VBY329 is designed for the prevention of Respiratory Syncytial Virus (RSV) infections in newborns, infants, and children, and results from Invivyd’s proprietary antibody discovery technology platformVBY329 meets Invivyd’s target profile of higher potency and improved barrier to resistance compared to standard of care RSV medicines, as assessed in vitro: Antiviral potency 1.5-fold greater on average than nirsevimab and 1.2-fold greater on average than clesrovimab against established authentic RSV strains rep ...

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].

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 Insights - Upstream Bio reported significant clinical advancements and financial results for Q2 2025, with a focus on its lead drug candidate, verekitug, aimed at treating respiratory diseases [1][5][12] Financial Performance - Revenue for Q2 2025 was $0.9 million, exceeding the estimate of $0.69 million and showing an 80% increase from $0.5 million in Q2 2024 [2][8] - Research and development expenses surged to $37.9 million, up 168.8% from $14.1 million in Q2 2024, primarily due to increased clinical and manufacturing costs related to verekitug [2][7] - General and administrative expenses rose to $7.4 million, an 85% increase from $4.0 million in Q2 2024 [2][7] - The net loss widened to $40.0 million compared to $14.7 million in Q2 2024, reflecting the transition to more expensive Phase 2 trials [2][8] - Cash reserves stood at $393.6 million as of June 30, 2025, expected to sustain operations through 2027 [8][12] Clinical Development - Upstream Bio is advancing verekitug through multiple Phase 2 clinical trials, with significant milestones achieved in severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) [1][4] - Patient enrollment for the VALIANT Phase 2 trial for severe asthma was completed in June 2025, with top-line results anticipated in early 2026 [5][12] - The VIBRANT Phase 2 trial for CRSwNP completed patient enrollment by January 2025, with efficacy data expected in Q3 2025 [5][12] - The company initiated dosing in the VENTURE Phase 2 trial for chronic obstructive pulmonary disease (COPD) in July 2025 [6][12] Product Pipeline and Competitive Position - Verekitug is the only monoclonal antibody in human trials targeting the TSLP receptor, which may offer longer intervals between doses compared to existing biologics [10][11] - The competitive landscape remains uncertain as there are no approved products or recent head-to-head data against other biologics [11] - The regulatory strategy focuses on trial endpoints that could support future marketing applications if successful [11] Future Outlook - Management highlighted two key upcoming catalysts: top-line data from the VIBRANT CRSwNP Phase 2 trial in Q3 2025 and the VALIANT severe asthma Phase 2 readout in Q1 2026 [12][13] - Investors are expected to closely monitor the outcomes of these trials, as positive results could lead to regulatory submissions and potential partnerships [13]

Core Insights - Invivyd, Inc. announced full Phase 1/2 clinical data for VYD2311, a next-generation monoclonal antibody (mAb) candidate aimed at preventing and treating COVID-19 [1] - VYD2311 is structurally 99%+ identical to previous antibodies and is designed to enhance potency and resistance against SARS-CoV-2 variants [2][10] - The Phase 1/2 study demonstrated that VYD2311 was well tolerated with mild to moderate adverse events and a long half-life, suggesting potential for long-term protection [4][5] Company Overview - Invivyd, Inc. is focused on developing innovative monoclonal antibodies to combat serious viral infectious diseases, starting with SARS-CoV-2 [18] - The company utilizes a proprietary technology platform to create antibodies that can adapt to viral evolution [18] Clinical Trial Details - The Phase 1/2 study involved 40 subjects and tested various routes of administration (IV, IM, SC) and doses to maximize flexibility for future registrational pathways [3] - VYD2311 showed a half-life ranging from 61 days (IV) to 76 days (IM), significantly longer than pemivibart's 49 days [5] Safety and Efficacy - All adverse events reported were mild to moderate, with no serious adverse events linked to the study drug [4] - The modeling analysis indicated that VYD2311 could provide robust protection against symptomatic COVID-19, potentially surpassing vaccine efficacy [8][10] Regulatory Plans - Invivyd plans to engage with the FDA in early Q3 2025 to discuss registration pathways for VYD2311 and subsequent COVID-19 mAbs [6][8] - The company aims to provide non-vaccine mediated protection for vulnerable populations, including the elderly and immunocompromised individuals [8][10]

