a sample of nearly 12 million people1: Immunocompromised people represented only Immunocompromised people accounted 4% of the study population for: EPOCH 2022 analysis2 ~23%
of COVID-19 Immunocompromised Immunocompetent hospitalizations people accounted for YET T ~30% of total costs for first COVID-19 hospitalization ~22% of COVID-19 despite accounting for only deaths ~3% of the study population Immunocompromised Even though almost 73% of the immunocompromised population had received 4
COVID-19 vaccine doses COVID-19=coronavirus disease 2019; EPOCH=Emerging Populations and Outcomes associated with COVID-19-Health Conditions in the United States; INFORM=INvestigation oF cOvid-19 Risk among iMmunocompromised populations. References: 1. Dube S, et al. Continued
increased risk of COVID-19 hospitalisation and death in immunocompromised individuals despite receipt of 4 vaccine doses: updated 2023 results from INFORM, a retrospective health database study in
England. Presented at ECCMID 2024 [posterP0409]; Barcelona, Spain; 2. Ketkar A, et al. Adv Ther. 2024;41(3):1075-1102. 9
WE BELIEVE COVID-19 VACCINES ARE INSUFFICIENT FOR REAL PROTECTION,
ESPECIALLY FOR IMMUNOCOMPROMISED PEOPLE Adults 18 years by 2023 2024 COVID-19 Vaccine1 immunocompromise/ Adjusted Vaccine Effectiveness Against Hospitalization vaccination status/days since dose [%,
(95% Confidence Interval)] The sole 2023-24 Vaccine Effectiveness (VE) estimate data Immunocompromised available for 2023 2024 vaccine dose, 7 days 29% (18 38) Immunocompromised (IC) 7 59
days earlier 38% (23 50) persons presented to ACIP shows VE at max ~38% reduction 60 119 days earlier 27% (10 41) in hospitalization over the short 120 179 days earlier 7% (-27 32)
term (when vaccine dose is given 7-59 days earlier)1 Non-immunocompromised 2023 2024 vaccine dose, 7 days 42% (37 46) Perhaps not surprisingly, the
7 59 days earlier 50% (44 55) CDC recommends IC 60 119 days earlier 41% (34 48) populations boost no more than every 2 months, or no more than 120 179 days earlier 16% (0 29) 6 times per year2 -60 -40 -20 0 20 40 60 80 100 CDC=U.S. Centers for Disease Control and Prevention;
COVID-19=coronavirus disease 2019; IC=immunocompromised. References: 1. FDA. Effectiveness of COVID-19 (2023-2024 Formula) vaccines, presented to the Advisory Committee
on Immunization Practices (ACIP), June 2024. Accessed July 1, 2024. https://www.fda.gov/media/179140/download 2. CDC. Interim 2023-2024 COVID-19 Immunization Schedule for Persons 6 Months of Age and
Older. Accessed July 19, 2024.
WHEREAS ANTIBODIES HAVE BEEN SHOWN TO PROTECT PEOPLE FROM GETTING SICK WITH
COVID-19 Adintrevimab1* Tixagevimab+cilgavimab Pemivibart3,4,* ( Evusheld )2* PROVENT 71% reduction* 77% reduction* 84% reduction* in risk of in risk of in risk of symptomatic COVID-19 symptomatic COVID-19 symptomatic COVID-19 through day 180 in Immunocompetent Cohort*
COVID-19= COVID-19=coronavirus disease 2019. *Figures provided represent relative risk reduction versus placebo. References: 1. Ison MG, et al. Open Forum Infect Dis.
2023 Jun 13;10(7):ofad314. 2. Levin MJ, et al. N Engl J Med. 2022;386(23):2188-2200. 3. Invivyd. Data on File. 4. Symptomatic COVID-19 event collection in the CANOPY clinical trial is an exploratory endpoint
and not part of the primary immunobridging endpoint of the CANOPY clinical trial. Adintrevimab is an investigational monoclonal antibody that has not been approved for use by any regulatory authorities; the safety and efficacy of adintrevimab have
not been established. No head-to-head clinical trials have been conducted between adintrevimab, pemivibart, and/or tixagevimab+cilgavimab, and comparative conclusions
cannot be made between antibodies. 11
WE SEE THE COVID-19 STANDARD OF CARE AS SUB-STANDARD, CREATING IMMENSE OPPORTUNITY FOR MONOCLONAL ANTIBODIES ~38% vaccine effectiveness against hospitalization in IC for 2023 2024 vaccine1 Prevention (Vaccines) Potential strain mismatch for
2024 2025 vaccine2,3 Paxlov is standard of care, but prominent drug- Outpatient drug interaction issues and potential for rebound4,5* >$10B Treatment Lagevri is associated with viral mutagenicity6 2024 Estimated Revenue8 Inpatient/
Veklury requires daily infusions over multiday Outpatient treatment period7 Treatment All trademarks and logos displayed are the property of their respective owners. Their use here is for identification purposes only and does not constitute
endorsement or affiliation. IC=immunocompromised; mAb=monoclonal antibody; WBC=white blood cell. *Primary objective of the trial was to compare the efficacy of nirmatrelvir ritonavir with that of placebo for the treatment of COVID-19, as measured by the difference in time to sustained alleviation of all targeted COVID-19 signs and symptoms through day 28. References: 1. FDA. Effectiveness of COVID-19 (2023-2024 Formula) vaccines, June 2024. Accessed July 1, 2024. https://www.fda.gov/media/179140/download 2. FDA. Updated COVID-19 Vaccines for Use in the United
States Beginning in Fall 2024. Accessed July 8, 2024.
