Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial
biotechnology company focused on innovating, developing, and
delivering novel polyclonal tumor infiltrating lymphocyte (TIL)
therapies for patients with cancer, today reported first quarter
2024 financial results and corporate updates.
Frederick Vogt, Ph.D., J.D., Interim President and Chief
Executive Officer of Iovance, stated, “The first quarter of 2024
was transformative for Iovance following our first FDA approval and
our strong start for the U.S. commercial launch of Amtagvi™ for
patients with advanced melanoma. Immediate demand for Amtagvi is
very high and continues to significantly increase across initial
ATCs. As of today, more than 100 patients have already enrolled for
Amtagvi therapy. We have successfully manufactured and delivered
Amtagvi to many ATCs where commercial patients are being treated.
We expect our launch momentum to remain strong and continue to
build as we ramp up the U.S. launch throughout 2024 with the
authorization of additional ATCs. We also continue to execute
across our broad clinical pipeline. As a fully integrated company,
Iovance is well positioned to remain the global leader in
innovating, developing, and delivering TIL cell therapy for
patients with cancer.”
Recent and First Quarter 2024 Highlights and Corporate
Updates
Amtagvi™ (Lifileucel) U.S. Approval and Launch
Highlights in Advanced Melanoma
- The U.S. FDA approved Amtagvi (lifileucel) on February 16,
2024, as the first treatment option for advanced melanoma after
anti-PD-1 and targeted therapy. Amtagvi is also the first and
only FDA-approved T cell therapy for a solid tumor indication.
- Since approval, more than 100 patients have enrolled for
Amtagvi therapy. The first patients have been successfully treated
and the balance are moving through the stages of the journey, which
includes surgery for cell collection, manufacturing, and the
Amtagvi treatment regimen.
- Onboarding is complete at more than 40 U.S. ATCs, up from 30
initial ATCs at approval. Iovance remains on track to onboard
approximately 50 ATCs by the end of May 2024 and expects to have
more than 70 ATCs onboarded by the end of 2024.
- Manufacturing turnaround time has been on-target with initial
launch expectations of approximately 34 days from inbound to return
shipment to ATCs. The commercial manufacturing experience to date
is consistent with prior clinical experience.
- The U.S. launch of Amtagvi, and additional sales of Proleukin®
used with the treatment regimen, are expected to drive significant
revenue for Iovance in 2024.
- Amtagvi was added as a preferred second-line or subsequent
therapy in the National Comprehensive Cancer Network® guidelines
for treatment of cutaneous melanoma.
- Reimbursement remains strong and on track at the ATCs with
progress toward coverage policies successful in many cases. As
anticipated, more than 75% of enrolled Amtagvi patients are covered
by private payers. To date, payers covering more than 200 million
lives have already authorized Amtagvi treatment for their patients,
setting a strong precedent for reimbursement success.
Lifileucel Launch Expansion into New Markets and
Indications
- Geographic expansion can more than double the total addressable
patient population for Amtagvi in advanced melanoma. Regulatory
dossiers remain on track for submission in the following markets
with significant populations of advanced melanoma patients:
- EU in the second quarter of 2024
- UK and Canada in the second half of 2024
- Australia and additional countries in 2025
Iovance TIL Cell Therapy Pipeline
Highlights
- Lifileucel in Frontline Advanced Melanoma
- The registrational Phase 3 TILVANCE-301 trial is well underway
to support accelerated and full U.S. approvals of Amtagvi in
combination with pembrolizumab in frontline advanced melanoma as
well as regular approval of Amtagvi in post-anti-PD-1
melanoma.
- Global site activation and patient enrollment continue with
strong momentum in the U.S., Europe, Australia, Canada, and
additional countries.
- An oral presentation of updated clinical data from Cohort 1A of
the IOV-COM-202 trial, which strongly supports the rationale for
TILVANCE-301 and the frontline melanoma opportunity, will be
presented at the American Society of Clinical Oncology (ASCO)
Annual Meeting on May 31, 2024.
