Slide 1: Pemgarda FDA Emergency Use Authorization
Exhibit 99.3 PEMGARDA FDA EMERGENCY USE AUTHORIZATION March 22, 2024 © 2024 Invivyd, Inc. Invivyd , Pemgarda , and the Ribbon logos are trademarks of Invivyd, Inc. All trademarks in this presentation are the property of their respective owners.
Slide 2: Cautionary Note Regarding Forward-Looking Statements
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
Slide 3: Agenda
AGENDA 1. Opening remarks & business updates − Dave Hering, Chief Executive Officer 2. Commercial launch plans − Jeremy Gowler, Chief Operating & Commercial Officer 3. Q&A 3
Slide 4: Immunity Is a Gradient
IMMUNITY IS A GRADIENT Immunity, titers, and correlates of efficacy “A Covid-19 Milestone Attained — A Correlate of Protection for Vaccines” Sterilizing Asymptomatic Symptomatic URI “Monoclonal antibody Symptomatic LRI levels and protection from COVID-19” Hospitalization / Death URI=Upper Respirator
Slide 5: Immunobridging Allows for Serial, Rapid Development
IMMUNOBRIDGING ALLOWS FOR SERIAL, RAPID DEVELOPMENT Jul 2022: Invivyd sets the goal of utilizing an immunobridging approach to accelerate development of its novel monoclonal antibody (mAb) candidates Dec 2022: Presented rationale on immunobridging approach at joint FDA-EMA workshop Mar 2023: VYD222
Slide 6: Now Authorized for Emergency Use in the U.S.
NOW AUTHORIZED FOR EMERGENCY USE IN THE U.S. The FDA Letter of Authorization and Fact Sheet for Healthcare Providers is available at PEMGARDA.com 6 6
Slide 7: Initial Commercial Focus on Highest Risk Immunocompromised Groups
INITIAL COMMERCIAL FOCUS ON HIGHEST RISK MODERATELY TO SEVERELY IMMUNOCOMPROMISED GROUPS Initial commercial focus: • ~485K who are moderately to severely immunocompromised and at highest risk for severe COVID-19: – 67K: stem cell transplants >9M 485K – 86K: solid organ transplants (liver/lung/kidney
Slide 8: Antibody Prophylaxis Was Growing Prior to Loss of Evusheld Activity
ANTIBODY PROPHYLAXIS WAS GROWING PRIOR TO LOSS OF EVUSHELD ACTIVITY EVUSHELD $2.2B in global revenue of Evusheld® in 2022, a mAb previously authorized to protect vulnerable populations from COVID-19 $1,400 $1,270M $1,200 $1,000 $914M $800 PEMGARDA $600 $400 $200 $135M $0 H2 2021 H1 2022 H2 2022 Sour
Slide 9: CANOPY Interim Data Update
INVIVYD by | } WA Wi) CANOPY interim Data Update
Slide 10: The Pemgarda EUA Is Based on the Ongoing CANOPY Trial
THE PEMGARDA EUA IS BASED ON THE ONGOING CANOPY TRIAL CANOPY CLINICAL TRIAL OVERVIEW VYD222 4500 mg IV (n≈300) COHORT A Open Label Moderate-to-severe immune // compromise (N≈300) Day 1 Month 3 Month 12 (Dosing) (Redosing) (Last visit) Primary endpoints: • Safety/tolerability • Day 28 serum virus neu
Slide 11: CANOPY Cohort A Comprises Older Medically Complex Subjects
CANOPY COHORT A, SINGLE ARM AND OPEN LABEL, COMPRISES OLDER MEDICALLY COMPLEX SUBJECTS Parameter Cohort A (N=306) Cohort B (N=479) Gender 61% female; 39% male 53% female; 47% male 59 years, median 48 years, median Age (31% aged 65 years or older) (18% aged 65 years or older) Moderate-to-severe immun
Slide 12: Overview of Interim CANOPY Cohort A Safety Data
OVERVIEW OF INTERIM CANOPY COHORT A CLINICAL TRIAL SAFETY DATA Anaphylaxis has been observed with VYD222 in 0.6% (4/623) of • The safety of VYD222 (PEMGARDA) is based on exposure of participants in the CANOPY clinical trial* 623 participants who received at least one dose of VYD222 4500 mg IV in one
