On this page of StockholderLetter.com we present the latest annual shareholder letter from IOVANCE BIOTHERAPEUTICS, INC. — ticker symbol IOVA. Reading current and past IOVA letters to shareholders can bring important insights into the investment thesis.

 •  4/30/2025 Letter Continued (Full PDF)
 •  4/27/2023 IOVA Stockholder Letter
 •  5/1/2024 IOVA Stockholder Letter
 •  More "Biotechnology" Category Stockholder Letters
 •  IOVA Benford's Law Stock Score = 88

IOVA Shareholder/Stockholder Letter Transcript:

ANNUAL
REPORT
24

Dear Iovance
Biotherapeutics
Shareholders,
2024 was a monumental
year for Iovance.
We transitioned to a commercial
company with two approved products
following the U.S. Food and Drug
Administration (FDA) approval of
Amtagvi   (lifileucel) on February 16,
2024. Amtagvi is the first treatment
option for advanced melanoma after
anti-PD-1 and targeted therapy, as
well as the first FDA-approved T cell
therapy for a solid tumor cancer. We
also advanced our robust development
pipeline as we continue to pursue our
vision to pioneer a transformational
approach to cure cancer by harnessing
the human immune system   s ability to
recognize and destroy diverse cancer
cells in each patient.
Our strong team and fully integrated infrastructure position
Iovance to drive continued adoption of Amtagvi and sales
growth for Proleukin in the U.S. and beyond. We have made
tremendous strides in building a broad treatment network.
After launching with 30 authorized treatment centers (ATCs)
at FDA approval, we achieved our goal of approximately 70
ATCs across 32 states by year end 2024. Nearly all addressable
patients currently live within 200 miles of an ATC. Iovance
field teams are actively engaging current and potential ATCs,
including top community oncologists and large community
practices, with a focus on high volume markets, to help drive
patients to ATCs.
At the end of 2024, more than 200 patients were treated
with Amtagvi during the first three quarters of launch and
to date more than 1,000 patients have received Iovance TIL
cell therapies across commercial and clinical settings. In the
coming year, we expect to treat hundreds of additional patients
as new and existing ATCs ramp up adoption and our clinical
trials enroll more patients.
Globally, Amtagvi may address more than approximately
30,000 melanoma patients annually in the U.S. and our initial
targeted international markets as the first and only approved
therapy for the treatment of adult patients with advanced
melanoma previously treated with a PD-1 and targeted
therapy. Three regulatory dossiers are currently under review
for potential approvals in the United Kingdom, Canada and
the European Union in 2025. To expand the Amtagvi market
opportunity into frontline advanced melanoma, we continued
to enroll patients in North America, Europe and Asia Pacific in
our global randomized TILVANCE-301 trial.
We have the manufacturing capabilities to deliver TIL cell
therapy to patients in the U.S. and around the world. Solid
tumors represent more than 90% of all cancers diagnosed
in the U.S. Lifileucel clinical programs are proceeding in
advanced non-small cell lung cancer (NSCLC) across various
patient populations and treatment settings. Our registrational

Phase 2 trial, IOV-LUN-202, is designed to support a
regulatory decision for U.S. accelerated approval of lifileucel
in 2027 in advanced NSCLC following standard of care chemoimmunotherapy. We are also excited about our Phase 2 trial of
lifileucel in advanced endometrial cancer, which presents
a significant opportunity for TIL cell therapy in the
emerging second-line setting, post-anti-PD1
therapy and chemotherapy.
Looking ahead, Iovance is poised to lead
next generation approaches to optimize
TIL cell therapy by applying our experience
in clinical development, industry-leading
scalable manufacturing and achieving
the first U.S. regulatory approval of a
cell therapy for a solid tumor cancer. For
example, we are enrolling in the first-inhuman trial of our first genetically modified
Iovance TIL therapy, IOV-4001. We are also
treating patients in a Phase 1/2 clinical trial of
our next generation IL-2 candidate, IOV-3001.
In addition, IOV-5001, a genetically engineered,
inducible, and tethered IL-12 TIL cell therapy, has the
potential to broaden applications for TIL cell therapy into
common solid tumor cancers with significant unmet need.
I am extremely proud of our organization today as we double
down on our mission to be the global leader in innovating,
developing and delivering TIL cell therapy. We are motivated
everyday by the hope we offer to patients with advanced
melanoma and other solid tumor cancers. More than 1,000
Iovance employees collectively represent a breadth and depth
of experience in developing and commercializing cell and
gene therapy as well as diversity in thought, background and
experience. As we continue to grow, we remain committed
to building and supporting a diverse workforce and a strong
corporate culture. As always, I am grateful for our dedicated
employees, clinical investigators, Amtagvi ATC teams,
collaboration partners, shareholders and, most importantly,
the patients and their loved ones who propel us to strive
toward our mission.
FREDERICK G. VOGT, PH.D., J.D.
Interim CEO, President, and General Counsel
   Globally, Amtagvi
may address more than
20,000 melanoma
patients annually
in the U.S. and our initial
targeted international
markets as the first and only
approved therapy for the
treatment of adult patients
with advanced melanoma
previously treated with a
PD-1 and targeted therapy.   

