# EDGAR Filing Document

**Accession Number:** 0001754068
**File Stem:** 0001193125-23-004128
**Filing Date:** 2023-1
**Character Count:** 15315
**Document Hash:** d6f7c1f75e9db84d1ca402582ed435f8
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-23-004128.hdr.sgml**: 20230109

**ACCESSION NUMBER**: 0001193125-23-004128

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230109

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230109

**DATE AS OF CHANGE**: 20230109

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Allovir, Inc.
- **CENTRAL INDEX KEY:** 0001754068
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **IRS NUMBER:** 831971007
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-39409
- **FILM NUMBER:** 23516532

**BUSINESS ADDRESS:**
- **STREET 1:** 1100 WINTER STREET
- **CITY:** WALTHAM
- **STATE:** MA
- **ZIP:** 02451
- **BUSINESS PHONE:** (617) 433-2605

**MAIL ADDRESS:**
- **STREET 1:** 1100 WINTER STREET
- **CITY:** WALTHAM
- **STATE:** MA
- **ZIP:** 02451

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** ViraCyte, Inc.
- **DATE OF NAME CHANGE:** 20180924

?xml version="1.0" encoding="utf-8" ? 8-K

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### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION

#### Washington, D.C. 20549

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### FORM 8-K

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#### CURRENT REPORT

#### Pursuant to Section 13 or 15(d)

#### of The Securities Exchange Act of 1934

#### Date of Report (Date of Earliest Event Reported): January 9, 2023

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## ALLOVIR, INC.

#### (Exact name of registrant as specified in its charter)

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| | | |
|:---|:---|:---|
| **Delaware** | **001-39409** | **83-1971007** |
| **(State or other jurisdiction**<br> **of incorporation)** | **(Commission**<br> **File Number)** | **(I.R.S. Employer**<br> **Identification No.)** |

---

#### AlloVir, Inc.

#### 1100 Winter Street

#### Waltham, Massachusetts 02451

#### (Address of principal executive offices, including zip code)
(617) 433-2605

#### (Registrant's telephone number, including area code)

#### Not Applicable

#### (Former Name or Former Address, if Changed Since Last Report)

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading**<br> **Symbol(s)** | **Name of each exchange**<br> **on which registered** |
| Common stock, $0.0001 Par Value | ALVR | Nasdaq Global Select Market |

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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| | |
|:---|:---|
| **Item 2.02.** | **Results of Operations and Financial Condition.**  |

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On January 9, 2023, AlloVir, Inc. (the "Company") issued the press release referred to in Item 7.01 of this Current Report on Form 8-K, which announced that its unaudited cash balance totaled $234 million as of December 31, 2022.

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| | |
|:---|:---|
| **Item 7.01.** | **Regulation FD Disclosure.**  |

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The Company is furnishing a press release, attached as Exhibit 99.1, to this Current Report on Form 8-K. The information in this Item 7.01 and Exhibit 99.1 attached hereto shall not be deemed "filed" for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.

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| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.**  |

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(d) Exhibits

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| | |
|:---|:---|
| **Exhibit**<br> **No.** | **Description** |
| 99.1 | [AlloVir, Inc. press release issued January 9, 2023.](d422387dex991.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

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#### SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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| | | |
|:---|:---|:---|
|  | **AlloVir, Inc.** | **AlloVir, Inc.** |
| Date: January 9, 2023 | By: | /s/ Edward Miller |
|  | Name: | Edward Miller |
|  | Title: | *General Counsel* |

---

## Exhibit 99.1

**Exhibit 99.1**![LOGO](g422387g0108021238694.jpg)

**<u>For Immediate Release</u>**

**AlloVir Announces Plans to Complete Enrollment in Three Phase 3 Posoleucel Studies in 2023** 

*Positive final posoleucel Phase 2 clinical data presented at ASH 2022 underscore potential as multi-virus prevention therapy and support ongoing global Phase 3 registration trial* 

*Completion of enrollment of all three posoleucel Phase 3 registrational trials anticipated* 

*by the end of 2023 and data readouts in 2024* 

*Topline results of posoleucel Phase 2 BKV treatment study in kidney transplant patients* 

*expected in 1Q 2023* 

WALTHAM, Mass. — January 9, 2023 — AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage, allogeneic T-cell immunotherapy company, today announced the company's 2023 priorities and anticipated future milestones across its pipeline of virus-specific T cell therapies, including its lead investigational therapy posoleucel. These updates will be the focus of a corporate presentation by Chief Executive Officer Diana Brainard, M.D., at the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, at 2:15 pm PT / 5:15 pm ET. A live webcast and archived replay of the presentation will be available in the Investors & Press section of the AlloVir website at <u>https://ir.allovir.com</u>.

