KLRS

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2 d114296dex991.htm

EX-99.1

EX-99.1

Exhibit 99.1

Kalaris Reports Second Quarter 2026 Financial Results and Provides Business Updates

Patient dosing is ongoing in the Phase 1b/2 study of TH103; preliminary data anticipated in 1H 2027

Potential Phase 3 clinical trials remain on track for initiation by year-end 2027

$93.5 million in cash, cash equivalents and marketable securities as of June 30, 2026 is expected to fund operations into the fourth quarter of 2027 and through key clinical milestones

BERKELEY HEIGHTS, N.J., August 11, 2026 (GLOBE NEWSWIRE) - Kalaris Therapeutics, Inc. (Nasdaq: KLRS) (“Kalaris”), a clinical stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases, today announced financial results for the second quarter ended June 30, 2026 and provided business updates.

“We made significant advances over the second quarter,” said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics. “We successfully manufactured new batches of clinical material and are currently dosing patients in our Phase 1b/2 study of TH103 for neovascular Age-related Macular Degeneration. We recently released expanded Phase 1a data for TH103 which continues to strengthen our confidence in potential TH103 differentiation. The additional data is consistent with the initial structural, functional and pharmacokinetic findings and reinforces our belief that TH103 has the potential to offer a best-in-class treatment option for patients with neovascular AMD.”

Business Updates

•

Recently released Phase 1a data from expanded patient cohorts that reinforce the positive BCVA, OCT, pharmacokinetic and time-to-retreatment findings observed in the original patient cohorts.

•

New manufacturing batch completed including process enhancements that have further reduced already low levels of process impurities.

•

Kalaris is currently conducting a Phase 1b/2, multi-ascending dose, dose-finding study evaluating up to four monthly loading doses of TH103. The study aims to assess the safety and efficacy of repeat doses of TH103 at different dose levels and to identify the optimal dose and regimen for potential Phase 3 development. Preliminary data from the Phase 1b/2 study is expected in the first half of 2027.

•

As previously announced, Kalaris expanded its leadership team with the hire of Liisa Bayko as Chief Financial Officer. Ms. Bayko brings more than two decades of experience in biotechnology finance, strategy, and capital markets, most recently serving as Managing Director and Senior Biotechnology Analyst at Evercore ISI, where she was consistently recognized as one of the industry’s top-ranked analysts covering small- and mid-cap biotechnology companies.

•

As announced recently, Kalaris appointed Laurie Keating to its Board of Directors. Ms. Keating brings extensive experience as a biotechnology executive and board member to assist Kalaris in achieving its next phase of growth.

Financial Results for the Second Quarter Ended June 30, 2026

Cash, Cash Equivalents and Marketable Securities: As of June 30, 2026, Kalaris had cash, cash equivalents and marketable securities of $93.5 million, compared with cash, cash equivalents and marketable securities of $118.0 million as of December 31, 2025. The decrease in cash, cash equivalents and marketable securities was primarily a result of cash used in operating activities during the period. Kalaris expects that its cash, cash equivalents and marketable securities as of June 30, 2026 will be sufficient to fund its operations into the fourth quarter of 2027.

Research and Development Expenses: Research and development expenses were $9.0 million for the quarter ended June 30, 2026, compared with $8.4 million for the quarter ended June 30, 2025. The increase was primarily attributable to an increase in Contract Research Organization and other clinical expenses as Kalaris opened additional investigational sites and enrolled patients in its clinical program for TH103, offset by a decrease in expenses related to manufacturing and process development activities.

General and Administrative Expenses: General and administrative expenses were $3.4 million for the quarter ended June 30, 2026, compared with $3.8 million for the quarter ended June 30, 2025. The decrease was primarily attributable to decreased legal, accounting, and other professional fees.

Net Loss: For the quarter ended June 30, 2026, net loss was $11.5 million compared with a net loss of $11.4 million for the quarter ended June 30, 2025. The total number of shares of common stock outstanding as of June 30, 2026 was 23,804,981.

About TH103

TH103 is an investigational dual-targeting biologic with the potential to be best-in class for neovascular and exudative retinal diseases. TH103 was engineered by VEGF scientific discoverer Dr. Napoleone Ferrara to achieve extended intraocular retention with enhanced VEGF inhibition through optimized bi

EX-99.1

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EX-99.1

EX-99.1

Exhibit 99.1

Kalaris Reports First Quarter 2026 Financial Results and Provides Business Updates

Patient screening now underway in the Phase 1b/2 study with the latest drug product batch on track to be

available to support upcoming dosing; preliminary data anticipated in 1H 2027

Planned Phase 3 clinical trials remain on track for 2027 year-end initiation

$104.9 million in cash, cash equivalents and marketable securities as of March 31, 2026 is expected to fund

operations into the fourth quarter of 2027 and through key clinical milestones

BERKELEY HEIGHTS, N.J., May 12, 2026 (GLOBE NEWSWIRE)—Kalaris Therapeutics, Inc. (Nasdaq: KLRS) (“Kalaris”), a clinical stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases, today announced financial results for the first quarter ended March 31, 2026 and provided business updates.

“I am happy to report that new batches of clinical material have been manufactured and are undergoing packaging and labeling, and we are currently screening patients for dosing in our Phase 1b/2 study of TH103 for neovascular Age-related Macular Degeneration,” said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics. “Our Phase 1b/2 multiple ascending dose trial is designed to accelerate TH103’s clinical development and inform dose selection for potential future Phase 3 development, and we look forward to sharing data from this ongoing trial in the first half of 2027.”

Q1 2026—Business Updates

•

On February 26th, Dean Eliott, MD, presented previously shared positive initial Phase 1a data at the 49th Annual Meeting of the Macula Society.

•

New manufacturing batch completed including process enhancements that have further reduced already low levels of process impurities.

•

Kalaris is currently conducting a Phase 1b/2, multi-ascending dose, dose-finding study evaluating four monthly loading doses of TH103. The study aims to assess the safety and efficacy of repeat doses of TH103 at different dose levels and to identify the optimal dose and regimen for potential Phase 3 development.

•

Preliminary data from the Phase 1b/2 study is expected in the first half of 2027.

Financial Results for the First Quarter Ended March 31, 2026

Cash, Cash Equivalents and Marketable Securities: As of March 31, 2026, Kalaris had cash, cash equivalents and marketable securities of $104.9 million, compared with cash and cash equivalents of $118.0 million as of December 31, 2025. The decrease in cash, cash equivalents and marketable securities was primarily a result of cash used in operating activities during the period. Kalaris expects that its cash, cash equivalents and marketable securities as of March 31, 2026 will be sufficient to fund its operations into the fourth quarter of 2027.

Research and Development Expenses: Research and development expenses were $7.6 million for the quarter ended March 31, 2026, compared with $6.0 million for the quarter ended March 31, 2025. The increase was primarily attributable to an increase in CRO and other clinical expenses as Kalaris opened additional investigational sites and enrolled patients in our clinical program.

General and Administrative Expenses: General and administrative expenses were $4.3 million for the quarter ended March 31, 2026, compared with $4.3 million for the quarter ended March 31, 2025.

Net Loss: For the quarter ended March 31, 2026, net loss was $10.9 million compared with a net loss of $10.2 million for the quarter ended March 31, 2025. The total number of shares of common stock outstanding as of March 31, 2025 was 22,992,291.

About Kalaris

Kalaris Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases. Founded by renowned scientist Dr. Napoleone Ferrara, whose pioneering research led to the development of anti-VEGF therapy, the company is committed to advancing novel therapeutic approaches for patients with sight-threatening retinal conditions with major unmet medical needs.

For more information, visit www.kalaristx.com.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risk and uncertainties. All statements, other than statements of historical fact, contained in this press release, including statements regarding the strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management of Kalaris; the therapeutic potential of TH103 for neovascular Age-related Macular Degeneration and other exudative and neovascular retinal diseases; the anticipated timeline for reporting data from the ongoing Phase 1b/2 clinical trial of TH103 and initiating Phase 3 clinical

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EX-99.1

Exhibit 99.1

Kalaris Reports Full Year 2025 Financial Results and Provides Business Updates

Positive initial data reported from Phase 1a Single Ascending Dose study in nAMD in December 2025;

preliminary data from ongoing Phase 1b/2 study expected in 1H 2027

Intend to initiate Phase 3 clinical trials by year-end 2027

Completed oversubscribed $50.0 million private placement in December 2025

$118.0 million in cash, cash equivalents and marketable securities as of December 31, 2025 is expected to

fund operations into the fourth quarter of 2027 and through key clinical milestones

BERKELEY HEIGHTS, N.J., March 17, 2026 (GLOBE NEWSWIRE) - Kalaris Therapeutics, Inc. (Nasdaq: KLRS) (“Kalaris”), a clinical stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases, today announced financial results for the full year ended December 31, 2025 and provided business updates.

