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| Item 7.01 | Regulation FD Disclosure. |
AlloVir, Inc. (the “Company”) is furnishing a corporate presentation, attached as Exhibit 99.1 to this Current Report on Form 8-K, which the Company intends to use from time to time in meetings with investors and others beginning on November 15, 2021. The corporate presentation will also be available in the investor relations section of the Company’s website at http://allovir.com.
The information in this Item 7.01 and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
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Description | |
| 99.1 | AlloVir, Inc. corporate presentation. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AlloVir, Inc. | ||||||
| Date: November 15, 2021 | By: | /s/ Edward Miller | ||||
| Name: Edward Miller | ||||||
| Title: General Counsel | ||||||
Exhibit 99.1 A Leader in Allogeneic, Off-the-Shelf, Virus-Specific T-Cell Therapies November 2021 CONFIDENTIAL & PROPRIETARY © 2021
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 © 2021
AlloVir: A Leading Innovator in Allogeneic, Off-the-Shelf, Virus-Specific T Cell Immunotherapies Clinically Large unmet need Rich Manufacturing validated and global pipeline at scale platform opportunity 4 products targeting 12 viruses Simple, non-gene-edited, Currently focused on stem cell 93% overall response rate in with both treatment and scalable process with and solid organ transplant Phase 2 study prevention potential manufacturing redundancy patients Posoleucel in 2 Phase 3 trials Expedited regulatory review Off-the-shelf delivery for patient Expanding to additional patient by end of 2021 and 2 ongoing pathways (RMAT, PRIME) access within 48 hours populations proof-of-concept studies RMAT = Regenerative Medicine Advanced Therapy designation granted by the US Food and Drug Administration; PRIME = Priority Medicines designation granted by the European Medicines Agency. 3 CONFIDENTIAL & PROPRIETARY © 2021
Our Pipeline Targets 12 Unique Viruses Candidate Target Population Target Indication Preclinical POC Pivotal vHC treatment Multi- VST Allo-HSCT AdV treatment Posoleucel Multi-virus (ALVR105) prevention* Kidney transplant BKV treatment Multi-virus Solid organ transplant prevention* IND Cleared Allo- / Auto-HSCT Q4 2020 hMPV, Flu, PIV, ALVR106 RSV treatment High-risk general population ALVR107 Chronic HBV HBV treatment Single VST COVID-19 Compassionate ALVR109 Immunocompromised treatment Use Access *Prevention of adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human herpesvirus 6 (HHV-6), JC virus (JCV). Allo-HSCT = allogeneic hematopoietic stem cell transplantation; Auto-HSCT = autologous HSCT; HBV = hepatitis B virus; hMPV = human metapneumovirus; Flu = influenza; PIV = parainfluenza virus; POC = proof-of-concept; RSV = respiratory syncytial virus; vHC = virus-associated hemorrhagic cystitis; VST = virus-specific T cell. 4 CONFIDENTIAL & PROPRIETARY © 2021
AlloVir’s Therapies Aim to Treat or Prevent Life-Threatening 1-13 Viral Diseases For Immunocompromised Patients Challenges Solution Vulnerable Populations Immunity Restored with VSTs Single and multiple viral infections are common in the VSTs are a clinically validated approach to immunocompromised: restoring protective T-cell immunity ‒ HSCT & SOT recipients ‒ The elderly & the very young ‒ Patients on chemotherapy or immunomodulators AlloVir’s VSTs: ‒ Address the underlying immune deficit Limited or No Treatment Options in high-risk patient populations Therapeutic options raise concerns about: ‒ Target multiple viruses with limited to ‒ Lack of efficacy for off-label treatments no treatment options ‒ Significant toxicity ‒ Emergence of resistance ‒ Offer off-the-shelf delivery to reach patients quickly Substantial Morbidity & Mortality Uncontrolled viral diseases can: ‒ Prolong hospitalization ‒ Increase risk for GVHD or graft rejection ‒ Cause end-organ damage ‒ Result in death GVHD = graft vs host disease; SOT = solid organ transplant. 