Invivyd Inc

Invivyd, Inc. engages in the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential. The firm develops antibodies that can neutralize SARS-CoV-2, SARS-CoV-1, and additional emergent coronaviruses. It offers, ADG20, a monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses. The company was founded by Tillman U. Gerngross, Ren Russo and Laura Walker on June 3, 2020 and is headquartered in Waltham, MA.

Earnings data Q2 2021

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Earnings data Q1 2022

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Earnings data Q1 2023

Earnings data Q2 2023

Earnings data Q3 2023

Earnings data Q4 2023

Earnings data Q1 2024

Earnings data Q2 2024

Earnings data Q3 2024

Invivyd Inc advances VYD222 for COVID-19, faces regulatory challenges

Invivyd Inc's progress with VYD222 for COVID-19 prevention is promising, supported by FDA clearance and financial stability.
While facing challenges in Phase III preparation and regulatory compliance, the company's strengths in neutralizing activity and biomarker research are notable.
Opportunities lie in market growth, regulatory pathways, and enhancing biomarker expectations for VYD222's success.

Invivyd reports robust Q2 earnings, poised for COVID-19 solution success

Invivyd Inc (IVVD) showcased a strong financial performance and promising progress in commercializing VYD222 during the Q2 2023 earnings call.
While facing challenges such as trial complexities and competitive landscape, the company's strengths in financial stability, positive trial results, and experienced management team position it well for future growth.
Opportunities abound in addressing the urgent need for COVID-19 protection, exploring commercial avenues, and establishing a strong market presence with VYD222.

Invivyd Inc reports robust Q3 performance and prepares for VYD222 launch

Invivyd Inc's Q3 2023 earnings call highlighted strong financial performance, progress in the CANOPY trial for VYD222, and strategic preparations for a potential market launch in 2024.
The company's focus on addressing the urgent need for monoclonal antibodies for immunocompromised individuals aligns with significant market opportunities and positions them for future success.
While facing challenges such as regulatory submissions and competitive pressures, Invivyd Inc remains optimistic about the potential impact of VYD222 and expresses gratitude for investor support.

Invivyd Inc reports strong cash position and FDA collaborations

Invivyd Inc focuses on addressing COVID-19 challenges with high efficacy antibodies.
The company's financials show strong cash position and potential for revenue growth.
Opportunities lie in FDA collaborations, clinical trials, and expanding treatment options.
Challenges include the need for revenue generation and uncertainties in product launch.

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WALTHAM, Mass., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that management will participate in a fireside chat and 1x1 investor meetings at the Guggenheim Securities Healthcare Innovation Conference taking place November 11-13, 2024.

Invivyd to Participate in the Guggenheim Securities Healthcare Innovation Conference

WALTHAM, Mass., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it will host a conference call on Thursday, November 14, 2024, at 8:30 a.m. ET to discuss its financial results for the third quarter ended September 30, 2024, and provide recent business highlights. Invivyd reported preliminary third quarter 2024 results via press release on October 29, 2024.

Invivyd to Host Third Quarter 2024 Financial Results and Corporate Update Conference Call on November 14, 2024

WALTHAM, Mass., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today reported preliminary third quarter (Q3) 2024 financial results and an update to prior financial guidance.

Invivyd Reports Preliminary Third Quarter 2024 Results, Withdraws Prior Financial Guidance, and Targets Near-Term Profitability

WALTHAM, Mass., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced positive 12-month exploratory clinical efficacy data from the company's ongoing CANOPY Phase 3 clinical trial of pemivibart, a half-life extended investigational monoclonal antibody (mAb), for the pre-exposure prophylaxis (PrEP) of COVID-19.

Invivyd Phase 3 Long-Term Exploratory Clinical Efficacy Data Shows PEMGARDA™ (pemivibart) Provided Substantial Protection from Symptomatic COVID-19 Versus Placebo Over Six Months of Follow-Up, With No Additional Doses, In Immunocompetent Participants

WALTHAM, Mass., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced the upcoming presentations of pemivibart data from its Phase 1 and Phase 3 clinical trials at IDWeek 2024. The conference is being held in Los Angeles, October 16-19, 2024.

Invivyd to Present PEMGARDA™ (pemivibart) Data at Infectious Disease Week (IDWeek) 2024

WALTHAM, Mass., Oct. 01, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) has re-issued an updated Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers (Fact Sheet) for PEMGARDA™ (pemivibart) to provide accurate in vitro neutralization activity of PEMGARDA against dominant circulating variants including KP.3.1.1 and LB.1.