“This past year was truly transformational for Kalaris,” said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics. “Following our initial listing as a public company in March 2025, we continued to advance our clinical program for TH103 throughout the year, culminating with the disclosure of positive initial Phase 1a single ascending dose data and concurrent oversubscribed private placement. In Q3 2025, we began to enroll patients in our Phase 1b/2 multiple ascending dose trial which is designed to accelerate TH103’s clinical development and inform dose selection for potential future Phase 3 development.”

Q4 2025 - Business Updates

•

Positive initial Phase 1a data reported in December 2025. The Phase 1a study evaluated a single intravitreal injection of TH103 at three dose levels (0.5 mg, 1.5 mg, 2.5 mg) in treatment-naïve nAMD patients. Thirteen patients completed 6 months of follow-up. Results demonstrated clinical activity on visual acuity and retinal anatomy, as well as pharmacokinetic data that support TH103’s molecular design and preclinical profile, including:

•

Mean 10-letter best corrected visual acuity (BCVA) improvement

•

Mean 129µm improvement in central subfield thickness (CST)

•

Mean ~95% reduction in central subfield intraretinal fluid

•

27 to 51-fold lower mean plasma Cmax than current leading approved anti-VEGF agents

TH103 was generally well-tolerated and that data supported further dose escalation. No dose-limiting toxicities or treatment-related serious adverse events were observed in the Phase 1a study.

TH103’s initial pharmacokinetic profile aligns with the molecule’s engineered properties and preclinical data demonstrating prolonged intraocular residence time.

•

Based on the positive Phase 1a data, Kalaris is currently conducting a Phase 1b/2, multi-ascending dose, dose-finding study evaluating four monthly loading doses of TH103. The study aims to assess the safety and efficacy of repeat doses of TH103 at different dose levels and to identify the optimal dose and regimen for potential Phase 3 development. Preliminary data from the Phase 1b/2 study is expected in the first half of 2027.

•

As announced in December 2025, Kalaris completed a private placement for aggregate gross proceeds of $50.0 million.

Financial Results for the Year Ended December 31, 2025

Cash, Cash Equivalents and Marketable Securities: As of December 31, 2025, Kalaris had cash, cash equivalents and marketable securities of $118.0 million, compared with cash and cash equivalents of $1.6 million as of December 31, 2024. The increase in cash, cash equivalents and marketable securities was primarily a result of the completion of its merger with AlloVir in March 2025 and the closing of its private placement in December 2025. Kalaris expects that its cash, cash equivalents and marketable securities as of December 31, 2025 will be sufficient to fund its operations into the fourth quarter of 2027.

Research and Development Expenses: Research and development expenses were $30.8 million for the year ended December 31, 2025, compared with $45.0 million for the year ended December 31, 2024. The decrease was primarily attributable to a $32.0 million royalty obligation expense for a Royalty agreement that Kalaris entered into with Samsara BioCapital, LP in July 2024, offset by an increase in costs related to the outsourcing of manufacturing and clinical-related costs to support the Phase 1a and Phase 1b/2 clinical trials.

General and Administrative Expenses: General and administrative expenses were $15.4 million for the year ended December 31, 2025, compared with $6.7 million for the year ended December 31, 2024. The increase was primarily attributable to an increase in insurance, legal, accounting, and other professional fees and personnel related costs to support operating as a public company.

Net Loss: For the year ended December 31, 2025, net loss was $43.4 million compared with a net loss of $69.2 million for the ye

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EX-99.1

Exhibit 99.1

Kalaris Reports Third Quarter 2025 Financial Results and Provides Business Updates

Phase 1a Single Ascending Dose trial remains on track for initial clinical data to be reported by year end 2025

Phase 1b/2 Multiple Ascending Dose trial currently enrolling, intended to inform dose selection for potential Phase 3 development program; initial clinical data expected in 2H 2026

Recent significant corporate milestones include the selection of a CDMO, CFO hire, and opening of corporate headquarters

Cash, cash equivalents and short-term investments of $77.0M as of September 30, 2025, expected to fund operations into 2027

Kalaris is currently evaluating TH103, a dual-targeting biologic designed to achieve superior VEGF inhibition and extended intraocular durability through optimized binding to VEGF receptor 1 ligands and concurrent heparan sulfate proteoglycan (HSPG) anchoring

BERKELEY HEIGHTS, N.J., November 12, 2025 (GLOBE NEWSWIRE) - Kalaris Therapeutics, Inc. (Nasdaq: KLRS) (“Kalaris”), a clinical-stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases, today announced financial results for the third quarter ended September 30, 2025, and provided business updates.

“The third quarter marked an important inflection point for Kalaris,” said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics. “Most importantly, we began enrolling our Phase 1b/2 multiple ascending dose trial of TH103 in neovascular age-related Macular Degeneration (nAMD). This Phase 1b/2 trial is designed to build on our ongoing Phase 1a single ascending dose trial; we look forward to reporting initial clinical data from our Phase 1a trial by the end of this year, including safety, preliminary efficacy (e.g., visual acuity and lesion morphology), and pharmacokinetics.”

In addition to progressing TH103’s clinical development program, Kalaris also entered a formal agreement with KBI Biopharma for clinical supply manufacturing. Mr. Oxtoby stated, “Working with KBI is an important step as we progress into a later stage biotech company. Our decision to work with KBI reflects their deep technical expertise to support continued development of TH103.” Katie Edgar, Chief Business Officer of KBI Biopharma, said, “We look forward to applying our scientific and regulatory acumen to helping progress Kalaris’ exciting product candidate. Our agreement with Kalaris reflects our shared commitment to patient impact.”

Business Updates

•

Initial clinical data from the Phase 1a clinical trial expected by year end 2025. The single ascending dose trial followed patients after a single injection of TH103 to assess the safety, pharmacokinetics, and preliminary treatment effect of TH103 in treatment naïve nAMD patients.

•

Newly initiated Phase 1b/2 dose-finding clinical trial is designed to evaluate multiple dose levels of TH103 in up to 80 nAMD patients. Patients are expected to receive 4 initial monthly intravitreal injections of TH103. Study assessments are expected to include safety and preliminary efficacy with a primary time point for analysis at one-month following the last injection with patients followed thereafter in an extension phase.

•

KBI Biopharma, based in North Carolina, selected as Kalaris’ Contract Development and Manufacturing Organization (CDMO) for clinical supply manufacturing of TH103.

•

As previously announced, Kalaris expanded its leadership team with the hire of Matthew Gall, Chief Financial Officer. Mr. Gall has over 20 years of corporate finance experience, including business development transactions and financial operations and strategy for both small and large biopharmaceutical companies.

•

New corporate headquarters opened in Berkeley Heights, New Jersey.

Financial Results for the Third Quarter Ended September 30, 2025

Cash, Cash Equivalents and Short-Term Investments: As of September 30, 2025, Kalaris had cash, cash equivalents and short-term investments of $77.0 million, compared with cash and cash equivalents of $1.6 million as of December 31, 2024. The increase in cash and cash equivalents was primarily a result of the completion of its merger with AlloVir in Q1 2025. Kalaris expects that its cash, cash equivalents and short-term investments as of September 30, 2025 will be sufficient to fund its operations into 2027.

Research and Development Expenses: Research and development expenses were $9.1 million for the quarter ended September 30, 2025, compared with $36.0 million for the quarter ended September 30, 2024. The decrease quarter-over-quarter was primarily attributable to a $32.0 million royalty obligation expense for a Royalty agreement entered into with Samsara in July 2024, offset by an increase in costs related to the outsourcing of manufacturing and clinical-related costs to support the ongoing Phase 1a and the newly initiated Phase 1b/2 clinical trial.

General and Adm

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EX-99.1

EX-99.1

Exhibit 99.1

Kalaris Reports Second Quarter 2025 Financial Results and

Provides Business Updates

Continuing to enroll nAMD patients in a Phase 1 trial of TH103, a novel, differentiated anti-VEGF agent

engineered to potentially provide longer-lasting and increased anti-VEGF activity to treat neovascular and

exudative diseases of the retina; initial clinical data is expected in Q4 2025

Cash and cash equivalents of $88.4M as of June 30, 2025, expected to fund operations into Q4 2026

PALO ALTO, Calif., August 13, 2025 (GLOBE NEWSWIRE) - Kalaris Therapeutics, Inc. (Nasdaq: KLRS) (“Kalaris”), a clinical-stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases, today announced financial results for the second quarter ended June 30, 2025, and provided a business update.