1. Abudayyeh A, et al. Am J Transplant. 2016;16:1492-1502; 2. Camargo JF, Komarduri KV. Hematol Oncol Stem Cell Ther. 2017;10:233-238; 3. Cesaro S, et al. Bone Marrow Transplant. 2018;doi:10.1038/s41409- 018-0421-0; 4. Leen AM, et al. Blood. 2009;114(19):4283-4292; 5. Perruccio K, et al. Biol Blood Marrow Transplant. 2018;24:2549-2557; 6. Saribas AS, et al. Future Virol. 2010;5(3):313-323. doi:10.2217/fvl.10.12; 7. Cho SY, et al. Kor J Intern Med. 2018;33:256-276; 8. Law N, Kumar D. Drugs Aging. 2017;34:743-754; 9. Gentile G, Antonelli G. Viruses. 2019;11:doi:10.3390/v11111049; 10. Kedia S, et al. J Stem Cell Res Ther. 2013;doi:10.4172/2157-7633.S3-002; 11. Ison MG, Hirsch HH. Clin Microbiol Rev. 2019;32(4):1-33; 12. Jose RJ, et al. 5 Medicine. 2020. doi:10.1016/j.mpmed.2020.03.006; 13. Simon AK, Hollander GA, McMichael A. Proc Biol Sci. 2015;282(1821):20143085. CONFIDENTIAL & PROPRIETARY © 2021
We Are Delivering on a Broad Set of Preclinical, Regulatory and Clinical Milestones Recent Milestones Remaining 2021 Catalysts Posoleucel✓ Pivotal trial initiation in vHC • Initial data presentation for multi-virus prevention trial ✓ FDA orphan drug designation for vHC treatment • Pivotal trial initiation for AdV ✓ POC trial initiation in multi-virus prevention • Abstract submission for early data from BKV in kidney transplant trial ✓ POC trial initiation in BKV in kidney transplant ✓ IND clearance by FDA for POC trial in multiple respiratory • POC trial initiation for multiple respiratory ALVR106 viruses viruses ✓ In vitro, preclinical, IND-enabling studies ALVR107 ✓ Initial preclinical and clinical data for SARS-CoV-2 ALVR109 6 CONFIDENTIAL & PROPRIETARY © 2021
AlloVir: A Leading Innovator in Allogeneic, Off-the-Shelf, Virus-Specific T Cell Immunotherapies Clinically Large unmet need Rich Manufacturing validated and global pipeline at scale platform opportunity 7 CONFIDENTIAL & PROPRIETARY © 2021
Our Patented and Highly Efficient Platform Delivers Rapid, Scalable, Off-the-Shelf VST Therapy VST profiling Carefully selected healthy VST selective expansion Cryopreservation and Treatment of patient & antigen selection seropositive donors using proprietary process storage at global depots Key Advantages • Rationally designed cell bank, facilitating availability of VSTs covering >95% of patients • Our VST platform minimizes antigen competition, enabling retention of VST diversity and polyclonality • Simple and robust manufacturing yields hundreds of VST doses from a single donor/production run • Our VSTs have long-term stability, supporting on-demand, broad availability for patients 8 CONFIDENTIAL & PROPRIETARY © 2021
Following HSCT, Patients are Susceptible to Life-Threatening 1-6 Viral Infections Window of Susceptibility 3,4,a Patients with Reactivation of Single or Multiple Viruses (%) Host T Cells HSCT-Derived T Cells >60 40–60 40–60 20–40 20–40 <20 <20 14 28 100 180 days post-HSCT HSCT Conditioning for HSCT Engraftment Post-Engraftment (Lymphodepletion) a Post 100-day data for proportion of patients with viral detection is from Huang YT, et al, as Hill J, et al only measured out to 100 days. 1. Kedia S, et al. J Stem Cell Res Ther 2013;S3; 2. Ison M, Hirsch H. Clin Microbiol Rev 2019;32:e00042-19; 3. Hill J, et al. Blood 2017;129:2316-25; 4. Huang YT, et al. Biol Blood Marrow Trans 2017;23:1759-66; 5. Stern L, et al. Front Immunol 2018;9:1672; 6. Hill J, et al. Clin Infect Dis 2018;66:368-75. 9 CONFIDENTIAL & PROPRIETARY © 2021
