Slide 1: Invivyd Q1 2025 Financial Results & Business Highlights
Exhibit 99.2 INVIVYD Q1 2025 FINANCIAL RESULTS & BUSINESS HIGHLIGHTS May 15, 2025 © 2025 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
u Executive Summary u Commercial Update u R&D Overview u Clinical & Regulatory Finance Q&A 3
Slide 4: Invivyd Focus: Growth and Evolution
INVIVYD FOCUS: GROWTH AND EVOLUTION • Executed a commercial field force changeover with expected growth disruption during Q1 • Key commercial metrics in Q2 encouraging; focus remains on break-even and beyond • Pemivibart epitope has remained stable across now incalculable virus evolution post- Omicr
Slide 5: Government / Regulatory Landscape
GOVERNMENT / REGULATORY LANDSCAPE • New Administration carries views on infectious disease that align with Invivyd strategy o Seek RCT for vaccines in contemporary, seropositive Americans against contemporary, immune- evasive virus, and hopefully over the long term, as for monoclonal antibodies (mAb
Slide 6: Agenda
u Executive Summary u Commercial Update R&D Overview Clinical & Regulatory Finance Q&A 6
Slide 7: PEMGARDA Launch to Date – Now with an In-House Commercial Team
PEMGARDA LAUNCH TO DATE – NOW WITH AN IN-HOUSE COMMERCIAL TEAM Built an Invivyd Field Team Building a Foundation • Field Force sized to meet the market at centers of excellence • SAMs manage top 75 academic centers • KAMs manage next 250 high-potential accounts • High clinical acumen & conviction Co
Slide 8: Key Launch Metrics Showing Expanded Commercial Footprint
KEY LAUNCH METRICS SHOWING EXPANDED COMMERCIAL FOOTPRINT Growth since As of Jan 1 As of Jan 31 As of Feb 28 As of Mar 31 As of Apr 30 Jan 1 HCP Interactions 8,608 8,819 9,630 10,533 11,669 37% Logged Unique Accounts 4,566 4,725 5,266 5,738 6,242 37% Called On Unique Accounts 534 562 586 617 642 20%
Slide 9: PEMGARDA Is Now on Several Society Guidelines
PEMGARDA IS NOW ON SEVERAL SOCIETY GUIDELINES NCCN GUIDELINES FOR IDSA GUIDELINES B-CELL LYMPHOMAS Pemivibart has been added to the NCCN IDSA Guidelines recommend: Guidelines® for B-cell Lymphomas as a PEMGARDA for PrEP in moderately or recommended option for pre-exposure severely immunocompromised
Slide 10: COVID-19 Poses a Year-Round Risk
COVID-19 POSES A YEAR-ROUND RISK INVIVYD IS LAUNCHING EDUCATIONAL COVID-19 CONTINUES TO CAUSE CAMPAIGN HIGHLIGHTING THE CONTINUED MORBIDITY & MORTALITY YEAR-ROUND THREAT OF COVID-19
Slide 11: PEMGARDA Is Priced for Value for Patients
PEMGARDA IS PRICED FOR VALUE FOR PATIENTS BELOW NEARLY ALL FDA-APPROVED MONOCLONAL ANTIBODIES LAUNCHED IN THE PAST 5 YEARS Estimated Annual Cost of Monoclonal Antibody Therapy Grouped by pricing tiers, 63 mAbs-based drugs approved from 2019 - 2024 $500,000 $450,000 WHY IT MATTERS: $400,000 $350,000
Slide 12: PEMGARDA (Pemivibart)
PEMGARDA (PEMIVIBART) Please see below PEMGARDA has not been approved but has been authorized for emergency use by the FDA under an emergency use authorization (EUA), for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kg) with m
Slide 13: Agenda
u Executive Summary u Commercial Update u R&D Overview Clinical & Regulatory Finance Q&A 13
Slide 14: Pemivibart Epitope and Potency Remain Stable
PEMIVIBART EPITOPE AND POTENCY REMAIN STABLE Virus Evolution • Pemivibart and Invivyd follow-on mAbs (e.g., VYD2311) are designed to target a highly conserved epitope • No significant structural change to the pemivibart epitope observed over an incalculably enormous quantum of virus variant explorat
Slide 15: Structure Predicts Function, No Change Expected