“We continued to enroll treatment-naïve nAMD patients in our open-label Phase 1 clinical trial of TH103 in the second quarter of 2025” said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics. “TH103 has exhibited differentiated anti-VEGF properties in multiple preclinical studies, and we believe it has the potential to improve efficacy and extend treatment duration compared to currently approved agents. We look forward to reporting initial clinical data later this year which will provide an initial read of safety and efficacy data of TH103 at multiple dose levels and help inform the next stage of our clinical development program.”

Business Updates

•

Kalaris is currently enrolling a Phase 1, single ascending dose trial to assess the safety, pharmacokinetics, and preliminary treatment effect of TH103 in neovascular Age-related Macular Degeneration (nAMD) patients. Initial clinical data is expected in the fourth quarter of 2025.

•

Kalaris recently expanded its leadership team with the hire of Kristine Curtiss, Senior Vice President of Clinical. Ms. Curtiss has over 25 years of clinical research and operations experience in ophthalmology-focused biotech companies, overseeing programs and building departments.

Financial Results for the Second Quarter Ended June 30, 2025

Cash and Cash Equivalents: As of June 30, 2025, Kalaris had cash and cash equivalents of $88.4 million, compared with cash and cash equivalents of $1.6 million as of December 31, 2024. The increase in cash and cash equivalents was primarily a result of the completion of its merger with AlloVir.

Research and Development Expenses: Research and development expenses were $8.4 million for the quarter ended June 30, 2025, compared with $3.2 million for the quarter ended June 30, 2024. The increase quarter-over-quarter was primarily attributable to an increase in costs related to the outsourcing of manufacturing and clinical-related costs as Kalaris initiated its Phase 1 clinical trial in June 2024.

General and Administrative Expenses: General and administrative expenses were $3.8 million for the quarter ended June 30, 2025, compared with $1.0 million for the quarter ended June 30, 2024. The increase quarter-over-quarter was primarily attributable to an increase in insurance, legal, accounting, and professional fees associated with operating as a public company.

Net Loss: For the quarter ended June 30, 2025, net loss was $11.4 million or $0.61 per share, compared with a net loss of $5.7 million or $4.26 per share for the quarter ended June 30, 2024. The total number of shares of common stock outstanding as of June 30, 2025 was 18,702,418.

About Kalaris

Kalaris is a clinical-stage

biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases. The company is focused on development of TH103, a novel, differentiated anti-VEGF investigational therapy. Developed by Dr. Napoleone Ferrara, TH103 is a fully humanized, recombinant fusion protein that acts against VEGF as a decoy receptor and has been specifically engineered for potentially improved VEGF inhibition and longer retention in the retina. TH103 is currently being evaluated in an ongoing, Phase 1 clinical trial for the treatment of neovascular Age-related Macular Degeneration (nAMD), with plans to develop TH103 for additional neovascular and exudative diseases of the retina such as Diabetic Macular Edema (DME), and Retinal Vein Occlusion (RVO).

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risk and uncertainties. All statements, other than statements of historical fact, contained in this press release, including statements regarding the strategy, future operations, prospects, plans and objectives of management of Kalaris, including the therapeutic potential of TH103, the anticipated timeline for reporting initial clinical data from

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EX-99.1

EX-99.1

Exhibit 99.1

Kalaris Reports First Quarter 2025 Financial Results and Provides Business Highlights

Actively enrolling nAMD patients in a Phase 1 trial of TH103, a novel, differentiated anti-VEGF agent engineered to potentially provide longer-lasting and increased anti-VEGF activity to treat neovascular and exudative diseases of the retina; initial clinical data is expected in Q4 2025

Cash and cash equivalents of $101M as of March 31, 2025, expected to fund operations into Q4 2026

PALO ALTO, Calif., May 14, 2025 (GLOBE NEWSWIRE) — Kalaris Therapeutics, Inc. (Nasdaq: KLRS) (“Kalaris”), a clinical-stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent diseases of the retina, today announced financial results for the first quarter ended March 31, 2025 and provided a business update.

“We are excited by our progress in 2025,” said Andrew Oxtoby, Chief Executive Officer of Kalaris. “We recently completed our merger with Allovir, and our Phase 1 trial investigating TH103 for nAMD is well underway. TH103 was engineered by VEGF pioneer, Napoleone Ferrara, MD, to address the limitations of current nAMD therapies and has demonstrated both potent anti-VEGF activity and sustained ocular residence time in preclinical studies. TH103 has the potential to provide longer-lasting and increased anti-VEGF activity to treat neovascular and exudative diseases of the retina. We look forward to reporting the initial clinical data from our Phase 1 trial in the fourth quarter of this year.”

Business Highlights

•

Kalaris is currently enrolling a Phase 1, single ascending dose trial to assess the safety, pharmacokinetics, and preliminary treatment effect of TH103 in nAMD patients. Initial clinical data is expected in the fourth quarter of 2025.

•

As previously announced, Kalaris completed its merger with AlloVir in March 2025.

•

As recently announced, Kalaris therapeutics had expanded its Board of Directors with the appointment of Leone Patterson as a director and Chair of the Audit Committee.

Financial Results for the First Quarter Ended March 31, 2025

Cash and Cash Equivalents: As of March 31, 2025, Kalaris had cash and cash equivalents of $101.0 million, compared with cash and cash equivalents of $1.6 million as of December 31, 2024. The increase in cash and cash equivalents was primarily a result of the completion of its merger with AlloVir.

Research and Development Expenses: Research and development expenses were $6.0 million for the quarter ended March 31, 2025, compared with $2.0 million for the quarter ended March 31, 2024. The increase quarter-over-quarter was primarily attributable to an increase in costs related to the outsourcing of manufacturing and clinical-related costs as Kalaris initiated its Phase 1 clinical trial in June 2024.

General and Administrative Expenses: General and administrative expenses were $4.3 million for the quarter ended March 31, 2025, compared with $0.6 million for the quarter ended March 31, 2024. The increase quarter-over-quarter was primarily attributable to a one-time charge for AlloVir’s directors and officers’ liability insurance and an increase in legal, accounting, and professional fees associated with operating as a public company.

Net Loss: For the quarter ended March 31, 2025, net loss was $10.2 million or $2.52 per share, compared with a net loss of $3.4 million or $2.60 per share for the quarter ended March 31, 2024. The total number of shares of common stock outstanding as of March 31, 2025 was 18,702,418.

About Kalaris

Kalaris is a clinical-stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases. The company is focused on development of TH103, a novel, differentiated anti-VEGF investigational therapy. Developed by Dr. Napoleone Ferrara, TH103 is a fully humanized, recombinant fusion protein that acts against VEGF as a decoy receptor and has been specifically engineered for potentially improved VEGF inhibition and longer retention in the retina. TH103 is currently being evaluated in an ongoing, Phase 1 clinical trial for the treatment of neovascular Age-related Macular Degeneration (nAMD), with plans to develop TH103 for additional neovascular and exudative diseases of the retina such as Diabetic Macular Edema (DME), and Retinal Vein Occlusion (RVO).

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risk and uncertainties. All statements, other than statements of historical fact, contained in this press release, including statements regarding the strategy, future operations, prospects, plans and objectives of management of Kalaris, including the therapeutic potential of TH103, the anticipate

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EX-99.1

Exhibit 99.1

Kalaris Announces Closing of Merger with AlloVir

Kalaris is focused on developing TH103, a novel, differentiated anti-VEGF agent engineered

to potentially provide longer-lasting and increased anti-VEGF activity to treat neovascular

and exudative diseases of the retina

Currently enrolling nAMD patients in a Phase 1 trial, with initial data from Part 1 of the trial

expected in the second half of 2025

Post-transaction cash of approximately $100 million expected to fund

operations into the fourth quarter of 2026

Shares expected to trade on Nasdaq under “KLRS”, effective March 19, 2025

PALO ALTO, Calif., March 18, 2025 (GLOBE NEWSWIRE) — Kalaris Therapeutics, Inc. (Nasdaq: KLRS)(“Kalaris”), a clinical-stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent diseases of the retina, today announced the completion of its previously announced merger with AlloVir, Inc. (“AlloVir”). The combined company will operate under the name Kalaris Therapeutics, Inc. and its shares are expected to begin trading on The Nasdaq Global Market on March 19, 2025 under the ticker symbol “KLRS.”

