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Invivyd: Maintaining Hold Rating With VYD2311 Alternative To Covid-19 Vaccination
Seeking Alpha· 2025-11-18 20:49
This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33. ...
Invivyd Announces Pricing of $125 Million Public Offering of Common Stock and Pre-Funded Warrants
Globenewswire· 2025-11-18 03:40
Core Viewpoint - Invivyd, Inc. has announced a public offering of 44 million shares of common stock at $2.50 per share, aiming to raise approximately $125 million before expenses [1][3]. Group 1: Offering Details - The offering includes 44,000,000 shares of common stock priced at $2.50 each and pre-funded warrants for 6,000,000 shares at $2.4999 each [1]. - Underwriters have a 30-day option to purchase an additional 7,500,000 shares at the public offering price [1]. - The offering is expected to close on or about November 19, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - Invivyd plans to use the net proceeds for commercial preparedness for the potential launch of VYD2311, ongoing 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]. Group 3: Company Background - Invivyd, Inc. is a biopharmaceutical company focused on providing protection against serious viral infectious diseases, starting with SARS-CoV-2, utilizing a proprietary technology platform for developing antibodies [7].
Adagio(IVVD) - 2025 Q3 - Earnings Call Transcript
2025-11-06 14:32
Financial Data and Key Metrics Changes - Invivyd's PEMGARDA revenues grew by 11% quarter-on-quarter and 41% year-over-year, reflecting ongoing market awareness efforts [19] - The company raised approximately $87 million in capital during the quarter, enhancing its financial position for upcoming clinical programs [5][19] Business Line Data and Key Metrics Changes - The commercial franchise for PEMGARDA is expanding, with over 15,000 contracted GPO sites and more than 1,200 sites offering infusion services, with 76% of those accounts reordering [14][15] - The company is transitioning from a smaller patient population to a broader market with the potential approval of VYD2311, aiming to replace current vaccine options [14][18] Market Data and Key Metrics Changes - COVID vaccine sales in the U.S. totaled $3.8 billion last year, indicating a significant market opportunity for Invivyd's products [18] - Current COVID vaccine uptake is substantially below that of influenza vaccines, despite higher public concern about COVID [17] Company Strategy and Development Direction - Invivyd is focused on advancing its next-generation antibody, VYD2311, which aims to provide a safer and more effective alternative to current COVID vaccines [4][18] - The company plans to initiate pivotal clinical studies for VYD2311 around year-end 2025, with top-line data expected in mid-2026 [7][13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming 12-18 months, highlighting the potential for significant advancements in COVID prevention for vulnerable populations [7] - The company aims to address safety concerns associated with COVID vaccines through its antibody-based approach, which is expected to have a favorable side effect profile [12][13] Other Important Information - The DECLARATION and LIBERTY studies are designed to provide critical data on the efficacy and safety of VYD2311 compared to existing vaccines [10][13] - Invivyd is also exploring early-stage discovery efforts in RSV and measles, with plans for rapid advancement into clinical development [31][33] Q&A Session Summary Question: Will Invivyd wind down PEMGARDA once the next-gen product is approved? - Management confirmed that there are no plans to actively sunset PEMGARDA, as it remains a differentiated medicine despite its scalability challenges [22] Question: Can you clarify the coordination between CBER and CDER for the LIBERTY study? - Management indicated that coordination between CBER and CDER is expected due to the unique nature of the study, but specific details are best addressed by the FDA [24][26] Question: What are the commercial team's current reach and plans for expansion? - The commercial team is building upon its foundation in infusion centers and plans to expand its reach through digital assets and increased field presence [30] Question: How does Invivyd intend to differentiate its early-stage discovery programs in RSV and measles? - Management highlighted the focus on viral resistance and biophysical properties as key differentiation factors for the new antibody programs [32][33]
