[Corporate Update and Financial Highlights](index=1&type=section&id=Corporate%20Update%20and%20Financial%20Highlights) [Executive Summary](index=1&type=section&id=Executive%20Summary) Vir Biotechnology reported significant progress in its clinical pipeline during Q2 2025, including the full initiation of the ECLIPSE registrational program for chronic hepatitis delta and the dosing of the first patient in a Phase 1 study for its oncology candidate, VIR-5525. The company maintains a strong financial position with **$892.1 million** in cash and investments, providing a projected operational runway into **mid-2027** - The ECLIPSE registrational program for chronic hepatitis delta is now fully underway[1](index=1&type=chunk) - The company has initiated a Phase 1 study for VIR-5525, an EGFR-targeting T-cell engager for solid tumors, marking the **third ongoing Phase 1 study** in its oncology pipeline[1](index=1&type=chunk)[2](index=2&type=chunk) Key Financial Metrics | Metric | Value | | :--- | :--- | | Cash and Investments (as of June 30, 2025) | $892.1 million | | Financial Runway | Into mid-2027 | - CEO Marianne De Backer highlighted the advancement of the PRO-XTEN™ dual-masked T-cell engager platform, which aims to expand the therapeutic index and address shortcomings of existing cancer treatments[2](index=2&type=chunk) [Pipeline Programs](index=1&type=section&id=Pipeline%20Programs) [Chronic Hepatitis Delta (CHD)](index=1&type=section&id=Chronic%20Hepatitis%20Delta%20%28CHD%29) The ECLIPSE registrational program for Chronic Hepatitis Delta (CHD) is now fully active, with patient enrollment initiated in the ECLIPSE 2 and ECLIPSE 3 trials. These studies are evaluating the combination of tobevibart and elebsiran against bulevirtide monotherapy in different patient populations. The program is designed to generate efficacy and safety data for global regulatory submissions and to support market access - The ECLIPSE registrational program is fully underway with the enrollment of the **first patients** in the ECLIPSE 2 and ECLIPSE 3 trials[3](index=3&type=chunk) - ECLIPSE 2 will assess the combination therapy in patients who have not responded to bulevirtide treatment, while ECLIPSE 3 will evaluate it in patients new to bulevirtide[3](index=3&type=chunk) - The program is structured to provide registrational data for US and European agencies (ECLIPSE 1 & 2) and supportive data for reimbursement in key markets (ECLIPSE 3)[3](index=3&type=chunk) [Solid Tumors](index=2&type=section&id=Solid%20Tumors) The company's oncology pipeline, centered on the PRO-XTEN™ dual-masked T-cell engager (TCE) platform, has advanced with the first patient dosed in the Phase 1 study of VIR-5525 (EGFR-targeting). Progress continues in the Phase 1 trials for VIR-5818 (HER2-targeting) and VIR-5500 (PSMA-targeting), with early data showing promising safety profiles and no dose-limiting toxicities. The platform is designed to minimize systemic toxicity while enabling selective cancer cell killing - **First patient dosed** in the Phase 1 study of VIR-5525, a PRO-XTEN™ dual-masked TCE targeting EGFR for various solid tumors like non-small cell lung cancer and colorectal cancer[7](index=7&type=chunk) - The Phase 1 trial of VIR-5818 (HER2-targeting) has completed monotherapy dose escalation and is now evaluating the candidate in combination with pembrolizumab[7](index=7&type=chunk) - VIR-5500 (PSMA-targeting) received FDA clearance to be evaluated in combination with androgen receptor pathway inhibitors for earlier lines of prostate cancer[7](index=7&type=chunk) - Early Phase 1 data for both VIR-5818 and VIR-5500 demonstrated promising safety, with **no dose-limiting cytokine release syndrome (CRS) observed**[7](index=7&type=chunk) [Preclinical Pipeline Candidates](index=2&type=section&id=Preclinical%20Pipeline%20Candidates) Vir is leveraging its immune system expertise and proprietary dAIsY™ AI engine to advance multiple undisclosed PRO-XTEN™ dual-masked T-cell engagers against clinically validated targets in solid tumors. In parallel, the company is progressing a broadly neutralizing antibody for HIV treatment in collaboration with the Gates Foundation - The company is developing multiple undisclosed PRO-XTEN™ dual-masked TCEs using its antibody discovery platform and proprietary dAIsY™ AI engine[7](index=7&type=chunk) - A broadly neutralizing antibody candidate for HIV treatment is being advanced in collaboration with the Gates Foundation[7](index=7&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) [Financial Position and Guidance](index=2&type=section&id=Financial%20Position%20and%20Guidance) As of June 30, 2025, Vir Biotechnology reported **$892.1 million** in cash, cash equivalents, and investments. The cash position decreased by **$127.7 million** during the quarter, partly due to **$50.5 million** in milestone payments for the ECLIPSE program. The company reaffirms its financial guidance, expecting its current cash reserves to fund operations into **mid-2027** Financial Position (as of June 30, 2025) | Financial Position (as of June 30, 2025) | Amount | | :--- | :--- | | Cash, Cash Equivalents and Investments | $892.1 million | | Restricted Cash and Cash Equivalents | $95.2 million | | Quarterly Cash Decrease | $127.7 million | - The company expects its cash, cash equivalents, and investments to be sufficient to fund operations into **mid-2027**[15](index=15&type=chunk) [Operating Results](index=3&type=section&id=Operating%20Results) For the second quarter of 2025, Vir reported total revenues of **$1.2 million**, a decrease from **$3.1 million** in the prior-year period. The company significantly narrowed its net loss to **$111.0 million**, or **$0.80 per share**, compared to a net loss of **$138.4 million**, or **$1.02 per share**, in Q2 2024. The improvement was primarily driven by reduced R&D and SG&A expenses resulting from cost-saving initiatives Operating Results (in millions, except per share) | Metric (in millions, except per share) | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Total Revenues | $1.2 | $3.1 | | R&D Expenses | $97.5 | $105.1 | | SG&A Expenses | $22.3 | $30.3 | | Net Loss | $(111.0) | $(138.4) | | Net Loss Per Share | $(0.80) | $(1.02) | - The decrease in R&D expenses was primarily due to cost savings from restructuring, partially offset by higher clinical expenses for the ECLIPSE and oncology programs[10](index=10&type=chunk) - SG&A expenses decreased due to efficiencies and cost savings from previously announced restructuring initiatives[11](index=11&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The company's balance sheet as of June 30, 2025, showed total assets of **$1.19 billion**, down from **$1.40 billion** at year-end 2024. The decrease was mainly driven by a reduction in cash and investments. Total liabilities remained relatively stable at **$245.1 million**, while total stockholders' equity decreased to **$947.5 million** from **$1.15 billion** Condensed Consolidated Balance Sheets (in thousands) | Balance Sheet (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Current Assets** | **$735,706** | **$1,042,458** | | Cash and cash equivalents | $211,104 | $222,947 | | Short-term investments | $387,645 | $678,051 | | **Total Assets** | **$1,192,532** | **$1,398,813** | | **Total Liabilities** | **$245,060** | **$248,428** | | **Total Stockholders' Equity** | **$947,472** | **$1,150,385** | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended June 30, 2025, Vir Biotechnology generated **$1.2 million** in total revenues. Total operating expenses were **$119.6 million**, a significant reduction from **$161.7 million** in the same period of 2024, primarily due to the completion of prior restructuring activities. This led to a net loss of **$111.0 million**, or **$0.80 per share** Condensed Consolidated Statements of Operations (in thousands) | Statement of Operations (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Total revenues | $1,214 | $3,075 | | Total operating expenses | $119,631 | $161,705 | | Loss from operations | $(118,417) | $(158,630) | | Net loss | $(110,958) | $(138,378) | | Net loss per share, basic and diluted | $(0.80) | $(1.02) |