Invivyd Announces U.S. FDA Has Updated the PEMGARDA™ EUA Fact Sheet with Accurate SARS-CoV-2 Variant Susceptibility and PEMGARDA Activity Data

WALTHAM, Mass., Sept. 23, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today provided detailed virology data supporting previously communicated neutralization activity results, along with a genetic and structural analysis of past and present SARS-CoV-2 variant spike proteins, including the established molecular target of pemivibart.

Invivyd Provides Detailed Virology Data and Analysis of SARS-CoV-2 Structural Biology Predicting Anticipated Neutralization Activity for PEMGARDA™ (pemivibart)

WALTHAM, Mass., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced a business readiness update in response to a recent increase in COVID-19 cases nationwide.

Invivyd at the Ready for Upcoming Respiratory Virus Season with PEMGARDA™ (pemivibart) to Help Protect Vulnerable Immunocompromised Persons from COVID-19

WALTHAM, Mass., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it will present at the following investor conferences:

Invivyd to Participate in Upcoming Investor Conferences

WALTHAM, Mass., Sept. 04, 2024 (GLOBE NEWSWIRE) --  Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced dosing of the first participants in the Phase 1 healthy volunteer clinical trial of VYD2311, a next generation monoclonal antibody (mAb) candidate for COVID-19. VYD2311 is a mAb with high in vitro neutralization potency shown against post-Omicron COVID-19 variants tested to date.

Invivyd Doses First Participants in Phase 1 Clinical Trial of VYD2311, a Next Generation Monoclonal Antibody Candidate for COVID-19, Building on the Success of PEMGARDA™

WALTHAM, Mass., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that new pseudovirus in vitro neutralization data show continued neutralizing activity of PEMGARDATM (pemivibart) and pipeline candidate VYD2311 against dominant SARS-CoV-2 variants KP.3.1.1 and LB.1, and others tested. The Center for Disease Control (CDC) estimates that KP.3.1.1 accounted for 42.2% of circulating variants of SARS-CoV-2 for the last two weeks of August and is the only major variant increasing in proportionality nationally.

Invivyd Announces Continued Neutralizing Activity of PEMGARDA™ (pemivibart) Against Dominant SARS-CoV-2 Variants KP.3.1.1 and LB.1, and Other Variants of Interest

WALTHAM, Mass., Aug. 27, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced positive 180-day exploratory clinical efficacy data from the company's ongoing CANOPY Phase 3 clinical trial of pemivibart, a half-life extended investigational monoclonal antibody (mAb), for the pre-exposure prophylaxis (PrEP) of COVID-19.

Invivyd Announces PEMGARDA™ (pemivibart) Demonstrated 84% Relative Risk Reduction in Symptomatic COVID-19 Compared to Placebo in an Exploratory Analysis from Ongoing CANOPY Phase 3 Clinical Trial

Invivyd, Inc. (NASDAQ:IVVD ) Q2 2024 Earnings Conference Call August 14, 2024 8:30 AM ET Company Participants Katie Falzone - VP, Corporate Controller Marc Elia - Chairperson, Board of Directors and Executive Committee Tim Lee - Chief Commercial Officer Bill Duke - CFO Robert Allen - Chief Scientific Officer Mark Wingertzahn - SVP of Clinical Development and Medical Affairs. Conference Call Participants Boran Wang - Guggenheim Securities Maxwell Skor - Morgan Stanley Operator Good day, and welcome to the Second Quarter Invivyd Earnings Conference Call.

Invivyd, Inc. (IVVD) Q2 2024 Earnings Call Transcript

Invivyd, Inc. (IVVD) came out with a quarterly loss of $0.40 per share versus the Zacks Consensus Estimate of a loss of $0.37. This compares to loss of $0.46 per share a year ago.

Invivyd, Inc. (IVVD) Reports Q2 Loss, Lags Revenue Estimates

WALTHAM, Mass., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced financial results for the quarter ended June 30, 2024, and recent business highlights.

Invivyd Reports Second Quarter 2024 Financial Results and Recent Business Highlights

WALTHAM, Mass., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it will host a conference call on Wednesday, August 14, 2024, at 8:30 a.m. ET to discuss its financial results for the second quarter ended June 30, 2024, and recent business highlights.

Invivyd to Host Conference Call Discussing Second Quarter 2024 Financial Results and Business Highlights

WALTHAM, Mass., July 01, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that as part of the annual reconstitution of the Russell stock indexes, Invivyd will be included in the Russell 2000® Index and the broad-market Russell 3000® Index, effective at the open of U.S. equity markets today.

