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.

 •  5/1/2024 Letter Continued (Full PDF)
 •  4/27/2023 IOVA Stockholder Letter
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 •  IOVA Benford's Law Stock Score = 90

IOVA Shareholder/Stockholder Letter Transcript:

A DECISIVE YEAR
ANNUAL
REPORT
2023

A DECISIVE YEAR
Dear Iovance
Biotherapeutics Shareholders,
2023 WAS A DECISIVE YEAR FOR IOVANCE. Throughout 2023,
we executed toward our    rst approval and commercial launch
while advancing our pipeline of novel cell therapies for cancer.
The U.S. Food and Drug Administration (FDA)
In 2024, we expect the U.S. launch to begin driving
approved Amtagvi    (li   leucel) on February 16, 2024
as the    rst treatment option for advanced melanoma
significant revenue from Amtagvi as well as Proleukin  ,
our interleukin-2 (IL-2) product used to promote T cell
after anti-PD-1 and targeted therapy. This landmark
activity following Amtagvi infusion. As part of our
approval also represents the    rst FDA-approved T cell
strategy to streamline and improve access to the TIL
therapy for a solid tumor cancer. Today, with our
treatment regimen, we acquired worldwide rights to
launch of Amtagvi, we are stepping up to start a new
Proleukin via a strategic transaction with Clinigen and
chapter of our vision to pioneer a transformational
successfully integrated the Proleukin business in 2023.
approach to cure cancer by harnessing the human
In 2024 and beyond, we expect both cost savings and
immune system   s ability to recognize and destroy
signi   cant additional revenue from Proleukin as we
diverse cancer cells in each patient.
realize the value of this strategic transaction.
I am extremely proud to lead our organization during
In parallel with its U.S. commercial launch, we are
our    rst approval and commercial launch. With a highly
actively executing our strategy to expand Amtagvi
coordinated effort, we received cells from our    rst
into new geographies and earlier treatment settings.
commercial patient and began manufacturing Amtagvi
Regulatory dossiers are planned in many additional
at our Iovance Cell Therapy Center (iCTC) within
a few short days of approval. Patients, advocates  
countries, beginning with the planned EU marketing
and healthcare providers are very excited about
of 2024. Introducing Amtagvi outside of the U.S.
the potential for Amtagvi, and there are numerous
can more than double the addressable patient
patients receiving Amtagvi treatment and many more
population while leveraging our existing manufacturing
preparing to embark on the treatment journey. With
capabilities. In addition, our global randomized
an unprecedented 30 authorized treatment centers
TILVANCE-301 trial continues to enroll patients and
at FDA approval, we are on track toward our goal
activate new sites in support of broadening our U.S.
of 50 authorized treatment centers by the end of
label to include frontline advanced melanoma.
authorization application (MAA) in the    rst half
May 2024. We expect these centers to start treating
initial patients as the earlier centers scale up their
Following the approval of Amtagvi, we continue to
efforts. Through the strength of our people and fully
develop our li   leucel cell therapy platform to address
integrated infrastructure, we are strongly positioned
a broad range of solid tumor indications, which
for a successful commercial launch and for establishing
represent more than 90% of all cancers diagnosed in
Amtagvi as standard of care after anti-PD-1 therapy in
the U.S. In 2023, we reported promising new data for
advanced melanoma.
our li   leucel clinical programs in advanced non-small

