Summary of Invivyd Conference Call Company Overview - **Company Name**: Invivyd - **Industry**: Biopharmaceuticals - **Focus**: Protection from serious viral infectious diseases, starting with SARS-CoV-2 - **Key Product**: PEMGARDA, a monoclonal antibody authorized for COVID-19 prevention in immunocompromised patients since spring 2024 [4][10] Core Points and Arguments - **PEMGARDA**: - Provides a unique alternative for immunocompromised individuals who do not receive adequate protection from vaccines [4] - Administered via a one-hour IV infusion, with a two-hour follow-up [4] - Demonstrated strong efficacy against various COVID-19 strains, maintaining activity where other products have failed [6] - Last quarter revenue reached $11.8 million, a significant increase from $2.3 million in the prior year [14] - **Next-Generation Antibody (VYD-2311)**: - Aims to improve upon PEMGARDA with a longer half-life and potential for intramuscular delivery, enhancing patient access [4][5][20] - Demonstrated a 76-day half-life for IM dosing and a 17-fold improvement in potency over PEMGARDA [21][22] - Expected to facilitate easier administration compared to IV infusion, potentially allowing for pharmacy distribution [7][20] - **Regulatory Environment**: - Improved relations with the FDA following a change in administration and leadership, facilitating a smoother path towards full approval for VYD-2311 [9] - Plans for a pivotal Phase 2/3 trial to support the Biologics License Application (BLA) [24] - **Market Opportunity**: - Anticipates increased demand for PEMGARDA and VYD-2311, especially with rising COVID-19 cases in certain regions [17][18] - Inclusion in treatment guidelines is crucial for physician adoption and payer engagement [16] Additional Important Content - **Future Development**: - Exploring additional applications for monoclonal antibodies, including programs for RSV and measles [12][29] - Aiming to position VYD-2311 for both prevention and potential treatment of COVID-19 [28] - **Financial Position**: - Recently raised $57.5 million to support ongoing commercialization and development efforts [39] - Focused on achieving cash flow breakeven through increased sales and cost mitigation strategies [39] - **Long-Term Vision**: - Invivyd aims to expand beyond COVID-19, targeting multiple disease states with its monoclonal antibody platform [41] This summary encapsulates the key insights from the conference call, highlighting Invivyd's current position, product offerings, regulatory strategies, and future growth potential.

Core Viewpoint - Invivyd, Inc. announced that the SPEAR Study Group has issued a consensus recommendation for a clinical study design to evaluate monoclonal antibody therapy for Long COVID, which will be presented to the NIH initiative RECOVER-TLC [1][2]. Group 1: Study Design and Objectives - The SPEAR Study Group aims to explore the role of persistent viral reservoirs and circulating spike protein in Long COVID through a proposed clinical study focusing on broadly neutralizing anti-SARS-CoV-2 spike protein monoclonal antibodies, including VYD2311 [2][5]. - Key elements of the proposed clinical study include deploying high levels of neutralizing monoclonal antibodies over the long term, a randomized placebo-controlled design with over 100 patients per arm, and measuring reduction in detectable spike antigen as a critical endpoint [6][5]. - The study will also explore potential symptom improvement using standardized instruments to correlate the modification of underlying chronic infection with clinical benefits [6][5]. Group 2: Presentation and Workshop - Drs. Amy Proal and David Putrino will present the proposed study design at the Second Annual RECOVER-TLC Workshop on September 9-10, 2025, in Bethesda, Maryland [3]. - Dr. David Putrino will present the study design for funding consideration on September 10, 2025, at 9:25 a.m. ET, while Dr. Amy Proal will discuss the antiviral landscape and implications for Long COVID research later that day at 1:00 p.m. ET [3]. Group 3: VYD2311 Overview - VYD2311 is a novel monoclonal antibody candidate developed to address the urgent need for new therapeutic options for COVID-19, with a pharmacokinetic profile that may allow for patient-friendly administration [7][8]. - The antibody was engineered using Invivyd's proprietary technology platform and is designed to neutralize contemporary virus lineages, leveraging the same backbone as other investigational mAbs with emergency use authorization [8][9].