- Lifileucel in Non-Small Cell Lung Cancer
(NSCLC)
- Enrollment resumed for new patients in the IOV-LUN-202
registrational Phase 2 trial in post-anti-PD-1 NSCLC soon after the
U.S. FDA lifted a partial clinical hold in the first quarter. The
IOV-LUN-202 trial includes clinical sites in the U.S., Canada, and
Europe, with plans to include additional regions with strong track
records for enrollment in lung cancer studies over the next few
months. Enrollment has restarted with high demand and the
registrational cohorts are expected to be fully enrolled in
2025.
- At a recent Type D meeting, the FDA provided positive
regulatory feedback on the proposed potency matrix for lifileucel
in NSCLC. The FDA previously provided positive regulatory feedback
that the design of the single-arm IOV-LUN-202 trial may be
acceptable for approval of lifileucel in post-anti-PD-1 NSCLC.
- Lifileucel in Endometrial Cancer
- A Phase 2 trial of lifileucel in advanced endometrial cancer
patients is on track to initiate in the second quarter of 2024. The
trial will enroll patients with advanced endometrial cancer who
progressed after platinum-based chemotherapy and anti-PD-(L)1
therapy regardless of mismatch repair (MMR) status. This clinical
program and trial design are supported by preclinical and
manufacturing success data to be presented at a conference in 2024
and has received positive feedback from gynecological oncology
experts.
- In 2024, an estimated 67,880 new cases of uterine cancer
(>90% of which are endometrial cancer) are expected to be
diagnosed, with 13,250 deaths expected in the US.1 There are no
currently approved therapies in the emerging second-line setting
after frontline post-anti-PD1 therapy and chemotherapy. Endometrial
cancer represents a significant opportunity for TIL cell therapy to
address an additional unmet medical need in the post-anti-PD-1
treatment setting and may address both MMR deficient and proficient
patients.
- Next Generation TIL Pipeline
- IOV-4001 (PD-1 Inactivated TIL Cell Therapy):
The Phase 1 safety portion concluded in the first in human
IOV-GM1-201 trial to investigate PD-1 inactivated TIL cell
therapy (IOV-4001) in previously treated advanced melanoma and
NSCLC, and the trial is progressing successfully into the
multi-center Phase 2 efficacy stage. Iovance continues to utilize
the TALEN® technology licensed from Cellectis to develop other
investigational gene-edited TIL cell therapies with multiple
knockout targets to potentially improve efficacy.
- Next Generation IL-2 for TIL Treatment
Regimen: Iovance plans to submit an Investigational New
Drug application (IND) for a Phase 1/2 clinical trial of IOV-3001,
a modified interleukin-2 (IL-2) fusion protein, for use in the TIL
therapy treatment regimen in the third quarter of 2024. Results
from non-human primate and IND-enabling studies of IOV-3001 will be
presented in a poster at ASCO 2024 and demonstrate the potential
for improved safety with strong effector T cell expansion.
- Next Generation, Cytokine-Tethered TIL
Therapy: A genetically engineered, inducible, and tethered
IL-12 TIL cell therapy, designated IOV-5001, is in IND-enabling
studies. In preclinical studies, IOV-5001 augmented anti-tumor
activity in vitro, and a clinical trial of a prior generation IL-12
TIL therapy at the National Cancer Institute showed improved
efficacy. An INTERACT meeting is planned with the FDA to discuss
IOV-5001 in the third quarter of 2024, followed by an IND
submission in early 2025.
Manufacturing Capacity Expansion
- The Iovance Cell Therapy Center (iCTC), and a nearby
FDA-approved contract manufacturer, are built today for capacity
for several thousands of patients annually. Capacity expansion is
currently underway at iCTC to supply TIL cell therapies for more
than 5,000 patients annually in the next few years.
