1. - David Hallal to continue as Executive Chairman of the AlloVir Board of Directors

    AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, announced today that its Board of Directors has appointed Diana M. Brainard, M.D., as the company's Chief Executive Officer (CEO), effective May 17, 2021. Dr. Brainard has served on AlloVir's Board of Directors since April 2019, initially as a Board Observer, and as an Independent Director since July 2020. Dr. Brainard currently serves as Senior Vice President and Head of the Virology Therapeutic Area at Gilead Sciences, Inc. She will succeed David Hallal, who will step down as CEO and continue to serve as Executive Chairman of the Board.

    This press release features multimedia. View the full…

    - David Hallal to continue as Executive Chairman of the AlloVir Board of Directors

    AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, announced today that its Board of Directors has appointed Diana M. Brainard, M.D., as the company's Chief Executive Officer (CEO), effective May 17, 2021. Dr. Brainard has served on AlloVir's Board of Directors since April 2019, initially as a Board Observer, and as an Independent Director since July 2020. Dr. Brainard currently serves as Senior Vice President and Head of the Virology Therapeutic Area at Gilead Sciences, Inc. She will succeed David Hallal, who will step down as CEO and continue to serve as Executive Chairman of the Board.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210322005752/en/

    AlloVir appoints Diana M. Brainard, M.D., as Chief Executive Officer, effective May 17, 2021 (Photo: Business Wire)

    AlloVir appoints Diana M. Brainard, M.D., as Chief Executive Officer, effective May 17, 2021 (Photo: Business Wire)

    A physician-scientist specializing in infectious diseases, Dr. Brainard has more than 20 years of experience in academic medicine and the biopharmaceutical industry, has authored more than 200 publications, and brings a passion for advancing therapies for life-threatening diseases. During more than a decade at Gilead, she has played an enterprise-wide leadership role building out the Virology franchise at the company, which generated more than $20 billion in revenue in 2020. During her ten years at Gilead, Dr. Brainard oversaw the successful development and approval of multiple transformative therapies for the prevention and/or treatment of viral diseases – including the top three U.S. drug launches of all time. Her recent success rapidly advancing remdesivir to become the first and only antiviral to receive regulatory approval for the treatment of COVID-19 earned her global recognition as one of the most influential people in the fight against COVID-19.

    "Over the past three years, AlloVir has advanced a robust clinical pipeline across multiple cell therapies and viral diseases, positioning the company to execute on up to eight pivotal and proof-of-concept studies by the end of 2021," said David Hallal, CEO and Chairman of AlloVir. "Given this progress, it is an ideal time for Diana to succeed me as CEO and leverage her extensive virology expertise and broad leadership experience to drive the next phase of AlloVir's growth. As an AlloVir board member, Diana is immersed in all facets of AlloVir's people, corporate objectives and plans, and I look forward to continuing to work with her as she builds an industry-leading, global, virus-specific T-cell therapy powerhouse."

    "Since joining AlloVir's Board, I have been impressed and inspired by the potential of our virus-specific T-cell platform and the impressive clinical data gathered to date," said Dr. Brainard, AlloVir's newly named Chief Executive Officer. "In recent months, the team has initiated three clinical trials with the company's lead therapy, Viralym-M, and a proof-of-concept clinical trial with ALVR109, a SARS-COV-2 virus-specific T-cell therapy. I'm honored by the confidence of the Board and look forward to working with our dedicated staff to continue AlloVir's relentless focus on scientific rigor and operational excellence to bring transformative new therapies to patients with, or at risk for, devastating and life-threatening viral diseases."

    Prior to Gilead, Dr. Brainard worked for Merck in early drug development both in clinical pharmacology and as the Infectious Diseases Lead in translational medicine. Dr. Brainard earned an undergraduate degree at Brown University and received her medical degree from the Tulane University School of Medicine. She continued her training in internal medicine at the Massachusetts General Hospital (MGH), and in infectious diseases at MGH and the Brigham and Women's Hospital, where she was board-certified in both Internal Medicine and Infectious Diseases. Following the completion of her medical training, she joined the faculty at Harvard Medical School, where she conducted National Institutes of Health (NIH)-funded research on HIV immunology and T cell trafficking.

    "Since launching in 2019, David has led AlloVir to extend its leadership position by advancing our pipeline of highly innovative mid- and late-stage clinical cell therapies for the treatment and prevention of viral diseases," said Jeffrey Bornstein a member of AlloVir's Board of Directors. "This leadership transition comes at a time of strength for AlloVir – with a world-renowned team of scientists, clinical and regulatory experts, and company builders, combined with a strong balance sheet. We are confident that under Diana's leadership, the company is uniquely poised to capitalize on the vast potential of AlloVir's allogeneic, ‘off-the-shelf,' virus-specific T cell therapy platform."

    In addition to his time as Executive Chairman of AlloVir's Board of Directors, David Hallal will continue to lead ElevateBio, which is the largest shareholder in AlloVir. AlloVir has expanded its manufacturing capacity by working with ElevateBio BaseCamp, as part of AlloVir's planned manufacturing capacity expansion and redundancy within the supply chain.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in pediatric and adult patients with weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, single and multi-virus specific T-cells targeting devastating viruses for patients with T-cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information visit www.allovir.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding AlloVir's development and regulatory status of our product candidates, the planned conduct of its preclinical studies and clinical trials and its prospects for success in those studies and trials, and its strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to AlloVir's financial results, the timing for the initiation and successful completion of AlloVir's clinical trials of its product candidates, whether and when, if at all, AlloVir's product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, competition from other biopharmaceutical companies, the impact of the COVID-19 pandemic on AlloVir's product development plans, supply chain, and business operations and other risks identified in AlloVir's SEC filings. AlloVir cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AlloVir disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent AlloVir's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

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  2. AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, will present a corporate overview at the 10th Annual SVB Leerink Global Healthcare Conference on February 26, 2021 at 4:20 p.m. ET.

    The presentation will be available on the Investors & Press section of the AlloVir website at https://ir.allovir.com. An archived replay of the presentation will be available for approximately 30 days following the presentation.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in pediatric and adult patients with weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic…

    AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, will present a corporate overview at the 10th Annual SVB Leerink Global Healthcare Conference on February 26, 2021 at 4:20 p.m. ET.

    The presentation will be available on the Investors & Press section of the AlloVir website at https://ir.allovir.com. An archived replay of the presentation will be available for approximately 30 days following the presentation.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in pediatric and adult patients with weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, single and multi-virus specific T-cells targeting devastating viruses for patients with T-cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information visit www.allovir.com.

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  3. - Subgroup analysis of Phase 2 CHARMS study shows rapid resolution of macroscopic hematuria in patients with virus-associated hemorrhagic cystitis treated with Viralym-M

    - Real world claims data analyses demonstrate worse clinical outcomes, and significantly higher healthcare costs and health resource utilization in allogeneic HSCT recipients with virus-associated hemorrhagic cystitis and dsDNA viral infections

    - ALVR109 preclinical data highlights opportunity to arrest the progression of COVID-19 by eradicating SARS-CoV-2 virus infected cells

    AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, today announced results of a subgroup analysis from a Phase 2, proof-of-concept study (CHARMS) evaluating the company's lead product…

    - Subgroup analysis of Phase 2 CHARMS study shows rapid resolution of macroscopic hematuria in patients with virus-associated hemorrhagic cystitis treated with Viralym-M

    - Real world claims data analyses demonstrate worse clinical outcomes, and significantly higher healthcare costs and health resource utilization in allogeneic HSCT recipients with virus-associated hemorrhagic cystitis and dsDNA viral infections

    - ALVR109 preclinical data highlights opportunity to arrest the progression of COVID-19 by eradicating SARS-CoV-2 virus infected cells

    AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, today announced results of a subgroup analysis from a Phase 2, proof-of-concept study (CHARMS) evaluating the company's lead product candidate, Viralym-M (ALVR105), an allogeneic, off-the-shelf, multi-virus specific investigational T-cell therapy (VST), in allogeneic hematopoietic stem cell transplant (allo-HSCT) recipients with virus-associated hemorrhagic cystitis (V-HC). These data are being presented in an oral presentation during the Transplantation & Cellular Therapy (TCT) Meeting of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR). Additionally, two separate oral presentations characterize the high economic and clinical burden of V-HC and double-stranded (ds) DNA viral infections in allo-HSCT recipients. Preclinical data was also presented in a poster presentation on ALVR109, AlloVir's virus-specific T-cell therapy targeting SARS-CoV-2, the virus responsible for COVID-19.

    "The data from the Phase 2 CHARMS study highlight Viralym-M's potential to treat and possibly prevent multiple viral infections and viral diseases. The findings presented at TCT show that this novel virus-specific T cell therapy has the potential to rapidly and effectively resolve macroscopic hematuria in allo-HSCT recipients with virus-associated hemorrhagic cystitis – a disease that currently has no effective treatment options and causes significant morbidity and increased risk of mortality," said Agustin Melian, MD, Chief Medical Officer and Head of Global Medical Sciences of AlloVir. "We have recently initiated our Phase 3, pivotal study of Viralym-M for the treatment of virus-associated hemorrhagic cystitis and look forward to advancing this therapy through development for patients in need."

    Data of Viralym-M in fifty-eight allo-HSCT recipients with at least one treatment-refractory viral infection caused by BK virus (BKV), cytomegalovirus (CMV), adenovirus (AdV), Epstein Barr virus (EBV), human herpesvirus 6 (HHV-6), and/or JC virus (JCV) were evaluated in the CHARMS Phase 2 study. The subgroup analysis presented at TCT included 26 patients who received intravenous VST infusions for the treatment of V-HC due to infection with BKV (n=23), AdV (n=2) and BKV and AdV (n=1). Infusions were well tolerated with mild, grade 1, de novo skin rash from graft-versus-host disease (GVHD) occurring in 15% of patients (n=4). In the 20 patients with available V-HC grading, resolution of macroscopic hematuria was observed in 60% and 80% of patients at two- and six-weeks post-infusion, respectively. In comparison, resolution of macroscopic hematuria was observed in <10% and 30% of patients at weeks two and six, respectively, in a contemporary cohort of allo-HSCT recipients (n=33) with V-HC who were not treated with Viralym-M.

    Health economic outcomes data was also presented in two separate oral presentations at the conference. The two presentations analyzed U.S. claims data to compare health care reimbursement, health resource utilization, and clinical outcomes in pediatric and adult allo-HSCT recipients with V-HC and those without V-HC, and allo-HSCT recipients with or without dsDNA infections, respectively. Both studies found that allo-HSCT recipients with V-HC and those with any dsDNA infection had higher reimbursement costs, increased hospital and ICU length of stay, and increased hospital readmission rates. The presence of V-HC or any dsDNA viral infection was associated with a higher risk of mortality.

