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Description

/s/ David Hallal

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

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.

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.

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.

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).

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.

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.

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

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.

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.

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.

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