Full Press Release Details
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
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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
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