    In addition, a poster presentation at the conference demonstrated the in vitro effector and safety profile of ALVR109, an allogeneic, off-the-shelf investigational VST therapy designed to target SARS-CoV-2, the virus that causes the severe and life-threatening viral disease, COVID-19. These data suggest the potential for using these VSTs to treat COVID-19 in hospitalized high-risk patients to prevent the development of severe disease. A clinical trial evaluating these banked, off-the-shelf SARS-CoV-2 specific T cells has been initiated at the Center for Cell and Gene Therapy, Baylor College of Medicine (BCM), Texas Children's Hospital, and Houston Methodist Hospital.

    Viral Infections in Immunocompromised Patients

    In healthy individuals, virus-specific T cells (VSTs) from the body's natural defense system provide protection against numerous disease-causing viruses. However, in patients with a weakened immune system these viruses may be uncontrolled. Viral diseases are common and can cause potentially devastating and life-threatening consequences in immunocompromised patients. For example, up to 90% of patients will reactivate at least one virus following an allogeneic stem cell transplant and two-thirds of these patients reactivate more than one virus, resulting in significant and prolonged morbidity, hospitalization, and premature death. Typically, when viruses infect immunocompromised patients, standard antiviral treatment does not address the underlying problem of a weakened immune system and therefore many patients suffer with life-threatening outcomes such as multi-organ damage and failure, and even death.

    Viralym-M

    Viralym-M (ALVR105) is an allogeneic, off-the-shelf, multi-virus specific investigational T-cell therapy targeting five devastating viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, and human herpesvirus 6. Viralym-M has the potential to transform care for transplant recipients as well as individuals who are at high risk for opportunistic viral infections by reducing or preventing disease morbidity and dramatically improving patient outcomes. Three pivotal and proof-of-concept clinical (POC) trials are ongoing and actively recruiting patients in indications such as treatment of virus-associated hemorrhagic cystitis and multi-virus prevention following allo-HSCT, and preemptive treatment of BK viremia in adult kidney transplant recipients. Additional pivotal and POC trials are expected to initiate for the treatment of CMV and the treatment of AdV in allo-HSCT recipients and in CMV for solid organ transplant recipients, respectively. For more information on the ongoing clinical trials visit clinicaltrials.gov.

    Viralym-M has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA), as well as PRIority MEdicines (PRIME) and Orphan Drug Designations (ODD) from the European Medicines Agency.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in pediatric and adult patients with weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, multi-virus specific T-cells targeting devastating viruses for patients with T-cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information visit http://www.allovir.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding AlloVir's development and regulatory status of our product candidates, the planned conduct of its preclinical studies and clinical trials and its prospects for success in those studies and trials, and its strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to AlloVir's financial results, the timing for the initiation and successful completion of AlloVir's clinical trials of its product candidates, whether and when, if at all, AlloVir's product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, competition from other biopharmaceutical companies, the impact of the COVID-19 pandemic on AlloVir's product development plans, supply chain, and business operations and other risks identified in AlloVir's SEC filings. AlloVir cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AlloVir disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent AlloVir's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

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  4. - Initiated Phase 3 pivotal clinical trial with Viralym-M, an off-the-shelf multi-virus-specific investigational T-cell therapy, for the treatment of virus-associated hemorrhagic cystitis

    - Initiated two additional Phase 2 proof-of-concept clinical trials with Viralym-M, including a first-of-its-kind, multi-virus prevention study in HSCT recipients and a study for the treatment BK viremia in kidney transplant recipients

    - Initiated a proof-of-concept clinical trial with ALVR109, an off-the-shelf virus-specific investigational T-cell therapy designed to combat SARS-CoV-2, to evaluate its safety and efficacy as a treatment for high-risk patients with COVID-19

    - FDA cleared IND for ALVR106, an allogeneic, off-the-shelf, multi-respiratory

    - Initiated Phase 3 pivotal clinical trial with Viralym-M, an off-the-shelf multi-virus-specific investigational T-cell therapy, for the treatment of virus-associated hemorrhagic cystitis

    - Initiated two additional Phase 2 proof-of-concept clinical trials with Viralym-M, including a first-of-its-kind, multi-virus prevention study in HSCT recipients and a study for the treatment BK viremia in kidney transplant recipients

    - Initiated a proof-of-concept clinical trial with ALVR109, an off-the-shelf virus-specific investigational T-cell therapy designed to combat SARS-CoV-2, to evaluate its safety and efficacy as a treatment for high-risk patients with COVID-19

    - FDA cleared IND for ALVR106, an allogeneic, off-the-shelf, multi-respiratory virus-specific investigational T-cell therapy

    AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, today provided a corporate update and reported full-year 2020 financial results for the period ended December 31, 2020.

    "Since completing our initial public offering in 2020, our team achieved our ambitious milestones, as planned. These milestones included obtaining clearance from the U.S. Food and Drug Administration (FDA) for two Investigational New Drug (IND) applications, initiating three clinical trials with our lead therapy, Viralym-M, as well as initiating our proof-of-concept (POC) clinical trial with our SARS-CoV-2 virus-specific T-cell (VST) therapy, ALVR109," said David Hallal, Chairman and Chief Executive Officer of AlloVir. "We're pleased that dosing has commenced with our initial two investigational VST therapies, Viralym-M and ALVR109. We look forward to enrolling an increasing number of patients in our clinical trials throughout 2021, while also initiating up to four additional clinical trials with our three clinical-stage cell therapies Viralym-M, ALVR109 and ALVR106."

    Recent Highlights

    Viralym-M for Allogeneic HSCT Recipients

    • The Phase 3, multicenter, double-blind placebo-controlled clinical trial to assess the safety and efficacy of Viralym-M for the treatment of virus-associated hemorrhagic cystitis (HC) in pediatric and adult patients following allogeneic hematopoietic stem cell transplantation (allo-HSCT) was initiated. Sites are actively recruiting patients and the trial is ongoing.
    • A first-of-its-kind, multi-virus prevention, Phase 2, POC clinical trial to assess the safety and efficacy of Viralym-M in pediatric and adult patients following allo-HSCT was initiated. The trial is targeting the prevention of BK virus (BKV), cytomegalovirus (CMV), adenovirus (AdV), Epstein Barr virus (EBV), human herpesvirus 6 (HHV-6), and JC virus (JCV). Sites are actively recruiting patients and the trial is ongoing.
    • Results from the Phase 2, POC CHARMS clinical trial with Viralym-M, and data that highlight the economic and clinical burden of virus-associated HC in pediatric and adult patients following allo-HSCT, were presented in two oral presentations at the 62nd American Society of Hematology Annual Meeting & Exposition (ASH) in December. The CHARMS data demonstrated that patients treated with Viralym-M saw a 93% response rate overall and a 100% response rate for at least one virus in patients with more than one viral infection. Viralym-M was generally well-tolerated in allo-HSCT patients with at least one drug refractory infection. Based on these data and the critical medical need, Viralym-M was granted PRIority MEdicines (PRIME) designation by the European Medicines Agency and Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA.

    Viralym-M for SOT Recipients

    • A Phase 2 POC trial of Viralym-M for the preemptive treatment of BK viremia in adult kidney transplant recipients has been initiated. BK viremia is one of the most feared complications for kidney transplant patients leading to decreased graft survival. Sites are actively recruiting patients and the trial is ongoing.

    ALVR109 for COVID-19

    • The Phase 1 POC clinical trial for ALVR109, an allogeneic, off-the-shelf VST therapy candidate designed to target SARS-CoV-2, the virus that causes the severe and life-threatening viral disease, COVID-19, has been initiated. The trial is actively recruiting patients and ongoing.
    • Preclinical ALVR109 data were presented during an oral presentation at ASH in December, demonstrating specific antiviral activity. In the study, the VST therapy produced effector molecules and selectively killed viral antigen-expressing targets while leaving non-infected targets intact.

    ALVR106 for Multi-Respiratory Viruses

    • AlloVir announced that the FDA cleared the IND application for ALVR106, an allogeneic, off-the-shelf, multi-respiratory VST therapy designed to target infections and diseases caused by respiratory syncytial virus (RSV), influenza, parainfluenza virus (PIV), and human metapneumovirus (hMPV).

    2021 Outlook

    Viralym-M for HSCT Recipients

    • Two additional pivotal clinical trials are expected to be initiated in 2021, including for the treatment of CMV and the treatment of AdV in adult and pediatric allo-HSCT recipients. CMV and AdV-associated diseases are among the leading causes of life-threatening complications following allo-HSCT, often resulting in multi-organ involvement with the viruses invading the brain, the lungs, the liver, and other vital organs.
    • Initial data from the open-label phase of the POC multi-virus prevention trial in allo-HSCT recipients is expected in the second half of 2021.

    Viralym-M for SOT Recipients

    • A Phase 1 POC clinical trial will be initiated in CMV for solid organ transplant recipients.
    • Interim data is also anticipated in the second half of 2021 from the POC trial in BK viremia in kidney transplant recipients.

    ALVR109 for COVID-19

    • Topline data from the ALVR109 POC clinical trial in COVID-19 is expected in the second half of 2021.

    ALVR106 for Multi-Respiratory Viruses

    • A POC clinical trial for ALVR106, targeting multiple respiratory viruses, including RSV, influenza, PIV, and hMPV, in allogeneic and autologous HSCT recipients, is expected to be initiated in the upcoming 2021 respiratory virus season.
    • The company will continue to assess the impact of the COVID-19 pandemic on the incidence, diagnosis, and treatment of the respiratory viral infections that ALVR106 targets.

    Pipeline Program and Corporate Milestones

    • The company plans to complete preclinical, IND-enabling studies for both ALVR107 for the treatment of hepatitis B virus and ALVR108 for the treatment of human herpesvirus-8 in the second half of 2021.
    • The company remains on track to expand the capacity of its manufacturing network in 2021 with the addition of ElevateBio Basecamp.