STRUCTURE PREDICTS FUNCTION, NO CHANGE EXPECTED Virus Evolution • Structural biology and epitope mapping suggest potential ongoing, long-term activity • Variant monitoring of SARS-CoV-2 indicates repeat and ancestral variant exploration, for which pemivibart and Invivyd follow-on mAbs appear well su
Slide 16: Respiratory Syncytial Virus (RSV) Discovery
RESPIRATORY SYNCYTIAL VIRUS (RSV) DISCOVERY • Well-developed mAb medical category devoted to Fusion Protein Trimer prevention of RSV in neonates and children <24 months • Current key molecules: o Pavilizumab (1998) - AstraZeneca o Nirsevimab (2023) - Sanofi o Clesrovimab (2025 expected) - Merck • Op
Slide 17: Measles (Rubeola) Virus Discovery
MEASLES (RUBEOLA) VIRUS DISCOVERY • Despite highly effective vaccines, U.S. herd Measles (MeV) Spectrum of Clinical Disease immunity against measles is at risk Multiple Points of Intervention • Multiple circulating strains make measles an attractive target for Invivyd technology • mAb envisioned to
Slide 18: Agenda
u Executive Summary u Commercial Update u R&D Overview u Clinical & Regulatory Finance Q&A 18
Slide 19: VYD2311 Overview
VYD2311 OVERVIEW • VYD2311 is the third iteration of Invivyd’s platform approach targeting SARS-CoV-2 spike protein • Carries 99%+ sequence identity to predicate antibodies, ADG20 and pemivibart; approximately same or less structural change, version to version, as mRNA vaccine updates • Series of an
Slide 20: VYD2311: Status of Phase 1 Clinical Trial
VYD2311: STATUS OF PHASE 1 CLINICAL TRIAL • In-life phase of the first-in-human safety and PK/PD Study Design evaluation through 180 days completed; data read- out anticipated later in Q2 2025 • Four doses / routes of administration interrogated at high doses to provide optimal forward flexibility i
Slide 21: Abbreviated Target Profile for VYD2311
ABBREVIATED TARGET PROFILE FOR VYD2311 Category VYD222 (PEMGARDA) VYD2311 Target Regulatory Plan EUA BLA (Accelerated -> Full approval) Indication / Target Pop PrEP: IC patients PrEP and Treatment: IC and non-IC IV IM / SC long interval Administration Route 1hr delivery Patient & system friendly 2 h
Slide 22: PEMGARDA Treatment EUA Background
PEMGARDA TREATMENT EUA BACKGROUND: IMMUNOCOMPROMISED PATIENTS WITH NO OPTIONS • EUA was the preferred concept for the Biden Administration FDA for mAbs • FDA indicated openness to an immunobridging treatment EUA for pemivibart in 1H 2024 based primarily on comparison to adintrevimab; clear desire wa
Slide 23: Excerpt from FDA Treatment EUA Declination Letter: The Overall Finding
EXCERPT FROM FDA TREATMENT EUA DECLINATION LETTER: THE OVERALL FINDING Based on the totality of scientific evidence FDA provided four specific arguments against available, we are unable to reasonably authorization relative to the bridging and expected efficacy (benefits) in their conclusions, as fol
Slide 24: FDA Reason 1: Immunobridge to Adintrevimab
FDA REASON 1: IMMUNOBRIDGE TO ADINTREVIMAB Calculated sVNA Titers Against Variants of SARS-CoV-2 Through 14 Days From Dosing Based on Population PK Estimates of Average Concentration (AUC/Time) When comparing the [titer] for pemivibart against KP.3.1.1 and XEC versus adintrevimab against Delta, the
Slide 25: Immunobridge to Adintrevimab Rebuttal
IMMUNOBRIDGE TO ADINTREVIMAB REBUTTAL Calculated sVNA Titers Against Variants of SARS-CoV-2 Through 14 Days From Dosing Based on Population PK Estimates of Average Concentration (AUC/Time • Pemivibart titers are actually above or comparable to adintrevimab for four days, after which they are below a
Slide 26: FDA Reason 2: Meta-Analytics
FDA REASON 2: META-ANALYTICS “When comparing pemivibart with the range Pemivibart of neutralization titer values of other RBD- targeting mAbs…titers for pemivibart against relevant SARS-CoV-2 variants are lower than those generated for most of the mAbs included in the meta-analysis. We believe that