Invivyd (IVVD) 2025 Conference September 03, 2025 02:10 PM ET Speaker0All right, I think we're ready to get started. Welcome, everyone. I'm Josh Schumer from the Cantor Biotech Equity Research team. Very pleased to introduce from Invivid, Mark Elliott, Chairman of the Board. Mark, give us a very quick snapshot of where Invivid is in prosecuting its portfolio of COVID monoclonal antibodies.Speaker1Sure. Thanks for having us. So, Invivid is a commercial stage company right now. We have an authorized medicine ...

Invivyd (NASDAQ: IVVD), a biopharmaceutical company focused on developing protection against serious viral infectious diseases, is back in the spotlight with notable share price movement.IVVD shares closed Monday’s regular session at $0.56, but surged 73% to $0.97 in Tuesday’s pre-market trading following renewed attention on its monoclonal antibody candidate positioned as an alternative to traditional COVID-19 vaccines.Invivyd one-day stock price chart. Source: Google FinanceThe spike followed a report fro ...

Core Viewpoint - Invivyd, Inc. has successfully closed a public offering of 89,234,480 shares of common stock, raising approximately $57.5 million in gross proceeds before expenses [1][3]. Group 1: Offering Details - The offering included the full exercise of an underwriter's option to purchase an additional 14,423,076 shares at a public offering price of $0.52 per share [1]. - Pre-funded warrants to purchase 21,342,442 shares were also included, priced at $0.5199 each, which reflects the common stock price minus a nominal exercise price [1]. - Cantor Fitzgerald acted as the sole book-running manager for the offering, with RA Capital Management and Janus Henderson Investors leading the financing [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for trial protocol development and advancement of the VYD2311 clinical program [3]. - Funds will also support research and development for pipeline programs targeting respiratory syncytial virus (RSV) and measles, as well as efforts related to monoclonal antibody therapy for Long COVID and COVID-19 Post-Vaccination Syndrome [3]. - Additional uses include working capital and other general corporate purposes [3]. Group 3: Company Background - Invivyd, Inc. is a biopharmaceutical company focused on providing protection against serious viral infectious diseases, starting with SARS-CoV-2 [7]. - The company employs a proprietary integrated technology platform designed to develop and adapt high-quality antibodies [7]. - In March 2024, Invivyd received emergency use authorization from the U.S. FDA for a monoclonal antibody in its innovative pipeline [7].

来源：视频滚动新闻 美股周四早盘，生物制药公司Invivyd（IVVD）股价重挫18%%，此前该公司宣布通过证券发行筹集 5000万美元资金。这笔融资将用于支持临床项目，包括针对长新冠的单克隆抗体疗法研究。 ...

Core Points - Invivyd, Inc. announced a public offering of 74,811,404 shares of common stock at $0.52 per share, along with pre-funded warrants for 21,342,442 shares at $0.5199 each, aiming for gross proceeds of approximately $50 million [1][3] - The offering is expected to close on or about August 22, 2025, subject to customary closing conditions [1] - Cantor is acting as the sole book-running manager for the offering [2] Use of Proceeds - The net proceeds will be utilized for trial protocol development and advancement of the VYD2311 clinical program, research and development for pipeline programs including RSV and measles, and efforts related to monoclonal antibody therapy for Long COVID and COVID-19 Post-Vaccination Syndrome [3] Company Overview - Invivyd, Inc. is a biopharmaceutical company focused on protection against serious viral infectious diseases, starting with SARS-CoV-2, and has a proprietary technology platform for developing antibodies [7]