Adagio(IVVD) - 2025 Q3 - Earnings Call Transcript
2025-11-06 14:30
Financial Data and Key Metrics Changes - Invivyd reported a significant increase in Pemgarda revenues, which grew by 11% quarter on quarter and 41% year over year, reflecting ongoing market awareness efforts [18] - The company raised approximately $87 million in capital during the quarter, enhancing its financial position to support pivotal clinical programs and commercial expansion [5][18] Business Line Data and Key Metrics Changes - The Pemgarda commercial franchise is expanding, with over 15,000 contracted GPO sites and more than 1,200 sites offering infusion, with 76% of those accounts reordering [13][14] - The company is transitioning from a smaller patient population to a broader market with the potential approval of VYD2311, which is expected to replace vaccines for COVID prevention [12][17] Market Data and Key Metrics Changes - The U.S. COVID vaccine market generated $3.8 billion in sales last year, but vaccine uptake remains lower than that of influenza vaccines, despite higher public concern about COVID [17] - The company sees a significant opportunity to improve safety and efficacy in COVID protection compared to existing vaccines, which may enhance market share if VYD2311 is approved [17] Company Strategy and Development Direction - Invivyd is focused on advancing its next-generation antibody, VYD2311, which aims to provide a safer and more effective alternative to current COVID vaccines [4][11] - The company is preparing for pivotal studies, with data expected in mid-2026, and is committed to maintaining operational discipline while expanding its commercial organization [5][11][18] Management's Comments on Operating Environment and Future Outlook - Management highlighted the importance of addressing the long-term efficacy and safety of COVID vaccines, noting the lack of modern randomized data on vaccine effectiveness [9][10] - The next 12 to 18 months are anticipated to be transformative for Invivyd, with a strong focus on clinical trials and potential market entry for VYD2311 [6][11] Other Important Information - The company is conducting studies to evaluate the safety and efficacy of VYD2311, including a head-to-head comparison with mRNA vaccines to address safety concerns among the public [10][11] - Invivyd is also exploring early-stage discovery efforts in RSV and measles, aiming to differentiate its products in these markets [29][30] Q&A Session Summary Question: Will Invivyd wind down Pemgarda once the next-gen product is approved? - Management confirmed that there are no plans to actively sunset Pemgarda, as it remains a differentiated medicine despite its scalability challenges [20][21] Question: Can you clarify the coordination between CBR and CDR for the Liberty study? - Management indicated that coordination between CBER and CDER is expected, but specific details would be best addressed by the FDA [22][23][25] Question: What are the commercial team's current reach and plans for expansion beyond infusion centers? - The commercial team is building upon its foundation to reach specialists caring for immunocompromised patients and plans to increase digital outreach and field presence [27][28] Question: How will Invivyd differentiate its early-stage discovery efforts in RSV and measles? - Management explained that differentiation will focus on resistance profiles and biophysical properties, with updates expected before the end of the year [29][30][32]
Adagio(IVVD) - 2025 Q3 - Earnings Call Presentation
2025-11-06 13:30
Invivyd Q3 Earnings Call & Business Update November 6, 2025 © 2025 Invivyd, Inc. All trademarks used in this presentation are the property of their respective owners. 1 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS 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 historical fact are forward-looking statements. Words such as "may," "will," "should," "expect," ...
Invivyd Reports Third Quarter 2025 Financial Results and Recent Business Highlights
Globenewswire· 2025-11-06 12:01