Kalaris is currently developing TH103, a novel, differentiated anti-vascular endothelial growth factor (“VEGF”) agent engineered to potentially provide longer-lasting and increased anti-VEGF activity to treat neovascular and exudative diseases of the retina. TH103 was specifically engineered to address the limitations of current neovascular Age-related Macular Degeneration (“nAMD”) therapies and has demonstrated both potent anti-VEGF activity and sustained ocular residence time in preclinical studies. Kalaris expects to report initial data from Part 1 of its ongoing Phase 1 clinical trial of TH103 in the second half of 2025.

The combined company’s cash and cash equivalents of approximately $100 million as of the closing date is expected to be sufficient to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2026. “We are delighted to close this transaction, which we expect will provide us with the financial resources to continue development of TH103 beyond the initiation of our planned Phase 2 clinical trial”, said Andrew Oxtoby, CEO of Kalaris Therapeutics.

About TH103 Phase 1 Clinical Trial

The ongoing Phase 1 open label clinical trial is evaluating TH103 in treatment-naïve nAMD patients. Enrollment in Part 1 of the trial began in August 2024, with initial data expected in the second half of 2025. The Phase 1 clinical trial is designed to evaluate safety, pharmacodynamics/pharmacokinetics, determine optimal dose, and assess preliminary evidence of treatment effect.

Transaction Details

Immediately following the closing of the merger, there are approximately 18,702,413 shares of the combined company’s common stock outstanding, with pre-merger Kalaris stockholders owning approximately 74.47% and pre-merger AlloVir stockholders owning approximately 25.53% of the combined company’s outstanding common stock on a fully-diluted basis. The combined company will be led by Andrew Oxtoby, CEO of Kalaris, and other members of the Kalaris management.

Leerink Partners acted as exclusive financial advisor to AlloVir, and Goodwin Procter LLP served as legal counsel to AlloVir. Wilmer Cutler Pickering Hale and Dorr LLP is serving as legal counsel to Kalaris.

About Kalaris

Kalaris is a clinical-stage

biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases. The company is focused on development of TH103, a novel, differentiated anti-VEGF investigational therapy. Developed by Dr. Napoleone Ferrara, TH103 is a fully humanized, recombinant fusion protein that acts against VEGF as a decoy receptor and has been specifically engineered for potentially improved VEGF inhibition and longer retention in the retina. TH103 is currently being evaluated in an ongoing, Phase 1 clinical trial for the treatment of neovascular Age-related Macular Degeneration (nAMD), with plans to develop TH103 for additional neovascular and exudative diseases of the retina such as Diabetic Macular Edema (DME), and Retinal Vein Occlusion (RVO).

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risk and uncertainties.

All statements, other than statements of historical fact, contained in this press release, including statements regarding the strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management of Kalaris, including those relating to the merger, the therapeutic potential of TH103, the anticipated timeline for

reporting data from the ongoing Phase 1 clinical trial of TH103 and the sufficiency

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EX-99.1

EX-99.1

Exhibit 99.1

AlloVir Reports Third Quarter 2023 Financial Results

—Posoleucel, a highly innovative off-the-shelf, multi-virus-specific investigational T cell therapy, continues to advance in three distinct, Phase 3, first-to-market indications in immunocompromised patients

—Enrollment in posoleucel pivotal Phase 3 multi-virus prevention, virus-associated hemorrhagic cystitis and adenovirus studies all progressing with topline data for all three studies anticipated in the second half of 2024

—Progressing global commercial launch planning for posoleucel across all indications

—As of September 30, 2023, AlloVir had cash, cash equivalents, and short-term investments of $213.3 million providing runway through all pivotal trial data readouts

Waltham, Mass – November 2, 2023 – AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage allogeneic T cell immunotherapy company, today reported financial results from the third quarter ended September 30, 2023. AlloVir continues to progress its highly innovative lead therapeutic candidate, posoleucel, by enrolling globally in three Phase 3 trials for first-to-market indications. AlloVir is in a position of strength with significant financial resources to support operations through topline data readouts for all three trials anticipated in the second half of 2024.

“At AlloVir, we are dedicated to serving immunocompromised patients suffering from devastating and life-threatening viral diseases,” said Diana Brainard, M.D., Chief Executive Officer, AlloVir. “We are working with urgency to complete enrollment in our three global Phase 3 pivotal trials of posoleucel to deliver this potentially transformative therapy to patients that can benefit from the prevention and treatment of viral diseases with limited to no approved or effective therapies today. We expect a catalyst rich next 12 months with clinical and regulatory milestones and continued commercial preparations in advance of a potential 2025 launch.”

Recent and Upcoming Highlights/Activities

•

The company’s Phase 3 registrational trials of posoleucel in allo-HCT patients continue to enroll with data anticipated from all three trials in the second half of 2024.

•

The company presented results from a Phase 2 randomized, placebo-controlled trial evaluating posoleucel for the treatment of BKV in adult kidney transplant recipients at the European Society for Organ Transplantation (ESOT) Congress 2023 in September.

•

The company continues to work with regulatory agencies to gain alignment on a Phase 3 clinical study design to evaluate posoleucel’s treatment of BKV infection in kidney transplant patients.

•

The company completed enrollment in Part A of the Phase 1b/2a clinical trial of ALVR106, a multi-respiratory virus-specific T cell therapy targeting human metapneumovirus, influenza, parainfluenza, and respiratory syncytial virus (RSV) in allo-HCT and solid organ transplant patients. Data will be shared at a future scientific congress.

Third Quarter Financial Results

•

Research and development expenses were $34.2 million for the quarter ended September 30, 2023, compared with $30.0 million for the quarter ended September 30, 2022. The increase year-over-year was primarily attributable to an increase in costs related to the development of the company’s lead product candidate, posoleucel.

•

General and administrative expenses were consistent at $12.8 million for the quarter ended September 30, 2023, compared with $12.9 million for the quarter ended September 30, 2022.

•

Stock-based compensation expenses were $10.5 million and $10.9 million for the quarter ended

September 30, 2023, and 2022, respectively.

•

As of September 30, 2023, AlloVir had cash, cash equivalents, and short-term investments of $213.3 million, compared with cash, cash equivalents, and short-term investments of $233.8 million as of December 31, 2022.

•

For the quarter ended September 30, 2023, net loss was $44.3 million or $0.39 per share compared with a net loss of $42.1 million or $0.50 per share for the quarter ended September 30, 2022.

2023 Financial Guidance

•

For fiscal year 2023, AlloVir expects operating expenses to be in the range of $150 million to $170 million, excluding non-cash expenses.

About Posoleucel

AlloVir’s lead product, posoleucel, is in late-stage clinical development as an allogeneic, off-the-shelf, multi-virus-specific T cell therapy targeting six viral pathogens in immunocompromised individuals: adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpesvirus-6 (HHV-6) and JC virus (JCV). In a Phase 2 open-label study of posoleucel for the prevention of clinically significant infections due to the six viruses posoleucel targets, 88% of allo-HCT patients who received posoleucel remained free of clinically significant infections through week 14, the primary endpoint. Moreover, the non-relapse mortality rate in patients who receiv

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EX-99.1

EX-99.1

Exhibit 99.1

AlloVir Reports Second Quarter 2023 Financial Results

Company’s three Phase 3 global registrational trials for its allogeneic, off-the-shelf, virus-specific T cell therapy, posoleucel, in three distinct, first-to-market indications in allo-HCT patients continue to enroll, with data anticipated in second half of 2024

Positive data from the Phase 2 trial of posoleucel for treatment of BK viremia in kidney transplant recipients presented orally at late-breaking session at the American Transplant Congress (ATC 2023)

ALVR106, a multi-respiratory virus-specific T cell therapy targeting human metapneumovirus, influenza, parainfluenza, and respiratory syncytial virus, completed enrollment in the dose-escalation (Part A) portion of the Phase 1b/2a clinical trial in HCT and solid organ transplant patients

Recent stock offering extends cash runway through Phase 3 data readouts and into 2025

Waltham, Mass – August 3, 2023 – AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage allogeneic T cell immunotherapy company, today reported financial results from the second quarter ended June 30, 2023. The company shared progress across its allogeneic, off-the-shelf virus-specific T cell (VST) programs, including its lead investigational therapy, posoleucel, for prevention and treatment of life-threatening infections and diseases from up to six viruses that commonly impact patients following allogeneic hematopoietic cell transplant (allo-HCT), and for the treatment of BK viremia (BKV) in adult kidney transplant recipients.

“We are excited to be advancing our company’s three Phase 3 global registrational trials of posoleucel for three indications that threaten allo-HCT recipients. Treating and preventing life-threatening viral infections using T cells that focus on restoring natural immunity addresses a significant unmet need for allo-HCT patients, which could have a significant impact on patient outcomes, morbidity, and survival,” said Diana Brainard, M.D., Chief Executive Officer, AlloVir. “We are very pleased with our progress to date and are on track to report data from all three studies in the second half of 2024.”