Company Overview - Vir Biotechnology, Inc. (VIR) is expected to report a year-over-year increase in earnings driven by higher revenues for the quarter ended June 2025, with a consensus outlook indicating a quarterly loss of $0.72 per share, reflecting a +29.4% change from the previous year [1][3] - Revenues are anticipated to reach $7.64 million, representing a significant increase of 148.1% compared to the same quarter last year [3] Earnings Estimates and Revisions - The consensus EPS estimate has been revised 7.54% higher in the last 30 days, indicating a collective reassessment by analysts [4] - The Most Accurate Estimate for Vir Biotechnology is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -22.91%, suggesting a bearish outlook from analysts [12] Earnings Surprise Prediction - The Zacks Earnings ESP model indicates that a positive or negative reading can predict the deviation of actual earnings from consensus estimates, but the predictive power is significant primarily for positive readings [9][10] - Vir Biotechnology currently holds a Zacks Rank of 3, which complicates the prediction of an earnings beat given the negative Earnings ESP [12] Historical Performance - In the last reported quarter, Vir Biotechnology was expected to post a loss of $0.83 per share but actually reported a loss of -$0.88, resulting in a surprise of -6.02% [13] - Over the past four quarters, the company has only beaten consensus EPS estimates once [14] Industry Context - In the Zacks Medical - Biomedical and Genetics industry, Beam Therapeutics Inc. (BEAM) is also expected to report a loss of $1.04 per share for the same quarter, with revenues projected at $13.79 million, up 17.2% year-over-year [18][19] - Beam Therapeutics has an Earnings ESP of -23.08% and a Zacks Rank of 4, indicating challenges in predicting an earnings beat [20]

Group 1 - Vir Biotechnology (NASDAQ: VIR) experienced a significant rally in share price earlier in the year, leading to optimism despite associated risks [1] - The company operates in the biotech sector, focusing on the science behind its business and clinical trials [1] Group 2 - The article emphasizes the importance of due diligence in biotech investments to avoid potential pitfalls [1]

Company Overview - Vir Biotechnology, Inc. (VIR) shares increased by 11.9% to close at $5.93, with trading volume significantly higher than usual, contrasting with a 2.2% loss over the past four weeks [1][2] Pipeline and Development - The rise in stock price is linked to positive investor sentiment regarding tobevibart, Vir Biotechnology's late-stage pipeline candidate, which is in a phase III ECLIPSE 1 study for chronic hepatitis delta (CHD) treatment [2] - The company is preparing to start a phase III ECLIPSE 2 study to evaluate the efficacy and safety of switching to tobevibart and elebsiran for CHD patients not achieving viral suppression with bulevirtide [2] Financial Expectations - The upcoming quarterly report is expected to show a loss of $0.74 per share, reflecting a year-over-year increase of 27.5%, while revenues are projected at $7.05 million, up 128.8% from the previous year [3] - The consensus EPS estimate for the quarter has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - Vir Biotechnology operates within the Zacks Medical - Biomedical and Genetics industry, which includes other companies like Opus Genetics, Inc. (IRD), that also has a Zacks Rank of 2 (Buy) [4][5]

Summary of Vir Biotechnology (VIR) FY Conference Call Company Overview - **Company**: Vir Biotechnology (VIR) - **Date of Conference**: May 27, 2025 - **Key Speakers**: Marianne DeBacker (CEO), Mika Derink (Executive VP of Therapeutic Oncology) Core Areas of Focus - **Hepatitis Delta Infections**: - Significant unmet need as patients with hepatitis B can rapidly progress to liver cirrhosis or hepatocellular carcinoma - ECLIPSE program is in registrational trials with no approved treatments in the US for hepatitis delta infection [3][4] - **Metastatic Solid Tumors**: - Development of a masked T cell engager platform showing promising data - Proof of concept established in two clinical studies targeting HER2 and PSMA, with a third program targeting EGFR set to start [4][5] Pipeline and Financial Position - **Pipeline Strength**: - Differentiated PRO X10 dual masking technology enhances safety and therapeutic index - Seven preclinical programs initiated alongside ongoing clinical studies [5][6] - **Financial Position**: - Approximately $1 billion in cash, providing runway into mid-2027 to advance key programs [6] Strategic Partnerships - **Acquisition of Pro X10 Platform**: - Acquired worldwide rights from Sanofi for oncology and infectious disease applications - Deal included