Amtagvi (Lifileucel) U.S. Launch
Highlights in Advanced Melanoma
Capacity Today
(as built)
up to
    The U.S. FDA approved Amtagvi (lifileucel) on February 16,
2024, as the first treatment option for patients with advanced
melanoma after anti-PD-1 and targeted therapy. Amtagvi is the
first FDA-approved T cell therapy for a solid tumor indication.
    Approximately 70 U.S. ATCs are active across 32 states and
95% of addressable patients live within 200 miles of an ATC.1
Additional U.S. ATCs will be added steadily throughout 2025,
focusing on quality ATCs with a high volume of eligible patients,
including large community practice ATCs.
2,000+
patients/yr
Site Expansion
(in progress)
5,000+
patients/yr
Manufacturing and Iovance
Cell Therapy Center (iCTC)
    > 1,000 clinical and commercial patients treated with Iovance TIL
therapy manufactured using proprietary Iovance processes1
    Currently built to supply TIL products for > 2,000 patients/year
    Expansion underway to increase capacity to > 5,000 patients/year
    Longer-term vision to support > 10,000 patients annually by
adding new facilities and further optimizing manufacturing and
testing processes
1
As of 2/27/2025
iCTC +Future
Site(s)
10,000+
patients/yr

Amtagvi    Patient Journey
Patient
Primary
Oncologist
Community
Practice
TREATMENT
Post-Regimen Follow-Up &
Return to Primary Oncologist
ATC Medical
Oncologist
Short-Course
Amtagvi    Patient Journey
Reimbursement
Approval
~3 Weeks
~34 DAYS
Lymphodepletion
Scheduling Tumor
Procurement
Goal: <2 weeks
Manufacturing,
Release & Shipment
Turnaround times will be reduced*
*Earlier time to treatment driven by faster reimbursement and scheduling, earlier lymphodepletion, and shorter turnaround for manufacturing/release as the launch continues
Solid Tumor Portfolio Highlights
INDICATION & TREATMENT SETTING
PHASE 1
PHASE 2
PHASE 3
Post-anti-PD-1 advanced melanoma (U.S.)
EMA, UK & Canada submitted
Commercial
Amtagvi treatment regimen (U.S.)
Advanced melanoma, renal cell carcinoma (U.S., ex-U.S.)
Label Expansion
Opportunities
RegistrationDirected
Lifileucel
Pipeline
NextGeneration
Products
Lifileucel + pembrolizumab
Frontline advanced melanoma
TILVANCE-301 Phase 3 (FTD, Confirmatory)
Lifileucel
Post-chemo & anti-PD-1 advanced NSCLC
IOV-LUN-202: Cohorts 1&2
Lifileucel
Post-chemo & anti-PD-1 endometrial cancer
IOV-END-201: Cohorts 1&2
Lifileucel, Lifileucel + ICI
1-4L ICI-na  ve & post-anti-PD1 advanced NSCLC
IOV-COM-202: Cohorts 3A-3E*
Lifileucel + ICI
ICI-na  ve advanced melanoma
IOV-COM-202: Cohorts 1A, 1D
Lifileucel core biopsy
2L post-chemo & post-anti-PD-1 advanced NSCLC
IOV-LUN-202: Cohort 3
PD-1 Inactivated TIL (IOV-4001)
Post anti-PD1 advanced melanoma
IOV-GM1-201: Cohort 1
PD-1 Inactivated TIL (IOV-4001)
2-4L incl. post-anti-PD-1 advanced NSCLC
IOV-GM1-201: Cohort 2
IL-2 analog (IOV-3001)
TIL treatment regimen
IOV-IL2-101
IL-12 tethered TIL (IOV-5001)
Basket trial (planned pre-IND in 2025)
Planned
*Enrollment complete in Cohort 3B
Abbreviations: 1L=first line; 2L=second line; 4L=fourth line; FTD=Fast Track Designation; ICI=immune checkpoint inhibitor; IL-2=interleukin 2; IL-12=interleukin 12; IND=investigational new drug application;
NSCLC=non-small cell lung cancer; PD-1=programmed cell death protein-1; TIL=tumor infiltrating lymphocytes
APPROVED



 4/30/2025 Letter Continued (Full PDF)