Recent Highlights

•

In May 2023, the company announced the appointment of Cintia Piccina, PharmD, MBA, as Chief Commercial Officer. Ms. Piccina is an industry veteran with cell therapy expertise and more than 25 years of global commercial leadership experience. She is driving AlloVir’s global commercialization strategy, with a focus on its lead product, posoleucel. She is also responsible for building a commercial team in anticipation of a potential 2025 launch.

•

AlloVir delivered an oral presentation at the 49th annual meeting of the European Society for Blood and Marrow Transplantation (EBMT 2023) detailing positive results from the Phase 2 study of posoleucel for the prevention of clinically significant infections from six common and devastating viruses in allo-HCT recipients, including 0% non-relapse mortality at the 52-week follow-up visit.

•

The company presented final results from a Phase 2 randomized, placebo-controlled trial evaluating posoleucel for the treatment of BKV in adult kidney transplant recipients at the American Transplant Congress (ATC 2023) in June 2023. Findings demonstrated that treatment with posoleucel was safe, well tolerated and produced clinically meaningful reductions in BK viral load as compared to placebo with the greatest antiviral activity seen among patients with higher viral loads and those who received more frequent posoleucel dosing. The company is preparing to meet with the FDA to gain alignment on a Phase 3 clinical study design to evaluate posoleucel’s treatment of BKV infection in kidney transplant patients.

•

In June 2023, the company closed a public offering of common stock with gross proceeds of approximately $75.0 million before deducting underwriting discounts and commissions and other estimated offering expenses. The company anticipates that its cash position will fund operations into 2025, through anticipated data readouts from the posoleucel Phase 3 trials.

•

The company completed enrollment in Part A of the Phase 1b/2a clinical trial of ALVR106, a multi-respiratory virus-specific T cell therapy targeting human metapneumovirus, influenza, parainfluenza, and respiratory syncytial virus (RSV) in allo-HCT and solid organ transplant patients. Data from this dose-escalation portion of the clinical trial will be submitted for presentation at a future scientific congress.

Upcoming Highlights/Activities

•

Data from three Phase 3 registrational trials of posoleucel in three indications for allo-HCT patients is anticipated in the second half of 2024:

•

The prevention of clinically significant infection or disease from adenovirus (AdV), BKV, cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpesvirus-6 (HHV-6) and JC virus (JCV)

•

The treatment of virus-associated hemorrhagic cystitis

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EX-99.1

EX-99.1

Exhibit 99.1

AlloVir Reports First Quarter 2023 Financial Results

Company’s three posoleucel Phase 3 global registrational trials for three distinct, first-to-market

indications continue to enroll with data readouts on track for 2024

Positive results from a randomized, double-blind, placebo-controlled Phase 2 study of posoleucel in

kidney transplant recipients with BK viremia will be presented at the American Transplant Congress 2023 later this quarter

WALTHAM, MA – May 4, 2023 – AlloVir (Nasdaq: ALVR), a late-clinical stage allogeneic T cell immunotherapy company, today reported financial results from the first quarter ended March 31, 2023. The company shared progress across its allogeneic, off-the-shelf-virus specific T cell (VST) programs, including its lead investigational therapy, posoleucel, for prevention and treatment of life-threatening infections and diseases from up to six viruses that commonly impact patients following allogeneic hematopoietic cell transplant (allo-HCT), and for the treatment of BK viremia (BKV) in adult kidney transplant recipients.

“We continue to focus our efforts on rapidly advancing the three global Phase 3 ongoing registrational trials evaluating our lead investigational product, posoleucel, for the prevention and treatment of common, yet devastating, and potentially life-threatening viral infections and diseases in allo-HCT patients where significant unmet need persists,” said Diana Brainard, MD, Chief Executive Officer, AlloVir. “In tandem, we reported final positive results from the Phase 2 study of posoleucel for the treatment of BKV, the first demonstration of its safety and antiviral effect in solid organ transplant recipients. We continue to be encouraged by the potential of posoleucel as a transformative therapeutic for transplant patients.”

Recent Highlights

•

In January 2023, the company announced plans to report data from its three Phase 3 registrational studies for posoleucel in 2024 across three distinct indications – the prevention of clinically significant infection or disease from adenovirus (AdV), BK virus, 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 or treatment options, threatening patient survival.

•

In February 2023, the company announced positive final results from a Phase 2 study of posoleucel being evaluated for the treatment of BKV in adult kidney transplant recipients, the first demonstration of posoleucel in solid organ transplant patients. Data demonstrate the safety profile of posoleucel and its antiviral activity, which is amplified in high viral load patients who have the greatest unmet need, suggesting it could potentially offer a transformative treatment option for kidney transplant patients with BKV.

•

Positive long-term follow-up data from the Phase 2 trial exploring the

potential of posoleucel for the prevention of clinically significant infections were presented at the 49th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT 2023) in April 2023. These new findings demonstrate that the high-risk allo-HCT patients who received posoleucel experienced continued low rates of clinically significant infections or end-organ disease and 0% non-relapse mortality. Data continue to substantiate the potential clinical benefit posoleucel could provide to high-risk allo-HCT patients.

•

In February 2023, a case report of the treatment of refractory AdV infection in a CAR-T recipient with posoleucel was presented at the 2023 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMR (Poster 453). Findings demonstrate that posoleucel appeared to be safe and effective against devastating viral infections in patients receiving lymphodepletion chemotherapy and CAR-T therapy.

•

The company announced the appointment of Derek Adams, PhD, a leading authority in biologic and gene therapies manufacturing, to its Board of Directors.

Upcoming Highlights/Activities

•

The company plans to present comprehensive results from the BKV Phase 2 study as a late-breaking oral

presentation at the American Transplant Congress (ATC) 2023 and will work with regulatory authorities and transplant specialists to inform next steps for this program as well as AlloVir’s broader solid organ transplant strategy.

First Quarter Financial Highlights

•

Research and development expenses were $30.7 million for the quarter ended March 31, 2023, compared with $29.1 million for the quarter ended March 31, 2022. The increase year-over-year was primarily attributable to an increase in costs related to the development of the company’s lead product candidate, posoleucel.

•

General and administrative expenses were $12.5 million for th

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EX-99.1

EX-99.1

Exhibit 99.1

AlloVir Reports Full-Year 2022 Financial Results and 2023 Outlook

Completion of enrollment of all three posoleucel Phase 3 registrational trials for three distinct, first-to-market indications anticipated by end of 2023 and data readouts in 2024

Positive final results from randomized, double-blind, placebo-controlled Phase 2 study of posoleucel in kidney transplant recipients with BK viremia announced separately today; company to host investor webcast at 9:00 a.m. EST

Strong cash position, with $233.8 million as of year-end 2022

WALTHAM, Mass.—(BUSINESS WIRE)— Feb. 15, 2023 —AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage allogeneic T cell immunotherapy company, today reported full-year 2022 financial results for the period ended December 31, 2022. The company also highlighted its progress and provided the outlook for 2023 and into 2024 across its allogeneic, off-the-shelf, virus-specific T cell (VST) programs, including its lead investigational therapy, posoleucel, for the treatment and prevention of life-threatening infections and diseases caused by six viruses that commonly impact patients following allogeneic hematopoietic cell transplant (allo-HCT).

“With the acceleration of the posoleucel multi-virus prevention study and continued enrollment in the viral hemorrhagic cystitis and adenovirus treatment Phase 3 studies in 2022, the posoleucel franchise is positioned for potentially significant value creation over the next 12-24 months,” said Diana Brainard, M.D., Chief Executive Officer, AlloVir. “During 2023, we plan to complete enrollment in our Phase 3 registrational studies, which would enable data readouts in 2024 and, with positive results, regulatory filings and acceleration of commercial preparations to follow.”

Dr. Brainard continued, “Today we also announced positive final Phase 2 results from our first study of posoleucel in the solid organ transplant setting, showing balanced safety across the posoleucel and placebo groups and clinically meaningful greater viral load declines with posoleucel versus placebo in kidney transplant patients with BKV. These results are important proof of concept for the use of posoleucel in the solid organ transplant setting. We look forward to working with regulatory authorities and transplant specialists on our future clinical development plans for this patient population with high unmet medical need.”

Recent Highlights

•

In an oral presentation at the American Society of Hematology (ASH) Annual Meeting and Exposition in December 2022, final data were presented from the Phase 2 study evaluating posoleucel for the prevention of clinically significant infections or diseases from adenovirus, BK virus, cytomegalovirus, Epstein-Barr virus, human herpesvirus-6 and JC virus in allo-HCT patients. The data demonstrated a substantial reduction in the expected rate of clinically significant viral infections in this high-risk patient population despite the expected high rates of viral reactivation observed. Biomarker data showed the persistence of posoleucel and association between expansion of functional VSTs and viral control.