upfront payment of $100 million and additional milestone payments [9][10] Clinical Trials and Data - **PSMA Targeted T Cell Engager (VIR 5500)**: - Early dose escalation data showed a 58% PSA50 response rate and an 8% PSA90 response rate in heavily pretreated patients [17][18] - No prophylactic steroids required, indicating a favorable safety profile [18][22] - **HER2 Program (VER 5818)**: - Combination with pembrolizumab showed a 50% tumor shrinkage rate in HER2 positive patients, with a 33% confirmed response rate in colorectal cancer subset [38][39] - Ongoing evaluation of dosing schedules and safety [39][45] - **EGFR Program (VIR 5525)**: - Anticipated first-in-human dosing in the first half of the year, with promising preclinical data [46] Hepatitis Delta Program - **ECLIPSE Trials**: - First patient dosed in ECLIPSE one trial, targeting completion of enrollment by the end of the year - Primary completion date for ECLIPSE one is December 2026, with potential data from ECLIPSE two available around the same timeframe [47][48][49] Regulatory Designations - The hepatitis delta program has received breakthrough designation, fast track designation, prime designation, and orphan drug designation, indicating a high unmet need and expedited development process [49] Conclusion - Vir Biotechnology is strategically focused on addressing significant unmet medical needs in hepatitis delta infections and metastatic solid tumors through innovative therapies and a strong financial position, with ongoing clinical trials expected to yield important data in the near future [50][51]

Summary of Vir Biotechnology (VIR) Conference Call Company Overview - **Company**: Vir Biotechnology (VIR) - **Event**: 2025 Bank of America Healthcare Conference - **Date**: May 14, 2025 Key Focus Areas - **Clinical Stage Pipeline**: The company is focused on two main areas: fighting infections and cancer using the human immune system [4][5] - **Hepatitis Delta Virus (HDV)**: The most advanced program targeting an orphan liver disease with no current treatments in the U.S. [5][19] - **Masked T Cell Engagers**: Programs targeting metastatic solid tumors, including HER2 and PSMA, both in phase one dose escalation [6][7] Hepatitis Delta Virus (HDV) Program - **ECLIPSE Trials**: - ECLIPSE one: For treatment-naive patients, primary completion expected by December 2026 [17][25] - ECLIPSE two: For patients on existing treatment (belabertide), with a 24-week endpoint [15][25] - ECLIPSE three: Head-to-head trial against belabertide [16] - **Compelling Data**: In the Solstice trial, 64% of patients achieved undetectable virus levels after 36 weeks [13] - **Market Need**: High mortality rate (50%) among untreated patients in the U.S. [19][20] - **Awareness Initiatives**: Working with KOLs and advocacy groups to increase awareness and improve diagnosis rates [29][30] T Cell Engager Platform - **ProXtent Platform**: A unique plug-and-play platform with a hydrophilic mask that enhances safety and efficacy [39][41] - **Dosing Flexibility**: Programs exploring every three-week dosing schedules, which could improve patient convenience [44][47] - **HER2 Program**: - Basket trial design with significant responses in various tumor types, including colorectal cancer [49][51] - 33% confirmed partial response in colorectal cancer patients at higher doses [51] - **PSMA Program**: - Early data shows robust PSA responses, with 58% achieving PSA 50 response [53] - Focus on therapeutic index to balance efficacy and safety [55] EGFR Program - **Upcoming Trials**: Targeting EGFR-positive patients in head and neck, lung, and colorectal cancers, with monotherapy and combination studies planned [56][58] Financial Overview - **Cash Position**: Approximately $1 billion, providing a runway into mid-2027 [63] - **Capital Allocation**: Prioritizing clinical stage programs while exploring partnerships for preclinical targets [66] Future Data Updates - **Expected Data Releases**: Anticipated updates on ECLIPSE trials, HER2, PSMA, and EGFR programs between now and 2027 [64] Conclusion - Vir Biotechnology is positioned to address significant unmet medical needs in both infectious diseases and oncology, with a strong pipeline and strategic focus on enhancing patient outcomes through innovative therapies and partnerships.