Financial Data and Key Metrics Changes - The company reported a significant increase in the overall response rate for its lead drug, tevesimig, in the second line biliary tract cancer study, with a response rate of 17.1% compared to 5.3% for the control arm, indicating a more than tripling of the response rate [12][13] - The study also showed a statistically significant difference with a p-value of 0.031, highlighting the drug's efficacy [13] Business Line Data and Key Metrics Changes - The lead program, tevesimig, is a bispecific antibody targeting DLL4 and VEGF A, which has shown promising results in clinical trials [4][7] - The company is also advancing CTX-471, a monoclonal antibody agonist targeting CD137, which has shown a 28% response rate in a post-PD-1 patient population [22][23] Market Data and Key Metrics Changes - The company identified a significant unmet medical need in the second line biliary tract cancer market, where there are currently no labeled therapies for the majority of patients [11] - The basket study for tevesimig in DLL4 positive cancers is expected to explore a range of solid tumor indications, indicating a broad market opportunity [19] Company Strategy and Development Direction - The company aims to leverage its unique StitchMaps platform to develop next-generation antibody therapeutics, focusing on dual blockade strategies to enhance efficacy in oncology [3][7] - Future plans include a Phase II basket study for tevesimig and potential label expansion studies following its approval [19] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the upcoming readouts for progression-free survival and overall survival, indicating a positive outlook for tevesimig's clinical development [17] - The company is optimistic about the performance of the control arm in clinical trials, suggesting a potential treatment effect that could lead to fewer deaths than initially expected [17] Other Important Information - The company has fast track status for tevesimig, which could expedite its approval process, with potential approval in the second half of 2026 [19][32] - The company is also developing CTX-8371, a PD-1 PD-L1 bispecific antibody, which is currently in Phase I studies and is expected to present clinical data in the second half of the year [29] Q&A Session Summary Question: Can you provide an overview of tevesimig's clinical data? - The overall response rate for tevesimig plus paclitaxel was 17.1%, significantly higher than the 5.3% for paclitaxel alone, with a statistically significant p-value of 0.031 [12][13] Question: What is the rationale behind the DLL4 positive cancers basket study? - DLL4 notch signaling is involved in various malignancies, and the company aims to explore the efficacy of tevesimig in these cancers due to its demonstrated monotherapy activity [19] Question: What are the upcoming catalysts for the company? - Key upcoming catalysts include readouts from the tevesimig study, the initiation of several important clinical trials, and data from the CTX-471 basket study [34]

Financial Data and Key Metrics Changes - The company reported sales of approximately $2.3 million in Q2 of the previous year, which increased to $9.3 million in Q3, and further to $13.8 million in Q4. In Q1 of the current year, sales reached $11.3 million, reflecting a transition to an internalized sales force [5][6][7]. Business Line Data and Key Metrics Changes - The company has launched a product for COVID-19 pre-exposure prophylaxis under emergency use authorization, with a focus on internalizing the sales force to drive growth [2][6]. - The sales force was fully trained and operational by the end of Q1, leading to positive trends in new account orders and interactions with healthcare providers [8][9]. Market Data and Key Metrics Changes - The COVID-19 therapy market was valued at over $9 billion last year, with the company currently capturing only a small share of the potential patient population eligible for its product [11][12]. - The company has been added to the NCCN guidelines for certain B-cell lymphomas, indicating a growing recognition of its product as a standard of care [12]. Company Strategy and Development Direction - The company is focusing on the development of next-generation antibodies, particularly VYD2311, which is expected to be more potent and have a longer half-life than existing products [17][24]. - There is an emphasis on expanding into other at-risk populations beyond the immunocompromised, including healthcare workers [25]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing relevance of their targeted epitopes against evolving SARS-CoV-2 variants, supported by extensive variant monitoring and surveillance [28][30]. - The company anticipates updates on RSV and measles programs by the end of 2025, indicating a strategic focus on addressing unmet medical needs in these areas [41]. Other Important Information - The FDA denied the treatment request for PEMGARDA, but the company sees this as an opportunity to engage with the new administration for future treatment indications [17][19]. - The company is open to business development discussions, including potential partnerships or government collaborations [46]. Q&A Session Summary Question: Can you provide updates on the sales force and its impact? - The internalized sales force has shown promising trends in new account orders and healthcare provider interactions, contributing to a return to growth [8][9]. Question: What is the company's strategy regarding payer reimbursement? - The company is covered by Medicare and Medicaid under EUA, with positive outcomes from major commercial payers [10]. Question: How does the company view the future of monoclonal antibodies in COVID treatment? - There is potential for monoclonal antibodies in treating COVID-19, especially for immunocompromised patients [14][15]. Question: What are the next steps for the measles and RSV programs? - The company anticipates updates on both programs by the end of 2025, with a focus on identifying candidates [41][42]. Question: How does the company plan to engage with regulatory agencies? - The company plans to engage with the FDA regarding treatment indications for next-generation antibodies and seeks alignment on expectations for monoclonal antibodies [18][20].