Phase 2 CHARMS Study Demonstrated 93% Efficacy of Posoleucel in 1,2 Treatment-Refractory Patients Safety: Posoleucel Well Tolerated Efficacy: Posoleucel Response Rate* 100 100 100 100 • Infusions were well tolerated 100% 94 93 ‒ n=3 developed isolated fever within 80% 24 hours of infusion; no immediate 75 toxicities observed 60% • 14 cases of acute GVHD 50 ‒ n=8 had pre-existing GVHD 40% ‒ n=6 de novo GVHD; all had transient 20% Grade I skin GVHD resolved with treatment † ‡ n= 58 11 18 17 8 2 1 1 0% • No cytokine release syndrome Overall Multiple BKV CMV AdV HHV-6 EBV JCV Viruses CR = Viral load return to normal range and resolution of clinical signs/symptoms PR = ≥50% decrease in viral load and/or 50% improvement of clinical signs/symptoms † *Response rate / patient includes partial response (PR) or complete response (CR) by 6 weeks post-posoleucel infusion; 58/59 patients were evaluable for response rate, 1 patient with HHV-6 was not evaluable for response rate; ‡ 11/11 patients had a response to ≥1 virus(es) and 19 of 23 viruses across the 11 patients responded to posoleucel. 1. Tzannou I, et al. J Clin Oncol 2017;35:3547-57; 2. Tzannou I, et al. ASH 2020. Accessed January 4, 2021. https://ash.confex.com/ash/2020/webprogram/Paper143037.html. 10 CONFIDENTIAL & PROPRIETARY © 2021
AlloVir: A Leading Innovator in Allogeneic, Off-the-Shelf, Virus-Specific T Cell Immunotherapies Clinically Large unmet need Rich Manufacturing validated and global pipeline at scale platform opportunity 11 CONFIDENTIAL & PROPRIETARY © 2021
Our Lead Candidate Posoleucel, a Multi-VST for Treatment and Prevention, Is a Pipeline in a Product Candidate Target Population Target Indication Preclinical POC Pivotal vHC treatment Multi- VST Allo-HSCT AdV treatment Posoleucel AdV, BKV, CMV, EBV, (ALVR105) HHV-6, JCV prevention Kidney transplant BKV treatment AdV, BKV, CMV, EBV, Solid organ transplant HHV-6, JCV prevention 12 CONFIDENTIAL & PROPRIETARY © 2021
Virus-Associated Hemorrhagic Cystitis in HSCT: A Devastating Disease With No Approved or Effective Treatment Options HC is caused by BKV and/or AdV and results 1-7 1-7 in severe morbidity & mortality There are no approved or effective therapies Red blood cell or platelet transfusions Severe bleeding due to hematuria Bladder arterial embolization and/or cystectomy Narcotics Severe, prolonged and intractable pain Continuous bladder irrigation Life-disturbing urinary symptoms Dialysis Kidney dysfunction / failure Increased mortality 1. Cesaro S, et al. J Antimicrob Chemother 2018;73:12-21; 2. Garguilo G, et al, ecancer 2014;8:420; 3. Silva Lde P, et al. Haematologica 2010;95:1183-90; 4. Kloos RQ, et al. Biol Blood Marrow Transplant 2013;19:1263-6; 5. Type B Briefing Package; 6. Laskin BL, et al. Clin Infect Dis 2020;71:3044-54; 7. Gilis L, et al. Bone Marrow Transplant 2014;49:664-70. 13 CONFIDENTIAL & PROPRIETARY © 2021
Patients Treated with Posoleucel or BK-VSTs Have Achieved Rapid Resolution of Macroscopic Hematuria CHARMS Study Patients Treated With Posoleucel MDACC Patients Treated with BK-VSTs vs 1 2 vs Historical Controls Receiving SOC Matched-pair Historical Controls Receiving SOC 100 100 Natural History / SOC (n=59) Natural History (n=33) BK-VSTs (n=59) Posoleucel (n=20) 80 80 60 60 40 40 20 20 0 0 Week 2 Week 4 Week 6 Week 2 Week 4 Week 6 1. Pfeiffer T, et al. Transplant Cell Ther 2021;27:S91-2; 2. Olson A, et al. J Clin Oncol 2021;39:2710-9. 14 CONFIDENTIAL & PROPRIETARY © 2021 % Resolved % Complete Response