Company Performance - Vir Biotechnology reported a quarterly loss of $0.88 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.83, and compared to a loss of $0.48 per share a year ago, indicating a significant decline in performance [1] - The company posted revenues of $3.03 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 84.51%, and a sharp decline from year-ago revenues of $56.38 million [2] - Over the last four quarters, Vir Biotechnology has only surpassed consensus EPS estimates once, indicating ongoing challenges in meeting market expectations [2] Stock Performance - Since the beginning of the year, Vir Biotechnology shares have lost approximately 23.3%, significantly underperforming the S&P 500, which declined by 4.7% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.84 on revenues of $15.97 million, and for the current fiscal year, it is -$3.40 on revenues of $61.56 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Vir Biotechnology belongs, is currently ranked in the top 35% of over 250 Zacks industries, suggesting a relatively strong position within the sector [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact Vir Biotechnology's stock performance [5]

Financial Performance - Total revenues for the three months ended March 31, 2025, were $3,032,000, a decrease of 94.66% compared to $56,376,000 for the same period in 2024[15]. - Net loss for the three months ended March 31, 2025, was $120,965,000, compared to a net loss of $65,276,000 for the same period in 2024, representing an increase in loss of 85.5%[15]. - The company reported a comprehensive loss of $121,223,000 for the three months ended March 31, 2025, compared to a comprehensive loss of $66,858,000 for the same period in 2024[18]. - Basic and diluted net loss per share for the three months ended March 31, 2025, was $(0.88), compared to $(0.48) for the same period in 2024[91]. - Total stock-based compensation expense decreased to $14,059,000 for the three months ended March 31, 2025, from $23,757,000 in 2024, a reduction of approximately 40.9%[89]. - The decrease in contract revenue for the three months ended March 31, 2025, was primarily due to $51.7 million of deferred revenue recognized in Q1 2024[133]. Research and Development - Research and development expenses increased to $118,645,000 for the three months ended March 31, 2025, from $100,125,000 in the same period of 2024, reflecting a rise of 18.4%[15]. - Research and development expenses primarily relate to discovery efforts and clinical development of product candidates, with expenses recognized as incurred[39]. - Clinical costs rose significantly by $8.999 million, from $11.607 million in 2024 to $20.606 million in 2025, attributed to the initiation of new oncology programs[135]. - The company has advanced a broadly neutralizing antibody to development candidate status in its HIV cure program in collaboration with the Gates Foundation[111]. - The company is conducting ongoing Phase 2 clinical trials for the combination of tobevibart and elebsiran, with the aim of achieving a functional cure for CHB[191]. - The company has been awarded grants totaling up to $49.9 million from the Gates Foundation to support various vaccine programs, with terms expiring through June 2027[60]. Cash and Investments - Cash and cash equivalents at the end of the period were $273,571,000, up from $222,947,000 at the end of 2024, indicating an increase of 22.7%[13]. - As of March 31, 2025, the Company had $1.02 billion in cash, cash equivalents, and investments, which is expected to fund operations for at least twelve months[28]. - The Company reported $94.4 million in restricted cash and cash equivalents as of March 31, 2025[28]. - The total financial assets as of March 31, 2025, amounted to $1,000.93 million, with cash, cash equivalents, and investments totaling $1,019.80 million[50]. - Cash used in operating activities decreased to $78.116 million in Q1 2025 from $109.390 million in Q1 2024, reflecting ongoing cost-saving measures[151]. - Cash provided by investing activities increased significantly to $126.818 million in Q1 2025, compared to $28.420 million in Q1 2024, primarily due to higher proceeds from investments[153]. Assets and Liabilities - Total assets decreased to $1,307,727,000 as of March 31, 2025, down from $1,398,813,000 as of December 31, 2024, a decline of 6.5%[13]. - Total stockholders' equity decreased to $1,043,819,000 as of March 31, 2025, from $1,150,385,000 as of December 31, 2024, a decrease of 9.3%[13]. - Total accrued and other liabilities increased to $104,126,000 as of March 31, 2025, compared to $85,873,000 as of December 31, 2024, reflecting a growth of approximately 21.2%[79]. - The company has unaccrued unpaid commitments of approximately $22 