UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 6, 2021
ALLOVIR, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-39409 | 83-1971007 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
AlloVir, Inc.
139 Main Street, Suite 500
Cambridge, Massachusetts 02142
(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)
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:
| Title of each class |
Trade Symbol(s) |
Name of each exchange on which registered | ||
| Common Stock, $0.0001 par value per share | ALVR | Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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. ☐
Item 2.02 Results of Operations and Financial Condition
On August 6, 2021, AlloVir, Inc. announced its financial results for the quarter ended June 30, 2021. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K, including Exhibit 99.1, attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press release dated August 6, 2021 | |
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.
| AlloVir, Inc. | ||||||
| Date: August 6, 2021 | By: | /s/ Edward Miller | ||||
| Name: Edward Miller | ||||||
| Title: General Counsel | ||||||
Exhibit 99.1
AlloVir Reports Second Quarter 2021 Financial Results
- Posoleucel (Viralym-M, ALVR105) proof-of-concept studies in multi-virus prevention in stem cell transplant patients and BK viremia in kidney transplant patients continue to progress with initial data expected 4Q21
- Posoleucel Phase 3 pivotal trial in virus-associated hemorrhagic cystitis continues to progress enrollment
- ALVR106 proof-of-concept study in respiratory syncytial virus, influenza, human metapneumovirus, and parainfluenza expected to initiate in 2H21
Cambridge, MA, August 6, 2021 – AlloVir (Nasdaq: ALVR), a late clinical-stage cell therapy company, today reported financial results for the second quarter ended June 30, 2021.
“We believe virus-specific T-cell therapies can have a meaningful impact in treating as well as preventing multiple devastating viral infections. This approach is groundbreaking in the field of stem cell transplantation – and has the potential to transform care for patients and health care providers,” said Dr. Diana Brainard, Chief Executive Officer of AlloVir. “We are pleased with the progress of our first-of-its-kind posoleucel (Viralym-M, ALVR105) multi-virus prevention clinical trial in allogeneic hematopoietic stem cell transplant recipients and look forward to sharing initial results from that study later this year. In addition, enrollment continues to progress in our posoleucel BK viremia in kidney transplant proof-of-concept study, as well as our registrational study in virus-associated hemorrhagic cystitis.”
Business Updates and Upcoming Milestones
Second Quarter Business and Scientific Milestones
| • | Dr. Diana Brainard officially commenced her role as Chief Executive Officer as of May 17 this year. Dr. Brainard is a physician-scientist specializing in infectious diseases, with more than 20 years of experience in the biopharmaceutical industry and academic medicine, most recently serving as Senior Vice President and Head of the Virology Therapeutic Area at Gilead Sciences. |
| • | Real-world data demonstrating the economic and clinical burden associated with virus-associated hemorrhagic cystitis following allogeneic hematopoietic stem cell transplant (allo-HSCT) was published in the journal Transplantation and Cellular Therapy. |
2021 Near-Term Priorities Across Programs
| • | Initial data from the Phase 2 open-label phase of the multi-virus prevention, proof-of-concept (POC) clinical trial to assess the safety and efficacy of posoleucel in pediatric and adult patients following allo-HSCT are expected in the fourth quarter of 2021. The clinical trial, targeting the prevention of clinically significant BK virus (BKV), cytomegalovirus (CMV), adenovirus (AdV), Epstein-Barr virus (EBV), human herpesvirus 6 (HHV-6), and JC virus (JCV) infections, is ongoing and continues to enroll patients. AlloVir embarked on this study since approximately 90% of all allo-HSCT patients experience at least one infection associated with BKV, CMV, AdV, EBV, or HHV-6, and over 60% of such patients experience infections caused by two or more of these five viruses within 100 days post allo-HSCT. |
| • | The Phase 3 multicenter, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of posoleucel for the treatment of virus-associated hemorrhagic cystitis (HC) in pediatric and adult patients following allo-HSCT, is ongoing and continues to enroll patients. Virus-associated HC, a well-described complication after HSCT, is a devastating inflammatory disease of the bladder with no approved or effective treatment options. Newly published data demonstrate that patients with virus-associated-HC had a 70% higher risk of mortality, and the viral disease was associated with significantly prolonged hospitalization including increased intensive care unit (ICU) stay and hospital readmission rates. |
| • | The Phase 2 POC clinical trial with posoleucel for the preemptive treatment of BK viremia in adult kidney transplant recipients is ongoing, with initial data anticipated in the fourth quarter of 2021. BK viremia, which is detected in up to 20% of kidney transplant patients, can be a devastating complication leading to decreased kidney survival and return to end-stage renal disease and dialysis. |