Upcoming ASCO 2024 Highlights for Iovance
- Oral Presentation: Efficacy and safety of lifileucel, an
autologous tumor-infiltrating lymphocyte cell therapy, and
pembrolizumab in patients with immune checkpoint inhibitor-naive
unresectable or metastatic melanoma: updated results from
IOV-COM-202 Cohort 1A
- Session: Melanoma/Skin Cancers, Friday, May 31, 2024, 2:45 -
5:45 p.m. CDT
- Poster: IOV-3001, a modified interleukin-2 fusion protein, for
potential use in tumor-infiltrating lymphocyte cell therapy
regimens
- Session: Developmental Therapeutics – Immunotherapy - Saturday,
June 1, 2024; 9:00 a.m. – 12:00 p.m. CDT
- Poster: Dynamics of circulating cytokines and chemokines during
and after tumor-infiltrating lymphocyte cell therapy with
lifileucel in advanced melanoma patients
- Session: Melanoma/Skin Cancers: Saturday, June 1, 2024,
1:30-4:30 p.m. CDT
Corporate Updates
- As of March 31, 2024, Iovance had cash, cash equivalents,
investments, and restricted cash of approximately $362.6 million,
compared to $346.3 million at December 31, 2023. The current cash
position and anticipated revenue from Amtagvi and Proleukin are
expected to be sufficient to fund current and planned operations
well into the second half of 2025.
- Iovance is now recognizing all Proleukin revenues for
commercial and clinical use and has recently commenced significant
sales to distributors. In the first quarter of 2024, Iovance
completed the transfer of marketing authorizations and began
distribution of Proleukin. Beginning in the second quarter of 2024,
Iovance expects to recognize significant incremental revenues for
Proleukin as part of the Amtagvi treatment regimen.
- Iovance currently owns more than 120 granted or
allowed U.S. and international patents for TIL-related
technologies, including TIL compositions and methods of treatment
and manufacturing in a broad range of cancers, with Gen 2 patent
rights expected to provide exclusivity into 2038 and additional
patent rights, including patents related to potency assays expected
to provide exclusivity into 2042. More information on Iovance’s
patent portfolio is available on the Intellectual Property page
on www.iovance.com.
First quarter 2024 Financial Results
Net loss for the first quarter ended March 31, 2024, was $113.0
million, or $0.42 per share, compared to a net loss of $107.4
million, or $0.50 per share, for the first quarter ended March 31,
2023. The net loss for the first quarter 2024 includes amortization
of intangible assets acquired as part of the Proleukin
transaction.
Revenue for the first quarter ended March 31, 2024, was $0.7
million from sales of Proleukin® in licensed markets outside of the
U.S. Cost of sales was $7.3 million, primarily related to
inventoriable costs associated with sales of Proleukin and non-cash
amortization expense for the acquired intangible asset for
developed technology during the first quarter of 2024. No revenue
or cost of sales were incurred for the first quarter ended March
31, 2023.
Research and development expenses were $79.8 million for the
first quarter ended March 31, 2024, a decrease of $2.9 million
compared to $82.7 million for the first quarter of 2023. The
decrease was primarily attributable to the transition to commercial
Amtagvi manufacturing in the most recent quarter, partially offset
by increased costs associated with the purchases of raw materials,
clinical trials driven primarily by the Phase 3 TILVANCE-301
clinical trial, and the planned EU regulatory submissions for
lifileucel.
Selling, general and administrative expenses were $31.4 million
for the first quarter ended March 31, 2024, an increase of $3.3
million compared to $28.1 million for the first quarter of 2023.
The increase was primarily attributable to increases in headcount
and related costs, including stock-based compensation, to support
the growth in the overall business and related corporate
infrastructure, as well as costs incurred to support the
commercialization of Amtagvi and Proleukin, partially offset by a
decrease in legal costs.
For additional information, please see the Company’s Selected
Condensed Consolidated Balance Sheet and Statement of Operations
below.
Webcast and Conference Call To
listen to the live or archived audio webcast, please register
at https://edge.media-server.com/mmc/p/m4tigan7. The live and
archived webcast can be accessed in the Investors section of the
Company’s website, IR.Iovance.com for one year.
1. National Cancer Institute Surveillance, Epidemiology and End
Results (SEER) Program. 2024 Estimates. https://seer.cancer.gov
About Iovance
Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. aims to be the global leader in
innovating, developing, and delivering tumor infiltrating
lymphocyte (TIL) therapies for patients with cancer. We are
pioneering a transformational approach to cure cancer by harnessing
the human immune system’s ability to recognize and destroy diverse
cancer cells in each patient. The Iovance TIL platform has
demonstrated promising clinical data across multiple solid tumors.
Iovance’s Amtagvi™ is the first FDA-approved T cell therapy for a
solid tumor indication. We are committed to continuous innovation
in cell therapy, including gene-edited cell therapy, that may
extend and improve life for patients with cancer. For more
information, please visit www.iovance.com.