cell lung cancer (NSCLC) across various patient populations
and treatment settings. In 2024, we expect to begin a
Phase 2 trial of li   leucel in advanced endometrial cancer.
Like NSCLC, endometrial cancer represents a signi   cant
opportunity for TIL cell therapy. There are currently no
approved therapies in the emerging second-line setting,
post-anti-PD 1 therapy and chemotherapy, and TIL cell
therapy may address mismatch repair (MMR) de   cient
and MMR proficient patient populations. In addition, we
continue to explore other indications for lifileucel as we
work to expand the label of Amtagvi beyond melanoma.
Looking further ahead, Iovance is also poised to lead next
generation approaches to optimize TIL cell therapy by
   Today, with our
launch of Amtagvi,
we are stepping up to
start a new chapter of
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.   
applying several advantages gained from our experience
in TIL cell therapy clinical development, industry-leading
scalable manufacturing, and regulatory approval of
Amtagvi. For example, we are enrolling the    rst-in-human
trial of our    rst genetically modi   ed Iovance TIL therapy,
IOV-4001. We are also advancing a next generation IL-2
candidate, IOV-3001, for clinical development alongside
cytokine tethered TIL therapies based on IL-12 as well as
other genetically engineered TIL therapies.
I am extremely proud of our organization today as we
realize our mission to be the global leader in innovating,
developing and delivering TIL cell therapy. We have more
than 600 Iovance employees who collectively represent
a breadth and depth of experience in developing and
commercializing cell and gene therapy. We believe the
quality of our people is a testament to the potential of
our Iovance TIL therapy in solid tumors and our ability
to maintain leadership within the    eld. Gender, cultural,
and ethnic diversity are also represented across our
management team, Board of Directors, and overall
organization. As we continue to grow, we remain
committed to building and supporting a diverse workforce
with a deep bench of talent and a strong corporate culture.
As always, I am grateful for our dedicated employees,
clinical investigators, Amtagvi treatment center teams,
collaboration partners, shareholders, and most importantly,
the patients and their loved ones who motivate us every
single day.
Frederick G. Vogt, Ph.D., J.D.
INTERIM CEO, PRESIDENT, AND GENERAL COUNSEL

Capacity Today
(as built)
up to
2,000+
patients/yr
Manufacturing and Iovance Cell
Therapy Center (iCTC)
Site Expansion
(in progress)
5,000+
    > 700 patients treated in clinical trials with Iovance TIL therapy
manufactured using proprietary Iovance processes1
patients/yr
    Currently built to supply TIL products for > 2,000 patients annually
    Expansion underway to increase capacity to > 5,000 patients annually
    Longer-term vision to support > 10,000 patients annually by adding
new facilities and further optimizing manufacturing and testing
processes
1
iCTC +Future
Site(s)
10,000+
patients/yr
As of December 31, 2023.
Amtagvi in Frontline
Advanced Melanoma
    Patient randomization began in global Phase 3
TILVANCE-301 trial which supports registration in frontline
advanced melanoma and full approval in post-anti-PD-1
advanced melanoma.
    Frontline advanced melanoma supported by positive
results for li   leucel in combination with pembrolizumab in
anti-PD-1 naive patients.

Amtagvi    Patient Journey
1
2
4
Treatment Decision &
Reimbursement Approval
Scheduling & Tumor
Tissue Procurement
Treatment Regimen
& Monitoring
AMTAGVI starts with a piece
of the patient   s tumor tissue
Lymphodepletion
AMTAGVI    (li   leucel)
Short-Course Proleukin  
3
T Cell Therapy Manufacturing & Release Testing
TIL cells are grown into the billions in a manufacturing facility
Solid Tumor Portfolio Highlights
RegistrationDirected
Additional
Pipeline
Next
Generation
PHASE 2
CANDIDATE
INDICATIONS
PHASE 1
Li   leucel + pembro
Frontline advanced melanoma
TILVANCE-301 Phase 3
Li   leucel
2L post-chemo & post-anti-PD-1 advanced NSCLC
IOV-LUN-202: Cohorts 1 & 2
Li   leucel
Post-chemo & post-anti-PD-1 cervical
C-145-04: Cohort 2
Li   leucel + pembro
1L chemo & anti-PD-1 na  ve cervical
C-145-04: Cohort 3*
Li   leucel
2L post-chemo & post-anti-PD-1 endometrial
Planned Phase 2
Li   leucel, Li   leucel + ICI
2-4L incl. post-anti-PD-1 advanced NSCLC
IOV-COM-202: Cohorts 3A, 3B*,3C
Li   leucel + ICI
1L advanced melanoma
IOV-COM-202: Cohort 1A
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
Li   leucel Gen 3 + core biopsy
2L post-chemo & post-anti-PD-1 advanced NSCLC
IOV-LUN-202: Cohort 3
PHASE 3
Con   rmatory, FTD
BTD, ODD
*Enrollment complete
Abbreviations: 1L=   rst line; 2L=second line; 4L=fourth line; BTD=Breakthrough Therapy Designation; FTD=Fast Track Designation; ICI = immune checkpoint inhibitors; NSCLC=non-small cell lung cancer;
ODD=Orphan Drug Designation; PD-1=programmed cell death protein-1; TIL=tumor in   ltrating lymphocytes



 5/1/2024 Letter Continued (Full PDF)