Core Viewpoint - Kuehn Law, PLLC is investigating potential breaches of fiduciary duties by officers and directors of AlloVir, Inc. related to misrepresentation of the company's posoleucel Phase 3 studies [1] Group 1: Allegations Against AlloVir - AlloVir insiders allegedly caused the company to misrepresent or fail to disclose that the posoleucel Phase 3 studies were unlikely to meet their primary endpoints [1] - It is suggested that the company is likely to discontinue the posoleucel Phase 3 studies as a result of the aforementioned issues [1] - The company is accused of overstating the efficacy and clinical and/or commercial prospects of posoleucel, leading to materially false and misleading public statements [1]

Clinical Trials and Product Development - The company announced the discontinuation of three Phase 3 trials for its lead product candidate, posoleucel, due to futility analyses indicating the studies were unlikely to meet primary endpoints[107]. - The company has paused the development of ALVR106 and ALVR107 pending the outcome of the strategic alternatives review[109]. - The company anticipates that research and development expenses will continue to decrease significantly due to the discontinuation of clinical trials and research activities[147]. - If product candidate development resumes, expenses are expected to increase significantly for clinical development and commercialization efforts[148]. Financial Performance - The company reported net losses of $6.1 million and $36.4 million for the three and six months ended June 30, 2024, respectively, with an accumulated deficit of $692.6 million as of the same date[114]. - The company reported a net loss of $6.1 million for the three months ended June 30, 2024, compared to a net loss of $45.3 million for the same period in 2023, an improvement of $39.2 million[133]. - The net loss for the six months ended June 30, 2024, was $36.4 million, significantly improved from a net loss of $86.5 million in the same period of 2023[154][155]. Cash and Investments - Cash, cash equivalents, and short-term investments totaled $129.6 million as of June 30, 2024, expected to fund operations for at least twelve months[119]. - As of June 30, 2024, the company had cash, cash equivalents, and short-term investments of $129.6 million, which are expected to fund operations for at least twelve months[146]. - The company has received net cash proceeds of approximately $156.3 million from preferred stock sales and $292.0 million from common stock sales in its IPO, among other financing activities[145]. - Net cash used in operating activities was $55.7 million for the six months ended June 30, 2024, compared to $59.2 million for the same period in 2023, reflecting a decrease of 5.9%[154][155]. - The company reported a net decrease in cash, cash equivalents, and restricted cash of $14.3 million for the six months ended June 30, 2024, compared to a decrease of $90.9 million in the same period of 2023[154]. Cost Management and Workforce Reduction - A workforce reduction plan was approved to reduce the workforce by approximately 95%, primarily completed by April 15, 2024[108]. - The company has implemented a plan to reduce costs and expenditures due to the discontinuation of clinical trials and research activities[115]. - Research and development expenses decreased to $0.1 million for the three months ended June 30, 2024, from $34.8 million in the same period of 2023, a reduction of $34.7 million due to the discontinuation of clinical trials and workforce reduction[134]. - General and administrative expenses were $7.2 million for the three months ended June 30, 2024, down from $12.5 million in the same period of 2023, a decrease of $5.3 million attributed to reduced personnel costs[135]. - Total operating expenses for the three months ended June 30, 2024, were $7.8 million, significantly lower than $47.3 million for the same period in 2023, reflecting a decrease of $39.5 million[133]. - Restructuring costs amounted to $0.5 million for the three months ended June 30, 2024, primarily related to severance and employee termination costs[136]. - For the six months ended June 30, 2024, research and development expenses totaled $12.3 million, down from $65.5 million in the same period of 2023, a decrease of $53.3 million[141]. Strategic Alternatives and Future Plans - The company plans to conduct a comprehensive review of strategic alternatives, including potential mergers, sales, or divestitures, to maximize stockholder value[108]. - The company expects to continue incurring costs related to the evaluation of strategic alternatives and operating as a public company[115]. - The company continues to rely on exemptions and reduced reporting requirements as an emerging growth company under the JOBS Act[161][162]. - There have been no significant changes to the company's critical accounting policies from those described in the previous Annual Report[160]. - The company is classified as a smaller reporting company, with market value held by non-affiliates below $700 million and annual revenue under $100 million[164].