Amtagvi™ and its accompanying design marks, Proleukin®,
Iovance®, and IovanceCares™ are trademarks and registered
trademarks of Iovance Biotherapeutics, Inc. or its
subsidiaries. All other trademarks and registered trademarks are
the property of their respective owners.
Forward-Looking Statements
Certain matters discussed in this press release are
“forward-looking statements” of Iovance Biotherapeutics, Inc.
(hereinafter referred to as the “Company,” “we,” “us,” or “our”)
within the meaning of the Private Securities Litigation Reform Act
of 1995 (the “PSLRA”). Without limiting the foregoing, we may, in
some cases, use terms such as “predicts,” “believes,” “potential,”
“continue,” “estimates,” “anticipates,” “expects,” “plans,”
“intends,” “forecast,” “guidance,” “outlook,” “may,” “could,”
“might,” “will,” “should,” or other words that convey uncertainty
of future events or outcomes and are intended to identify
forward-looking statements. Forward-looking statements are based on
assumptions and assessments made in light of management’s
experience and perception of historical trends, current conditions,
expected future developments, and other factors believed to be
appropriate. Forward-looking statements in this press release are
made as of the date of this press release, and we undertake no duty
to update or revise any such statements, whether as a result of new
information, future events, or otherwise. Forward-looking
statements are not guarantees of future performance and are subject
to risks, uncertainties, and other factors, many of which are
outside of our control, that may cause actual results, levels of
activity, performance, achievements, and developments to be
materially different from those expressed in or implied by these
forward-looking statements. Important factors that could cause
actual results, developments, and business decisions to differ
materially from forward-looking statements are described in the
sections titled "Risk Factors" in our filings with the U.S.
Securities and Exchange Commission, including our most recent
Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and
include, but are not limited to, the following substantial known
and unknown risks and uncertainties inherent in our business: the
risks related to our ability to successfully commercialize our
products, including Amtagvi, for which we have obtained U.S. Food
and Drug Administration (“FDA”) approval, and Proleukin, for which
we have obtained FDA and European Medicines Agency (“EMA”)
approval; the risk that the EMA or other ex-U.S. regulatory
authorities may not approve or may delay approval for our marketing
authorization application submission for lifileucel in metastatic
melanoma; the acceptance by the market of our products, including
Amtagvi and Proleukin, and their potential pricing and/or
reimbursement by payors, if approved (in the case of our product
candidates), in the U.S. and other international markets and
whether such acceptance is sufficient to support continued
commercialization or development of our products, including Amtagvi
and Proleukin, or product candidates, respectively; the risk
whether the number of patients treated and/or ATCs is an
appropriate measure of commercial success and/or recognized
revenue; future competitive or other market factors may adversely
affect the commercial potential for Amtagvi or Proleukin; the risk
regarding our ability or inability to manufacture our therapies
using third party manufacturers or at our own facility, including
our ability to increase manufacturing capacity at such third party
manufacturers and our own facility, may adversely affect our
commercial launch; the results of clinical trials with
collaborators using different manufacturing processes may not be
reflected in our sponsored trials; the risk regarding the
successful integration of the recent Proleukin acquisition; the
risk that the successful development or commercialization of our
products, including Amtagvi and Proleukin, may not generate
sufficient revenue from product sales, and we may not become
profitable in the near term, or at all; the risks related to the
timing of and our ability to successfully develop, submit, obtain,
or maintain FDA, EMA, or other regulatory authority approval of, or
other action with respect to, our product candidates; whether
clinical trial results from our pivotal studies and cohorts, and
meetings with the FDA, EMA, or other regulatory authorities may
support registrational studies and subsequent approvals by the FDA,
EMA, or other regulatory authorities, including the risk that the
planned single arm Phase 2 IOV-LUN-202 trial may not support
registration; preliminary and interim clinical results, which may
include efficacy and safety results from ongoing clinical trials or
cohorts may not be reflected in the final analyses of our ongoing
clinical trials or subgroups within these trials or in other prior
trials or cohorts; the risk that enrollment may need to be adjusted
for our trials and cohorts within those trials based on FDA and
other regulatory agency input; the risk that the changing landscape
of care for cervical cancer patients may impact our clinical trials
in this indication; the risk that we may be required to conduct
additional clinical trials or modify ongoing or future clinical
trials based on feedback from the FDA, EMA, or other regulatory
authorities; the risk that our interpretation of the results of our
clinical trials or communications with the FDA, EMA, or other
regulatory authorities may differ from the interpretation of such
results or communications by such regulatory authorities (including
from our prior meetings with the FDA regarding our non-small cell
lung cancer clinical trials); the risk that clinical data from
ongoing clinical trials of Amtagvi will not continue or be repeated
in ongoing or planned clinical trials or may not support regulatory
approval or renewal of authorization; the risk that unanticipated
expenses may decrease our estimated cash balances and forecasts and
increase our estimated capital requirements; the effects of the
COVID-19 pandemic; and other factors, including general economic
conditions and regulatory developments, not within our control.