Core Insights - Invivyd, Inc. reported strong financial results for Q3 2025, with a net product revenue of $13.1 million, reflecting a 41% year-over-year growth and an 11% quarter-over-quarter growth [5][10] - The company is preparing for pivotal studies and a potential commercial launch of VYD2311, an antibody alternative to COVID vaccination, following recent IND clearance and FDA alignment [2][4] - Invivyd's cash position improved significantly, ending Q3 2025 with $85 million in cash and cash equivalents, bolstered by a public offering and ATM facility [5][10] Recent Business Highlights - The company is focused on the urgent need for antibody protection against COVID-19 and is also exploring additional pathogens beyond COVID [2][3] - The REVOLUTION clinical program for VYD2311 includes two pivotal trials: DECLARATION and LIBERTY, expected to begin around year-end 2025, with top-line data anticipated by mid-2026 [5][6][7] Clinical & Regulatory Developments - Invivyd received U.S. IND clearance for VYD2311, which is designed to prevent COVID-19, and is preparing for the initiation of the DECLARATION and LIBERTY clinical trials [5][6] - The DECLARATION trial will evaluate the safety and efficacy of VYD2311 in preventing symptomatic COVID-19, while the LIBERTY trial will assess its interaction with mRNA-based COVID vaccines [6][7] Commercial Execution - The uptake of PEMGARDA (pemivibart) continues to grow among healthcare providers, supported by Invivyd's sales force [6] - Positive in vitro neutralization data for PEMGARDA and VYD2311 against the XFG variant of SARS-CoV-2 was announced, indicating no significant change in neutralization activity [6][8] Corporate and Financial Updates - The company reported a net loss of $10.5 million for Q3 2025, a significant reduction from a net loss of $60.7 million in Q3 2024 [10][27] - Research and development expenses decreased to $8 million in Q3 2025 from $57.9 million in the same period of 2024, primarily due to reduced clinical trial costs [10][27] Pipeline Expansion - Invivyd is initiating discovery efforts to expand its pipeline beyond SARS-CoV-2, targeting potential pathogens such as respiratory syncytial virus (RSV) and measles [8][9]
Invivyd (NasdaqGM:IVVD) Update / Briefing Transcript
2025-10-30 13:30
Summary of Invivyd Revolution Pivotal Program Conference Call Company Overview - **Company**: Invivyd - **Product**: VYD2311, an antibody developed as an alternative to COVID vaccination and for other potential uses Key Industry Insights - **COVID Landscape**: The current and future endemic COVID situation is still evolving, with significant systemic medical implications beyond respiratory symptoms, including cardiovascular and organ damage [9][10] - **Vaccine Efficacy**: Initial COVID vaccines showed short-term efficacy, but long-term protection has been questioned due to the evolving nature of the virus and the limitations of the human immune response [10][12] Core Points and Arguments - **Antibody Technology**: Invivyd focuses on developing antibodies that enhance human immune responses, aiming for a best-in-class safety and efficacy profile [6][7] - **Expansion Beyond COVID**: The company is exploring treatments for acute COVID, long COVID, and other viral pathogens like RSV and measles [7] - **Clinical Trials**: The Revolution Program includes a Phase 1/2 study and a Phase 3 randomized placebo-controlled study (Declaration) to assess VYD2311's efficacy in preventing symptomatic COVID-19 [29][34] - **Efficacy Expectations**: The Declaration study aims for a 70% to 90% reduction in symptomatic COVID-19 compared to placebo over a 90-day period [36][64] Important Data and Projections - **Commercial Opportunity**: U.S. COVID vaccine sales totaled $3.8 billion last year, with lower uptake compared to influenza vaccines, indicating a significant market opportunity for VYD2311 [46][74] - **Safety Profile**: VYD2311 has shown a favorable safety profile even at suprapharmacologic doses, with no significant adverse findings in preclinical testing [31][33] Additional Considerations - **Public Perception**: There is a notable fear and mistrust regarding COVID vaccination among the public, which presents an opportunity for Invivyd to restore trust through its antibody solutions [13][14] - **Regulatory Coordination**: The Liberty study will assess the safety and tolerability of mRNA vaccines versus VYD2311, which may inform future labeling and guidance for healthcare providers [42][43] - **Manufacturing and Delivery**: Invivyd is confident in its manufacturing capabilities to meet potential demand for VYD2311, which is designed for easy administration [90] Conclusion - Invivyd is positioned to offer a novel solution in the COVID landscape with VYD2311, focusing on safety, efficacy, and addressing public concerns about vaccination. The company is actively preparing for clinical trials and commercial opportunities while navigating regulatory landscapes.