    2020 Financial Highlights

    • Research and development expenses were $49.7 million for the year ended December 31, 2020 compared to $16.2 million for the year ended December 31, 2019. The increase year-over-year is attributable to costs related to the development of the company's product candidates, increased activity in outsourcing of manufacturing, and an increase in headcount and external consultants in support of research activities.
    • General and administrative expense was $21.6 million for the year ended December 31, 2020 compared to $10.6 million for the year ended December 31, 2019. The increase year-over-year was primarily attributable to legal, accounting and professional fees related to costs associated with operating activities and preparing for and executing the company's initial public offering.
    • Stock-based compensation expense was $9.4 million and $2.9 million for the years ended December 31, 2020 and 2019, respectively.
    • As of December 31, 2020, AlloVir had cash, cash equivalents, and marketable securities of $356.3 million, which compares to cash, cash equivalents, and marketable securities of $126.1 million as of December 31, 2019.
    • For the year ended December 31, 2020, net loss was $69.8 million or $2.59 per share compared to a net loss of $23.8 million or $18.54 per share for the year ended December 31, 2019. The total number of common shares outstanding as of December 31, 2020 was 61,931,255.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in pediatric and adult patients with weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, single and multi-virus specific T-cells targeting devastating viruses for patients with T-cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information visit www.allovir.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding AlloVir's development and regulatory status of our product candidates, the planned conduct of its preclinical studies and clinical trials and its prospects for success in those studies and trials, and its strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to AlloVir's financial results, the timing for the initiation and successful completion of AlloVir's clinical trials of its product candidates, whether and when, if at all, AlloVir's product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, competition from other biopharmaceutical companies, the impact of the COVID-19 pandemic on AlloVir's product development plans, supply chain, and business operations and other risks identified in AlloVir's SEC filings. AlloVir cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AlloVir disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent AlloVir's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

     
    ALLOVIR, INC.
    CONSOLIDATED BALANCE SHEETS
    (unaudited, in thousands)
     

    December 31,

    2020

     

    2019

    Assets
    Current assets:
    Cash, cash equivalents and short-term investments $

    356,324

    $

    126,077

    Other current assets

    4,993

    1,236

    Total current assets

    361,317

    127,313

     
    Other assets

    9,504

    12,109

    Total assets $

    370,821

    $

    139,422

    Liabilities and stockholders' equity (deficit)
    Current liabilities $

    12,294

    $

    9,106

    Long-term liabilities

    5,463

    8,692

    Total liabilities

    17,757

    17,798

     
    Preferred stock

    173,127

    Total stockholders' equity (deficit)

    353,064

    (51,503)

    Total liabilities, preferred stock, and stockholders' equity (deficit) $

    370,821

    $

    139,422

     
    ALLOVIR, INC.
    CONSOLIDATED STATEMENTS OF OPERATIONS
    (unaudited, in thousands, except share and per share data)
     

    Years Ended December 31,

    2020

    2019

    Revenue $

    $

    165

    Operating expenses:
    Research and development

    49,663

    16,248

    General and administrative

    21,646

    10,618

    Total operating expenses

    71,309

    26,866

    Loss from operations

    (71,309)

    (26,701)

    Total other income, net:
    Interest income

    1,330

    2,065

    Other income, net

    195

    797

    Net loss $

    (69,784)

    $

    (23,839)

    Net loss per share --- basic and diluted $

    (2.59)

    $

    (18.54)

    Weighted-average common shares outstanding---basic and diluted

    26,897,390

    1,285,933

     

     

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  5. AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, announced that it will present three oral presentations and one poster presentation during the Transplantation & Cellular Therapy Meeting of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) taking place virtually February 8 – 12, 2021.

    Details of the oral presentations are as follows:

    Presentation Title: Economic and Clinical Burden of Virus-Associated Hemorrhagic Cystitis in Pediatric and Adult Patients Following Allogeneic Hematopoietic Stem Cell Transplantation
    Presenter: Joseph P. McGuirk, DO, The University of Kansas Cancer Center
    Assigned session: Oral Abstract - Session…

    AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, announced that it will present three oral presentations and one poster presentation during the Transplantation & Cellular Therapy Meeting of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) taking place virtually February 8 – 12, 2021.

    Details of the oral presentations are as follows:

    Presentation Title: Economic and Clinical Burden of Virus-Associated Hemorrhagic Cystitis in Pediatric and Adult Patients Following Allogeneic Hematopoietic Stem Cell Transplantation

    Presenter: Joseph P. McGuirk, DO, The University of Kansas Cancer Center

    Assigned session: Oral Abstract - Session C - Health Services

    Session Date & Time: Monday, February 8, 2021, 2:30 p.m. CST

    Presentation Tine: 2:30 – 2:45 p.m. CST

    Abstract Number: 19

    Presentation Title: Economic Burden and Health Resource Utilization Associated with dsDNA Virus Infections in Allogeneic Hematopoietic Cell Transplantation Recipients

    Presenter: Richard Maziarz, MD, Knight Cancer Institute, Oregon Health and Science University

    Assigned session
    : Oral Abstract - Session C - Health Services

    Session Date & Time: Monday, February 8, 2021, 2:30 p.m. CST

    Presentation Time: 3:15 – 3:30 p.m. CST

    Abstract Number: 22

    Presentation Title: Allogeneic, Off-the-Shelf, Multi-Virus Specific T-Lymphocytes for the Treatment of Virus-Associated Hemorrhagic Cystitis in the Post-HSCT Setting

    Presenter: Thomas Pfeiffer, MD, Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital, Houston Methodist Hospital, Houston, TX

    Assigned session
    : Oral Abstract - Session M - Infection and Immunity

    Session Date & Time: Thursday, February 11, 2021, 3:00 p.m. CST

    Presentation Time: 4:45 – 5:00 p.m. CST

    Abstract Number: 95

    Details of the poster presentations are as follows:

    Presentation Title: Allogeneic, Off-the-Shelf, Sars-CoV-2-Specific T Cells to Treat High-Risk Patients with COVID-19

    Presenter: Spyridoula Vasileiou, Ph.D., Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and The Methodist Hospital

    Poster number: 422

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with weakened immune systems. The company's innovative and proprietary technology platform leverages off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viruses for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information visit www.allovir.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding AlloVir's development and regulatory status of our product candidates and its strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to AlloVir's financial results, the timing for completion of AlloVir's clinical trials of its product candidates, whether and when, if at all, AlloVir's product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, competition from other biopharmaceutical companies, and other risks identified in AlloVir's SEC filings. AlloVir cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AlloVir disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent AlloVir's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

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  6. AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, will present a corporate overview at the 39th Annual J.P. Morgan Healthcare Conference on January 11, 2021 at 9:10 a.m. ET.

    An audio-only webcast of the presentation will be available on January 11th on the Investors & Press section of the AlloVir website at https://ir.allovir.com. An archived replay of the presentation will be available for approximately 30 days following the presentation.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf…

    AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, will present a corporate overview at the 39th Annual J.P. Morgan Healthcare Conference on January 11, 2021 at 9:10 a.m. ET.

    An audio-only webcast of the presentation will be available on January 11th on the Investors & Press section of the AlloVir website at https://ir.allovir.com. An archived replay of the presentation will be available for approximately 30 days following the presentation.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viruses for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information visit www.allovir.com.

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  7. Proof-of-concept phase 1/2 trial to initiate in 2021 to treat severe respiratory viral infections in patients following hematopoietic stem cell transplantation

    ALVR106 designed to target devastating diseases caused by four respiratory viruses: respiratory syncytial virus, influenza, parainfluenza virus, and human metapneumovirus

    AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for ALVR106, an allogeneic, off-the-shelf virus-specific T cell therapy (VST) designed to target infections and diseases caused by respiratory syncytial virus (RSV), influenza, parainfluenza virus (PIV), and human metapneumovirus (hMPV…

    Proof-of-concept phase 1/2 trial to initiate in 2021 to treat severe respiratory viral infections in patients following hematopoietic stem cell transplantation

    ALVR106 designed to target devastating diseases caused by four respiratory viruses: respiratory syncytial virus, influenza, parainfluenza virus, and human metapneumovirus

    AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for ALVR106, an allogeneic, off-the-shelf virus-specific T cell therapy (VST) designed to target infections and diseases caused by respiratory syncytial virus (RSV), influenza, parainfluenza virus (PIV), and human metapneumovirus (hMPV). The IND enables AlloVir to initiate a Phase 1/2 proof-of-concept clinical study in allogeneic and autologous hematopoietic stem cell transplant (HSCT) patients with respiratory infections caused by RSV, influenza, PIV or hMPV.

    "Respiratory viruses are a leading cause of morbidity and mortality in HSCT patients, and based on evidence from our preclinical studies, we believe ALVR106 could transform the treatment and prevention of respiratory infections and substantially reduce the associated morbidity and mortality of these infections in the future," said Ercem Atillasoy, M.D., Chief Regulatory and Safety Officer of AlloVir. "The clearance of the IND for ALVR106 advances our third program into clinical trials further exploring the power of our proprietary virus-specific T cell therapy platform."

    Respiratory tract infections due to RSV, influenza, PIV, and hMPV are a major public health concern and are detected in up to 40 percent of allogeneic HSCT patients. These viral infections can progress from upper respiratory tract infections to more serious lower respiratory tract infections, which are associated with mortality rates of 20-45 percent in HSCT patients.

    As previously disclosed, this proof-of-concept clinical trial will initiate in 2021 as the company is assessing the impact of the COVID-19 pandemic on the incidence, diagnosis, and treatment of the respiratory viral infections which ALVR106 targets.

    About ALVR106

    ALVR106 is an allogeneic, off-the-shelf, multi-virus specific VST investigational therapy designed to target infections and diseases caused by the respiratory syncytial virus (RSV), influenza, parainfluenza virus (PIV), and human metapneumovirus (hMPV). In vitro data demonstrate that ALVR106 has antiviral activity against each of the targeted viruses with minimal or no activity against non-virus-infected cells. This preclinical data supports the potential for antiviral benefit and safety of ALVR106 when administered to patients.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viruses for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information visit www.allovir.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding AlloVir's development and regulatory status of our product candidates and its strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to AlloVir's financial results, the timing for completion of AlloVir's clinical trials of its product candidates, whether and when, if at all, AlloVir's product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, competition from other biopharmaceutical companies, and other risks identified in AlloVir's SEC filings. AlloVir cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AlloVir disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent AlloVir's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

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  8. Company Profile for AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with severely weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viruses for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio.

    Company:

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with severely weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viruses for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio.

