Core Viewpoint - The biopharmaceutical company Invivyd (IVVD) experienced a significant stock price drop of 18% following the announcement of a $50 million securities offering aimed at funding clinical projects, including research on monoclonal antibody therapies for long COVID [1] Group 1 - Invivyd's stock price fell by 18% in early trading on Thursday [1] - The company announced a securities offering to raise $50 million [1] - The funds will be used to support clinical projects, specifically research on monoclonal antibody therapies for long COVID [1]

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]

PART I [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201%2E%20Financial%20Statements%20%28Unaudited%29) This section presents Invivyd, Inc.'s unaudited condensed consolidated financial statements as of June 30, 2025, including balance sheets, statements of operations, stockholders' equity, and cash flows, along with notes, reflecting increased product revenue but continued net losses and a "going concern" warning [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2025, shows total assets decreased to **$89.1 million** from **$129.5 million** at year-end 2024, primarily due to reduced cash and cash equivalents, with total stockholders' equity also declining to **$42.8 million** from **$67.5 million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $34,905 | $69,349 | | Total current assets | $59,281 | $100,681 | | Total assets | $89,138 | $129,515 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $44,451 | $61,976 | | Total liabilities | $46,349 | $61,976 | | Total stockholders' equity | $42,789 | $67,539 | | Total liabilities and stockholders' equity | $89,138 | $129,515 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three and six months ended June 30, 2025, the company reported significant year-over-year revenue growth from PEMGARDA, while net losses narrowed considerably due to lower research and development and SG&A expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | Six Months 2025 | Six Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Product revenue, net | $11,786 | $2,264 | $23,090 | $2,264 | | Research and development | $9,573 | $30,334 | $20,214 | $61,494 | | Selling, general and administrative | $16,588 | $21,089 | $33,339 | $36,018 | | Loss from operations | ($15,060) | ($49,247) | ($31,982) | ($95,336) | | Net loss | ($14,660) | ($47,247) | ($30,949) | ($90,743) | | Net loss per share | ($0.12) | ($0.40) | ($0.26) | ($0.77) | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Total stockholders' equity decreased from **$67.5 million** at the end of 2024 to **$42.8 million** as of June 30, 2025, primarily due to the **$30.9 million** net loss for the six-month period, partially offset by stock-based compensation and stock option exercises - Total stockholders' equity decreased from **$67.5 million** on December 31, 2024, to **$42.8 million** on June 30, 2025, mainly due to the accumulated deficit increasing from **$902.0 million** to **$932.9 million**[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, the company used **$34.4 million** in cash from operating activities, resulting in a net decrease in cash and cash equivalents of **$34.4 million** and an ending cash balance of **$34.9 million** Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($34,430) | ($91,813) | | Net cash used in investing activities | ($155) | ($140) | | Net cash provided by financing activities | $141 | $39,193 | | **Net decrease in cash and cash equivalents** | **($34,444)** | **($52,760)** | | Cash and cash equivalents at end of period | $34,905 | $147,881 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes provide critical details on accounting policies and specific financial items, including the Emergency Use Authorization for PEMGARDA, progress on VYD2311, and a significant disclosure of substantial doubt about the company's ability to continue as a going concern - The company's first monoclonal antibody, PEMGARDA®, received Emergency Use Authorization (EUA) from the FDA on March 22, 2024, for the pre-exposure prophylaxis of COVID-19 in certain immunocompromised individuals[27](index=27&type=chunk)[28](index=28&type=chunk) - The company has concluded that there is substantial doubt about its ability to continue as a going concern, as current cash and cash equivalents are not sufficient to fund operating expenses and capital requirements beyond one year from the financial statement issuance