First Registrational Trial for Posoleucel Has Been Initiated for the Treatment of Virus-Associated Hemorrhagic Cystitis Posoleucel 7 7 2x10 (<40 kg) or 4x10 (≥40 kg) cells R 3:2 N=125 Placebo infusion 0 2 24 Week Dose End of study • Phase 3, multicenter, double-blind, placebo-controlled • Key eligibility criteria: patients with vHC following allogeneic HSCT – Macroscopic hematuria (Grade ≥3) – Viruria – Dysuria, lower abdominal pain and/or pain associated with spasm • Primary endpoint: time to resolution of macroscopic hematuria through Week 24 ClinicalTrials.gov NCT04390113. 15 CONFIDENTIAL & PROPRIETARY © 2021
Posoleucel is Designed to Treat and Prevent Viral Infections and 1-6 Diseases Until the Patient’s Own Immune System Recovers Posoleucel Window of Susceptibility 3,4,a Patients with Reactivation of Single or Multiple Viruses (%) Host T Cells HSCT-Derived T Cells >60 40–60 40–60 20–40 20–40 <20 <20 14 28 100 180 days post-HSCT HSCT Conditioning for HSCT Engraftment Post-Engraftment (Lymphodepletion) a Post 100-day data for proportion of patients with viral detection is from Huang YT, et al, as Hill J, et al only measured out to 100 days. 1. Kedia S, et al. J Stem Cell Res Ther 2013;S3; 2. Ison M, Hirsch H. Clin Microbiol Rev 2019;32:e00042-19; 3. Hill J, et al. Blood 2017;129:2316-25; 4. Huang YT, et al. Biol Blood Marrow Trans 2017;23:1759-66; 5. Stern L, et al. Front Immunol 2018;9:1672; 6. Hill J, et al. Clin Infect Dis 2018;66:368-75. 16 CONFIDENTIAL & PROPRIETARY © 2021
A Phase 2 Posoleucel Trial Has Been Initiated for Multi-Virus Prevention, With Initial Data Available in December 2021 Phase 2 Posoleucel 7 7 2x10 (<40 kg) or 4x10 (≥40 kg) cells R 1:1 Posoleucel open-label (N=25) 7 7 2x10 (<40 kg) or 4x10 (≥40 kg) cells N=125 Placebo infusion Week 0 12 14 24 Week 0 12 14 24 Dose Primary Key secondary Dose Primary Key secondary endpoint endpoint endpoint endpoint • Phase 2, multicenter trial—initially open-label, followed by randomized, double-blind, placebo-controlled • Key eligibility criteria: high-risk allo-HSCT recipients – Age ≥1 year – Aviremic or viremic without clinically significant disease* • Primary endpoint: reduction in clinically significant viral infection and disease *Cohort A (preemptive), positive for ≥1 virus; cohort B (prophylactic), undetectable for all 6 viruses. ClinicalTrials.gov NCT04693637. 17 CONFIDENTIAL & PROPRIETARY © 2021
BK Virus in Kidney Transplant Patients Leads to Decreased Graft Survival 3 BKV Nephropathy Associated with Poor Graft Survival 100 • 10–20% of KT patients have BK viremia and up to 50% progress to 90 1 BK nephropathy 80 Patients without BKV nephropathy • BKV viremia and BK nephropathy 70 are associated with decreased graft 2 3 60 function and graft survival p<0.001 Patients with 50 • There are no approved or effective BKV nephropathy 40 treatments 0 0.5 1 2 3 4 5 Post-transplant years 1. Hirsch H, et al. Clin Transplant 2019;33:e13528; 2. Elfadawy N, et al. Clin J Am Soc Nephrol 2014; 3. Vasudev B, et al. Kidney International 2005;68:1834-9. 18 CONFIDENTIAL & PROPRIETARY © 2021 % Graft Survival
A Phase 2 Posoleucel Trial Has Been Initiated for BK Virus Treatment in Kidney Transplant Recipients Cohort A: low viral load (1000–<10,000 BKV copies/mL) Cohort B: higher viral load (10,000–50,000 BKV copies/mL) Posoleucel Posoleucel 7 7 4x10 (≥40 kg) Q7d x 3 4x10 (≥40 kg) cells + Q14d or Q28d (double dummy design) x 12 weeks (dosing frequency determined in Cohort A) R 1:1 R 1:1 N=42 N=28 Placebo infusion Placebo infusion Week 24 96 Week 24 96 Primary End of long-term Primary End of long-term follow-up endpoint follow-up endpoint End of study • Phase 2, multicenter, randomized, double-blind, placebo-controlled, multiple dosing interval, 3-period study • Key eligibility criteria: adults 1–24 months post-kidney transplant • Primary endpoint: safety and tolerability • Key secondary endpoint: reduction in BK viremia • Cohort B to begin following Cohort A interim analysis Clinicaltrials.gov NCT04605484. 19 CONFIDENTIAL & PROPRIETARY © 2021