Page 2

•

Final topline data from the posoleucel Phase 2 BKV treatment study in kidney transplant patients were reported earlier today. Posoleucel was generally well tolerated in the study and demonstrated clinically meaningful antiviral efficacy consistenly across multiple BK viral load measures. The greatest effect was observed with biweekly posoleucel dosing in patients with screening viral load ≥10,000 copies/mL, who are at highest risk for BKV-associated graft loss.

•

In January 2023, final data from the CHARMS Phase 2 study of posoleucel for the treatment of viral infections in treatment-refractory allo-HCT patients were published in Clinical Cancer Research. The data demonstrated that 95% of patients with one or more treatment-refractory infections achieved a clinical response with posoleucel.

•

A compassionate use case report of posoleucel therapy for BKV nephropathy in a kidney transplant patient was presented in a poster at the annual meeting of the American Society of Nephrology in November 2022. Following posoleucel therapy, the patient experienced a significant reduction in BK viral load.

•

In November 2022, a manuscript was published in Haematologica describing the development and first clinical use of ALVR109 for the treatment of COVID-19. The data underscore the company’s ability to rapidly develop VSTs for emerging viral threats and the potential application of these VSTs for the treatment of respiratory viruses.

•

In the fourth quarter of 2022, the company established a scientific advisory board comprised of experts in cell therapies, stem cell and solid organ transplantation and infectious diseases. The standing group of advisors will provide insights and external perspective that will guide the advancement of the company’s science and pipeline.

•

A

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EX-99.1

EX-99.1

Exhibit 99.1

For Immediate Release

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 https://ir.allovir.com.

“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-

Posoleucel

Multi-Virus Prevention in Allo-HCT Patients

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 64th 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 (NCT05305040) 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.

vHC and AdV Treatment in Allo-HCT Patients

Global enrollment is ongoing in Phase 3 registrational studies of posoleucel for the treatment of vHC (NCT04390113) and AdV infection (NCT05179057), 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.

BKV Treatment in Kidney Transplant Patients

Topline final data from the Phase 2 study (NCT04605484) 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.

ALVR106

A Phase 1b/2 proof-of-concept clinical study (NCT04933968) of ALVR106 for the treatmen

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EX-99.1

EX-99.1

Exhibit 99.1

AlloVir Reports Third Quarter 2022 Financial Results

Posoleucel Continues to Advance in Three Ongoing Multi-National Phase 3 Registrational Trials

Final Data Presentation from Posoleucel Phase 2 Multi-Virus Prevention Study by Year-End

Company to Host Investor Webcast on December 14 with Clinical Trial Investigators on Posoleucel for Prevention of Viral Infections in Patients Following Allogeneic Stem Cell Transplant

Final Topline Data from Posoleucel Phase 2 Study for Treatment of BK Viremia in Kidney Transplant Patients on Track to be Released in Q1 2023

Waltham, Mass., November 3, 2022 – AlloVir, Inc. (Nasdaq: ALVR), a late-clinical stage allogeneic T cell immunotherapy company, today reported financial results for the third quarter ended September 30, 2022, and shared progress across its allogeneic, off-the-shelf, virus-specific T cell (VST) programs, including its lead investigational therapy, posoleucel, for the treatment and prevention of life-threatening infections and diseases from up to six viruses that commonly impact patients following allogeneic hematopoietic cell transplant (allo-HCT).

“We are focused on rapidly advancing the ongoing posoleucel Phase 3 registrational trials, with the goal of delivering a significant clinical advance for allo-HCT patients who currently have very limited therapeutic and preventive options for these common, yet devastating and potentially life-threatening, viral infections and diseases,” said Diana Brainard, M.D., Chief Executive Officer, AlloVir. “We are particularly excited to report final data before year-end from the Phase 2 multi-virus prevention study, where preliminary results supported the acceleration of our global Phase 3 study for this potential indication. Preventing clinically significant viral infections and diseases after allo-HCT represents the most transformative use of posoleucel.”

Investor Webcast

AlloVir plans to host an investor webcast on Wednesday, December 14 at 4:30 p.m. ET, to discuss the unmet medical need for and clinical value of a multi-virus prevention approach in the management of allo-HCT patients. The webcast will feature remarks from CEO Diana Brainard; infectious disease specialist Sanjeet Singh Dadwal, M.D., City of Hope; and hematologist-oncologist and transplant specialist Joseph McGuirk, D.O., University of Kansas Medical Center.

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

Recent Highlights

•

The Phase 3 study of posoleucel for the prevention of clinically significant infections and end-organ disease from posoleucel’s six target viruses in high-risk allo-HCT patients, continued to expand, with ongoing patient enrollment in the U.S., Europe and Asia.

The multi-virus prevention study evaluates the use of posoleucel either as prophylactic

therapy in patients without viremia or preemptive therapy for patients who have reactivated one or more of the target viruses: adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpes virus-6 (HHV-6) and JC virus (JCV). Multi-virus prevention has the potential to transform the management of allo-HCT patients, who currently have limited to no approved treatment or prevention options for these devastating infections that threaten patient survival.

•

Enrollment in the posoleucel Phase 3 treatment trials also continues to progress, with virus-associated hemorrhagic cystitis trial sites at leading transplant centers in the U.S., Europe and Asia, and adenovirus trial sites at leading centers in the U.S. and Europe, with a focus on the pediatric patient population.

•

Pediatric data from the CHARMS Phase 2 study of posoleucel for the treatment of severe, drug-refractory viral infections in pediatric allo-HCT patients were presented in a poster (Abstract 2161) at IDWeek in October 2022. The data continue to support the potential of posoleucel as a treatment for viral infections and diseases in this patient population.

•

In July 2022, the European Medicines Agency confirmed that the orphan medicinal product designation granted to posoleucel to treat viral infections and diseases from AdV, BKV, CMV, EBV, and HHV-6 in allo-HCT patients also applies to the potential prevention of infections or disease by these multiple viruses in this patient population.

Posoleucel previously received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration for multi-virus prevention, the treatment of AdV infection and the treatment of virus-associated hemorrhagic cystitis in adults and children, all following allo-HCT. To the Company’s knowledge, posoleucel is the only cell or gene therapy with three RMAT designations.

•

In July 2022,

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EX-99.1

EX-99.1

Exhibit 99.1

AlloVir Reports Second Quarter 2022 Financial Results

Three Phase 3 Posoleucel Registrational Trials Continue to Expand Globally, Enrolling Patients in the U.S., Europe and Asia

Company Is On Track to Release Final Results of Posoleucel Phase 2 Multi-Virus Prevention Study at Year-End and Topline Results of Phase 2 BKV Treatment Study in Kidney Transplant Patients in 1Q ‘23

$126.6 Million Registered Direct Offering in July 2022 Will Support the Completion of Three Phase 3 Registrational Trials of Posoleucel and Global Regulatory Submissions

Waltham, Mass., August 4, 2022 – AlloVir, Inc. (Nasdaq: ALVR), a multiple Phase 3 clinical trial stage allogeneic T cell immunotherapy company, today reported financial results for the second quarter ended June 30, 2022. The Company also shared progress across its pipeline of multi-virus specific T cell (VST) therapies, including continued positive, preliminary Phase 2 data on posoleucel and the securing of additional capital to enable the completion of the three ongoing Phase 3 registrational trials of posoleucel and global regulatory submissions for three distinct indications – the treatment of virus-associated hemorrhagic cystitis (vHC), the treatment of adenovirus (AdV) infection, and the prevention of clinically significant infections from AdV, BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpes virus-6 (HHV-6) and JC virus (JCV), all in allogeneic hematopoietic cell transplant (allo-HCT) recipients.

“In the first half of 2022, AlloVir made great progress advancing our pipeline of off-the-shelf, multi-virus specific T cell therapies, especially with our lead candidate, posoleucel. The preliminary Phase 2 multi-virus prevention data have strengthened awareness of the transformational potential of posoleucel as preemptive or prophylactic therapy for viral infections post allo-HCT and have facilitated engagement in our Phase 3 program with leading international transplant centers,” said Diana Brainard, M.D., Chief Executive Officer, AlloVir. “In addition, we are excited to have the strong support of our investors who recently provided additional capital to enable the completion, data readouts and global regulatory submissions for all three ongoing Phase 3 registrational trials of posoleucel. We believe their investment demonstrates a strong affirmation of our science and ability to execute our plans to deliver this potentially transformative therapy to immunocompromised patients in need.”