    Company:

    AlloVir

     

     

    Headquarters Address:

    139 Main Street

     

    Suite 500

     

    Cambridge, MA 02142

     

     

    Main Telephone:

    617-433-2605

     

     

    Website:

    www.allovir.com

     

     

    Ticker/ISIN:

    ALVR(NASDAQ)/US0198181036

     

     

    Type of Organization:

    Public

     

     

    Industry:

    Biotechnology

     

     

    Key Executives:

    CEO: David Hallal

     

    CFO: Vikas Sinha

     

     

    Investor Relations

     

    Contact:

    Medha Chadha

    Phone:

    917-765-2125

    Email:

     

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  9. - Viralym-M, an allogeneic, off-the-shelf, multi-virus specific T-cell therapy demonstrates 93% of patients achieved a clinical response after treatment of viral infections and disease in patients following allogeneic HSCT

    - Real-world findings demonstrate significantly higher healthcare costs, health resource utilization and worse clinical outcomes in allogeneic HSCT patients with virus-associated hemorrhagic cystitis

    AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, today announced that results from the Phase 2, proof-of-concept CHARMS study demonstrated that an allogeneic, off-the-shelf, multi-virus specific T cell therapy, Viralym-M (ALVR105), achieved a 93% clinical response and was generally well-tolerated in allogeneic…

    - Viralym-M, an allogeneic, off-the-shelf, multi-virus specific T-cell therapy demonstrates 93% of patients achieved a clinical response after treatment of viral infections and disease in patients following allogeneic HSCT

    - Real-world findings demonstrate significantly higher healthcare costs, health resource utilization and worse clinical outcomes in allogeneic HSCT patients with virus-associated hemorrhagic cystitis

    AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, today announced that results from the Phase 2, proof-of-concept CHARMS study demonstrated that an allogeneic, off-the-shelf, multi-virus specific T cell therapy, Viralym-M (ALVR105), achieved a 93% clinical response and was generally well-tolerated in allogeneic hematopoietic stem cell transplantation (allo-HSCT) patients with at least one drug refractory infection. The findings were highlighted during an oral presentation at the 62nd American Society of Hematology Annual Meeting (ASH). In a second oral presentation, a health outcomes analysis showed the high economic and clinical burden of virus-associated hemorrhagic cystitis (V-HC) in patients following allo-HSCT.

    "There is an urgent need for new therapies that improve the treatment and prevention of viral infections which have significantly impacted immunocompromised patients as well as burdened the healthcare system," said Agustin Melian, MD, Chief Medical Officer and Head of Global Medical Sciences of AlloVir. "The data presented at ASH highlight the potential of Viralym-M in treating immunocompromised patients who are at a greater risk of viral infection."

    Oral Presentation: Treatment of Severe, Drug-Refractory Viral Infections with Allogeneic, Off-the-Shelf, Multi-virus Specific T Cell Therapy in Patients Following HSCT: Results from a Phase 2 Study

    Presenter: Bilal Omer, MD, Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital, Houston Methodist Hospital, Houston, TX

    Efficacy and safety data of Viralym-M in allo-HSCT recipients with at least one treatment-refractory infection (BKV, CMV, AdV, EBV, HHV-6, and/or JCV) were evaluated in the CHARMS study, a Phase 2 proof-of-concept clinical trial. Allo-HSCT patients who had either failed antiviral therapy or were unable to tolerate standard antivirals were enrolled and received a single infusion of Viralym-M. If a partial response was achieved, patients could receive up to four additional doses after four weeks, at two-week intervals.

    Ninety-three percent (93%) of the patients achieved a complete (viral load returning to normal range and resolution of clinical signs/symptoms) or partial (a ≥50% decrease in viral load and/or 50% improvement of clinical signs/symptoms) response by six weeks post-infusion. One hundred percent (100%) of patients who had two or more viral infections (11 of 11) responded to Viralym-M with 19 of the 23 viral infections across these 11 patients responding to treatment. Treatment with Viralym-M was generally well tolerated.

    "Patients receiving an allogeneic hematopoietic stem cell transplant are at increased risk for multiple viral infections and diseases, which ultimately put them at risk for serious and life-threatening outcomes," said Bilal Omer, MD, Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital, Houston Methodist Hospital and presenting author. "Currently there is a lack of effective treatments and those that are available have significant toxicities. Data from the CHARMS study suggest that Viralym-M has the potential to safely and effectively treat the most common viral infections in patients following allogeneic HSCT and may address a critical unmet need in this patient population."

    Oral Presentation: Economic and Clinical Burden of Virus-Associated Hemorrhagic Cystitis in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation

    Presenter: Joseph P. McGuirk, DO, the University of Kansas Cancer Center, Westwood, KS

    U.S. claims data were analyzed to compare health care reimbursement, health resource utilization, and clinical outcomes between allo-HSCT patients with virus-associated hemorrhagic cystitis (V-HC) to those without V-HC. The unadjusted mean reimbursement per patient group was $292,401 higher for patients with V-HC compared to patients without V-HC. Adjusted reimbursements were also significantly higher for V-HC patients with and without GVHD compared to patients without V-HC (p<.0001).

    V-HC was associated with increased hospital length of stay and additional days in the intensive care unit. Readmission rates also increased for patients with V-HC compared to those without V-HC (p<.0001). The mean overall hospital LOS was prolonged by 27.1 days (p<0.0001), or 55% longer, for allo-HSCT patients with V-HC versus patients without V-HC.

    In an adjusted analysis examining time to all-cause mortality, patients with V-HC had a 70% higher risk of mortality, even after adjusting for presence of GVHD as well as other baseline factors. V-HC was also associated with increased incidence for renal impairment in the follow-up period in patients with or without GVHD.

    "Viral infections or disease including the viruses associated with hemorrhagic cystitis are a major complication in patients who have undergone allogeneic hematopoietic stem cell transplantation," said Joseph P. McGuirk, DO, the University of Kansas Cancer Center and presenting author. "These data show that virus associated hemorrhagic cystitis has a significant impact on patient outcomes including a greater risk of death and new renal impairment, while also placing a substantial burden on our healthcare system, highlighting the unmet clinical need for effective strategies to prevent and/or treat virus-associated hemorrhagic cystitis in allo-HSCT recipients."

    Viral Infections in Immunocompromised Patients

    In healthy individuals, virus-specific T-cells (VSTs) from the body's natural defense system provide protection against numerous disease-causing viruses. However, in patients with a weakened immune system these viruses may be uncontrolled. Viral diseases are common and can cause potentially devastating and life-threatening consequences in immunocompromised patients. For example, up to 90% of patients will reactivate at least one virus following an allogeneic stem cell transplant and two-thirds of these patients reactivate more than one virus, resulting in significant and prolonged morbidity, hospitalization, and premature death. Typically, when viruses infect immunocompromised patients, standard antiviral treatment does not address the underlying problem of a weakened immune system and therefore many patients suffer with life-threatening outcomes such as multi-organ damage and failure, and even death.

    Viralym-M (ALVR105)

    AlloVir's lead product Viralym-M (ALVR105) is in late-stage clinical development as an allogeneic, off-the-shelf, multi-virus specific T-cell therapy targeting six common viral pathogens in immunocompromised individuals: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6, and JC virus. The company plans to initiate a Phase 3, multicenter, double-blind, placebo-controlled study to assess the efficacy and safety of Viralym-M for the treatment of patients with virus-associated hemorrhagic cystitis (V-HC) following allo-HSCT before year end. A proof-of-concept clinical trial targeting the prevention of BKV, CMV, AdV, EBV, HHV-6, and JCV in patients following allo-HSCT is also expected to initiate by the end of 2020. Viralym-M has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA), as well as PRIority MEdicines (PRIME) and Orphan Drug Designations (ODD) from the European Medicines Agency.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viruses for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information visit www.allovir.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding AlloVir's development and regulatory status of our product candidates and its strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to AlloVir's financial results, the timing for completion of AlloVir's clinical trials of its product candidates, whether and when, if at all, AlloVir's product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, competition from other biopharmaceutical companies, and other risks identified in AlloVir's SEC filings. AlloVir cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AlloVir disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent AlloVir's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

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  10. - Data presented in an oral presentation at the 62nd American Society of Hematology Annual Meeting

    - Proof-of-concept clinical trial underway for high-risk patients with COVID-19

    AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, today announced that preclinical data presented in an oral presentation at the 62nd American Society of Hematology (ASH) Annual Meeting, demonstrates selective antiviral activity of ALVR109 –the company's virus-specific T cell therapy designed to combat SARS-CoV-2, the virus responsible for COVID-19. The data presented found that the SARS-CoV-2 virus-specific T cell therapy, ALVR109, was able to produce effector molecules and selectively kill viral antigen-expressing targets, while leaving non-infected…

    - Data presented in an oral presentation at the 62nd American Society of Hematology Annual Meeting

    - Proof-of-concept clinical trial underway for high-risk patients with COVID-19

    AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, today announced that preclinical data presented in an oral presentation at the 62nd American Society of Hematology (ASH) Annual Meeting, demonstrates selective antiviral activity of ALVR109 –the company's virus-specific T cell therapy designed to combat SARS-CoV-2, the virus responsible for COVID-19. The data presented found that the SARS-CoV-2 virus-specific T cell therapy, ALVR109, was able to produce effector molecules and selectively kill viral antigen-expressing targets, while leaving non-infected targets intact. These data suggest the potential for using these cells to treat COVID-19 in hospitalized high-risk patients in order to prevent the development of severe disease. These data were featured in the ASH Annual Meeting press program. A clinical trial evaluating ALVR109 has recently been initiated at the Center for Cell and Gene Therapy, Baylor College of Medicine (BCM), Texas Children's Hospital, and Houston Methodist Hospital. Researchers at BCM and AlloVir developed a bank of off-the-shelf, SARS-CoV-2 specific T cells that are ready to be administered to patients enrolled in the study.

    "It's increasingly clear that T cell dysregulation is a critical factor in the development of severe COVID-19 and that the presence of healthy SARS-CoV-2-specific CD4+ and CD8+ T cells is important in helping patients fight off the virus," said Ann Leen, Ph.D., Chief Scientific Officer at AlloVir. "Given the unprecedented threat and impact of COVID-19 and the ongoing need for protective and therapeutic options, we rapidly immunologically profiled SARS-CoV-2 and developed ALVR109. The pre-clinical data presented at ASH shows that we can robustly generate T cells with the desired effector profile and AlloVir is sponsoring a proof-of-concept clinical trial being conducted in the Houston Methodist Hospital. The objectives of this trial are to assess the safety and efficacy of ALVR109 in preventing severe disease in hospitalized COVID-19 patients with high-risk features."