Adenovirus is Life-Threatening and Has No Approved Treatment 1 • AdV viremia occurs in 32% of pediatric and 6% adult allogeneic HSCT patients 2 • Potentially life-threatening consequences ‒ Pneumonia ‒ Hepatitis ‒ Hemorrhagic enteritis or cystitis 3 ‒ Multi-organ failure / death • No approved therapies – Cidofovir used off-label with significant toxicity and no supportive efficacy data 1. Sedláček P, et al. Biol Blood Marrow Transplant 2019;25:810-8; 2. Lion T. Clin Microbiol Rev 2014;27:441-62; 3. Deambrosis D, et al. J Clin Virol 2020;127:104373. 20 CONFIDENTIAL & PROPRIETARY © 2021
Second Phase 3 Posoleucel Trial Will Be Initiated By End of 2021 for Adenovirus Treatment Primary Dose endpoint End of study Week 0 2 4 Safety follow-up 24 Posoleucel 7 7 2x10 (<40 kg) or 4x10 (≥40 kg) cells R 1:1 N=80 Placebo infusion • Phase 3, randomized, double-blind, placebo-controlled • Key eligibility criteria: age >1 year with – Allo-HCT ≥21 days prior to randomization, with engraftment AND – AdV viremia ≥10,000 copies/mL, OR 2 consecutive and rising AdV viremia ≥1,000 copies/mL AND 3 Abs lymphocyte count <180/mm OR T cell depletion • Primary endpoint: reduction in viral load • Patients with disease progression can enter optional 24-week cross-over period after Week 4 21 CONFIDENTIAL & PROPRIETARY © 2021
Extending Our Platform to Tackle Respiratory Viral Infections Multi- VST Candidate Target Population Target Indication Preclinical POC Pivotal IND Cleared Allo- / Auto-HSCT Q4 2020 hMPV, Flu, PIV, ALVR106 RSV treatment High-risk general population 22 CONFIDENTIAL & PROPRIETARY © 2021
ALVR106 Offers Potent, Selective Antiviral Activity Against 1-3 Respiratory Viruses of Significant Concern for HSCT Patients • Present in up to 40% URTI of allo-HSCT patients hMPV Influenza • No or limited care options PIV RSV • Approximately 50% progress to LRTI • 20–45% mortality rate in this LRTI population LRTI LRTI = lower respiratory tract infection; URTI = upper respiratory tract infection. 1. Ison M, Hirsch H. Clin Microbiol Rev 2019;32:e00042-19; 2. Versluys AB, Boelens JJ. Front Microbiol 2018;9:2795; 3. Piñana J, et al. J Infect 2020;80:333‐41. 23 CONFIDENTIAL & PROPRIETARY © 2021
ALVR106 POC Study Targeting hMPV, Flu, PIV and RSV To be Initiated in 2021 Part A: Dose Escalation Part B: Efficacy Expansion Primary Efficacy Primary Efficacy Dose Endpoint Dose Endpoint Follow-up Follow-up Week 0 1 4 52 0 4 52 ALVR106 ALVR106 Dose escalation Dose selected from Part A R 3:1 R 2:1 N=16–32 N=45 Placebo infusion Placebo infusion Safety review allows for start of next patient / dose cohort • Phase 1/2, double-blind, placebo-controlled, dose escalation and expansion study to assess safety and dose selection of ALVR106 for the treatment of high-risk patients with RTIs following HSCT • Key eligibility criteria: HSCT recipients 17–75 years with hMPV, influenza, PIV or RSV detected, and new respiratory symptoms ≤4 days before screening • Primary efficacy endpoint: reduction in viral load • Part B to begin following Part A safety and efficacy review 24 CONFIDENTIAL & PROPRIETARY © 2021
Applying Our Platform to Support HBV Cure Candidate Target Population Target Indication Preclinical POC Pivotal Single ALVR107 Chronic HBV HBV treatment VST 25 CONFIDENTIAL & PROPRIETARY © 2021
