The DECLARATION (safety and efficacy vs. placebo) and LIBERTY (exploratory safety head-to-head and combination with mRNA-based COVID vaccination) clinical trials are expected to begin around year-end 2025; top-line data anticipated mid-2026DECLARATION is a Phase 3, randomized, placebo-controlled clinical trial to evaluate prevention of COVID, at three months, from a single intramuscular (IM) dose of VYD2311, with longer-term protection anticipated. A second VYD2311 arm will evaluate monthly IM doses to demo ...

In this article, we will be taking a look at the 15 Best Biotech Penny Stocks to Invest in Right Now. Invivyd, Inc. stands among them. Invivyd, Inc. (NASDAQ:IVVD) is a commercial-stage biopharmaceutical company focused on developing antibody-based therapies for serious viral infections, including COVID-19 and influenza. Its INVYMAB platform combines viral surveillance, predictive modeling, and advanced antibody engineering to deliver next-generation monoclonal antibody (mAb) solutions. Recently, Invivyd, ...

In this article, we will be taking a look at the 15 Best Biotech Penny Stocks to Invest in Right Now.Jared Holz, the healthcare strategist for Mizuho, spoke on CNBC’s “Closing Bell Overtime” in July on whether the biotech industry is ready for a breakthrough. Given that there are hundreds of publicly traded stocks that don’t amount to anything overall, he said that the biotech industry has been a “super tough sector” in any case. He went on to say that it is difficult to make an industrial decision because ...

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].

Summary of Invivyd (IVVD) Conference Call - September 03, 2025 Company Overview - **Company**: Invivyd (IVVD) - **Product**: PEMGARDA, a monoclonal antibody authorized under Emergency Use Authorization for the prevention of COVID-19 in certain immunocompromised individuals [2][4] Core Points and Arguments 1. **Current Status**: Invivyd is a commercial-stage company with an authorized product, PEMGARDA, and is developing a next-generation monoclonal antibody, VYD2311, aimed at improving efficacy and safety compared to existing vaccines [2][3][4] 2. **Technological Advantage**: The company emphasizes its unique technology that allows for the evolution of antibodies to enhance their biophysical properties, which is expected to lead to better medical outcomes for patients [3][4] 3. **Regulatory Engagement**: Invivyd has had constructive dialogues with the FDA regarding the development of VYD2311, which is positioned as a potential alternative to vaccines for COVID-19 [4][5][22] 4. **Market Positioning**: The company aims to shift the reliance from vaccines to monoclonal antibodies for COVID-19 prevention, targeting both high-risk adults and pediatric populations [5][14] 5. **Clinical Efficacy**: PEMGARDA has shown an 85% to 94% reduction in the likelihood of getting sick, although it is described as a specialty medicine with logistical challenges for administration [8][10] 6. **Future Development**: The company plans to conduct clinical trials for VYD2311, which is expected to have a favorable product profile compared to vaccines, including higher efficacy, safety, and durability [24][25][39] 7. **Commercial Strategy**: Invivyd is focused on education and engagement with key opinion leaders and decision-makers to prepare for the commercialization of VYD2311 [40][41] 8. **Cost Structure**: The expected cost of goods sold (COGS) for VYD2311 is projected to be below $100, with a retail price potentially around several hundred dollars, aiming to provide a broad population medicine rather than a specialty product [44][45][46] Important but Overlooked Content 1. **Regulatory History**: The regulatory journey of PEMGARDA has been complex, with the FDA and EMA initially defining its role narrowly, which has impacted its market penetration [7][10] 2. **Public Perception**: The company acknowledges the challenges posed by public perception and misinformation regarding COVID-19 treatments and vaccines, emphasizing the need for clear communication of the benefits of monoclonal antibodies [28][30] 3. **Potential for Resistance**: Invivyd is aware of the potential for emerging resistance to antibodies but believes that their current product, VYD2311, will maintain efficacy due to its stable epitope [47][48] This summary encapsulates the key points discussed during the conference call, highlighting Invivyd's strategic direction, product development, and market positioning in the context of COVID-19 treatment.

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].

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]

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]

Core Insights - Invivyd, Inc. is entering a transformative phase with a focus on VYD2311 as a promising alternative to COVID-19 vaccination, supported by recent clinical trial data [2][5][7] - The company reported a significant year-over-year increase in net product revenue for PEMGARDA, reaching $11.8 million in Q2 2025, representing a 413% growth [5][9] - Despite not meeting the near-term profitability target for the first half of 2025, Invivyd remains optimistic about achieving profitability with the upcoming respiratory virus season [5][9] Recent Business Highlights - The company is actively designing clinical and go-to-market strategies for VYD2311, which has shown an attractive safety profile and pharmacokinetics in Phase 1/2 trials [2][5] - Invivyd anticipates identifying a best-in-class RSV candidate in Q3 2025 and a preclinical measles candidate by the end of 2025 [2][5] Clinical & Regulatory Developments - Invivyd has aligned with the U.S. FDA on a rapid pathway to full approval for VYD2311, which aims to protect American adults and adolescents from COVID-19 [5][7] - The VYD2311 candidate demonstrated a 76-day observed half-life for intramuscular administration, indicating potential for long-term protection [5][6] Commercial Execution - PEMGARDA's uptake is increasing among healthcare providers for immunocompromised patients, supported by Invivyd's sales force and expanded field presence [6][10] - The product has been included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for B-Cell Lymphomas [6] Financial Results - For Q2 2025, Invivyd reported a net loss of $14.7 million, a decrease from $47.2 million in Q2 2024, with a net loss per share of $0.12 [9][28] - Research and development expenses were $9.6 million for the quarter, down from $30.3 million in the same period of 2024, primarily due to reduced clinical trial costs [9][28] Pipeline Expansion - The company is exploring pipeline expansion beyond SARS-CoV-2, including potential targets like RSV and measles [11][19] - Invivyd has formed the SPEAR Study Group to assess monoclonal antibody therapy effects for Long COVID and COVID-19 Post-Vaccination Syndrome [11][19]