    About these data:

    To first identify immunogenic and protective SARS-CoV-2 antigens, researchers screened peripheral blood mononuclear cells (PBMCs) from convalescent individuals who had naturally controlled and cleared the virus using peptide libraries spanning structural, non-structural, and accessory SARS-CoV-2-derived proteins. Of the proteins screened, a subset was identified to advance to clinical virus-specific T cell manufacturing using AlloVir's proprietary and optimized manufacturing and cell culture process.

    The data show ALVR109 is comprised almost exclusively of CD3+ T cells, with a mixture of cytotoxic (CD8+) and helper (CD4+) T cells. T cells fight viruses in two ways – helper CD4+ T cells spur B cells and other immune defenders into action and killer CD8+ T cells seek out and destroy the virus. In preclinical assessments ALVR109 was Th1-polarized, polyclonal, polyfunctional and selectively able to kill viral antigen-expressing targets indicative of both the selectivity of these cells and potential for safe clinical use.

    Spyridoula Vasileiou, Ph.D., from the Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and presenting author said, "Our goal is to attack the virus at multiple points in its life cycle by targeting various virus-specific antigens to effectively and efficiently eliminate SARS-CoV-2 infected cells in patients with COVID-19. When we infuse these cells to patients, these virus-specific T cells have the capacity to expand and migrate to infected cells to selectively target the virus."

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viruses for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information visit www.allovir.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding AlloVir's development and regulatory status of our product candidates and its strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to AlloVir's financial results, the timing for completion of AlloVir's clinical trials of its product candidates, whether and when, if at all, AlloVir's product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, competition from other biopharmaceutical companies, and other risks identified in AlloVir's SEC filings. AlloVir cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AlloVir disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent AlloVir's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

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  11. AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, will present a corporate overview at the Piper Sandler 32nd Annual Virtual Healthcare Conference on December 1, 2020.

    The presentations will be available for registered attendees via the Piper Sandler conference site from November 23 to December 3 and will also be available on the Investors & Press section of the AlloVir website at https://ir.allovir.com. An archived replay of the presentation will be available for approximately 30 days following the presentation.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with weakened immune systems. The…

    AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, will present a corporate overview at the Piper Sandler 32nd Annual Virtual Healthcare Conference on December 1, 2020.

    The presentations will be available for registered attendees via the Piper Sandler conference site from November 23 to December 3 and will also be available on the Investors & Press section of the AlloVir website at https://ir.allovir.com. An archived replay of the presentation will be available for approximately 30 days following the presentation.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viruses for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information visit www.allovir.com.

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  12. - Completed initial public offering raising $317.7M in gross proceeds

    - Viralym-M (multi-virus-specific T cell therapy) registrational study in lead indication in virus-associated hemorrhagic cystitis and proof-of-concept study in prevention of multiple viral infections on track to initiate before year end

    - ALVR109 (virus-specific T cell therapy designed to combat SARS-CoV-2) Phase 1/2 clinical trial initiated for the treatment of high risk COVID-19 patients

    - Commenced tech transfer for AlloVir proprietary virus-specific T-cell manufacturing process to ElevateBio BaseCamp, as part of planned manufacturing capacity expansion and redundancy within supply chain

    CAMBRIDGE, Mass., Nov. 10, 2020 (GLOBE NEWSWIRE) -- AlloVir…

    - Completed initial public offering raising $317.7M in gross proceeds

    - Viralym-M (multi-virus-specific T cell therapy) registrational study in lead indication in virus-associated hemorrhagic cystitis and proof-of-concept study in prevention of multiple viral infections on track to initiate before year end

    - ALVR109 (virus-specific T cell therapy designed to combat SARS-CoV-2) Phase 1/2 clinical trial initiated for the treatment of high risk COVID-19 patients

    - Commenced tech transfer for AlloVir proprietary virus-specific T-cell manufacturing process to ElevateBio BaseCamp, as part of planned manufacturing capacity expansion and redundancy within supply chain

    CAMBRIDGE, Mass., Nov. 10, 2020 (GLOBE NEWSWIRE) -- AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, today reported financial results for the third quarter ended September 30, 2020.

    "In the third quarter, we completed our $317.7 million initial public offering creating a solid financial foundation for the next stage of AlloVir's growth," said David Hallal, Chairman and Chief Executive Officer of AlloVir. "We are now focused on leveraging our robust capabilities to execute our objectives across our pipeline, including commencing up to nine pivotal and proof-of-concept studies across three cell therapies this year and throughout 2021."

    David Hallal continued, "the Phase 1/2 clinical trial with ALVR109, our virus-specific T cell therapy designed to combat SARS-CoV-2 – the virus that causes COVID-19 – has been initiated in high-risk patients and we are on track to initiate two additional studies with our lead product, Viralym-M, including a registrational, Phase 3 clinical trial for the treatment of virus-associated hemorrhagic cystitis and a proof-of-concept study for the prevention of multiple viral infections, both in allogeneic stem cell transplant patients before year end."

    Third Quarter Business Highlights

    • In August, the company closed its initial public offering (IPO) raising $317.7 million in gross proceeds prior to deducting underwriting discounts, commissions and offering expenses. The company expects its current cash and cash equivalents, inclusive of IPO net proceeds, will be sufficient to fund its current operating plan into 2023.
    • AlloVir expanded its regulatory expertise and management team by hiring Ercem Atillasoy, M.D., to the newly created position of Chief Regulatory and Safety Officer. Dr. Atillasoy has over 25 years of experience in clinical development, regulatory affairs, and safety. Most recently, he was the regulatory head at Merck and Co., responsible for all regulatory activities globally for the Infectious Disease and Vaccines franchises.
    • In September, Dana Alexander, M.B.A., joined the team as Senior Vice President, Technical Operations. Mr. Alexander brings more than 20 years of experience in biopharmaceutical operations, most recently as Head of Viral Vector Business Operations and Site General Manager at Brammer Bio, now part of Thermo Fisher Scientific. Prior to Brammer Bio, he held senior operational and manufacturing leadership positions at Anika Therapeutics and Genzyme, a Sanofi Company.
    • AlloVir has commenced tech transfer of its proprietary T cell manufacturing platform to ElevateBio BaseCamp, creating redundancy and ensuring manufacturing supply for full clinical pipeline with dedicated good manufacturing practice (GMP) capacity.

    Viralym-M (ALVR105) Program Highlights

    • The planned Phase 3, multicenter, double-blind, placebo-controlled study to assess the efficacy and safety of Viralym-M for the treatment of patients with virus-associated hemorrhagic cystitis (HC) following allogeneic hematopoietic stem cell transplantation (allo-HSCT) is on track to initiate in before year end.
    • Additionally, a proof-of-concept (POC) clinical trial targeting the prevention of BK virus (BKV), cytomegalovirus (CMV), adenovirus (AdV), Epstein Barr virus (EBV), human herpesvirus 6 (HHV-6), and JC virus (JCV) in patients following allo-HSCT is also expected to initiate before year end
    • Real-world data demonstrating the burden of multi-virus infections following allo-HSCT, was presented in a poster session at IDWeek 2020.
    • Results from the Phase 2, POC, CHARMS study with Viralym-M as well as data demonstrating the economic and clinical burden of virus-associated HC in patients following allo-HSCT will be showcased in two oral presentations at the 62nd American Society of Hematology Annual Meeting & Exposition (ASH) in December 2020.

    ALVR109 Program Highlights

    • Initial clinical trial manufacturing runs of ALVR109 have been released and the proof-of-concept clinical trial with ALVR109 has been initiated.
    • In September, the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug application (IND) for ALVR109, AlloVir's allogeneic, off-the-shelf, virus-specific T cell therapy candidate designed to target SARS-CoV-2, the virus that causes the severe and life-threatening viral disease, COVID-19.
    • Pre-clinical data on this program will be presented in an oral session at ASH and will be featured in the conference press program.

    ALVR106 Program Highlights

    • AlloVir anticipates filing the IND before year end for ALVR106, an allogeneic, off-the-shelf, multi-respiratory, virus-specific T cell therapy designed to target respiratory syncytial virus (RSV), influenza, parainfluenza virus (PIV), and human metapneumovirus (hMPV).
    • The POC clinical trial will now initiate in 2021 as the company is assessing the impact of the COVID-19 pandemic on the incidence, diagnosis and treatment of the respiratory viral infections which ALVR106 targets.
    • Real-world data demonstrating the burden of respiratory tract infections following allo-HSCT was presented in an oral session at IDWeek 2020.

    Third Quarter 2020 Financial Highlights

    • Research and development expenses were $17.2 million for the quarter ended September 30, 2020 compared to $5.7 million for the quarter ended September 30, 2019. The increase year-over-year is attributable to costs related to the development of the company's product candidates, increased activity in outsourcing of manufacturing, and an increase in headcount and external consultants in support of research activities.
    • General and administrative expense was $6.7 million for the quarter ended September 30, 2020 compared to $2.8 million for the quarter ended September 30, 2019. The increase year-over-year was primarily attributable to legal, accounting and professional fees related to costs associated with operating activities and the preparations for becoming a public company.
    • Stock-based compensation expense was $3.9 million and $0.6 million for the three months ended September 30, 2020 and 2019, respectively.
    • As of September 30, 2020, AlloVir had cash, cash equivalents, and marketable securities of $378.5 million, which compares to cash, cash equivalents, and marketable securities of $104.5 million as of June 30, 2020.
    • For the quarter ended September 30, 2020, net loss was $23.6 million or $0.58 per share compared to a net loss of $7.3 million or $4.97 per share for the quarter ended September 30, 2019. The total number of common shares outstanding as of September 30, 2020 was 65,106,873.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viruses for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information visit www.allovir.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding AlloVir's development and regulatory status of our product candidates and its strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to AlloVir's financial results, the timing for completion of AlloVir's clinical trials of its product candidates, whether and when, if at all, AlloVir's product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, competition from other biopharmaceutical companies, and other risks identified in AlloVir's SEC filings. AlloVir cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AlloVir disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent AlloVir's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.



