Preliminary Q4 2025 PEMGARDA® (pemivibart) net product revenue of $17.2 million, representing 25% growth year-over-year and 31% growth quarter-over-quarterPreliminary ending 2025 cash and cash equivalents of $226.7 million after raising over $200 million from financing transactions in 2H 2025Announced initiation of DECLARATION Phase 3 pivotal clinical trial of vaccine-alternative antibody VYD2311 to prevent COVID, with top-line data expected mid-2026; Fast Track designation for VYD2311 granted by FDA in Dec ...

Invivyd Inc. (NASDAQ:IVVD) is one of the best biotech penny stocks to buy according to analysts. On December 22, BTIG analyst Thomas Shrader initiated coverage of Invivyd with a Buy rating and $10 price target. BTIG maintained this stance on Invivyd, citing the company’s established expertise in antibody production. The firm informed investors that VYD2311’s market potential far exceeds that of Pemgarda, which positions the stock for significant growth. Additionally, on December 23, Invivyd announced two ...

Core Insights - Invivyd, Inc. announced that the FDA has granted Fast Track designation for VYD2311, a monoclonal antibody candidate aimed at preventing COVID-19 [1][2] Group 1: FDA Fast Track Designation - Fast Track designation allows for expedited development and review of drugs addressing serious conditions and unmet medical needs, potentially leading to priority review and reduced regulatory timelines [2] - VYD2311 is specifically designated for individuals with underlying risk factors for severe COVID-19 [2] Group 2: Clinical Trials - The DECLARATION trial is a Phase 3, randomized, triple-blind, placebo-controlled study to evaluate the safety and efficacy of VYD2311 in preventing symptomatic COVID-19 [4][7] - The trial will enroll approximately 1,770 participants, including adults and adolescents, and will compare a single or monthly dose of VYD2311 against a placebo [4][7] - Top-line data from the DECLARATION trial is expected by mid-2026 [3] Group 3: Product Information - VYD2311 is a novel monoclonal antibody developed to address the urgent need for new prophylactic and therapeutic options against COVID-19 [5] - The antibody is engineered using Invivyd's proprietary technology platform and is designed to neutralize contemporary virus lineages [6] - VYD2311 shares the same antibody backbone as other investigational monoclonal antibodies in Invivyd's pipeline, which have shown promising results in clinical trials [6] Group 4: Company Overview - Invivyd, Inc. is focused on delivering protection from serious viral infectious diseases, starting with SARS-CoV-2 [8] - The company utilizes a unique integrated technology platform to develop and adapt antibodies for various viral threats [8]

DECLARATION is a Phase 3, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of VYD2311 in the prevention of COVID versus placebo, at three months, from a single intramuscular (IM) dose, with protection beyond three months anticipated  A second arm will evaluate monthly IM doses versus placebo to demonstrate the safety and efficacy of more frequent dosing to support individual choice should at-risk persons seek periodic extra protection from COVIDPrimary endpoint is the reduct ...

Invivyd (NasdaqGM:IVVD) FY Conference December 02, 2025 02:35 PM ET Company ParticipantsTimothy Lee - Chief Commercial OfficerRobert Allen - Chief Scientific OfficerConference Call ParticipantsNone - AnalystNoneWell, thank you, guys. Super excited to have management team from Invivyd join us. And I'm sorry, Mark, couldn't make it, but I'll let you kick things off, and I feel like there's a lot to talk about since it's weekend.Timothy LeeThere is. You know, it's a very exciting time at Invivyd. And for those ...

Core Insights - The article discusses the investment analysis service provided by Biotech Analysis Central, focusing on pharmaceutical companies and their potential for long-term value generation [1][2]. Company Overview - Invivyd, Inc. (IVVD) is highlighted as a company of interest, particularly in the context of its development of monoclonal antibodies (mAb) for COVID-19 and respiratory syncytial virus (RSV) [2]. Service Features - Biotech Analysis Central offers a comprehensive library of over 600 biotech investing articles, a model portfolio featuring more than 10 small and mid-cap stocks, and various analysis and news reports aimed at assisting healthcare investors [2]. - The subscription service is priced at $49 per month, with a discounted annual plan available at $399, representing a 33.50% savings [1].

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].

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]

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]

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," ...