3. Novavax Press Release. Accessed July 8, 2024. https://ir.novavax.com/press-releases/2024-06-14-Novavax-Submits-Application-to-U-S-FDA-for-Updated-Protein-based-2024-2025-Formula-COVID-19-Vaccine
4. PAXLOVID [Fact Sheet for Healthcare Providers]. Pfizer. 2023. 5. Hammond J, et al. N Engl J Med. 2024;390(13):1186-1195. 6. IDSA. Trial Shows Increased SARS-CoV-2 Mutations, Delayed Viral Clearance With Molnupiravir Treatment. Accessed July 31, 2024. https://www.idsociety.org/covid-19-real-time-learning-network/therapeutics-and-interventions/trial-shows-increased-sars-cov-2-mutations-delayed-viral-clearance-with-molnupiravir-treatment/#/+/0/publishedDate_na_dt/desc/
7. Veklury (remdesivir) [Prescribing Information]. Gilead Sciences; February 2024. 8. Company Form 10-Qs, Earnings Releases, and Guidances. 12
AGENDA What We Do How We Do It Where We Are What Comes Next 13
THE REALITY: SARS-COV-2
CONTINUES TO EVOLVE1, AND SO MUST WE Others have tried with mAbs, but succumbed to inevitable viral evolution2 100% 80% I mourned 60% the loss of 40% monoclonal antibodies 20% as the virus 0% evolved
2020-Jan 2020-Mar 2020-May 2020-Jul 2020-Sep 2020-Nov 2021-Jan 2021-Mar 2021-May 2021-Jul 2021-Sep 2021-Nov 2022-Jan 2022-Mar 2022-May 2022-Jul 2022-Sep 2022-Nov 2023-Jan 2023-Mar 2023-May 2023-Jul 2023-Sep 2023-Nov 2024-Jan 2024-Mar 2024-May their utility Evushel | Dec 2021 Jan2023 PEMGARD | away. (annualizing at ~$2b and growing at Mar 2024 extinguishment) Jason Gallagher, REGEN-COV | Nov 2020 to Jan 2022 PharmD, FCCP, FIDP, BCPS at Sotrovimab | May 2021 to April 2022 Temple Bebtelovimab | University Bamlanivimab | Actemra | Feb 2022 to Nov 2022 Nov 2020 to Jun 2021 to April
2021 Dec 2021 EUA for treatment mAb* Bamlanivimab + etesevimab | Feb 2021 to Jan 2022 EUA for PrEP mAb* EUA=emergency use authorization; mAb=monoclonal antibody; PrEP=Pre-exposure prophylaxis; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2. All trademarks are the property of their respective owners. References: 1. Nextstrain. Accessed July 1, 2024. https://nextstrain.org/ncov/gisaid/global/all-time 2. CMS. Accessed July 1, 2024. https://www.cms.gov/monoclonal *See respective Healthcare Professional Fact Sheets for product-specific information. As it
relates to PEMGARDA, please see the PEMGARDA full product Fact Sheet for Healthcare Providers, including Important Safety Information and Boxed Warning. 14
ADDRESSING REALITY: INVIVYD S PROPRIETARY PLATFORM We are working to raise the bar on the standard of care
by continually staying ahead of viral evolution Rapid mAb Engineering Rapid Immunobridging Studies Commercial Opportunity Privileged epitopes Master clinical trial protocol Multiple profiles anticipated to be anticipated to
streamline generated for specific molecules Rapid affinity maturation evaluation of serial mAbs and use cases Surveillance-informed metrics Compact clinical programs to We intend to consider diverse for greater variation
resistance evaluate new mAbs expected to routes of administration (e.g., IV, rapidly generate data for IM, SC) for future mAb candidates treatment and prevention use cases IM=intramuscular; IV=intravenous; mAb=monoclonal antibody; SC=subcutaneous.
Reference: Invivyd. Data on File. 15
OUR PLATFORM OFFERS HIGH SPEED, HIGH CONFIDENCE INNOVATION General alignment reached with the U.S. FDA on a
repeatable, expedient EUA pathway for the prevention and treatment of COVID-19, based on compact clinical programs to establish safety and immunobridging for serial mAbs Discovery & CMC Constant
monitoring & screening Rapid, low-cost IND enablement1 First in Human Initial safety & PK cohorts Immunobridging Master, registrational clinical trial protocol expected to enable: Pivotal
Clinical Compact pivotal cohorts (300-600) Trial Design Short-term (Day 7) and long-term (Day 28) PK / sVNA endpoint EUA Future potential EUAs for serial, novel mAbs using an immunobridging