Clinical Trials and Product Development - The company announced the discontinuation of three Phase 3 trials for its lead product candidate, posoleucel, after futility analyses indicated they were unlikely to meet primary endpoints[94]. - The company has paused the development of its investigational VST therapies, including ALVR106 and ALVR107, pending the outcome of the strategic alternatives review[96]. - The company has faced disruptions in clinical trials and operations due to the COVID-19 pandemic, which may continue to impact future development[107]. Financial Performance - The company reported a net loss of $30.3 million for the three months ended March 31, 2024, with an accumulated deficit of $686.5 million[101]. - The company has not generated any revenue from product sales and has incurred significant operating losses since inception[97]. - Research and development expenses decreased to $12.2 million for Q1 2024 from $30.7 million in Q1 2023, a reduction of $18.5 million due to the discontinuation of clinical trials and workforce reduction[124]. - General and administrative expenses were $10.7 million in Q1 2024, down from $12.5 million in Q1 2023, reflecting a decrease of $1.9 million primarily due to reduced personnel costs[125]. - Total operating expenses decreased to $32.3 million in Q1 2024 from $43.2 million in Q1 2023, a decline of $10.9 million[122]. - Net cash used in operating activities was $44.4 million for Q1 2024, compared to $32.1 million in Q1 2023, reflecting a significant increase in cash outflow[136]. Cash and Liquidity - As of March 31, 2024, the company had cash, cash equivalents, and short-term investments totaling $140.5 million, expected to fund operations for at least twelve months[107]. - Cash, cash equivalents, and short-term investments totaled $140.5 million as of March 31, 2024, enabling the company to fund operations for at least the next twelve months[129]. - The company has received net cash proceeds of approximately $156.3 million from preferred stock sales and $292.0 million from its IPO, supporting its liquidity[128]. Workforce and Restructuring - A workforce reduction plan was approved in January 2024, resulting in a reduction of approximately 95% of the workforce, aimed at capital preservation[95]. - Restructuring costs amounted to $9.5 million in Q1 2024, primarily related to severance and employee termination costs[126]. - The company expects to continue incurring costs related to evaluating strategic alternatives and operating as a public company, despite the workforce reduction[102]. Strategic Alternatives - The company plans to conduct a comprehensive review of strategic alternatives, including potential mergers, sales, or divestitures, to maximize stockholder value[95]. - Future funding requirements may increase significantly if the company resumes development of product candidates, depending on various factors including regulatory approvals and commercialization activities[132]. Accounting and Reporting - The company prepares its unaudited condensed consolidated financial statements in accordance with U.S. GAAP, requiring estimates and judgments that affect reported amounts of assets and liabilities[141]. - The company has elected to take advantage of the extended transition period for complying with new or revised accounting standards as an emerging growth company[142]. - The company will remain an emerging growth company until it has total annual gross revenues of at least $1.235 billion or the market value of its common shares held by non-affiliates exceeds $700 million[144]. - The company is classified as a "smaller reporting company," with a market value of stock held by non-affiliates less than $700 million and annual revenue below $100 million[145]. - As a smaller reporting company, the company may present only the two most recent fiscal years of audited financial statements in its Annual Report on Form 10-K[145]. - The company is not required to disclose quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company[147]. - Recently issued accounting pronouncements that may impact the company's financial position are disclosed in Note 2 of the condensed consolidated financial statements[146].

