Invivyd, Inc. (NASDAQ: NASDAQ: IVVD ) is a biotechnology company that, for the most part, concerns itself with developing antibody-based treatments for infectious diseases—COVID-19 being its primary focus. Established in 2020 and operating out of Massachusetts, the company reliesThe mission of Grassroots Trading rests on the following principles: providing objective, unbiased, and balanced research, backed by solid data and completely void of emotional influences or preference for companies; focusing on sma ...

Core Insights - Invivyd, Inc. announced positive data from its Phase 1/2 clinical trial of VYD2311, a novel monoclonal antibody designed as an alternative to COVID-19 vaccination and for treatment [1][2][10] Group 1: Clinical Trial Details - The ongoing Phase 1/2 trial involves 40 subjects and evaluates the safety and pharmacokinetic profile of VYD2311 across multiple administration routes: intravenous, intramuscular, and subcutaneous [3][7] - All planned doses have been administered, with only long-term follow-up remaining [3][7] - Adverse events reported so far are mild to moderate, primarily related to injection site reactions [4][7] Group 2: Pharmacokinetics and Efficacy - As of Day 65, serum concentrations of VYD2311 remain high, indicating a potential long clinical dosing interval [5][7] - VYD2311 shows an average 17-fold greater neutralization potency against contemporary SARS-CoV-2 variants compared to pemivibart [8][9] - The clinical profile of VYD2311 suggests stronger protection (70-90%) from symptomatic COVID-19 disease and less frequent dosing [7][9] Group 3: Market Potential and Strategic Vision - The company aims to provide a more effective and convenient option for managing COVID-19, addressing the limitations of current vaccines [10][11] - VYD2311 is positioned as a potential long-acting treatment option, suitable for immunocompromised individuals who may benefit from higher serum virus neutralizing antibody titers [9][10] - The company emphasizes the importance of advancing VYD2311 to populations at highest risk of COVID-19, highlighting the ongoing burden of the disease [10][22]

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 | ...