million under the Tobevibart Agreements and $8 million under the Elebsiran Agreements as of March 31, 2025[80]. Strategic Initiatives - The company has entered into a sales agreement to offer and sell shares of its common stock for an aggregate offering price of up to $300 million[27]. - The company agreed to pay Alnylam $30 million in connection with the Restated Alnylam Agreement, recorded as research and development expenses for the three months ended March 31, 2025[72]. - The company intends to explore additional strategic collaborations to gain access to new product candidates and technologies[211]. - A core element of the business strategy includes acquiring or in-licensing technologies for serious infectious diseases and cancer treatment[210]. Clinical Development - The company enrolled the first patient in its phase 3 ECLIPSE registrational program for hepatitis delta virus (HDV) in the first quarter of 2025, indicating progress in its clinical development pipeline[105]. - The company is advancing phase 1 clinical studies for its dual-masked T-cell engagers, with VIR-5525 expected to begin studies in the second quarter of 2025[105]. - The first Phase 3 trial, ECLIPSE 1, for Chronic Hepatitis Delta (CHD) has enrolled its first patient in March 2025 and is progressing as planned[108]. - Interim and preliminary data from clinical studies may change, impacting business prospects and stock price[196]. Risks and Challenges - The company anticipates continuing to incur significant expenses and net losses in the foreseeable future as it develops its product candidates and technology platforms[169]. - The company may require substantial additional funding to finance its operations and may need to seek additional financing sooner than planned[174]. - The company faces risks related to the commercialization of product candidates, including the need for a viable pricing structure and reimbursement approvals[187]. - Delays in patient enrollment could lead to increased costs and program delays, affecting the ability to develop product candidates[205]. - Regulatory authorities may impose restrictions or withdraw approvals based on safety concerns, affecting the company's reputation and operations[208].

Financial Data and Key Metrics Changes - R&D expenses for Q1 2025 were $118.6 million, up from $100.1 million in Q1 2024, primarily due to a $30 million payment to Alnylam and expenses related to the ECLIPSE program initiation [36] - SG&A expenses for Q1 2025 were CAD 23.9 million, down from CAD 36.3 million in Q1 2024, largely due to cost savings from headcount reductions [37] - Net loss for Q1 2025 was $121 million compared to a net loss of $65.3 million in Q1 2024, driven by a significant drop in revenue from $52 million to approximately $3 million [38] Business Line Data and Key Metrics Changes - The hepatitis delta program has initiated the ECLIPSE Phase III program, with the first patient enrolled, marking a significant milestone [22] - The oncology portfolio continues to progress, with promising data from the Pro X10 dual masked T cell engager programs, particularly in HER2 positive colorectal cancer [15][28] Market Data and Key Metrics Changes - The estimated addressable market for hepatitis delta includes approximately 61,000 RNA positive patients in the U.S. and 113,000 in EU member countries plus the UK, highlighting the potential for significant commercial opportunity [10] - The company emphasizes that hepatitis delta has characteristics of a rare disease market with severe outcomes, supporting a value-based pricing model [11] Company Strategy and Development Direction - The strategic focus remains on advancing both infectious disease and oncology programs, with a commitment to developing a new standard of care for hepatitis delta virus infection [8] - The company is exploring collaborations to maximize value from the Pro X10 platform and has advanced a broadly neutralizing antibody in its HIV cure program [19] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the challenging market environment for the biotechnology sector but emphasizes a disciplined approach to capital allocation and operational excellence [20] - The company maintains a strong cash position of approximately $1 billion, providing a runway extending into mid-2027 to advance key programs [39] Other Important Information - The agreement with Alnylam regarding the profit-sharing arrangement has been clarified, with the company recognizing CAD 30 million as R&D expense in Q1 2025 [39] - The company is preparing for the upcoming EASL Congress to present data from its hepatitis B program and the Solstice trial [26] Q&A Session Summary Question: Alnylam decision and future oncology updates - Alnylam opted out of the profit-sharing