Recent Highlights

•

The Phase 3 study of posoleucel for the prevention of clinically significant infections and end-organ disease from posoleucel’s six target viruses in high-risk allo-HCT patients, continued to expand globally in the second quarter of this year, with patients enrolling in the U.S., Europe and Asia.

The multi-virus prevention study evaluates the use of posoleucel either as prophylactic therapy in patients without

viremia or preemptive therapy for patients who have reactivated one or more of the target viruses. Multi-virus prevention has the potential to transform the management of transplant patients, who currently have limited to no approved treatment options for these devastating infections that threaten patient survival.

-more-

Page 2

•

In July 2022, the Company received confirmation from the European Medicines Agency that the orphan medicinal product designation granted to posoleucel as a potential treatment of viral diseases and infections from AdV, BKV, CMV, EBV and HHV-6 in patients undergoing HCT also applies to the potential prevention of these multiple viruses in this patient population.

This adds to the Regenerative Medicine Advanced Therapy (RMAT) designation for multi-virus prevention that the U.S. Food and Drug Administration granted to posoleucel in April 2022, and prior RMAT designations for the treatment of AdV infection and for the treatment of hemorrhagic cystitis caused by BK viremia in adults and children, all following allo-HCT. To the Company’s knowledge, posoleucel is the only cell or gene therapy with three RMAT designations.

•

New health economic and outcomes research (HEOR) data describing the clinical and economic burden of multiple viral infections post allo-HCT were published in Transplantation and Cellular Therapy in June 2022. The data demonstrate that patients with multiple viral infections post allo-HCT had a higher risk of all-cause mortality and were associated with greater health resource utilization and higher healthcare costs, supporting the value proposition of a multi-virus prevention therapy.

•

Two compassionate use case reports of posoleucel therapy for refractory disseminated AdV infection post allo-HCT

were presented at the 2022 Tandem Meetings |Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Res

EX-99.1

2 d339026dex991.htm

EX-99.1

EX-99.1

Exhibit 99.1

For Immediate Release

AlloVir Reports First Quarter 2022 Financial Results

Initiated posoleucel registrational study to prevent six devastating viral infections and now enrolling high-risk allo-HCT patients in the U.S., Western Europe and Asia

FDA granted RMAT designation to posoleucel for Phase 3 multi-virus prevention indication with an estimated annual addressable patient population of 40,000 allo-HCT patients

Progressed enrollment in three Phase 3 studies for posoleucel and a Phase 2 trial for ALVR106

Completed enrollment in Phase 2 study of posoleucel for the treatment of BK viremia in kidney transplant patients; initial blinded data will be presented at the American Transplant Congress in June

Waltham, Mass., May 5, 2022 – AlloVir, Inc. (Nasdaq: ALVR), a multiple Phase 3 clinical trial stage allogeneic T cell immunotherapy company, today reported financial results for the first quarter ended March 31, 2022. The company also shared progress across its virus-specific T cell (VST) programs, with its lead product, posoleucel, advancing into Phase 3 development for the prevention of infections and disease from six devastating viruses that commonly impact patients following allogeneic hematopoietic cell transplant (allo-HCT) – adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpes virus-6 (HHV-6) and JC virus (JCV). Multi-virus prevention has the potential to transform the management of transplant patients, who currently have limited to no approved treatment options for these infections that threaten patient survival. The U.S. Food and Drug Administration (FDA) granted posoleucel Regenerative Medicine Advanced Therapy (RMAT) designation for this multi-virus prevention approach in high-risk adult and pediatric allo-HCT patients.

“We are focused on rapidly advancing our lead product candidate, posoleucel, with the aim of delivering this potentially transformative therapy to patients in need as quickly as possible. Based on the strength of our Phase 2 data in both treatment and prevention, we now have three Phase 3 studies underway that aim to address a spectrum of needs in the post-allo-HCT setting – as a treatment for patients already suffering the devastating impact of viral infections and disease, as a preemptive therapy for patients who have reactivated one or more viruses, and as a prophylactic therapy in high-risk patients without viremia,” said Diana Brainard, M.D., Chief Executive Officer, AlloVir. “The multi-virus prevention approach is the most transformative use of posoleucel and, accordingly, we are seeing strong enthusiasm from hematologists and infectious disease specialists as we expand our Phase 3 study sites and enrollment.”

Recent Highlights

•

At the Annual Meeting of the European Society for Blood and Bone Marrow Transplantation (EBMT) in March 2022, AlloVir reported updated preliminary data from the open-label Phase 2 study assessing the safety and efficacy of posoleucel for multi-virus prevention in high-risk allo-HCT patients. The updated data set, which includes more patients and longer follow-up, continues to demonstrate a substantial reduction in the expected rate of clinically significant infections with posoleucel therapy.

Page 2

•

Based on the initial Phase 2 prevention study data, AlloVir initiated a global Phase 3 registrational study of posoleucel for the prevention of clinically significant infections and end-organ disease from posoleucel’s six target viruses in high-risk allo-HCT patients, either as prophylactic therapy in patients without viremia or preemptive therapy for patients who have reactivated one or more viruses. As 90% of allo-HCT patients reactivate at least one of these viruses, there is a large global market opportunity for the prevention of devastating viral diseases, with an estimated addressable patient population of 40,000 allo-HCT patients annually.

•

In April 2022, FDA granted posoleucel a third RMAT designation for multi-virus prevention, based on the initial Phase 2 prevention study data. This adds to existing RMAT designations for the treatment of AdV infection and for the treatment of hemorrhagic cystitis caused by BK viremia in adults and children, both following allo-HCT. Posoleucel is the only cell or gene therapy with three RMAT indications.

•

AlloVir initiated a Phase 3 registrational study of posoleucel for the treatment of AdV infections in adult and pediatric allo-HCT patients. AdV-associated viral disease is among the leading causes of life-threatening complications following allo-HCT, often involving multiple vital organs, including the brain, lungs and liver, and occurs in 32% of pediatric and 6% of adult allo-HCT patients.

•

Two compassionate use case reports of posoleucel therapy for refractory disseminated AdV infection post allo-HCT were presented at the 2022 Tandem Meetings |Transplantation & Cellular Therapy Meetings o

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Exhibit 99.1

For Immediate Release

AlloVir Reports Full-Year 2021 Financial Results and 2022 Outlook

Three ongoing Phase 3 registrational studies of posoleucel expected in 2022, targeting treatment and

prevention indications with no approved therapies

Expanded enrollment in Phase 2 proof-of-concept study of posoleucel for the preemptive treatment of BK

viremia in kidney transplant recipients; initial data submitted for presentation in 1H 2022

Advancing two additional virus-specific T cell therapies – ALVR106 to treat common respiratory viral

infections and ALVR107 for hepatitis B cure

Strong cash position, with $248.1 million as of year-end 2021

Waltham, Mass., February 10, 2022 – AlloVir (Nasdaq: ALVR), a late clinical-stage allogeneic T cell immunotherapy company, today reported full-year 2021 financial results for the period ended December 31, 2021. The company also provided the outlook for 2022 across its pipeline of allogeneic, off-the-shelf, virus-specific T cell (VST) therapies for immunocompromised patients, including its lead product posoleucel, an investigational VST in development for the treatment and prevention of infections and diseases caused by six common devastating viruses – adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpesvirus-6 (HHV-6) and JC virus (JCV).

“2022 is a year of execution and expansion for our clinical development program, as we implement three Phase 3 registrational studies across sites in North America, Europe and Asia, present new data that expand on posoleucel’s potential in both the treatment and prevention of six life-threatening viruses, and continue to advance two additional VST therapies,” said Diana Brainard, M.D., Chief Executive Officer of AlloVir. “Beyond our clinical development programs, we are also advancing the manufacturing of posoleucel in anticipation of commercial product requirements and global distribution. Our non-gene-edited VST manufacturing platform is commercially scalable and can achieve cost of goods similar to biologics. This positions us well for the next stage of our company’s growth as our pipeline continues to mature.”

Recent Highlights

Advancing Posoleucel Development

•

At the American Society of Hematology (ASH) Annual Meeting in December 2021, AlloVir reported positive preliminary data from the open-label Phase 2 study assessing the safety and efficacy of posoleucel for the prevention of multiple viruses in high-risk allogeneic hematopoietic cell transplant (allo-HCT) patients. The preliminary data set demonstrated a substantial reduction in the expected rate of clinically significant viral infections or diseases and facilitates an accelerated path to Phase 3 development, which has been agreed to in principle by the U.S. Food and Drug Administration (FDA). The Phase 3 registrational study is expected to initiate in the first half of 2022.