date[38](index=38&type=chunk) - As of June 30, 2025, the company had noncancelable purchase obligations of **$29.4 million** due to its manufacturing partner WuXi Biologics, expected to be paid in 2025[103](index=103&type=chunk)[104](index=104&type=chunk) - On April 18, 2025, the company entered into a Loan and Security Agreement for a senior secured term loan facility of up to **$30 million**, contingent on meeting certain financial and revenue milestones, with no funds drawn as of June 30, 2025[110](index=110&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=37&type=section&id=Item%202%2E%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, liquidity, and business outlook, highlighting PEMGARDA's commercialization and VYD2311's development, while reiterating substantial doubt about its going concern ability and the need for additional funding [Results of Operations](index=47&type=section&id=Results%20of%20Operations) This section details the comparison of operating results for the three and six months ended June 30, 2025 and 2024, showing net product revenue increased to **$11.8 million** from **$2.3 million** in Q2 2025, and net loss narrowed to **$14.7 million** from **$47.2 million**, primarily due to a **$20.8 million** decrease in R&D expenses Comparison of Results for the Six Months Ended June 30 (in thousands) | Item | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Product revenue, net | $23,090 | $2,264 | $20,826 | | Research and development | $20,214 | $61,494 | ($41,280) | | Selling, general and administrative | $33,339 | $36,018 | ($2,679) | | Loss from operations | ($31,982) | ($95,336) | $63,354 | | Net loss | ($30,949) | ($90,743) | $59,794 | - The decrease in R&D expenses for the first six months of 2025 was primarily driven by reduced contract costs for commercial manufacturing and clinical trials for both the pemivibart and VYD2311 programs[209](index=209&type=chunk) - The company noted that if pre-EUA manufacturing costs had been capitalized instead of expensed as R&D, its reported product margins would approach **80%**[196](index=196&type=chunk)[204](index=204&type=chunk) [Liquidity and Capital Resources](index=51&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity position is critical, with cash and cash equivalents at **$34.9 million** as of June 30, 2025, which management explicitly states is insufficient to support operations for the next year, leading to substantial doubt about its ability to continue as a going concern without additional funding - As of June 30, 2025, the company had cash and cash equivalents of **$34.9 million**[213](index=213&type=chunk) - The company concludes there is substantial doubt about its ability to continue as a going concern, as it will not have sufficient cash to fund operations beyond one year without additional financing or revenue contributions[173](index=173&type=chunk)[224](index=224&type=chunk) - In February 2024, the company raised **$39.3 million** in net proceeds by selling **9 million** shares through its "at the market" (ATM) sales agreement, with **$34.5 million** remaining available for sale as of June 30, 2025[214](index=214&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=55&type=section&id=Item%203%2E%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is therefore not required to provide the information for this item - As a smaller reporting company, Invivyd is not required to provide quantitative and qualitative disclosures about market risk[234](index=234&type=chunk) [Controls and Procedures](index=55&type=section&id=Item%204%2E%20Controls%20and%20Procedures) Management, including the Chief Financial Officer, evaluated the company's disclosure controls and procedures and concluded they were effective at a reasonable assurance level as of June 30, 2025, with no material changes to internal control over financial reporting identified during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[236](index=236&type=chunk) - There were no material changes in the company's internal control over financial reporting during the quarter ended June 30, 2025[237](index=237&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=56&type=section&id=Item%201%2E%20Legal%20Proceedings) As of June 30, 2025, the company reports that it was not a party to any material legal proceedings - The company was not a party to any material legal proceedings as of June 30, 2025[240](index=240&type=chunk) [Risk Factors](index=56&type=section&id=Item%201A%2E%20Risk%20Factors) This