ALVR107: Proof-of-Concept Has Been Established for Potential of Adoptive T Cell Therapy to Achieve Functional HBV Cure Significant Unmet Medical Need for HBsAg+ Allo-HSCT Patients Achieved Functional 1 Curative Therapies Cure Post-transplant With HBsAg loss Without HBsAg loss 100 • Nearly 300 million people globally have 100 chronic hepatitis B infection 77 80 • Chronic infection can lead to cirrhosis and cancer 60 • Life-long suppressive antiviral therapy is 40 the only treatment option: no curative 23 therapies exist 20 0 24/31 24/31 0/51 51/51 0 With Natural Immunity Without Natural Immunity • 83% (20/24) HBsAg+ recipients achieved sustained HBsAg loss post-transplant 1. Hui CK, et al. Blood 2005;106:464-9; HBsAg = hepatitis B surface antigen. 26 CONFIDENTIAL & PROPRIETARY © 2021 % Recipients
AlloVir: A Leading Innovator in Allogeneic, Off-the-Shelf, Virus-Specific T Cell Immunotherapies Clinically Large unmet need Rich Manufacturing validated and global pipeline at scale platform opportunity 27 CONFIDENTIAL & PROPRIETARY © 2021
Simple, Scalable Manufacturing Approach for a Complex “Living” Product, Anticipating Future Needs Non-gene-edited Single use Manufacturing End-to-end process components/technology redundancy supply chain Key Takeaways • Current manufacturing capacity is meeting our clinical development needs – investigational product supply already available for ongoing and planned posoleucel Phase 3 clinical studies • We are simultaneously preparing for commercial supply needs, further developing our production process and analytics to be BLA-ready • We are building out global capabilities to support international clinical trials and commercialization 28 CONFIDENTIAL & PROPRIETARY © 2021
AlloVir: A Leading Innovator in Allogeneic, Off-the-Shelf, Virus-Specific T Cell Immunotherapies Clinically Large unmet need Rich Manufacturing validated and global pipeline at scale platform opportunity 29 CONFIDENTIAL & PROPRIETARY © 2021
Posoleucel: Large Addressable Patient Population for the Treatment and Prevention of Devastating Viral Diseases Annual Commercial Opportunity for Posoleucel Additional opportunities in other immunocompromised ~148k patients ~110k ~148k Posoleucel treatment and prevention in ~38k HSCT and SOT 1 2 3 Treatment and Treatment and Total Addressable Prevention in HSCT Prevention in SOT Patient Population *Projected addressable patient population in 2025 for posoleucel indications in target markets in NA, EU, LATAM and A/P. Source: AlloVir analysis. 30 CONFIDENTIAL & PROPRIETARY © 2021 Annual Addressable Patients in 2025*
HSCT Recipients with Virus-Associated HC and Multi-Virus Infections Incur Greater Healthcare Reimbursements (Real-World Claims Analysis) 1 2,3 Allo-HCT Recipients with HC Allo-HCT Recipients with Multi-Virus Infections 1 infection 2 infections ≥3 infections No infection Mean Adjusted Total Reimbursements * With vHC Without vHC $800k $1000k $843k * * $800k $539k $571k $600k * $441k $561k $600k $426k $400k $355k $409k $400k $314k $290K $228k $200k $198k $200k $0 $0 With GVHD Without GVHD With GVHD Without GVHD *p<0.0001. Least squares mean and 95% confidence intervals are shown for the adjusted reimbursements for each patient group. All reimbursed amounts in the insurance claims up to 1-year post-transplant were reported, including those for inpatient services and admission summaries, outpatient services, and outpatient pharmaceutical dispensed claims 1. McGuirk J, et al. Transplant Cell Ther 2021;27:P505.E1-9; 2. Hill JA, et. al. Open Forum Infect Dis 2020;7:S573-4. 31 CONFIDENTIAL & PROPRIETARY © 2021
