ALVR AlloVir Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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Viralym-M (ALVR105)
Multi-virus prevention trial
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Phase 2
Phase 2
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ALVR109
COVID-19
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Phase 1/2
Phase 1/2
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Viralym-M (ALVR105)
BK virus
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Phase 2
Phase 2
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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Viralym-M (ALVR105)
Cytomegalovirus (CMV)
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Phase 2
Phase 2
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Phase 2 trial to be initiated 2H 2021.
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Viralym-M (ALVR105)
Aleution disease virus (ADV)
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Phase 2
Phase 2
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Phase 2 trial to be initiated 2H 2021.
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ALVR106
RSV, influenza
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Phase 1
Phase 1
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Phase 1 trial to commence 2H 2021.
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Viralym-M (ALVR105)
Virus-associated hemorrhagic cystitis
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Phase 3
Phase 3
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Phase 3 trial has been initiated.
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Latest News
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- Viralym-M pivotal trial in virus-associated hemorrhagic cystitis continues to progress enrollment
- Viralym-M proof-of-concept studies in multi-virus prevention in stem cell transplant and BK viremia in kidney transplant continue to progress with initial data expected 4Q21
- Additional Viralym-M pivotal and proof-of-concept clinical trials expected to initiate in 2H21
- ALVR109 proof-of-concept study in high-risk COVID-19 patients progressing, initial data expected in 4Q21
- ALVR106 IND cleared with proof-of-concept study in RSV, influenza, human metapneumovirus, and parainfluenza expected to initiate in 2H21
- Dr. Diana Brainard's transition from independent director to CEO has commenced with an official start date of May 17; David Hallal to continue to serve as Executive Chairman of the Board
AlloVir (NASDAQ:ALVR), a late clinical-stage cell therapy company, today reported financial results for the first quarter ended March 31, 2021.
"The first quarter of 2021 was one of significant progress for AlloVir and moved us closer towards our ambition to transform the lives of patients suffering from devastating and life-threatening viral diseases," said David Hallal, Chief Executive Officer and Chairman of the Board, AlloVir. "The appointment of Dr. Diana Brainard as our new CEO brings an unparalleled track record of success in building strong, durable global virology franchises, that have impacted the world, and I look forward to working with Diana and the team in my new role as Executive Chairman of the Board."
Dr. Diana Brainard, AlloVir's newly named Chief Executive Officer, continued by saying, "With a world-renowned team of scientists, clinical and regulatory experts, and company operators, AlloVir has quickly advanced to become a leader in the development of innovative cell therapies. The remainder of 2021 will be an exciting time of growth for the company, which is on track to have initial data readouts from three clinical trials and initiate up to four more this year. Together with the Board, the executive team and all of AlloVir's high-performing employees, I look forward to advancing our impressive pipeline of mid- and late-stage clinical trials with a commitment to bringing innovative therapies to patients in need around the globe."
Business Updates and Upcoming Milestones
First Quarter Business and Scientific Updates
- Announced appointment of Dr. Diana Brainard as Chief Executive Officer, effective May 17, 2021. 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.
- The World Health Organization (WHO) approved posoleucel as the recommended international nonproprietary name for Viralym-M (ALVR105).
- Data were presented in an oral presentation at the 2021 Transplantation & Cellular Therapy Meeting Digital Experience from the Phase 2 proof-of-concept (POC) CHARMS study. The subgroup analysis found that treatment with Viralym-M for virus-associated hemorrhagic cystitis (HC) in the post allogeneic hematopoietic stem cell transplant (allo-HSCT) setting was generally safe and well-tolerated and associated with rapid resolution of macroscopic hematuria.
- Real-world data demonstrating the economic and clinical burden associated with viral infections and diseases following allo-HSCT in pediatric and adult patients were presented at the 2021 Transplantation & Cellular Therapy Meeting Digital Experience, and a publication summarizing the burden of virus-associated HC following allo-HSCT was published online in the journal Transplantation and Cellular Therapy.