Strategic Review and Business Operations - The company is undergoing a comprehensive review of strategic alternatives aimed at maximizing shareholder value, including potential mergers, sales, or divestitures, with no set timetable for completion [169]. - A workforce reduction of approximately 95% is expected to be completed by April 15, 2024, to reduce costs and preserve capital, with estimated restructuring charges of around $13 million [172]. - The company has discontinued three global Phase 3 studies of posoleucel and other clinical development programs as part of its strategic review [172]. - The strategic review process may incur substantial costs, including legal and accounting fees, which could decrease available cash for business operations [169]. - The company has not set a definitive course of action regarding its strategic review, and any potential transaction may not yield the anticipated benefits [171]. - The company may pursue dissolution and liquidation if a strategic transaction is not consummated, impacting cash available for distribution to shareholders [171]. Regulatory and Clinical Development Challenges - The majority of the company's product candidates are still in preclinical development, with no regulatory approvals obtained for any product candidates, including posoleucel and ALVR106 [175]. - The company anticipates significant costs associated with the commercialization of any approved product candidates, which may hinder profitability [175]. - The ability to successfully develop and commercialize product candidates is contingent upon various factors, including regulatory approvals and market acceptance [175]. - The regulatory approval process for the company's novel multi-VST-cell therapy is complex and may take longer than for other pharmaceutical products due to the lack of existing FDA-approved cell-based therapies for viral diseases [181]. - The company faces risks related to the unpredictability of clinical trial results, which could significantly harm its business and prospects if regulatory approval is not obtained [180]. - Disruptions at the FDA and other regulatory agencies due to funding shortages could hinder timely product development and approval, negatively impacting the company's operations [182]. - The company must navigate a rigorous regulatory landscape for gene and cell therapy, which is subject to frequent changes and heightened scrutiny [183]. - Clinical trials may experience delays due to various factors, including difficulties in recruiting suitable subjects and obtaining necessary regulatory approvals [189]. - The company relies on CROs and other vendors for clinical trial execution, which may impact the timely conduct of trials due to limited influence over their performance [192]. - The FDA may impose additional post-market requirements, such as Risk Evaluation and Mitigation Strategies, which could affect commercialization plans [187]. Financial Condition and Funding - The company incurred net losses of $190.4 million and $168.7 million for the years ended December 31, 2023 and 2022, respectively, with an accumulated deficit of $656.2 million as of December 31, 2023 [290]. - The company anticipates significant losses to continue for the foreseeable future as it progresses with research and development and seeks regulatory approvals for its product candidates [290]. - The company will need substantial additional funding to support the development and commercialization of its product candidates, which may be delayed or reduced if capital is not raised [295]. - The company believes its existing cash resources will fund operating expenses for at least twelve months following the issuance of financial statements, but this estimate may prove incorrect [298]. - The company had cash, cash equivalents, and short-term investments of $183.9 million as of December 31, 2023 [297]. Market and Competitive Landscape - The total addressable market opportunity for posoleucel will depend on acceptance by the medical community, patient access, drug pricing, and reimbursement, which may affect revenue and profitability [214]. - The company faces substantial competition from pharmaceutical and biotechnology enterprises, which may impact its commercial opportunities if competitors develop safer or more effective products [209]. - There are currently no FDA- or EMA-approved drugs for the company's indications, except for COVID-19, which may affect market entry and pricing strategies [210]. - The commercial success of the company's product candidates depends on significant market acceptance among healthcare providers and patients, influenced by factors such as efficacy, safety, and reimbursement availability [228]. Intellectual Property and Licensing - The company relies heavily on the BCM License for intellectual property, data, and know-how, which is critical for the commercialization of its product candidates [320]. - Disputes may arise regarding the scope of rights under licensing agreements, potentially impacting the company's ability to develop and commercialize products [321]. - The company has limited control over the patent application process and enforcement of intellectual property rights licensed from third parties, which may affect its competitive position [323]. - The company has filed multiple patent applications for its product candidates, but there is no assurance that these will result in issued patents or that they will be enforceable [336]. Compliance and Regulatory Risks - Compliance with healthcare laws and regulations may result in significant civil, criminal, and administrative penalties, including exclusion from government-funded healthcare programs [244]. - The company is subject to evolving compliance requirements that impose significant costs, including organizational changes and additional protection technologies [249]. - Regulatory authorities may impose sanctions for non-compliance, impacting business and financial condition [315]. - The company may face penalties or restrictions if it fails to comply with regulatory requirements, which could inhibit commercialization efforts [222]. Employee and Operational Risks - The company is highly dependent on key personnel, and any loss of these individuals could delay product development and harm business operations [252]. - The company had 112 employees as of December 31, 2023, and anticipates needing additional personnel for future growth and development [258]. - Changes in U.S. immigration laws could adversely affect the company's ability to hire skilled personnel, impacting its operations [254]. Stock and Market Performance - The trading price of the company's common stock is likely to be highly volatile, influenced by various factors including clinical trial results and regulatory decisions [357]. - The company has not maintained a minimum closing bid price of $1.00 per share for the last 30 consecutive business days, as notified by Nasdaq [360]. - The company has until August 7, 2024, to regain compliance with the Minimum Bid Price Requirement, which requires the closing bid price to be $1.00 or more for at least 10 consecutive business days [361].

Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against AlloVir, Inc. due to allegations of violations of federal securities laws related to misleading statements about the posoleucel Phase 3 studies [1][2]. Summary by Sections Legal Investigation - Faruqi & Faruqi, LLP is encouraging investors who suffered losses exceeding $25,000 in AlloVir stock or options between March 22, 2022, and December 21, 2023, to contact them for legal options [1]. - The firm has a history of recovering hundreds of millions of dollars for investors since its founding in 1995 [2]. Allegations Against AlloVir - The complaint alleges that AlloVir and its executives made false and misleading statements regarding the posoleucel Phase 3 studies, including: - The studies were unlikely to meet their primary endpoints [2]. - The likelihood of discontinuation of the posoleucel Phase 3 studies [2]. - Overstating the efficacy and commercial prospects of posoleucel [2]. - Public statements made by the company were materially false and misleading [2]. Stock Price Impact - Following the announcement on December 22, 2023, that AlloVir would discontinue the posoleucel Phase 3 studies due to efficacy concerns, the stock price fell by $1.57 per share, or 67.38%, closing at $0.76 per share [3]. Class Action Details - The lead plaintiff in a class action is the investor with the largest financial interest who directs the litigation on behalf of the class [3]. - Any member of the class can move the court to serve as lead plaintiff or remain an absent class member without affecting their ability to share in any recovery [3].

Group 1 - AlloVir, Inc. (ALVR) has shown a year-to-date return of approximately 4.4%, outperforming the Medical sector average return of about -0.9% [2][3] - The Zacks Consensus Estimate for ALVR's full-year earnings has increased by 57.9% in the past quarter, indicating improved analyst sentiment and a more positive earnings outlook [2] - AlloVir, Inc. currently holds a Zacks Rank of 2 (Buy), suggesting it is positioned to outperform the broader market in the near term [1][2] Group 2 - AlloVir, Inc. is part of the Medical - Drugs industry, which consists of 192 individual stocks and is currently ranked 94 in the Zacks Industry Rank [3] - The Medical - Drugs industry has experienced a year-to-date loss of about -0.9%, indicating that ALVR is performing better than its industry peers [3] - In comparison, Arcutis Biotherapeutics, Inc. (ARQT), another stock in the Medical sector, has achieved a year-to-date return of 64.1% and also holds a Zacks Rank of 2 (Buy) [2][3]

A downtrend has been apparent in AlloVir, Inc. (ALVR) lately with too much selling pressure. The stock has declined 72.4% over the past four weeks. However, given the fact that it is now in oversold territory and Wall Street analysts are majorly in agreement about the company's ability to report better earnings than they predicted earlier, the stock could be due for a turnaround.Guide to Identifying Oversold StocksWe use Relative Strength Index (RSI), one of the most commonly used technical indicators, for ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________to __________________ Commission File Number: 001-39409 ALLOVIR, INC. (Exact Name of Registrant as Specified in its Charter) Delaware (S ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________to __________________ Commission File Number: 001-39409 ALLOVIR, INC. (Exact Name of Registrant as Specified in its Charter) Delaware (State ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________to __________________ Commission File Number: 001-39409 ALLOVIR, INC. (Exact Name of Registrant as Specified in its Charter) Delaware (State ...