    ALLOVIR, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
    UNAUDITED
                
     Three Months Ended Nine Months Ended
    (in thousands, except share and per share data)September 30, September 30,
      2020   2019   2020   2019 
    Revenue$  $  $  $165 
    Operating expenses:           
    Research and development 17,182   5,655   32,906   9,561 
    General and administrative 6,718   2,823   12,987   7,800 
    Total operating expenses 23,900   8,478   45,893   17,361 
    Loss from operations (23,900)  (8,478)  (45,893)  (17,196)
    Total other income, net:           
    Interest income 112   781   735   1,400 
    Other income, net 174   427   573   700 
    Net loss$(23,614) $(7,270) $(44,585) $(15,096)
    Net loss per share --- basic and diluted$(0.58) $(4.97) $(2.93) $(13.67)
    Weighted-average common shares outstanding---basic and diluted 40,465,705   1,463,421   15,195,000   1,104,454 
                





    ALLOVIR, INC.
    CONDENSED CONSOLIDATED BALANCE SHEETS
    UNAUDITED
          
    (in thousands)September 30,  December 31,
     2020 2019
    Assets     
    Current assets:     
    Cash, cash equivalents and short-term investments$378,488 $126,077 
    Other current assets 5,453  1,236 
    Total current assets 383,941  127,313 
          
    Other assets 9,769  12,109 
    Total assets$393,710 $139,422 
    Liabilities and stockholders' deficit     
    Current liabilities$13,521 $9,106 
    Long-term liabilities 6,286  8,692 
    Total liabilities 19,807  17,798 
          
    Preferred stock   173,127 
    Total stockholders' equity (deficit) 373,903  (51,503)
    Total liabilities, preferred stock, and stockholders' deficit$393,710 $139,422 
          



    Media contact:

    Courtney Heath

    ScientPR



    617-872-2462

    Investor contact:

    Medha Chadha

    AlloVir

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  13. CAMBRIDGE, Mass., Nov. 04, 2020 (GLOBE NEWSWIRE) -- AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, announced that it will present three abstracts as oral presentations that support its pipeline of allogeneic, off-the-shelf virus-specific T cell therapies during the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition taking place virtually December 5 – 8, 2020.

    Details of the presentations at ASH are as follows:

    Presentation Title: Using Allogeneic, Off-the-Shelf, SARS-CoV-2-specific T Cells to Treat High Risk Patients with COVID-19*
    Session Name: Adoptive Immunotherapy: Mechanisms and New Approaches: Adoptive Cell Therapy beyond CAR T cells
    Session Date & Time: Monday, December 7, 2020, 9 – 10:30 a.m…

    CAMBRIDGE, Mass., Nov. 04, 2020 (GLOBE NEWSWIRE) -- AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, announced that it will present three abstracts as oral presentations that support its pipeline of allogeneic, off-the-shelf virus-specific T cell therapies during the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition taking place virtually December 5 – 8, 2020.

    Details of the presentations at ASH are as follows:

    Presentation Title: Using Allogeneic, Off-the-Shelf, SARS-CoV-2-specific T Cells to Treat High Risk Patients with COVID-19*

    Session Name: Adoptive Immunotherapy: Mechanisms and New Approaches: Adoptive Cell Therapy beyond CAR T cells

    Session Date & Time: Monday, December 7, 2020, 9 – 10:30 a.m.

    Presentation Time: 10:00 a.m. PT (1:00 p.m. ET)

    Presenter: Spyridoula Vasileiou, Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and The Methodist Hospital

    Abstract Number: 612

    *This abstract will be highlighted in an ASH press briefing on Saturday, December 5, 8:00 a.m. PT (11:00 – 11:30 a.m. ET.)

    Presentation Title: Treatment of severe, drug-refractory viral infections with allogeneic, off-the-shelf multi-virus specific T cell therapy in patients following HSCT: Results from a phase 2 Study

    Session Name: Adoptive Immunotherapy: Mechanisms and New Approaches: Adoptive Cell Therapy beyond CAR T cells

    Session Date & Time: Monday, December 7, 2020, 9 – 10:30 a.m.

    Presentation Time: 9:15 a.m. PT (12:15 p.m. ET)

    Presenter: Ifigeneia Tzannou, Center for Cell and Gene Therapy, Baylor College of Medicine, Texas Children's Hospital and The Methodist Hospital

    Abstract Number: 609

    Presentation Title: Economic and Clinical Burden of Virus Associated Hemorrhagic Cystitis in Patients Following Allogeneic Hematopoietic Stem Cell Transplantation

    Session Name: Health Services Research—Malignant Conditions (Lymphoid Disease) I

    Session Date and Time: Monday, December 7, 2020, 1:30 – 3:00 p.m.

    Presentation Time: 2:45 p.m. PT (5:45 p.m. ET)

    Presenter: Joseph P. McGuirk, DO, The University of Kansas Cancer Center

    Abstract Number: 747

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with severely weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viruses for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information visit www.allovir.com

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding AlloVir's development and regulatory status of our product candidates and its strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to AlloVir's financial results, the timing for completion of AlloVir's clinical trials of its product candidates, whether and when, if at all, AlloVir's product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, competition from other biopharmaceutical companies, and other risks identified in AlloVir's SEC filings. AlloVir cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AlloVir disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent AlloVir's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

    Media contact:

    Courtney Heath

    ScientPR

      

    617-872-2462                

    Investor contact:

    Medha Chadha

    AlloVir

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  14. CAMBRIDGE, Mass., Oct. 21, 2020 (GLOBE NEWSWIRE) -- AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, today announced that health outcomes analyses to be presented at IDWeek™ 2020 demonstrate the economic and clinical burden associated with respiratory tract infections and multi-virus infections following allogeneic hematopoietic cell transplantation (allo-HCT). The presentations include an oral presentation evaluating the economic and clinical burden of respiratory virus infections (RVI) in allo-HCT recipients and a poster presentation on health resource utilization and costs associated with multi-virus infections after allo-HCT. The studies report on U.S. claims data analyses of 13,363 allo-HCT patients between Jan. 1, 2012…

    CAMBRIDGE, Mass., Oct. 21, 2020 (GLOBE NEWSWIRE) -- AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, today announced that health outcomes analyses to be presented at IDWeek™ 2020 demonstrate the economic and clinical burden associated with respiratory tract infections and multi-virus infections following allogeneic hematopoietic cell transplantation (allo-HCT). The presentations include an oral presentation evaluating the economic and clinical burden of respiratory virus infections (RVI) in allo-HCT recipients and a poster presentation on health resource utilization and costs associated with multi-virus infections after allo-HCT. The studies report on U.S. claims data analyses of 13,363 allo-HCT patients between Jan. 1, 2012 and Dec. 31, 2017 to assess total healthcare reimbursement, health resource utilization (HRU), and clinical outcomes in the year following allo-HCT.

    Oral Presentation: Economic and Clinical Burden of Respiratory Virus Infections in Allogeneic Hematopoietic Cell Transplantation Recipients

    Date: On Demand, Starting Wednesday, October 21

    Presenter: Michael G. Ison, MD, MS, Northwestern University Feinberg School of Medicine, Chicago, IL

    U.S. claims data from the Decision Resources Group Real World Evidence Data Repository was analyzed to identify allo-HCT recipients from 2012 – 2017 to assess health care reimbursements, HRU, and clinical outcomes in the one-year following allo-HCT in patients with and without RVI. The analysis studied patients who had been coded with one of four RVIs, including respiratory syncytial virus (RSV), influenza, parainfluenza virus (PIV), and human metapneumovirus (hMPV). A generalized linear model was used to determine adjusted total reimbursement stratified by the presence or absence of any acute or chronic graft-versus-host diseases (GVHD) after adjusting for age, health plan, underlying disease, stem cell source, number of comorbidities, baseline costs, and follow-up time.

    Unadjusted median reimbursements were $132,395 higher for any RVI ($139,439 RSV, $101,963 influenza, $185,041 PIV, and $248,029 hMPV) compared to those without RVIs. Adjusted reimbursements were significantly higher for patients with any RVI compared to patients without that infection (p<.0001) with or without GVHD. Patients with any RVI had significantly longer length of stay (LOS) for the HCT hospitalization, higher readmission rate, and longer LOS after allo-HCT hospitalization compared to patients without RVI (p<.0001). The mean overall hospital LOS was significantly longer for patients with an RVI as compared to those without (13 days; p<.0001): 11 days longer for patients with RSV (p<.0001), 10 days longer for patients with influenza (p=.0002), 28 days longer for patients with PIV (p=.0001), and 19 days longer for patients with hMPV (p<.0001). A significantly higher proportion of patients with any RVI had pneumonia as compared to patients without that infection, irrespective of presence of GVHD (p< .0001). In the adjusted analysis, the presence of any RVI was significantly associated with all-cause mortality, regardless of the presence of GVHD (p<.0001).

    "Patients with T cell deficiencies, like those undergoing HCT, are at higher risk for respiratory viral infections," said Michael G. Ison, MD, MS, Professor, Northwestern University Feinberg School of Medicine and presenting author. "These data show that respiratory viral infections have a significant impact on patient outcomes, as exemplified by a higher proportion of patients developing pneumonia and a greater risk of mortality. Additionally, the burden to our healthcare system is great in terms of higher total cost, prolonged patient hospitalization, and more frequent patient readmissions. It's clear we need better treatment options to help patients prevent and fight off these commonly occurring respiratory viruses."

    Poster Presentation: Healthcare Resource Utilization and Costs Associated with Multi-virus Infection After Allogeneic Hematopoietic Cell Transplantation

    Date: On Demand, Starting Wednesday, October 21

    Poster #1089

    Presenter: Joshua A. Hill, MD, Assistant Professor, Fred Hutchinson Cancer Research Center, University of Washington, Seattle

    U.S. claims data was analyzed to compare health care reimbursements, HRU, and clinical outcomes between allo-HCT patients with no versus multiple dsDNA infections due to cytomegalovirus (CMV), BK virus (BKV), Epstein-Barr virus (EBV), JC virus (JCV), adenovirus (AdV), and human herpesvirus-6 (HHV-6). The unadjusted mean reimbursements per patient group were $266,345 for individuals who did not have a dsDNA viral infection compared to $431,614 for patients with one virus; $639,097 for those with two viruses; and $964,378 for those with three or more viruses. Adjusted reimbursements were significantly higher for each additional viral infection among patients with and without GVHD compared to patients with no viral infections (p<.0001). HRU also increased as the number of viral infections increased: the mean overall hospital LOS increased significantly with each additional viral infection (p<.0001): 41.3 days for patients with no viruses compared to 61.4 days for one virus, 77.0 days for two viruses, and 103.3 days for three or more viruses. The LOS and the number of days in the ICU during the index hospitalization as well as in readmissions after index also increased significantly with each additional viral infection (p<.0001 for both outcomes).