Slide 13: Higher Rate of Hypersensitivity Observed in Open-Label Cohort A
HIGHER RATE OF HYPERSENSITIVITY OBSERVED IN OPEN-LABEL UNCONTROLLED COHORT A Anaphylaxis and Systemic Infusion-related Reactions and Hypersensitivity Reactions Cohort A (Cohort with moderate-to-severe immune compromise) In Cohort A, the reactions were generally mild VYD222 First & Second Dose, (17/2
Slide 14: CANOPY Cohort A Bridges sVNA Titers From Adintrevimab to Pemgarda
CANOPY COHORT A BRIDGES SVNA TITERS FROM ADINTREVIMAB TO PEMGARDA From the EVADE clinical trial studying adintrevimab, a titer of The Day 90 reference titer from EVADE was used to 3514 at Day 90 was conservatively selected as the reference titer extrapolate a Day 28 reference (target) titer for the
Slide 15: Immunobridging Results Include Very High Calculated Titers
IMMUNOBRIDGING RESULTS INCLUDE VERY HIGH CALCULATED TITERS ACROSS THE CANOPY CLINICAL TRIAL 90-DAY DOSING INTERVAL Cohort A – Calculated VYD222 sVNA Titer Results Against JN.1 Cohort A - Calculated VYD222 sVNA titers against JN.1 based on observed PK concentration by timepoints Result Parameter GMT
Slide 16: Pemgarda Designed to Re-Start an Important Category of Medicines
PEMGARDA DESIGNED TO RE-START AN IMPORTANT CATEGORY OF MEDICINES THAT ADDRESSES VIRAL EVOLUTION + + INVYMAB PLATFORM APPROACH CANOPY clinical trial designed in collaboration with FDA to address critical needs in the COVID-19 prophylaxis category PEMGARDA is the first product from a repeatable proces
Slide 17: Commercial Launch Plans
Commercial Launch Plans Jeremy Gowler Chief Operating & Commercial Officer 17
Slide 18: Experienced Commercial Team Well-Positioned to Launch Pemgarda
• Poised to offer an important product to an established, yet open market that has been without a PrEP mAb for >1 year • Initial PEMGARDA inventory manufactured & expected to be ready for purchase through major distributors imminently EXPERIENCED COMMERCIAL • Invivyd sales & marketing leadership tea
Slide 19: Engaging With Key Payors to Secure Broad Coverage
ENGAGING WITH KEY PAYORS TO SECURE BROAD COVERAGE ANTICIPATED PAYOR MIX ANTICIPATED U.S. TIMELINES Pricing established and Publication of interim product available for ~35% ~15% CANOPY data distribution Medicare Medicaid Other Authorization Medicare coverage Commercial coverage within weeks within w
Slide 20: We Plan to Share a Variety of Launch Metrics in Coming Quarters
WE PLAN TO SHARE A VARIETY OF LAUNCH METRICS IN COMING QUARTERS TO PROVIDE VISIBILITY INTO OUR PROGRESS Example metrics: Patient lives covered via CMS & commercial payors Progress reaching/calling on targeted institutions Number of target accounts that have ordered product Number of targeted account
Slide 21: Invivyd
INVIVYD Oza
Slide 22: Important Safety Information
IMPORTANT SAFETY INFORMATION WARNING: ANAPHYLAXIS ADVERSE REACTIONS The most common adverse events (all grades, incidence ≥2%) observed in participants who have • Anaphylaxis has been observed with PEMGARDA in 0.6% (4/623) of participants in a clinical moderate-to-severe immune compromise treated wi
Slide 23: Limitations of Authorized Use
LIMITATIONS OF AUTHORIZED USE The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory reporting of all serious adverse events* and medication errors potentially related to PEMGARDA within 7 calendar days from • PEMGARDA is not authorized for use: the healt
Slide 24: Thank You
INVIVYD | ‘a | THANK you! i