AlloVir: A Leading Innovator in Allogeneic, Off-the-Shelf, Virus-Specific T Cell Immunotherapies Clinically Large unmet need Rich Manufacturing validated and global pipeline at scale platform opportunity 4 products targeting 12 viruses Simple, non-gene-edited, Currently focused on stem cell 93% overall response rate in with both treatment and scalable process with and solid organ transplant Phase 2 study prevention potential manufacturing redundancy patients Posoleucel in 2 Phase 3 trials Expedited regulatory review Off-the-shelf delivery for patient Expanding to additional patient by end of 2021 and 2 ongoing pathways (RMAT, PRIME) access within 48 hours populations proof-of-concept studies 32 CONFIDENTIAL & PROPRIETARY © 2021
AlloVir is Led by an Experienced Management Team with a Strong Operating and Scientific Foundation Vikas Sinha, MBA Ann Leen, Ph.D. Diana Brainard, M.D. President & Chief Financial Officer Chief Scientific Officer Chief Executive Officer CFO of ElevateBio Co-Founder of AlloVir Former SVP, Head Virology, Gilead Former CFO, Alexion, Bayer Professor, BCM CAGT Jeroen van Beek, Ph.D. Ercem Atillasoy, M.D. Agustin Melian, M.D. Chief Commercial Officer Chief Regulatory & Safety Officer Chief Medical Officer Former CCO, Tricida, Former VP, Global Regulatory Affairs Former SVP, Alexion, Merck Alexion, Pfizer & Clinical Safety, Merck Dana Alexander Sonia Choi Edward Miller, J.D. SVP, CMC Operations SVP, Corporate Affairs and IR General Counsel Former VP, Operations, Former Interim Head, Public Affairs, Former SVP, Alexion, Boehringer Brammer Bio; COO, Anika Gilead Ingelheim Therapeutics 33 CONFIDENTIAL & PROPRIETARY © 2021
Key Investment Highlights Versatile engine for allogeneic, off-the-shelf, VST therapies Targeting 12 life-threatening viruses with no or limited treatments Lead product, posoleucel, with multiple target indications Rich pipeline advancing 2 additional, prioritized VSTs Catalyst-driven story Experienced management team 34 CONFIDENTIAL & PROPRIETARY © 2021
Appendix CONFIDENTIAL & PROPRIETARY © 2021 CONFIDENTIAL & PROPRIETARY © 2021
Nearly Two-Thirds of Allogeneic HSCT Recipients Have More Than One dsDNA Viral Infection Incidence of Viral Infections BKV, CMV, AdV, EBV and HHV-6 Virus 100% ≥1 80% ≥2 60% 40% ≥3 20% ≥4 0 0 10 20 30 40 50 60 70 80 90 100 Days After HSCT A 37% increase of non-relapse mortality for every log increase in viral load from Day 1–100 in allogeneic HSCT patients Hill J, et al. Blood 2017;129:2316-25 36 CONFIDENTIAL & PROPRIETARY © 2021 Cumulative Incidence Probability
Posoleucel Phase 2 Proof-of-Concept Study, CHARMS, Generated Promising Preliminary Disease Outcome and Safety Data 7 Posoleucel 2x10 cells (N=59*) 0 6 Follow-up 48 Week † Dose Clinical End of study Endpoints • Phase 2, proof-of-concept, open label study to assess the safety and clinical effects of posoleucel in allogeneic HSCT recipients with ≥1 treatment-refractory infections • Key eligibility criteria: refractory AdV, BKV, CMV, EBV, HHV-6 and/or JCV – Failure of antiviral therapy OR – Unable to tolerate standard antivirals • Study endpoint: safety • Clinical endpoints: viral load, clinical and virologic responses *Patients with partial response may receive ≤4 additional doses after 4 weeks at 2-week intervals. † The CHARMS trial treated 58 unique patients. One patient was counted twice: enrolled twice, treated first for AdV and then for JCV. One patient with HHV-6 was not evaluable for response rate 1. Tzannou I, et al. J Clin Oncol 2017;35:3547-57; 2. Tzannou I, et al. ASH 2020. Accessed January 4, 2021. https://ash.confex.com/ash/2020/webprogram/Paper143037.html. 37 CONFIDENTIAL & PROPRIETARY © 2021