| • | A POC clinical trial of ALVR106, an allogeneic, off-the-shelf, multi-respiratory virus-specific T-cell therapy designed to target infections and diseases caused by respiratory syncytial virus (RSV), influenza, parainfluenza virus (PIV), and human metapneumovirus (hMPV), in allogeneic and autologous HSCT recipients is expected to be initiated in the second half of 2021 to coincide with the anticipated upcoming flu/respiratory virus season. |
| • | The Phase 1 POC clinical trial 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, is ongoing. However, with the efficacy of available vaccines and therapies to prevent serious disease, the company does not currently see a role for ALVR109 to treat a broad patient population. There may be a future role for ALVR109 to treat immunocompromised patients who are not adequately served by available vaccines and therapies. The company is monitoring the evolution of the SARS-CoV-2 virus and the COVID-19 pandemic to guide the next steps for this program. |
| • | The company is on track to complete preclinical and IND-enabling studies for ALVR107 to treat hepatitis B virus (HBV) in the second half of 2021. Chronic HBV infection is associated with significant morbidity and mortality. Current treatment options for chronic HBV consist of life-long antiviral therapy to suppress virus replication, which can slow the progression of liver cirrhosis and reduce the incidence of liver cancer, but there are no curative therapies available. |
Second Quarter 2021 Financial Highlights
| • | Research and development expenses were $25.7 million for the quarter ended June 30, 2021, compared to $8.9 million for the quarter ended June 30, 2020. 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. |
| • | The general and administrative expense was $12.0 million for the quarter ended June 30, 2021, compared to $3.3 million for the quarter ended June 30, 2020. The increase year-over-year was primarily attributable to increased headcount and professional fees for legal and accounting associated with operating as a public company. |
| • | Stock-based compensation expense was $9.7 million and $0.5 million for the quarters ended June 30, 2021, and 2020, respectively. |
| • | As of June 30, 2021, AlloVir had cash, cash equivalents, and marketable securities of $313.3 million, which compares to cash, cash equivalents, and marketable securities of $356.3 million as of December 31, 2020. |
| • | For the quarter ended June 30, 2021, the net loss was $37.6 million or $0.60 per share compared to a net loss of $11.6 million or $4.43 per share for the quarter ended June 30, 2020. |
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 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 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.
ALLOVlR, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
| June 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Assets |
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| Current assets: |
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| Cash, cash equivalents and short-term investments |
$ | 313,337 | $ | 356,324 | ||||
| Other current assets |
2,708 | 4,993 | ||||||
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| Total current assets |
316,045 | 361,317 | ||||||
| Other assets |
11,466 | 9,504 | ||||||
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| Total assets |
$ | 327,511 | $ | 370,821 | ||||
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| Liabilities and stockholders’ equity |
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| Current liabilities |
$ | 20,708 | $ | 12,294 | ||||
| Long-term liabilities |
4,334 | 5,463 | ||||||
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| Total liabilities |
25,042 | 17,757 | ||||||
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| Total stockholders’ equity |
302,469 | 353,064 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 327,511 | $ | 370,821 | ||||
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ALLOVIR, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except share and per share data)
| Three Months Ended June 30, |
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| 2021 | 2020 | |||||||
| Operating expenses: |
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| Research and development |
25,677 | 8,885 | ||||||
| General and administrative |
11,978 | 3,268 | ||||||
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| Total operating expenses |
37,655 | 12,153 | ||||||
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| Loss from operations |
(37,655 | ) | (12,153 | ) | ||||
| Total other income (loss), net: |
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| Interest income |
475 | 166 | ||||||
| Other income (loss), net |
(408 | ) | 355 | |||||
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| Net loss |
$ | (37,588 | ) | $ | (11,632 | ) | ||
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| Net loss per share—basic and diluted |
$ | (0.60 | ) | $ | (4.43 | ) | ||
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| Weighted-average common shares outstanding—basic and diluted |
62,344,718 | 2,625,648 | ||||||
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Media contact:
Courtney Heath
ScientPR
AlloVirPR@scientpr.com
617-872-2462
Investor contact:
Medha Chadha
AlloVir
ir@allovir.com