section updates the company's risk factors, highlighting the risk of being delisted from the Nasdaq Global Market for failing to meet the minimum **$1.00** bid price requirement and risks associated with the new Loan and Security Agreement, including restrictive covenants, default conditions, and the uncertainty of being able to draw down funds if milestones are not met - The company is at risk of being delisted from Nasdaq, having received a non-compliance notice on April 21, 2025, for its stock price closing below **$1.00** for 30 consecutive days, and has until October 20, 2025, to regain compliance[244](index=244&type=chunk) - The new Loan Agreement contains covenants that limit the company's operational flexibility, and a default could lead to acceleration of debt repayment and foreclosure on assets[247](index=247&type=chunk)[259](index=259&type=chunk) - Access to the tranches of the **$30 million** term loan facility is contingent on achieving certain net product revenue milestones, which had not been satisfied as of June 30, 2025[257](index=257&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=60&type=section&id=Item%202%2E%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports that it did not issue any unregistered equity securities during the three months ended June 30, 2025 - No unregistered equity securities were sold during the second quarter of 2025[261](index=261&type=chunk) [Other Information](index=62&type=section&id=Item%205%2E%20Other%20Information) During the second quarter of 2025, none of the company's directors or officers adopted or terminated a Rule 10b5-1 trading arrangement - No directors or officers adopted or terminated a Rule 10b5-1 trading plan during the three months ended June 30, 2025[265](index=265&type=chunk) [Exhibits](index=63&type=section&id=Item%206%2E%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents, the new loan agreement, and officer certifications

[Management Commentary](index=1&type=section&id=Management%20Commentary) Management expressed optimism for VYD2311 as a COVID-19 alternative, focused on PEMGARDA® growth, and pipeline expansion into RSV and measles - The company is actively designing the clinical and go-to-market strategy for VYD2311, which it views as a potential alternative to **COVID-19 vaccination**[2](index=2&type=chunk) - While PEMGARDA's Q2 growth was modest, the company is focused on solidifying its market position as a leading provider of **monoclonal antibody technology for COVID-19 protection**[2](index=2&type=chunk) - Pipeline expansion is a key focus, with plans to identify a **best-in-class RSV candidate in Q3 2025** and a **preclinical measles candidate by the end of 2025**[2](index=2&type=chunk) [Recent Business Highlights](index=1&type=section&id=Recent%20Business%20Highlights) Invivyd achieved significant PEMGARDA® revenue growth, advanced VYD2311 with FDA alignment, expanded its pipeline, and secured additional financing [Commercial Execution](index=1&type=section&id=Commercial%20Execution) PEMGARDA® uptake is growing among immunocompromised patients, supported by an expanded sales force and NCCN® guideline inclusion - Uptake of PEMGARDA® is growing among providers for immunocompromised patients, supported by an **expanded internal sales force**[5](index=5&type=chunk) - Pemivibart has been added to the **NCCN® Clinical Practice Guidelines in Oncology for B-Cell Lymphomas**, a key endorsement[5](index=5&type=chunk) [Clinical & Regulatory Developments](index=2&type=section&id=Clinical%20%26%20Regulatory%20Developments) Invivyd reported positive VYD2311 Phase 1/2 data, demonstrating a long half-life and aligning with the FDA on a rapid BLA pathway via a single Phase 2/3 trial - VYD2311 demonstrated a favorable safety profile in its Phase 1/2 trial, with an **observed half-life of 76 days** for the intramuscular (IM) route, suggesting potential for long-term protection[4](index=4&type=chunk)[8](index=8&type=chunk) - The company has aligned with the U.S. FDA on a **rapid pathway to full approval (BLA) for VYD2311**, intended to protect adults and adolescents from COVID-19[4](index=4&type=chunk)[8](index=8&type=chunk) - The BLA pathway will be supported by a **single Phase 2/3 randomized, double-blind, placebo-controlled trial** with a primary endpoint of reduction in symptomatic COVID-19[8](index=8&type=chunk) [Pipeline Expansion](index=2&type=section&id=Pipeline%20Expansion) The company is actively expanding its pipeline beyond