    Allo-HCT patients with multiple dsDNA viral infections have worse clinical outcomes such as new diagnosis of renal impairment, irrespective of the presence of GVHD, and higher mortality rate for patients with GVHD. Among patients with GVHD, all-cause mortality (21.0%-21.4%) and new diagnosis of renal impairment (27.5%-35.7%) were significantly higher for patients with one or more viral infections as compared to patients with no viral infections (all-cause mortality: 16.8%; new diagnosis of renal impairment: 22.3%). Among patients without GVHD, new diagnosis of renal impairment (20.9%-30.2%) was significantly higher for patients with one or more viral infections as compared to patients with no viral infections (14.6%). In addition, patients with an increasing number of viral infections had a higher risk of all-cause mortality, after adjusting for GVHD and baseline characteristics.

    "Allogeneic hematopoietic cell transplantation has revolutionized the way we treat some cancers," said Joshua A. Hill, MD, Assistant Professor, Fred Hutchinson Cancer Research Center and presenting author. "However, because of the conditioning regimen required to prepare patients for the transplant, it puts them in an immunocompromised state and at greater risk for viral infections. These data show that these viral infections have both significant impact on patient outcomes and on the health care systems working to treat them. For many of the viruses affecting these patients, there are limited or no treatment options."

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with severely weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viruses for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information visit www.allovir.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding AlloVir's development and regulatory status of our product candidates and its strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to AlloVir's financial results, the timing for completion of AlloVir's clinical trials of its product candidates, whether and when, if at all, AlloVir's product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, competition from other biopharmaceutical companies, and other risks identified in AlloVir's SEC filings. AlloVir cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AlloVir disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent AlloVir's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

    Media contact:

    Courtney Heath

    ScientPR



    617-872-2462

    Investor contact:

    Medha Chadha

    AlloVir

    Primary Logo

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  15. - ALVR109 is an allogeneic, off-the-shelf virus-specific T cell therapy candidate designed to target SARS-CoV-2 for high-risk COVID-19 patients

    - Proof-of-concept clinical trial with ALVR109 to begin in Q42020

    CAMBRIDGE, Mass., Sept. 17, 2020 (GLOBE NEWSWIRE) -- AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) for ALVR109, an allogeneic, off-the-shelf virus-specific T cell therapy candidate designed to target SARS-CoV-2, the virus that causes the severe and life-threatening viral disease, COVID-19. ALVR109 is being developed to arrest the progression of COVID-19 by eradicating SARS-CoV-2 virus-infected…

    - ALVR109 is an allogeneic, off-the-shelf virus-specific T cell therapy candidate designed to target SARS-CoV-2 for high-risk COVID-19 patients

    - Proof-of-concept clinical trial with ALVR109 to begin in Q42020

    CAMBRIDGE, Mass., Sept. 17, 2020 (GLOBE NEWSWIRE) -- AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) for ALVR109, an allogeneic, off-the-shelf virus-specific T cell therapy candidate designed to target SARS-CoV-2, the virus that causes the severe and life-threatening viral disease, COVID-19. ALVR109 is being developed to arrest the progression of COVID-19 by eradicating SARS-CoV-2 virus-infected cells.

    "SARS-CoV-2 continues to have a devastating impact on patients and families around the world," said David Hallal, Chairman and Chief Executive Officer of AlloVir. "There is an increasing body of evidence about the important role of T cells in the body's fight against COVID-19. At AlloVir, together with our colleagues at Baylor College of Medicine, we are working with a great sense of urgency to leverage our highly innovative virus-specific T-cell platform to advance ALVR109 into a proof-of-concept study in high-risk COVID-19 patients."

    Early research suggests that T cells play an important role in the body's fight against COVID-19. Over 80% of hospitalized patients with COVID-19 are lymphopenic, with reduced CD8+ and CD4+ T cell counts. These reductions in T cell counts correlate negatively with survival. Reduced T cell counts have been observed to be prevalent in older COVID-19 patients and those with severe illness, regardless of age.

    On March 23, 2020, AlloVir announced it expanded its research collaboration with Baylor College of Medicine (BCM) to discover and develop allogeneic, off-the-shelf, virus-specific T-cell therapies for COVID-19. Following the submission of the IND for ALVR109 by BCM, the FDA notified BCM of a clinical hold due to questions related to raw materials used in the manufacturing process for ALVR109. BCM submitted a complete response to the questions identified in the clinical hold and the FDA has removed the hold allowing the clinical study to start.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with severely weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viruses for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information visit www.allovir.com.

    AlloVir uses its website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. Such disclosures will be included on the Company's website in the ‘Investors & Media' section. Accordingly, investors should monitor such portions of the AlloVir website, in addition to following press releases, SEC filings and public conference calls and webcasts.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding AlloVir's development and regulatory status of our product candidates and its strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to AlloVir's financial results, the timing for completion of AlloVir's clinical trials of its product candidates, whether and when, if at all, AlloVir's product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, competition from other biopharmaceutical companies, and other risks identified in AlloVir's SEC filings. AlloVir cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AlloVir disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent AlloVir's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

    Media contact:

    Courtney Heath

    ScientPR



    617-872-2462                                                              

    Investor contact:

    Medha Chadha

    AlloVir

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  16. CAMBRIDGE, Mass., Sept. 08, 2020 (GLOBE NEWSWIRE) -- AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, announced the appointment of Ercem Atillasoy, M.D., as the company's Chief Regulatory and Safety Officer, a newly created position. Dr. Atillasoy brings nearly 25 years of experience leading drug, biologic, and infectious disease product development. Most recently, Dr. Atillasoy was at Merck Research Laboratories serving as Vice President and Therapeutic Area Head of Vaccines and Infectious Disease in Global Regulatory Affairs and Clinical Safety. He had responsibility and oversight for Merck's extensive portfolio of infectious disease products, many of which have transformed human health. In addition, he oversaw engagement…

    CAMBRIDGE, Mass., Sept. 08, 2020 (GLOBE NEWSWIRE) -- AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, announced the appointment of Ercem Atillasoy, M.D., as the company's Chief Regulatory and Safety Officer, a newly created position. Dr. Atillasoy brings nearly 25 years of experience leading drug, biologic, and infectious disease product development. Most recently, Dr. Atillasoy was at Merck Research Laboratories serving as Vice President and Therapeutic Area Head of Vaccines and Infectious Disease in Global Regulatory Affairs and Clinical Safety. He had responsibility and oversight for Merck's extensive portfolio of infectious disease products, many of which have transformed human health. In addition, he oversaw engagement and strategy with regulatory agencies across the world, including those in the United States, Europe, Japan, and China.

    "We are delighted that Ercem is joining AlloVir as we prepare to enter multiple late-stage clinical trials across our pipeline of highly innovative therapeutics for patients suffering from, or at risk of, life-threatening viral diseases," said David Hallal, Chairman and Chief Executive Officer of AlloVir. "Ercem's extensive global regulatory expertise and successes within the infectious disease therapeutic area represent a very important addition to our executive team as we expand our development programs in the U.S., Europe, and Asia."

    During his nearly 20 years at Merck, Dr. Atillasoy had an instrumental role in expediting development and approval of novel medicines and vaccines that have changed the world, including vaccines against viruses, such as Ebola (Ervebo®), human papillomaviruses that cause cancers, (Gardasil® and Gardasil®9), rotaviruses (RotaTeq®), and those that cause pediatric illnesses (ProQuad® and Vaxelis™). Most recently, he had regulatory oversight for Merck's publicly announced investigational COVID-19-related vaccine and small molecule programs. Dr. Atillasoy has led regulatory filings and approvals for many antiviral agents, such as those against HIV (Isentress®, Delstrigo™, and Pifeltro™), cytomegalovirus (Prevymis™), and hepatitis C (Zepatier®). In addition, Dr. Atillasoy oversaw the first investigational new drug (IND) filing for Keytruda® for melanoma, and he has supported approval of other oncology products including Zolinza® for cutaneous T cell lymphoma and Emend® for the prevention of chemotherapy-associated nausea.*

    "AlloVir has built a proprietary, highly efficient technology platform that has yielded an investigational pipeline of allogeneic, off-the-shelf T cell therapies. The platform offers novel solutions with potential to address significant unmet global health needs among patients suffering from viral diseases who lack effective treatments today," said Dr. Atillasoy. "I am excited to join the AlloVir team and guide our products through development and anticipated regulatory filings and approvals."

    Earlier in his career, Dr. Atillasoy worked with the Medical Affairs Departments at Sandoz and Novartis Pharmaceuticals, where he supported licensure of anti-infective, dermatology, tissue engineered products (including Apligraf®)*, and cell therapies. In addition to his professional accomplishments, Dr. Atillasoy was selected and currently serves as the industry representative to the U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmologic Drugs Advisory Committee and served as Merck's senior representative to the PhRMA Regulatory Steering Group and the BIO Vaccine Regulatory Advisory Committee. Dr. Atillasoy has published papers on a range of topics, including infectious disease, gene therapy, melanoma, dermatology, and tissue engineering.

    Dr. Atillasoy is a graduate of the Yale University School of Medicine and completed his medical internship at Yale New Haven Hospital and his dermatology residency at the University of Pennsylvania. He conducted research in carcinogenesis and gene therapy at the Wistar Institute. He graduated summa cum laude with a Bachelor of Arts degree in English from the City University of New York.

    *Ervebo®, Gardasil® and Gardasil®9, RotaTeq®, ProQuad® Isentress®, Zepatier®, Zolinza®, Keytruda® and Emend® are registered trademarks of Merck and Co., Inc. Vaxelis™, Delstrigo™, Pifeltro™, and Prevymis™ are trademarks of Merck and Co., Inc. Apligraf® is a registered trademark of Organogenesis Inc.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with severely weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viruses for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information visit www.allovir.com.

    AlloVir uses its website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. Such disclosures will be included on the Company's website in the ‘Investors & Media' section. Accordingly, investors should monitor such portions of the AlloVir website, in addition to following press releases, SEC filings and public conference calls and webcasts.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding AlloVir's development and regulatory status of our product candidates and its strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to AlloVir's financial results, the timing for completion of AlloVir's clinical trials of its product candidates, whether and when, if at all, AlloVir's product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, competition from other biopharmaceutical companies, and other risks identified in AlloVir's SEC filings. AlloVir cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AlloVir disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent AlloVir's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

    Media contact:

    Courtney Heath

    ScientPR



    617-872-2462

    Investor contact:

    Medha Chadha

    AlloVir

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  17. CAMBRIDGE, Mass., Sept. 02, 2020 (GLOBE NEWSWIRE) -- AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, today reported financial results for the second quarter ended June 30, 2020.

    "AlloVir has achieved important scientific and operational milestones that have us well positioned for growth," said David Hallal, Chairman and Chief Executive Officer of AlloVir. "As we have advanced our portfolio of allogeneic, off -the-shelf, virus specific T cell therapies and are bolstered by a strong cash position stemming from our recent IPO, we look forward to executing our robust plans to progress the important pivotal and proof-of-concept studies across our pipeline."