IOVANCE BIOTHERAPEUTICS, INC. |
Selected Condensed Consolidated Balance
Sheets |
(in thousands) |
|
|
|
|
|
|
|
|
|
|
March 31, 2024(unaudited) |
|
December 31, 2023 |
|
Cash, cash equivalents, and investments |
|
$ |
356,195 |
|
|
$ |
279,867 |
|
|
Restricted cash |
|
$ |
6,430 |
|
|
$ |
66,430 |
|
|
Total assets |
|
$ |
869,830 |
|
|
$ |
780,351 |
|
|
Stockholders' equity |
|
$ |
680,024 |
|
|
$ |
584,613 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Statements of
Operations |
(Unaudited, in thousands, except per share
information) |
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended |
|
|
|
March 31, |
|
|
|
|
2024 |
2023 |
|
Revenue |
|
|
|
|
|
|
|
Product revenue |
|
$ |
715 |
|
|
$ |
— |
|
|
Total revenue |
|
|
715 |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
Costs and
expenses* |
|
|
|
|
|
|
|
Cost of sales |
|
$ |
7,261 |
|
|
$ |
— |
|
|
Research and development |
|
|
79,783 |
|
|
|
82,734 |
|
|
Selling, general and administrative |
|
|
31,393 |
|
|
|
28,122 |
|
|
Total costs and expenses |
|
|
118,437 |
|
|
|
110,856 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(117,722 |
) |
|
|
(110,856 |
) |
|
Other
income |
|
|
|
|
|
|
|
Interest income, net |
|
|
3,338 |
|
|
|
3,486 |
|
|
Net loss before income
taxes |
|
$ |
(114,384 |
) |
|
$ |
(107,370 |
) |
|
Income tax benefit |
|
|
1,408 |
|
|
|
— |
|
|
Net Loss |
|
$ |
(112,976 |
) |
|
$ |
(107,370 |
) |
|
|
|
|
|
|
|
|
|
Net Loss Per Share of
Common Stock, Basic and Diluted |
|
$ |
(0.42 |
) |
|
$ |
(0.50 |
) |
|
|
|
|
|
|
|
|
|
Weighted Average
Shares of Common Stock Outstanding, Basic and Diluted |
|
|
266,220 |
|
|
|
213,694 |
|
|
|
|
|
|
|
|
|
|
*Includes stock-based
compensation as follows: |
|
|
|
|
|
|
|
Research and development |
|
$ |
8,915 |
|
|
$ |
8,859 |
|
|
Selling, general and administrative |
|
|
8,263 |
|
|
|
6,806 |
|
|
Total stock-based
compensation included in costs and expenses |
|
$ |
17,178 |
|
|
$ |
15,665 |
|
|
|
|
|
|
|
|
|
|
CONTACTS
Iovance Biotherapeutics, Inc.: Sara
Pellegrino, IRC SVP, Investor Relations & Corporate
Communications 650-260-7120 ext.
264 Sara.Pellegrino@iovance.com
Jen Saunders Senior Director, Investor Relations &
Corporate
Communications 267-485-3119 Jen.Saunders@iovance.com
Grafico Azioni Iovance Biotherapeutics (NASDAQ:IOVA)
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Grafico Azioni Iovance Biotherapeutics (NASDAQ:IOVA)
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Da Dic 2023 a Dic 2024