SARS-CoV-2, targeting RSV and measles candidates for identification by Q4 2025 - Invivyd has initiated **discovery efforts to expand its pipeline** to include potential targets like **respiratory syncytial virus (RSV)** and **measles**[8](index=8&type=chunk) - The company expects to provide an update on the identification of an **RSV candidate in Q3 2025** and a **preclinical measles candidate in Q4 2025**[8](index=8&type=chunk) [Corporate and Financial Updates](index=3&type=section&id=Corporate%20and%20Financial%20Updates) Invivyd formed the SPEAR Study Group for Long COVID research and secured a $30 million non-dilutive term loan facility to strengthen its financial position - In July 2025, the **SPEAR (Spike Protein Elimination and Recovery) Study Group** was formed to assess **mAb therapy for Long COVID**[13](index=13&type=chunk) - In April 2025, the company entered into a **$30 million non-dilutive term loan facility** with Silicon Valley Bank to support balance sheet optionality[13](index=13&type=chunk) [Second Quarter 2025 Financial Results](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) Invivyd reported $11.8 million net product revenue for Q2 2025, a 413% increase, significantly reducing its net loss to $14.7 million due to higher revenue and lower R&D expenses [Statement of Operations](index=8&type=section&id=Statement%20of%20Operations) Q2 2025 saw total revenue reach $11.8 million, a substantial increase from the prior year, with reduced operating expenses leading to a narrowed net loss of $14.7 million Q2 2025 Statement of Operations Highlights (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | **Product Revenue, Net** | **$11,786** | **$2,264** | **+413%** | | R&D Expenses | $9,573 | $30,334 | -68.4% | | SG&A Expenses | $16,588 | $21,089 | -21.3% | | Loss from Operations | ($15,060) | ($49,247) | +69.4% | | **Net Loss** | **($14,660)** | **($47,247)** | **+68.9%** | | **Net Loss Per Share** | **($0.12)** | **($0.40)** | **+70.0%** | [Balance Sheet](index=7&type=section&id=Balance%20Sheet) As of June 30, 2025, Invivyd reported total assets of $89.1 million, total liabilities of $46.3 million, and cash and cash equivalents of $34.9 million Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Cash and cash equivalents** | **$34,905** | **$69,349** | | Total current assets | $59,281 | $100,681 | | **Total assets** | **$89,138** | **$129,515** | | Total current liabilities | $44,451 | $61,976 | | **Total liabilities** | **$46,349** | **$61,976** | | **Total stockholders' equity** | **$42,789** | **$67,539** | [Product and Pipeline Overview](index=3&type=section&id=Product%20and%20Pipeline%20Overview) This section details PEMGARDA®, an authorized COVID-19 prevention antibody, VYD2311, a next-generation candidate, and the foundational CANOPY clinical trial data [PEMGARDA® (pemivibart)](index=3&type=section&id=PEMGARDA%C2%AE%20(pemivibart)) PEMGARDA® is an FDA-authorized monoclonal antibody for pre-exposure prophylaxis of COVID-19 in immunocompromised individuals, with a boxed warning for anaphylaxis - PEMGARDA is **authorized under an EUA for pre-exposure prophylaxis of COVID-19** in adults and adolescents (≥12 years, ≥40 kg) with **moderate-to-severe immune compromise**[11](index=11&type=chunk) - It is **not authorized for treatment of COVID-19 or post-exposure prophylaxis** and is **not a substitute for recommended COVID-19 vaccination**[12](index=12&type=chunk) - The product has a **boxed warning for anaphylaxis**, which has been observed in patients[14](index=14&type=chunk) [VYD2311](index=4&type=section&id=VYD2311) VYD2311 is a novel, next-generation monoclonal antibody for COVID-19 prevention and treatment, engineered for broad neutralization and patient-friendly intramuscular administration - VYD2311 is a **novel mAb candidate** being developed for both **COVID-19 prevention and treatment**[18](index=18&type=chunk) - Its **pharmacokinetic profile** may enable more **patient-friendly delivery**, such as an **intramuscular (IM) route of administration**[18](index=18&type=chunk) - The antibody was engineered using Invivyd's proprietary platform to optimize **neutralization of contemporary virus lineages**[19](index=19&type=chunk) [CANOPY Clinical Trial](index=4&type=section&id=CANOPY%20Clinical%20Trial) The CANOPY Phase 3 trial evaluated pemivibart's safety and immunobridging, enrolling immunocompromised and at-risk adults - The **CANOPY Phase 3 trial** was designed to assess the **safety of pemivibart** and to use an **immunobridging approach** to historical data for the **prevention of symptomatic COVID-19**[17](index=17&type=chunk) - The trial enrolled two groups: **Cohort A (moderate-to-severe immune compromise)** and **Cohort B (adults without immune compromise but at risk of infection)**[17](index=17&type=chunk) [Cautionary Note Regarding Forward-Looking Statements](index=5&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This section warns investors that forward-looking statements are subject to significant risks, including market acceptance, regulatory outcomes, and clinical trial success, which could cause actual results to differ - The report includes **forward-looking statements** concerning **profitability targets, market position, R&D plans for VYD2311, and pipeline expansion into RSV and measles**[22](index=22&type=chunk) - Numerous risks could cause actual results to differ, including **market acceptance and reimbursement for PEMGARDA, regulatory approval processes, clinical trial enrollment and outcomes, competition, and manufacturing challenges**[22](index=22&type=chunk)

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]

Core Viewpoint - Invivyd, Inc. has received guidance from the U.S. FDA on a rapid pathway for Biologics License Application (BLA) approval for its monoclonal antibody candidate VYD2311, aimed at preventing COVID-19, which could provide an alternative to vaccines for the American population [1][2][3] Group 1: FDA Guidance and Clinical Trials - The FDA advised that a single Phase 2/3 randomized, double-blind, placebo-controlled trial could support a BLA submission for VYD2311, focusing on symptomatic COVID-19 events [1][3] - Invivyd plans to study two doses of VYD2311 to evaluate differences in protection levels and safety, aiming to provide more options for COVID-19 protection [2][4] - The primary endpoint for the trial is RT-PCR-confirmed symptomatic COVID-19, with a measurement timepoint expected at 12 weeks, and a potential longer duration of 24 weeks [3][4] Group 2: Product Profile and Market Position - VYD2311 is designed to be a low-dose, intramuscular, scalable, and cost-effective option for adults and adolescents, with potential expansion to pediatric populations [4][5] - The antibody is engineered to neutralize contemporary virus lineages and is based on a common molecular lineage with other successful Invivyd antibodies [2][8] - Invivyd's analysis suggests that VYD2311 may provide robust, long-term protection from symptomatic COVID-19 due to its high potency and long half-life of approximately 76 days [4][5] Group 3: Strategic Importance and Future Plans - The company emphasizes the importance of providing a non-vaccine choice for COVID-19 prevention amidst declining public trust in vaccines [2][3] - Invivyd has quantities of VYD2311 available for clinical supply and potential commercial launch, indicating readiness for market introduction if approved [6][8] - The company aims to finalize a pivotal clinical trial design with the FDA and is committed to advancing innovative solutions for COVID-19 prevention [6][3]

Core Insights - Invivyd, Inc. has announced the addition of Dr. Akiko Iwasaki to the SPEAR Study Group, which focuses on the biology and clinical implications of persistent SARS-CoV-2 spike antigen [1][2] - The SPEAR Study Group aims to assess the safety and exploratory efficacy of monoclonal antibodies in individuals suffering from Long COVID and COVID-19 Post-Vaccination Syndrome (PVS) [3][4] Company Developments - Dr. Iwasaki is recognized for her research on viral pathogenesis and post-viral chronic conditions, including Long COVID, and leads several studies related to these areas [2] - The SPEAR Study Group was established in response to reports suggesting symptom improvement in Long COVID patients following administration of PEMGARDA, a monoclonal antibody authorized for emergency use [3][4] - Invivyd is utilizing monoclonal antibody technology to provide therapeutic options for individuals affected by Long COVID and PVS [3][4] Product Information - PEMGARDA (pemivibart) is an investigational monoclonal antibody with demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants [5][6] - VYD2311 is a novel monoclonal antibody candidate being developed to address the urgent need for new COVID-19 prophylactic and therapeutic options [11][12] - Both PEMGARDA and VYD2311 are engineered to target the SARS-CoV-2 spike protein, aiming to inhibit virus attachment to human cells [5][12]