Commercial Performance & Strategy - Invivyd's Q1 2025 net product revenue for PEMGARDA was $11.3 million[82] - HCP interactions increased by 37% from 8,608 on January 1 to 11,669 on April 30[12] - The number of accounts called on increased by 37% from 4,566 on January 1 to 6,242 on April 30[12] - Accounts ordering PEMGARDA increased by 20% from 534 on January 1 to 642 on April 30[12] - PEMGARDA is priced lower than nearly all FDA-approved monoclonal antibodies launched in the past 5 years, ranking 59 out of 63 mAb drugs based on annual pricing[24] Research & Development - VYD2311 is designed to target a highly conserved epitope on SARS-CoV-2, with >15x improved neutralization potency relative to VYD222 (PEMGARDA)[47, 51] - The in-life phase of the Phase 1 clinical trial for VYD2311 has been completed, with data read-out anticipated later in Q2 2025[50] - Invivyd is conducting discovery programs for RSV and measles, with progress updates expected by the end of 2025[5, 41, 45] Financial Status - Operating expenses decreased to $27.4 million in Q1 2025 from $32.3 million in Q4 2024[82] - The company ended Q1 2025 with approximately $48.1 million in cash and cash equivalents[82] - A $30 million loan facility was secured in April 2025[5, 82]

Core Insights - Invivyd, Inc. reported financial results for Q1 2025, highlighting a strategic shift to internalize its sales force, which initially created challenges but is now showing signs of growth and momentum [2][6][7]. Financial Results - For Q1 2025, Invivyd reported net product revenue of $11.3 million from PEMGARDA™, a decrease from $13.8 million in Q4 2024, with no revenue reported in Q1 2024 [7][15]. - The company recorded a net loss of $16.3 million for Q1 2025, an improvement from a net loss of $43.5 million in the same period of 2024, resulting in a net loss per share of $0.14 compared to $0.38 in Q1 2024 [15][28]. Cash Position and Funding - As of March 31, 2025, Invivyd had cash and cash equivalents of $48.1 million and secured a $30 million non-dilutive term loan facility to support its operations and potential growth [4][15]. Business Highlights - The company is targeting near-term profitability by the end of the first half of 2025, supported by anticipated growth in net product revenue and a reduction in operating expenses [2][7]. - PEMGARDA's uptake is increasing among healthcare providers for immunocompromised patients, aided by the internalized sales force [8]. Pipeline Developments - VYD2311 Phase 1 clinical trial data read-out is expected later in Q2 2025, with ongoing evaluations for pipeline expansion beyond SARS-CoV-2, including potential targets like respiratory syncytial virus (RSV) and measles [5][8][19]. - The FDA declined Invivyd's request to expand the EUA for PEMGARDA to treat mild-to-moderate COVID-19, but the reasoning may provide a near-term pathway for VYD2311 [8]. Regulatory and Safety Updates - Since the EUA of PEMGARDA in March 2024, no documented cases of anaphylaxis have been reported across thousands of doses administered [7][8]. - In vitro data indicate sustained neutralizing activity of PEMGARDA against dominant SARS-CoV-2 variants, which represent over 75% of circulating variants in the U.S. [8].