    Second Quarter 2020 Financial Highlights

    • Research and development…

    CAMBRIDGE, Mass., Sept. 02, 2020 (GLOBE NEWSWIRE) -- AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, today reported financial results for the second quarter ended June 30, 2020.

    "AlloVir has achieved important scientific and operational milestones that have us well positioned for growth," said David Hallal, Chairman and Chief Executive Officer of AlloVir. "As we have advanced our portfolio of allogeneic, off -the-shelf, virus specific T cell therapies and are bolstered by a strong cash position stemming from our recent IPO, we look forward to executing our robust plans to progress the important pivotal and proof-of-concept studies across our pipeline."

    Second Quarter 2020 Financial Highlights

    • Research and development expenses were $8.9 million for the quarter ended June 30, 2020 compared to $2.8 million for the quarter ended June 30, 2019. The increase year-over-year is attributable to costs related to the development of the company's product candidates, increased activity in outsourcing of manufacturing, and an increase in headcount and external consultants in support of research activities.
    • General and administrative expense was $3.3 million for the quarter ended June 30, 2020 compared to $3.2 million for the quarter ended June 30, 2019. The increase year-over-year was primarily attributable to legal, accounting and professional fees related to costs associated with operating activities and the preparations for becoming a public company.
    • Stock-based compensation expense was $0.5 million and $1.4 million for the three months ended June 30, 2020 and 2019, respectively.
    • As of June 30, 2020, AlloVir had cash, cash equivalents, and marketable securities of $104.5 million, which compares to cash, cash equivalents, and marketable securities of $126.1 million as of December 31, 2019.
    • For the quarter ended June 30, 2020, net loss was $11.6 million or $4.43 per share compared to a net loss of $5.3 million or $5.05 per share for the quarter ended June 30, 2019. The total number of common shares and preferred shares outstanding as of June 30, 2020 was 2,801,059 and 59,398,350, respectively. For purposes of calculating the earnings per share, only the common shares were used in the denominator.

    Subsequent Events

    • In August, the Company closed on an initial public offering raising $317.7mm in gross proceeds prior to deducting underwriting discounts, commissions and offering expenses. We believe that the net proceeds from our IPO, together with our existing cash, cash equivalents and short-term investments, will enable us to fund our operating expenses and capital expenditure requirements into 2023.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with severely weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viruses for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information visit www.allovir.com.

    AlloVir uses its website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. Such disclosures will be included on the Company's website in the ‘Investors & Media' section. Accordingly, investors should monitor such portions of the AlloVir website, in addition to following press releases, SEC filings and public conference calls and webcasts.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding AlloVir's development and regulatory status of our product candidates and its strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to AlloVir's financial results, the timing for completion of AlloVir's clinical trials of its product candidates, whether and when, if at all, AlloVir's product candidates will receive approval from the U.S. Food and Drug Administration, or FDA, or other foreign regulatory authorities, competition from other biopharmaceutical companies, and other risks identified in AlloVir's SEC filings. AlloVir cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AlloVir disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent AlloVir's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.



     AlloVir, Inc. Statement of Operations (Unaudited)

    Three and Six Months Ended June 30, 2020 and 2019
      
                    
       Three Months Ended Six Months Ended  
     (in thousands, except share and per share data)June 30, June 30,  
       2020  2019  2020  2019  
     Revenue $  $  $  $165   
     Operating expenses:              
     Research and development  8,885   2,755   15,724   3,906   
     General and administrative  3,268   3,190   6,269   4,977   
     Total operating expenses **  12,153   5,945   21,993   8,883   
     Loss from operations  (12,153)  (5,945)  (21,993)  (8,718)  
     Total other income, net:              
     Interest income  166   503   623   619   
     Other income, net  355   140   399   273   
     Net loss $(11,632) $(5,302) $(20,971) $(7,826)  
     Net loss per share --- basic and diluted $(4.43) $(5.05) $(8.66) $(8.49)  
     Weighted-average common shares outstanding---basic and diluted  2,625,648   1,050,190   2,420,797   921,995   
                    



     AlloVir, Inc. Balance Sheet

    As of June 30, 2020 (Unaudited) and December 31, 2019
            
     (in thousands) June 30,  December 31,
       2020

     2019
     Assets      
     Current assets:      
     Cash, cash equivalents and short-term investments $104,451  $126,077 
     Other current assets  2,837   1,236 
     Total current assets  107,288   127,313 
            
     Other assets  10,558   12,109 
     Total assets $117,846  $139,422 
     Liabilities and stockholders' deficit      
     Current liabilities $8,915  $9,106 
     Long-term liabilities  7,098   8,692 
     Total liabilities  16,013   17,798 
            
     Preferred Stock  173,127   173,127 
     Total stockholders' deficit  (71,294)  (51,503)
     Total liabilities, preferred stock, and stockholders' deficit$117,846  $139,422 

     

    Media contact:

    Courtney Heath

    ScientPR



    617-872-2462
    Investor contact:

    Medha Chadha

    AlloVir

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  18. CAMBRIDGE, Mass., Aug. 25, 2020 (GLOBE NEWSWIRE) -- AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, will present a corporate overview at the virtual Morgan Stanley 18th Annual Global Healthcare Conference on September 17, 2020 at 5:00 p.m. ET.

    A live webcast of the presentation will be available on the Investors & Press section of the AlloVir website at https://ir.allovir.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

    About AlloVir
    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with severely weakened immune systems. The company's innovative and…

    CAMBRIDGE, Mass., Aug. 25, 2020 (GLOBE NEWSWIRE) -- AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, will present a corporate overview at the virtual Morgan Stanley 18th Annual Global Healthcare Conference on September 17, 2020 at 5:00 p.m. ET.

    A live webcast of the presentation will be available on the Investors & Press section of the AlloVir website at https://ir.allovir.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with severely weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viruses for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio. For more information visit www.allovir.com.

    Media contact:

    Courtney Heath

    ScientPR



    617-872-2462

    Investor contact:

    Medha Chadha

    AlloVir

     

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  19. CAMBRIDGE, Mass., Aug. 03, 2020 (GLOBE NEWSWIRE) -- AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, today announced the closing of its upsized initial public offering of 18,687,500 shares of common stock, which includes the exercise in full of the underwriters' option to purchase up to 2,437,500 additional shares of common stock, at a public offering price of $17.00 per share, before underwriting discounts and commissions. All of the common stock was offered by AlloVir. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by AlloVir, were approximately $317.7 million. AlloVir's common stock is listed on The Nasdaq Global Market under the ticker…

    CAMBRIDGE, Mass., Aug. 03, 2020 (GLOBE NEWSWIRE) -- AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, today announced the closing of its upsized initial public offering of 18,687,500 shares of common stock, which includes the exercise in full of the underwriters' option to purchase up to 2,437,500 additional shares of common stock, at a public offering price of $17.00 per share, before underwriting discounts and commissions. All of the common stock was offered by AlloVir. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by AlloVir, were approximately $317.7 million. AlloVir's common stock is listed on The Nasdaq Global Market under the ticker symbol "ALVR."

    Morgan Stanley, J.P. Morgan, SVB Leerink and Piper Sandler & Co. acted as joint book-running managers for the offering.

    A registration statement relating to the shares being sold in this offering has been filed with the Securities and Exchange Commission and was declared effective on July 29, 2020. The offering was made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at ; from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204 or email at ; from SVB Leerink LLC, by mail at One Federal Street, 37th Floor, Boston, MA 02110, Attention: Syndicate Department, by telephone at (800) 808-7525, ext. 6218, or by email at ; or from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924, or by email at .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities law of any such state or jurisdiction.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with severely weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viruses for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio.

    Media contact:

    Courtney Heath

    ScientPR



    617-872-2462                                                                                      

    Investor contact:

    Medha Chadha

    AlloVir

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  20. CAMBRIDGE, Mass., July 30, 2020 (GLOBE NEWSWIRE) -- AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, today announced the pricing of its upsized initial public offering of 16,250,000 shares of common stock at a public offering price of $17.00 per share, before underwriting discounts and commissions. AlloVir's common stock is expected to begin trading on The Nasdaq Global Market on July 30, 2020 under the ticker symbol "ALVR." All of the common stock is being offered by AlloVir. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by AlloVir, are expected to be $276.25 million, excluding any exercise of the underwriters' option to purchase additional…

    CAMBRIDGE, Mass., July 30, 2020 (GLOBE NEWSWIRE) -- AlloVir, Inc. (NASDAQ:ALVR), a late clinical-stage cell therapy company, today announced the pricing of its upsized initial public offering of 16,250,000 shares of common stock at a public offering price of $17.00 per share, before underwriting discounts and commissions. AlloVir's common stock is expected to begin trading on The Nasdaq Global Market on July 30, 2020 under the ticker symbol "ALVR." All of the common stock is being offered by AlloVir. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by AlloVir, are expected to be $276.25 million, excluding any exercise of the underwriters' option to purchase additional shares. The offering is expected to close on August 3, 2020, subject to satisfaction of customary closing conditions. AlloVir has granted the underwriters a 30-day option to purchase up to an additional 2,437,500 shares of AlloVir's common stock at the initial public offering price, less underwriting discounts and commissions.

    Morgan Stanley, J.P. Morgan, SVB Leerink and Piper Sandler & Co. are acting as joint book-running managers for the offering.

    A registration statement relating to the shares being sold in this offering has been filed with the Securities and Exchange Commission and was declared effective on July 29, 2020. The offering is being made only by means of a prospectus. Copies of the final prospectus may be obtained, when available, from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at ; from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204 or email at ; from SVB Leerink LLC, by mail at One Federal Street, 37th Floor, Boston, MA 02110, Attention: Syndicate Department, by telephone at (800) 808-7525, ext. 6218, or by email at ; or from Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924, or by email at .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities law of any such state or jurisdiction.

    About AlloVir

    AlloVir is a leading late clinical-stage cell therapy company with a focus on restoring natural immunity against life-threatening viral diseases in patients with severely weakened immune systems. The company's innovative and proprietary technology platforms leverage off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viruses for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enables the potential for the treatment and prevention of a spectrum of devastating viruses with each single allogeneic cell therapy. The company is advancing multiple mid- and late-stage clinical trials across its product portfolio.

    Media contact:

    Courtney Heath

    ScientPR



    617-872-2462                                                                                      

    Investor contact:

    Medha Chadha

    AlloVir

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