Invivyd (NasdaqGM:IVVD) Earnings Call Presentation
2025-10-30 12:30
COVID Landscape and Vaccine Challenges - COVID vaccines may face durability issues due to the nature of coronavirus immunity[9, 10] - A CDC survey in June-July 2024 indicated that 20% of adults avoided COVID vaccines due to concerns about serious/unknown side effects[13] - Americans have avoided COVID vaccines due to safety fears and mistrust[12] Invivyd's Antibody Approach - Invivyd is developing best-in-class antibody protection and treatment of viral threats[5] - Invivyd's monoclonal antibodies can be engineered for consistent high activity, unlike vaccines[19] - Pemivibart's target epitope has remained relatively unchanged over the past 3 years[22, 23] - VYD2311 is a minimally evolved molecular engineered antibody designed to improve performance[24] REVOLUTION Clinical Program - VYD2311 Phase 1/2 study showed attractive safety at high doses, up to 4500 mg IV[35, 38] - The DECLARATION Phase 3 clinical trial will evaluate prevention of symptomatic COVID at three months[45] - The company aims for a 70%-90% reduction in symptomatic COVID with a 250 mg single dose IM of VYD2311 versus placebo over 3 months[47] Commercial Landscape - Approximately 342 million of the US population is 12+[74] - In the 24-25 flu season, 147 million flu vaccine doses were administered[75] - 36% was the 2023-2024 vaccine dose, ≥7 days 18 and over vaccine efficacy (VE) reduction in hospitalization estimate from CDC[73]
Invivyd to Host Webcast on the REVOLUTION Clinical Program for VYD2311, a Vaccine-Alternative Antibody to Prevent COVID
Globenewswire· 2025-10-28 11:01
Core Viewpoint - Invivyd, Inc. is set to host a live webcast on October 30, 2025, to present an overview of its REVOLUTION clinical program for VYD2311, a monoclonal antibody candidate aimed at preventing COVID-19 [1][2]. Group 1: Company Overview - Invivyd, Inc. is a biopharmaceutical company focused on providing protection against serious viral infectious diseases, starting with SARS-CoV-2 [5]. - The company utilizes a proprietary integrated technology platform designed to develop and adapt antibodies [5]. Group 2: Product Details - VYD2311 is a novel monoclonal antibody candidate developed for COVID-19, addressing the urgent need for new prophylactic and therapeutic options [3]. - The pharmacokinetic profile and antiviral potency of VYD2311 may allow for clinically meaningful titer levels through more patient-friendly administration methods, such as intramuscular injection [3]. - VYD2311 was engineered using Invivyd's proprietary technology and is optimized for neutralizing contemporary virus lineages [4]. Group 3: Clinical Program - The webcast will provide an overview and details of the trials included in the REVOLUTION clinical program [2]. - VYD2311 shares the same antibody backbone as pemivibart, which has received emergency use authorization in the U.S. for pre-exposure prophylaxis of symptomatic COVID-19 in certain immunocompromised patients [4].
Invivyd Announces U.S. IND Clearance and Alignment with U.S. FDA on Pivotal Clinical Program for VYD2311, a Vaccine-Alternative Antibody to Prevent COVID
Globenewswire· 2025-10-06 11:01
Core Insights - Invivyd, Inc. has received FDA clearance for its Investigational New Drug application to advance the REVOLUTION clinical program for VYD2311, a monoclonal antibody candidate aimed at preventing COVID-19 [1][2] Clinical Trials Overview - The DECLARATION clinical trial is a Phase 3 pivotal trial designed to evaluate the safety and efficacy of VYD2311 against a placebo, focusing on the prevention of symptomatic COVID-19 [2][5] - The LIBERTY clinical trial will compare the safety and tolerability of VYD2311 against mRNA-based COVID vaccines and will explore the co-administration of VYD2311 with vaccination [2][4] - Both trials are expected to start around the end of 2025, with top-line data anticipated by mid-2026 [5][6] Trial Design and Objectives - The DECLARATION trial will assess the prevention of symptomatic COVID-19 at three months with either a single dose or monthly doses of VYD2311, administered via intramuscular injection [3][5] - The LIBERTY trial aims to demonstrate the safety and tolerability advantages of antibody-based prophylaxis compared to mRNA vaccines, and to gather data on the interaction between VYD2311 and mRNA vaccines [4][5] Strategic Goals - The REVOLUTION program aims to provide at-risk populations with a flexible and safe alternative for COVID-19 protection, allowing individuals to choose the timing and quantity of their protection [6][8] - Invivyd has produced commercial launch quantities of VYD2311 and secured funding to support the execution of clinical trials [6][10] Product Information - VYD2311 is a novel monoclonal antibody candidate developed to address the urgent need for new prophylactic options against COVID-19, with a focus on delivering clinically meaningful titer levels through patient-friendly administration [8][9] - The antibody is engineered using Invivyd's proprietary technology platform, optimized for neutralizing contemporary virus lineages [9][10]