Core Viewpoint - Invivyd, Inc. has initiated an underwritten public offering of its common stock, with an option for underwriters to purchase an additional 15% of the shares sold at the public offering price [1][3]. Group 1: Offering Details - The offering is subject to market conditions and there is no assurance regarding its completion or the actual size and terms [1]. - Cantor is acting as the sole book-running manager for the offering [2]. - The offering will be conducted under a shelf registration statement filed with the SEC, which was declared effective on October 5, 2022 [4]. Group 2: Use of Proceeds - Invivyd plans to use the net proceeds from the offering for trial protocol development, advancement of the VYD2311 clinical program, and research related to its pipeline programs, including RSV and measles [3]. - Additional uses of the proceeds include efforts related to monoclonal antibody therapy for Long COVID and COVID-19 Post-Vaccination Syndrome, as well as general corporate purposes [3]. Group 3: Company Background - Invivyd, Inc. is a biopharmaceutical company focused on providing protection against serious viral infectious diseases, starting with SARS-CoV-2 [7]. - The company utilizes a proprietary technology platform to develop and adapt antibodies, and received emergency use authorization for a monoclonal antibody in March 2024 [7].

COVID-19 Landscape and Strategy - COVID-19 is the leading cause of hospitalizations and death from respiratory viruses in the U S, with 460,000 hospitalizations and 45,200 deaths between October 1, 2023, and June 15, 2024[7] - The company believes COVID-19 vaccines do not provide sufficient protection, with vaccine effectiveness against hospitalization for immunocompromised adults at a maximum of approximately 36% within 7-59 days of the 2023-2024 vaccine dose[19] - Monoclonal antibodies have demonstrated a significant reduction in the risk of symptomatic COVID-19, with pemivibart showing an 84-94% reduction in risk in ordinary Americans[22] - The company aims to provide Americans with a choice for COVID-19 protection through VYD2311, a monoclonal antibody with high efficacy and long duration of protection, contrasting with the reactogenic and modestly effective COVID-19 vaccines[48, 49] Pipeline and Development - Pemgarda has received emergency use authorization (EUA) from the U S FDA in March 2024 for pre-exposure prophylaxis of COVID-19 in certain immunocompromised persons[29] - VYD2311 is designed to be a high potency, long half-life monoclonal antibody for COVID-19, with an observed IM half-life of 76 days in the first-in-human trial[39, 40] - The company is planning a Phase 2/3 clinical trial for VYD2311 for the prevention of COVID-19, supported by a single, randomized, double-blind, placebo-controlled trial[29] - The company is in the discovery phase for RSV prevention and early discovery for measles and influenza prevention[29] Financials - Q2 2025 Pemgarda net product revenue was $11 8 million[66] - The company ended Q2 2025 with approximately $34 9 million in cash and cash equivalents[66]

Core Insights - Invivyd, Inc. announced positive in vitro neutralization data for PEMGARDA (pemivibart) against the XFG variant of SARS-CoV-2, indicating no significant change in neutralization activity [1][2][3] - The company anticipates continued clinical activity for pemivibart as the targeted epitopes remain structurally intact across various SARS-CoV-2 variants [2][3] - Invivyd is advancing its next-generation monoclonal antibody candidate, VYD2311, which has shown similar neutralization results with higher potency [3][12] Company Developments - PEMGARDA is authorized by the FDA for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients, demonstrating consistent in vitro neutralizing activity over several years [1][4][7] - The company plans to provide updated data on PEMGARDA's neutralizing activity to the FDA, which will be included in the PEMGARDA Fact Sheet for Healthcare Providers [4][5] - VYD2311 is designed to offer a more patient-friendly administration route and aims to address the urgent need for new COVID-19 prophylactic and therapeutic options [12][13] Industry Context - COVID-19 activity is reportedly on the rise in the U.S., with high levels of viral activity detected in wastewater across 12 states, and infections growing in 34 states [2][3] - The CDC's data indicates that the XFG variant is contributing to a growing wave of COVID-19 cases in America, reinforcing the need for effective treatments like PEMGARDA and VYD2311 [5][6] - The stability of the epitopes targeted by Invivyd's monoclonal antibodies across SARS-CoV-2 evolution highlights the company's robust molecular design strategy [3][4]