Slide 27: Meta-Analytics Rebuttal
META-ANALYTICS REBUTTAL • More titer may well be more attractive Pemivibart absent a maximum tolerated dose, on that we agree, however: o The dose:response curve on titer appears to flatten meaningfully at levels much beyond pemivibart o We are not choosing between high titer and very high titer, we
Slide 28: FDA Reason 3: Optimal Dose for Severely Immunocompromised
FDA REASON 3: OPTIMAL DOSE FOR SEVERELY IMMUNOCOMPROMISED Optimal drug concentrations / titers for successful treatment in immunocompetent individuals may differ substantially from those required in severely immunocompromised individuals who lack an adequate immunological response after infection is
Slide 29: Optimal Dose Rebuttal
OPTIMAL DOSE REBUTTAL So, if FDA does not know the optimal dose, which is itself an odd concept in drug development, the FDA would prefer that “severely immunocompromised” persons who lack an adequate immunological response after infection is established … … do their best to survive infection with n
Slide 30: FDA Reason 4: Other mAb Activities
FDA REASON 4: OTHER MAB ACTIVITIES Variability in antibody-mediated activities other than neutralization may contribute to differences in treatment effects between antibodies and may not be readily normalizable, thus limiting the ability to conclude comparable effectiveness based on upon similar neu
Slide 31: Rebuttal: Other mAb Activities
REBUTTAL: OTHER MAB ACTIVITIES • Pemivibart and adintrevimab both retain effector function, arguing for enhanced activity in active treatment versus other antibodies • Fc effector function assessed and found comparable between adintrevimab and pemivibart; no surprise given structural identity 31
Slide 32: The Current State of Play
THE CURRENT STATE OF PLAY • The Biden Administration prioritized prevention over treatment; the new Administration appears to be reversing course • Pemivibart EUA treatment declination letter signatory at OND and leadership at CDER, OID has either been fired or resigned • Invivyd is planning to reen
Slide 33: VYD2311 Would Seem to Address FDA Treatment EUA Declination Logic
VYD2311 WOULD SEEM TO ADDRESS FDA TREATMENT EUA DECLINATION LOGIC sVNA Titers for Relevant COVID-19 mAbs • VYD2311 shows a multi-fold increase in titers compared to predicate antibodies VYD-2311 (high dose IV) • Goal would be to deploy sufficient Regen-Cov (IV) antiviral activity rapidly, with goal
Slide 34: Agenda
u Executive Summary u Commercial Update u R&D Overview u Clinical & Regulatory u Finance Q&A 34
Slide 35: Financials
FINANCIALS • Q1 2025 PEMGARDA (pemivibart) net product revenue of $11.3 million • Continued execution of financial discipline and reduction of operating expenses – $27.4 million in Q1 2025 vs. $32.3 million in Q4 2024 • Ended Q1 2025 with approximately $48.1 million in cash and cash equivalents; pot
Slide 36: Agenda
u Executive Summary u Commercial Update u R&D Overview u Clinical and Regulatory u Finance u Q&A 36
Slide 37: Appendix: FDA Declination Letter (February 2025), Excerpt
APPENDIX: FDA DECLINATION LETTER (FEBRUARY 2025), EXCERPT 37 Source: Invivyd Data on File
Slide 38: Appendix: FDA Declination Letter (February 2025), Excerpt
APPENDIX: FDA DECLINATION LETTER (FEBRUARY 2025), EXCERPT 38 Source: Invivyd Data on File
Slide 39: Appendix: FDA Declination Letter (February 2025), Excerpt
APPENDIX: FDA DECLINATION LETTER (FEBRUARY 2025), EXCERPT * NB: The supportive meta-analysis for immunobridging was presented via two marginally different analytics, hence the FDA notes areas of uncertainty for all three methods * 39 Source: Invivyd Data on File