Core Insights - Invivyd, Inc. announced preliminary financial results for Q4 2024, highlighting significant revenue growth and operational efficiency improvements [1][2][3] Financial Performance - The company reported preliminary Q4 2024 net product revenue of $13.8 million, a 48% increase from Q3 2024's $9.3 million [3][7] - Total operating costs and expenses for Q4 2024 were approximately $32 million, reflecting a 55% reduction compared to Q3 2024's $71.6 million [3][7] - Invivyd ended 2024 with $69.3 million in cash and cash equivalents, along with $10.9 million in outstanding accounts receivable [2][7] Profitability Outlook - The company continues to target near-term profitability by the end of the first half of 2025, leveraging existing cash, anticipated revenue growth, and reduced manufacturing expenses [2][7] Product Information - PEMGARDA™ (pemivibart) is an investigational monoclonal antibody designed for pre-exposure prophylaxis against COVID-19, showing in vitro neutralizing activity against major SARS-CoV-2 variants [4][5][11] - VYD2311 is another monoclonal antibody candidate in development, aimed at providing new prophylactic and therapeutic options for COVID-19 [11][12] Regulatory Status - PEMGARDA has received emergency use authorization (EUA) from the U.S. FDA for specific immunocompromised populations, although it is not authorized for treatment or post-exposure prophylaxis of COVID-19 [5][6][10]

Treatment immunobridging analysis, routinely updated for contemporary SARS-CoV-2 variants, compares pemivibart antiviral titers to adintrevimab antiviral titers from the company’s previous Phase 2/3 clinical trial of adintrevimab for the treatment of COVID-19 (STAMP), in which adintrevimab conferred a 66% to 74% reduction in risk of hospitalization or death from COVID-19 compared to placebo depending on time of therapy startMost recent updated analysis provided to FDA, incorporating current dominant SARS-Co ...

Core Findings - New in vitro neutralization data show continued neutralizing activity of PEMGARDA™ (pemivibart) and pipeline candidate VYD2311 against dominant SARS-CoV-2 variant XEC, consistent with previous data for KP 3 1 1 [1][2] - XEC and KP 3 1 1 accounted for 69% of U S circulating SARS-CoV-2 variants for the two weeks ended December 21, 2024 [1] - PEMGARDA has demonstrated neutralizing activity against over 75% of currently circulating U S variants and all prior variants tested to date [6] - Data submitted to FDA, with timely update to PEMGARDA™ Fact Sheet for Healthcare Providers anticipated [2][7] Product Details - PEMGARDA (pemivibart) is an investigational monoclonal antibody (mAb) authorized for emergency use by the U S FDA for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise [3][11] - PEMGARDA targets the SARS-CoV-2 spike protein receptor binding domain (RBD), inhibiting virus attachment to the human ACE2 receptor on host cells [11] - VYD2311, a novel mAb candidate, is being developed for COVID-19 to address the urgent need for new therapeutic options for vulnerable populations, including immunocompromised individuals [15][16] Research and Development - Invivyd leverages a consistent, high-quality, independent, third-party pseudoviral system for testing pemivibart, supported by extensive structure-based and proprietary analytics [1][9] - The company's INVYMAB™ platform combines viral surveillance, predictive modeling, and advanced antibody engineering to facilitate the rapid, serial generation of new mAbs to address evolving viral threats [17] - Pemivibart has demonstrated antiviral activity in neutralization assays representing 39 distinct SARS-CoV-2 variants across almost three years of rapid virus evolution [10] Market and Industry Context - The emergency use of PEMGARDA is authorized only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is ≤90% [14] - Invivyd received emergency use authorization (EUA) from the U S FDA for PEMGARDA in March 2024, marking its first mAb in a planned series of innovative antibody candidates [17]

INVIVYD INVIVYD Q3 2024 FINANCIAL RESULTS & BUSINESS HIGHLIGHTS November 14, 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. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS 2 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 histo ...

Start Time: 08:30 January 1, 0000 9:18 AM ET Invivyd, Inc. (NASDAQ:IVVD) Q3 2024 Earnings Conference Call November 14, 2024, 08:30 AM ET Company Participants Marc Elia - Chairperson, Board of Directors and Executive Committee Tim Lee - COO Bill Duke - CFO Robert Allen - CSO Mark Wingertzahn - SVP of Clinical Development and Medical Affairs Katie Falzone - VP, Corporate Controller Conference Call Participants Maxwell Skor - Morgan Stanley Michael Yee - Jefferies Jason Kolbert - D. Boral Capital Luis Santos - ...

Invivyd, Inc. (IVVD) came out with a quarterly loss of $0.51 per share versus the Zacks Consensus Estimate of a loss of $0.33. This compares to loss of $0.36 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -54.55%. A quarter ago, it was expected that this company would post a loss of $0.37 per share when it actually produced a loss of $0.40, delivering a surprise of -8.11%.Over the last four quarters, the company has surpassed ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-40703 INVIVYD, INC. (Exact Name of Registrant as Specified in its Charter) Delaware ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): October 29, 2024 Invivyd, Inc. | --- | --- | --- | |-------------------------------------------------------------------|------------------------------------------------------------------------------------|------------------------------| | (Exact Name \nDelaware \n(State or Other Jurisdiction | ...

Q3 2024 PEMGARDA™ (pemivibart) net product revenue of $9.3 million; Invivyd ended Q3 2024 with $106.9 million in cash and cash equivalentsTargets near-term (1H 2025) profitability with existing cash and cash equivalents, anticipated growth of net product revenue, and various operational efficiency improvementsPEMGARDA Fact Sheet updated to properly reflect neutralization activity of PEMGARDA against current circulating variants tested; on track for continued growth now reflective of ongoing commercial optim ...

The New England Journal of Medicine (NEJM) Letter to the Editor outlines the novel, rapid immunobridging authorization pathway for PEMGARDA and provides an updated correlate of protection curve for monoclonal antibody protection from symptomatic COVID-19The updated correlate of protection analysis published in the Letter to the Editor indicates the potential for strong protection from symptomatic COVID-19 at titer levels well below doses explored clinically with pemivibart, consistent with recently disclose ...