arrangement based on their strategic portfolio prioritization, prior to the latest HCV functional cure data being available [47] - Future oncology data updates will include mature data at higher dose levels and comparative data between dosing regimens, expected to be shared at medical congresses or focused investor events [46] Question: ECLIPSE study enrollment and timelines - The ECLIPSE one study aims to complete enrollment by the end of 2025, with ECLIPSE two having a 24-week endpoint [55] Question: Competitive positioning of T cell engagers - The company believes its dual mask technology offers a favorable safety profile and differentiates it from competitors, with a focus on convenience and quality of life for patients [60][62] Question: Functional cure rates and HBV program development - The company anticipates presenting data showing a 20% functional cure rate in the doublet and a 30% in the triplet at the upcoming EASL [77] - Further development of the HBV program is contingent on securing a global development and commercialization partner [78] Question: Changes in U.S. guidelines for HBV diagnosis - No changes have been made to U.S. guidelines for delta diagnosis, but there is hope for increased awareness and reflex testing in the future [101]

Financial Data and Key Metrics Changes - R&D expenses for Q1 2025 were $118.6 million, up from $100.1 million in Q1 2024, primarily due to a $30 million payment to Alnylam and expenses related to the ECLIPSE program initiation [32][33] - Net loss for Q1 2025 was $121 million compared to a net loss of $65.3 million in Q1 2024, largely due to a significant drop in revenue from $52 million in Q1 2024 to approximately $3 million in Q1 2025 [35] - The company ended the quarter with approximately $1 billion in cash, providing a cash runway extending into mid-2027 [36][17] Business Line Data and Key Metrics Changes - The ECLIPSE Phase III program for hepatitis delta virus infection was initiated, with the first patient enrolled in Q1 2025 [6][19] - The oncology portfolio continues to progress, with promising data from the Pro X10 dual masked T cell engager programs, particularly for VER5818 and VER5500 [12][13][28] Market Data and Key Metrics Changes - The estimated addressable market for hepatitis delta includes approximately 61,000 RNA positive patients in the U.S. and 113,000 in EU member countries plus the UK [7][10] - The company emphasizes the severe outcomes associated with hepatitis delta, with over 50% of patients succumbing to liver-related deaths within ten years of diagnosis [8] Company Strategy and Development Direction - The strategic focus remains on advancing both infectious disease and oncology programs, with a commitment to developing a new standard of care for hepatitis delta virus infection [6][5] - The company is exploring potential collaborations to maximize value from the Pro X10 platform and is advancing several next-generation targets in oncology [16][15] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the challenging market environment for the biotechnology sector but emphasizes a disciplined approach to capital allocation and operational excellence [17] - The company remains confident in its ability to develop transformative medicines for patients with significant unmet needs, which will drive value creation for shareholders [17][18] Other Important Information - The agreement with Alnylam regarding Elapsiran has been clarified, with Alnylam opting not to participate in profit-sharing, which was anticipated and factored into long-term financial planning [11][36] - The company is preparing for the EASL Congress to present data from its hepatitis B program and ongoing studies [12][22] Q&A Session Summary Question: Alnylam decision and future oncology updates - Alnylam opted out of the profit-sharing arrangement before the latest data was available, based on their strategic portfolio prioritization [44] - Next updates on oncology programs will include mature data at higher dose levels and comparative data between dosing regimens [43] Question: EASL and ECLIPSE study timelines - The ECLIPSE one study aims to complete enrollment by the end of 2025, with ECLIPSE two having a 24-week endpoint [50][51] Question: Competitive positioning of PSMA targeting program - The company believes its dual mask technology offers a favorable safety profile and differentiates it from competitors [56] Question: HBV program and functional cure expectations - The company anticipates presenting data showing a 20% functional cure rate for the doublet and 30% for the triplet at EASL [68] Question: HBV diagnosis and guidelines - No changes to U.S. guidelines for delta diagnosis yet, but there is hope for increased awareness and reflex testing in the future [93][94]