Invivyd Announces its Addition to the Russell 2000® and Russell 3000® Indexes

WALTHAM, Mass., June 14, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that VYD222 (pemivibart), a half-life extended investigational monoclonal antibody (mAb), shows continued in vitro neutralization activity in pseudovirus assays designed to represent the predominant emerging variants of SARS-CoV-2, including the KP.1.1 FLiRT and KP.3 variants. FLiRT variants account for over half of circulating SARS-CoV-2 variant sequences for the two-week period ending June 8, 2024, with KP.3 prevalence increasing and the Centers for Disease Control and Prevention (CDC) predicting it will become the most dominant SARS-CoV-2 lineage nationally in the near term. Of note, VYD222 has previously demonstrated antiviral in vitro neutralization activity against ancestral XBB lineage viruses that also encoded mutations described in the FLip and FLiRT nomenclature.

Invivyd Announces Antiviral Activity of VYD222 (pemivibart) Against SARS-CoV-2 KP.1.1 FLiRT & KP.3 Variants

WALTHAM, Mass., June 03, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that its management team is scheduled to participate in a fireside chat at the Jefferies Global Healthcare Conference on Thursday, June 6, 2024 at 3:00 p.m. ET in New York, NY.

Invivyd to Participate at the Jefferies Global Healthcare Conference

WALTHAM, Mass., May 31, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced general alignment with the U.S. Food and Drug Administration (FDA) on an expedient, repeatable immunobridging pathway to future potential emergency use authorizations (EUAs) for serial, novel monoclonal antibodies (mAbs) for the prevention and treatment of symptomatic COVID-19. Coupled with Invivyd's proprietary mAb technology platform and engineering capabilities, this pathway provides the company with the opportunity to rapidly, efficiently, and durably deliver high value medicines that prevent and treat symptomatic COVID-19 in vulnerable populations.

Invivyd Announces General Alignment with U.S. FDA on a Repeatable, Expedient Emergency Use Authorization Pathway for the Prevention and Treatment of Symptomatic COVID-19, Based on Compact Clinical Programs to Establish Safety and Immunobridging for Serial

WALTHAM, Mass., May 31, 2024 (GLOBE NEWSWIRE) --  Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that Timothy Lee will be appointed Invivyd's Chief Commercial Officer and will join the company's executive leadership team. Mr. Lee's appointment follows the decision by the Board of Directors to eliminate the Chief Operating Officer role as part of its ongoing efforts to reallocate resources to support the launch of PEMGARDA, resulting in Jeremy Gowler's departure. In the ongoing transitional period, Invivyd's Chief Financial Officer, William Duke, Jr. will assume the role of Principal Executive Officer, and the Board of Directors will continue its ongoing search for a permanent Chief Executive Officer.

Invivyd Announces the Appointment of Timothy Lee as Chief Commercial Officer

WALTHAM, Mass., May 29, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that it will present preliminary, subset analyses from the CANOPY Phase 3 clinical trial of VYD222 (pemivibart) for pre-exposure prophylaxis of COVID-19 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and at the 2024 American Transplant Congress (ATC).

Invivyd to Present Data at 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and 2024 American Transplant Congress (ATC)

WALTHAM, Mass., May 22, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that two new independent directors, Dr. Srishti Gupta and Kevin F. McLaughlin, were elected to its Board of Directors at the annual meeting of stockholders on May 21, 2024. Dr. Gupta will serve as the Chairperson of the Compensation Committee and Mr. McLaughlin will serve as the Chairperson of the Audit Committee.

Invivyd Elects Two New Independent Members to its Board of Directors

WALTHAM, Mass., May 13, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced that Marc Elia, Chairman of the Invivyd Board of Directors, is scheduled to present in a fireside chat at the H.C. Wainwright 2nd Annual BioConnect Investor Conference on Monday, May 20, 2024 at 3:00 p.m. ET in New York, NY.

Invivyd to Participate at the H.C. Wainwright 2nd Annual BioConnect Investor Conference

Invivyd, Inc. (NASDAQ:IVVD ) Q1 2024 Results Conference Call May 9, 2024 4:30 PM ET Company Participants Scott Young - Vice President of Investor Relations & Corporate Communications Marc Elia - Chairman of Directors Bill Duke - Chief Financial Officer Jeremy Gowler - Interim CEO & Chief Operating & Commercial Officer Mark Wingertzahn - Senior Vice President of Clinical Development & Medical Affairs Robert Allen - Chief Scientific Officer Conference Call Participants Maxwell Skor - Morgan Stanley Patrick Trucchio - H.C. Wainwright & Co Evan Wang - Guggenheim Securities Jenna Li - Jefferies Operator Welcome to the Invivyd conference call.

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