"The positive posoleucel Phase 2 data we reported in 2022 and the enthusiasm we are seeing from transplant centers give us further confidence in our Phase 3 strategy for posoleucel and our ability to execute on our trials in 2023," said Dr. Brainard. "Our Phase 2 multi-virus prevention study data underscore the potential for posoleucel to be transformative for allo-HCT patients by substantially reducing clinically significant infections from six viruses that are devastating for this vulnerable population. Viral infections are a leading cause of non-relapse mortality, generate substantial healthcare expenditures, exact a significant emotional burden on patients and their caregivers, and unfortunately most viruses targeted by posoleucel currently have no preventive therapies."

Posoleucel is an investigational T cell therapy that targets multiple viruses that commonly reactivate in patients who have received allogeneic hematopoietic cell transplants (allo-HCTs) or solid organ transplants. The therapy is being evaluated in three Phase 3 registrational studies for three distinct indications — the prevention of clinically significant infections or disease from adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpesvirus-6 (HHV-6) and JC virus (JCV), the treatment of virus-associated hemorrhagic cystitis (vHC), and the treatment of AdV infection, all in allo-HCT patients. These viral infections have limited to no approved preventive therapies and treatment options, threatening patient survival.

-more-

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**Posoleucel** 

<u>Multi-Virus Prevention in Allo-HCT Patients</u> 

Multi-virus prevention represents the most transformational potential use of posoleucel, moving upstream to prevent the progression of viral reactivations to clinically significant infections and avoid the deleterious downstream effects of these infections. Final data from the open-label, Phase 2 multi-virus prevention study of posoleucel were recently presented at the 64<sup>th</sup> ASH Annual Meeting and Exposition. Results showed that high-risk allo-HCT patients who received posoleucel had substantially lower than expected rates of clinically significant viral infections from posoleucel's six target viruses, and that repeat dosing was generally safe and well tolerated.

The posoleucel Phase 3 multi-virus prevention trial (<u>NCT05305040</u>) is enrolling adult and pediatric patients in the U.S., Europe, Asia, Australia and Canada. Enrollment is expected to complete by year-end 2023, enabling topline data in mid-2024.

<u>vHC and AdV Treatment in Allo-HCT Patients</u> 

Global enrollment is ongoing in Phase 3 registrational studies of posoleucel for the treatment of vHC (<u>NCT04390113</u>) and AdV infection (<u>NCT05179057</u>), both in adult and pediatric allo-HCT patients. Given the high proportion of sites participating in multiple posoleucel Phase 3 studies and the intentional prioritization of the multi-virus prevention trial, both the vHC and AdV studies are expected to complete enrollment by year-end 2023, with topline data anticipated in 2024.

<u>BKV Treatment in Kidney Transplant Patients</u> 

Topline final data from the Phase 2 study (<u>NCT04605484</u>) of posoleucel for the treatment of BK viremia in kidney transplant patients are expected in the first quarter of 2023. These data will inform next steps for this potential indication as well as our broader strategy in solid organ transplant patients.

**Earlier Stage Pipeline** 

AlloVir's early clinical and preclinical VST therapy candidates provide portfolio expansion opportunities, with pipeline advancement led by AlloVir or a potential partner.

<u>ALVR106</u> 

A Phase 1b/2 proof-of-concept clinical study (<u>NCT04933968</u>) of ALVR106 for the treatment of respiratory syncytial virus (RSV), human metapneumovirus, parainfluenza, and influenza, is enrolling auto- and allo-HCT patients in the U.S. into the dose escalation part of this two-part study.

<u>ALVR107</u> 

Preclinical and IND-enabling studies of ALVR107 for chronic HBV have been completed and continue to support the potential for ALVR107 to achieve functional HBV cure. The company expects to initiate clinical development of ALVR107 upon completion of the posoleucel Phase 3 registrational studies.

<u>ALVR109</u> 

The company continues to make ALVR109 available to physicians in response to appropriate compassionate use requests. Positive reports of ALVR109 compassionate use in immune-compromised patients have been published and presented at the 2022 American Transplant Congress, providing important insight into the potential utility of a virus-specific T cell approach to treating respiratory viruses in immunocompromised patients.

-more-

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<u>Financial Guidance</u> 

As of December 31, 2022, the company's cash balance was $234 million. For fiscal year 2023, AlloVir expects operating expenses to be in the range of $150 million to $170 million, excluding non-cash stock compensation expenses. The cash balance amount is preliminary and subject to revisions until the company reports its full financial results for fiscal year 2022.

**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 for patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases. AlloVir's technology and manufacturing process enable 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 <u>www.allovir.com</u> or follow us on <u>Twitter</u> or <u>LinkedIn</u>.

**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 the safety, efficacy and regulatory and clinical progress of our product candidates, including posoleucel, 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, including but not limited to the risks discussed in AlloVir's Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 and in our other filings with the SEC. 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 and Investor Contact:** 

Sonia Choi

AlloVir

<u>schoi@allovir.com</u>