-more-

Page 2

•

In December 2021, AlloVir initiated a global Phase 3 registrational study of posoleucel for the treatment of AdV infections in adult and pediatric allo-HCT patients. The study is the second registrational trial of posoleucel to initiate. AdV-associated viral disease is among the leading causes of life-threatening complications following allo-HCT, often involving multiple vital organs, including the brain, lungs and liver, and occurs in 32% of pediatric and 6% of adult allo-HSCT patients.

•

The FDA granted posoleucel Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of AdV infections, based on Phase 2 data and in recognition of the potential for posoleucel to address an unmet medical need. The FDA previously granted RMAT and orphan drug designations (ODD) to posoleucel for the treatment of hemorrhagic cystitis (HC) caused by BKV in adults and children following allo-HCT. The European Medicines Agency has granted posoleucel PRIority Medicines (PRIME) designation for the treatment of serious infections with AdV, BKV, CMV, EBV and HHV-6, and Orphan Medicinal Product (OMP) designation as a potential treatment of viral diseases and infections in patients undergoing HCT.

•

Following a review at the end of last year of initial, blinded safety data from the ongoing posoleucel proof-of-concept (POC) study for BK viremia treatment in adult kidney transplant recipients, the study has been amended to begin enrolling patients with higher viral loads. BKV is detected in up to 20% of kidney transplant patients and can lead to graft loss and a return to end-stage renal disease and dialysis. There are no approved or effective BKV treatments.

Expanding into Respiratory Viruses

•

A Phase 1/2 POC study of ALVR106, an investigational multi-respiratory VST therapy designed to target infections and diseases caused by human metapneumovirus, influenza, parainfluenza virus and respiratory syncytial virus in autologous and allo-HCT recipients initiated in December 2021.

•

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Exhibit 99.1 A Leader in Allogeneic, Off-the-Shelf, Virus-Specific T Cell Therapies J.P. Morgan Healthcare Conference January 10, 2022 CONFIDENTIAL & PROPRIETARY © 2022

Disclaimer This presentation has been prepared by AlloVir, Inc. (“we,” “us,” “our,” “AlloVir” or the “Company”) and is made for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy securities. This

presentation may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the safety, efficacy and regulatory and clinical

progress of our product candidates, including posoleucel. All such forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. The use of words such as, but not limited to, “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar words or expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results and other future conditions. All statements other than statements of historical facts contained in this presentation, including statements regarding future results of operations and financial position, business strategy, current and prospective product candidates ongoing, and planned clinical trials and preclinical activities, including the initiation, timing, enrollment, progress and results of our preclinical and clinical studies and our research and development programs, product approvals, research and development costs, current and prospective collaborations, timing and likelihood of success, including our ability to advance and successfully complete clinical studies, the timing and likelihood of success of our clinical trials, and the timing or likelihood of regulatory filings and approvals, expectations regarding market acceptance and size, plans for launch and commercialization, plans and objectives of management for future operations, and future results of anticipated product candidates, are forward-looking statements. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. These statements are also subject to a number of material risks and uncertainties that are discussed in the section entitled Risk Factors in our quarterly report on Form 10- Q for the fiscal quarter ended September 30, 2021, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any

forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data

obtained from third-party sources and the Company’s own internal estimates and research. While we believe these third-party sources to be reliable as of the date of this presentation, we have not independently verified, and we make no representation as to the adequacy, fairness, accuracy or completeness of any information obtained from third-party sources. In addition, all of the market data included in this presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while we believe our own internal research is reliable, such research has not been verified by any independent source. 2 CONFIDENTIAL & PROPRIETARY © 2022

AlloVir By the Numbers 12 4 3 5 7 INVESTIGATIONAL T A R G E T P O T E N T I A L P H A S E 3 R E G U L A T O R Y T H E R A P I E S VIRUSES STUDIES DESIGNATIONS* INDICATIONS 90 CLINICAL $ TRIAL SITES 69 .1 248 100+ ON 3 DIFFERENT CONTINENTS I N C A S H , C A S H E Q U I V A L E N T S ACROSS 5 CLINICAL STUDIES ‡ E M P L O Y E E S & M A R K E T A B L E S E C U R I T I E S *FDA Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation (ODD) for virus-associated HC treatment, and RMAT for AdV treatment; EMA Priority Medicines (PRIME) design

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Exhibit 99.1

For Immediate Release

AlloVir Reports Third Quarter 2021 Financial Results

Company is prioritizing prevention and treatment programs with the potential to transform transplant patient care and outcomes

Positive interim data from posoleucel multi-virus prevention Phase 2 study will be presented at ASH

Posoleucel Phase 3 study for the treatment of adenovirus and ALVR106 proof-of-concept clinical trial for the treatment of multiple respiratory viruses are on track to initiate this year

Cambridge, Mass., November 5, 2021 – AlloVir (Nasdaq: ALVR), a late clinical-stage cell therapy company, today reported financial results for the third quarter ended September 30, 2021. The company also shared progress on the advancement of its prioritized virus-specific T cell (VST) programs to prevent or treat life-threatening viral diseases.

“AlloVir’s allogeneic, off-the-shelf, virus-specific T cell platform has the potential to transform the care of and outcomes for patients – from stem cell and solid organ transplant recipients to broader patient groups with immunodeficiency. The interim data we will be presenting at ASH provide the first look at the potential for posoleucel, a multi-virus specific T cell therapy, to change the treatment paradigm for stem cell transplant recipients, moving upstream to prevent the most common life-threatening viral diseases for these patients before they occur,” said Diana Brainard, M.D., Chief Executive Officer, AlloVir. “Across our portfolio, we are prioritizing programs with the largest potential benefit for patients, including the prevention of life-threatening viral diseases caused by six devastating viruses with a single therapy. We are focusing on key areas where there are limited or no treatment options, such as hemorrhagic cystitis, BK viremia and adenovirus.”

Upcoming Q4 2021 Highlights/Activities:

•

Initial data from the open-label cohort of a Phase 2 clinical trial to assess the safety and efficacy of

posoleucel for the prevention of multiple viruses following allogeneic hematopoietic stem cell transplantation (allo-HSCT) will be presented at the 63rd American Society of Hematology Annual Meeting in December (Abstract #1760). The study is evaluating the potential for posoleucel to prevent clinically significant viral infections (adenovirus, BK virus, cytomegalovirus, Epstein-Barr virus, human herpesvirus-6, JC virus) in high-risk, adult and pediatric allo-HSCT patients. The study is ongoing and continues to enroll patients.

•

In December, AlloVir plans to submit initial data from its Phase 2 proof-of-concept (POC) clinical trial with posoleucel for the preemptive treatment of BK viremia in adult kidney transplant recipients, for presentation at a scientific congress in the first half of 2022. BK viremia is detected in up to 20% of kidney transplant patients and can lead to nephropathy causing decreased kidney survival and a return to end-stage renal disease and dialysis.

-more-

Page 2

•

AlloVir remains on track to initiate a Phase 3 study this year evaluating posoleucel for the treatment of adenovirus (AdV) in adult and pediatric allo-HSCT recipients. AdV-associated viral disease is among the leading causes of life-threatening complications following allo-HSCT, occurring in 32% of pediatric and 6% of adult allo-HSCT patients. AdV-associated viral disease often results in multi-organ involvement with the virus invading the brain, lungs, liver and other vital organs. There is no approved treatment for adenovirus infection.

•

A POC clinical trial of ALVR106, an investigational multi-respiratory VST therapy designed to target infections and diseases caused by human metapneumovirus, influenza, parainfluenza virus and respiratory syncytial virus in allogeneic and autologous HSCT recipients, is on track to initiate before year-end, coinciding with the respiratory virus season.

•

Preclinical and Investigational New Drug (IND)-enabling studies for ALVR107 to treat hepatitis B virus (HBV) are on track for completion by the end of this year. 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. However, there are no curative therapies available.

Recent Clinical and Scientific Highlights:

•

Positive preclinical and early clinical data presented in an oral presentation at IDWeek™ 2021 demonstrated that ALVR109, an investigational VST therapy targeting SARS-CoV-2, provides antiviral activity and coverage against multiple variant strains, including Delta. Beyond SARS-CoV-2, these data reinforce the potential for AlloVir’s VST therapies to address the major public health issue posed by ubiquitous respiratory viruses.

•

In October, the U.S. Food and Drug Administration granted Orphan Drug

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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 ongo

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Exhibit 99.1

AlloVir Reports First Quarter 2021 Financial Results

- 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

CAMBRIDGE, Mass.—(BUSINESS WIRE)—May 6, 2021 – 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