Viralym-M for HSCT Recipients
- The Phase 3 multicenter, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of Viralym-M for the treatment of virus-associated HC in pediatric and adult patients following allo-HSCT, is ongoing. Virus-associated HC, a common manifestation after HSCT, is a devastating disease with no approved or effective treatment options.
- 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 is ongoing, and initial data from the open-label phase of the trial are expected in the fourth quarter of 2021. The trial is targeting the prevention of clinically significant BK virus (BKV), cytomegalovirus (CMV), adenovirus (AdV), Epstein-Barr virus (EBV), human herpesvirus 6 (HHV-6), or JC virus (JCV) infections.
- Two additional pivotal clinical trials are expected to initiate in the second half of 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.
Viralym-M for Solid Organ Transplant (SOT) Recipients
- The Phase 2 POC trial 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 can be a devastating complication for kidney transplant patients leading to decreased kidney survival and return to End-Stage Renal Disease and dialysis.
- A Phase 2 POC trial in CMV for SOT recipients is expected to initiate in the second half of 2021.
ALVR109 for COVID-19
- The POC clinical trial of ALVR109 – a virus-specific T-cell targeting SARS-CoV-2, the virus that causes the severe and life-threatening viral disease, COVID-19 – is ongoing with initial data expected in the fourth quarter of 2021.
ALVR106 for Multi-Respiratory Viruses
- In Q4 2020, the FDA cleared the IND application for 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).
- A POC clinical trial of ALVR106 in allogeneic and autologous HSCT recipients is expected to be initiated in the second half of 2021.
- 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 Programs
- The company is on track to complete preclinical and IND-enabling studies for both ALVR107 to treat hepatitis B virus and ALVR108 for the treatment of human herpesvirus-8 in the second half of 2021.
First Quarter 2021 Financial Highlights
- Research and development expenses were $20.4 million for the quarter ended March 31, 2021, compared to $6.8 million for the quarter ended March 31, 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 $10.5 million for the quarter ended March 31, 2021, compared to $3.0 million for the quarter ended March 31, 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 $8.1 million and $0.6 million for the quarter ended March 31, 2021, and 2020, respectively.
- As of March 31, 2021, AlloVir had cash, cash equivalents, and marketable securities of $337.0 million, which compares to cash, cash equivalents, and marketable securities of $356.3 million as of December 31, 2020.
- For the quarter ended March 31, 2021, net loss was $30.9 million or $0.50 per share compared to a net loss of $9.3 million or $4.21 per share for the quarter ended March 31, 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.
ALLOVIR, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited, in thousands) March 31,
December 31,
2021
2020
Assets Current assets: Cash, cash equivalents and short-term investments $ 336,992
$ 356,324
Other current assets 2,672
4,993
Total current assets 339,664
361,317
Other assets 11,617
9,504
Total assets $ 351,281
$ 370,821
Liabilities and stockholders' equity Current liabilities $ 15,500
$ 12,294
Long-term liabilities 5,412
5,463
Total liabilities 20,912
17,757
Total stockholders' equity 330,369
353,064
Total liabilities and stockholders' equity $ 351,281
$ 370,821
ALLOVIR, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited, in thousands, except share and per share data) Three Months Ended
March 31,2021
2020
Operating expenses: Research and development 20,393
6,839
General and administrative 10,470
3,001
Total operating expenses 30,863
9,840
Loss from operations (30,863)
(9,840)
Total other income (loss), net: Interest income 505
457
Other income (loss), net (565)
44
Net loss $ (30,923)
$ (9,339)
Net loss per share --- basic and diluted $ (0.50)
$ (4.21)
Weighted-average common shares outstanding---basic and diluted 62,193,734
2,215,958
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- 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.
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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.View source version on businesswire.com: https://www.businesswire.com/news/home/20210322005752/en/
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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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210217005078/en/
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AlloVir Research Presented at the 2021 Transplantation & Cellular Therapy Meeting Digital ExperienceView Full Article Hide Full Article
- 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210211005862/en/
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- 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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