Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology
company focused on innovating, developing, and delivering novel
polyclonal tumor infiltrating lymphocyte (TIL) therapies for
patients with cancer, today reported third quarter and year-to-date
2023 financial results and corporate updates.
Frederick Vogt, Ph.D., J.D., Interim President and Chief
Executive Officer of Iovance, stated, “Iovance continues to make
significant progress toward commercialization while pursuing
opportunities for our TIL therapies in additional geographies and
solid tumor cancers. The Priority Review of our BLA for lifileucel
in advanced melanoma remains on track. We are prepared to rapidly
serve the U.S. melanoma community immediately following an FDA
approval, with additional regulatory submissions commencing in the
first half of next year to expand into Europe and other
geographies. We are also excited about our lung cancer development
strategy, including positive momentum for our registrational
IOV-LUN-202 trial in advanced non-small cell lung cancer patients.
We are well positioned to execute on our regulatory, pipeline,
manufacturing, and commercial launch activities to advance our
mission to be the global leader in TIL therapy.”
Recent and Third Quarter 2023 Highlights and Corporate
Updates
Lifileucel in Advanced
MelanomaRegulatory Highlights
- The BLA Priority Review remains on track for lifileucel for
patients with advanced melanoma with a PDUFA date of February 24,
2024. Iovance continues to work with the FDA to expedite approval
of lifileucel in advance of the PDUFA date. All pre-approval
inspections of clinical sites, internal and external manufacturing,
and testing facilities have been successfully completed.
- Following lifileucel’s initial U.S. launch, Iovance’s expansion
strategy is expected to more than double the total addressable
advanced melanoma patient population for lifileucel. Iovance has
recently made significant progress toward the goal of bringing
lifileucel to new geographies:
- Following recent positive feedback from the European Medicines
Agency (EMA) on Cohorts 2 and 4 of the C-144-01 clinical trial,
Iovance plans to submit a marketing authorization application (MAA)
in the European Union for lifileucel in advanced melanoma in the
first half of 2024.
- Iovance is also engaged with the Medicines and Healthcare
products Regulatory Agency (MHRA) in the United Kingdom (U.K.) and
Health Canada. Iovance also plans to submit an MAA for lifileucel
in the U.K. and a new drug submission (NDS) in Canada in the second
half of 2024.
- Additional regulatory submissions for lifileucel are planned
for Australia and other countries with significant populations of
advanced melanoma patients.
- Patient enrollment and global site activation continue in the
registrational Phase 3 TILVANCE-301 trial to support accelerated
and full approvals of lifileucel in combination with pembrolizumab
in frontline advanced melanoma. Recent site activations include
additional U.S. sites and the first site in Australia, with
regulatory clearances obtained to open sites in the U.K. and
Canada. TILVANCE-301 is a confirmatory trial to support full
approval of lifileucel in post-anti-PD-1 advanced melanoma.
TILVANCE-301 remains on track to be well underway at the time of
potential accelerated approval for lifileucel in this initial
indication.
- A subanalysis from the C-144-01
trial of patients with advanced mucosal melanoma was presented at
the European Society for Medical Oncology (ESMO) Congress 2023,
October 20-24, 2023, Madrid, Spain. In these difficult-to-treat
patients, a confirmed objective response rate (ORR) of 50.0% was
observed, with 67% of responses ongoing at 24+ months.
Manufacturing and Commercial Preparations
- Pre-approval onboarding steps to treat melanoma patients with
lifileucel upon approval have been completed at approximately 30
ATCs. Approximately 50 ATCs are expected to be onboard within 90
days of the PDUFA date, demonstrating the strong excitement and
demand in the melanoma community for the launch of lifileucel. The
Iovance team is partnering with ATCs to build their TIL service
lines and working with payers to speed reimbursement. Iovance
expects rapid uptake of lifileucel in the U.S. market in 2024 given
the extensive commercialization, manufacturing, patient access, and
reimbursement preparations, as well as the lack of alternative
options for advanced melanoma patients. Following the ongoing
successful integration of the Proleukin® acquisition, significant
revenue increases from the Proleukin® business are also expected in
2024.
- To date, more than 600 patients have been treated with Iovance
TIL therapy manufactured using proprietary Iovance processes, with
a manufacturing success rate of more than 90%.
- The Iovance Cell Therapy Center (iCTC) is currently
manufacturing TIL therapies for clinical trials while executing
activities to support BLA review in preparation for initiating
commercial supply. The iCTC facility currently has annual
capacity to supply TIL therapies for 2,000+ patients, with
buildable shell space to ultimately supply TIL therapies for 5,000+
patients. Iovance also has additional contract manufacturing
flexibility and capacity to meet potential commercial and clinical
demand.
Iovance TIL Therapy in Advanced Non-Small Cell Lung
Cancer (NSCLC)
- Registrational Phase 2 Trial IOV-LUN-202 in
Post-Anti-PD-1 NSCLC: Enrollment in IOV-LUN-202 is ongoing
at more than 40 clinical sites in
the U.S., Canada, and Europe, and is on track
to be completed in the second half of 2024. There is strong
physician interest and momentum for center participation following
the positive preliminary data analysis and FDA regulatory feedback
that the design of the single-arm IOV-LUN-202 trial may be
acceptable for approval of LN-145 TIL therapy in post-anti-PD-1
NSCLC.
- NSCLC Clinical Trial Regulatory Update:
Iovance is planning to meet with the FDA in early 2024 to discuss a
potential registrational trial of lifileucel in combination with
pembrolizumab after standard of care chemotherapy to serve as the
confirmatory trial for IOV-LUN-202 in post-anti-PD-1 melanoma and
to support accelerated approval in frontline advanced NSCLC.
- Iovance TIL Therapy in Combination with Anti-PD-1 in
Frontline Advanced NSCLC: Detailed results from Cohort 3A
of the IOV-COM-202 clinical trial, exploring TIL in combination
with pembrolizumab in anti-PD-1 naïve advanced NSCLC patients, were
presented at an oral session during the IASLC 2023 World Congress
on Lung Cancer (WCLC 2023).
Iovance TIL Therapy in Endometrial Cancer
- Iovance is expanding its robust clinical portfolio with a new
TIL therapy program in post-anti-PD-1 and post-chemotherapy
advanced endometrial cancer. Advanced endometrial cancer represents
a significant opportunity for TIL therapy, with no currently
approved therapies in the emerging second-line setting,
post-anti-PD1 therapy and chemotherapy. A Phase 1/2 study in
mismatch repair (MMR) deficient and MMR proficient patient
populations is expected to commence in the first half of 2024. More
than 10,000 women are expected to die in the U.S. in 2023 from
endometrial cancer, representing a significant patient population
with unmet medical need.1
Additional Pipeline Highlights
- Additional clinical trials of Iovance TIL therapies include
IOV-GM1-201 to investigate PD-1 inactivated TIL therapy
(IOV-4001) in previously treated advanced melanoma or NSCLC as well
as pivotal Cohort 2 in the ongoing C-145-04 trial of
lifileucel to support a BLA in cervical cancer following
progression on or after chemotherapy and pembrolizumab.
- A novel interleukin-2 (IL-2) analog (IOV-3001) is in
Investigational New Drug (IND)-enabling studies supporting its use
as part of the TIL treatment regimen following TIL infusion.
- Additional research and preclinical
studies are exploring approaches to increase TIL potency using
CD39/69 double negative TILs and stable gene incorporation
enhancements such as tethered cytokines.
Corporate Updates
- As of September 30, 2023, Iovance’s unaudited cash position is
approximately $427.8 million. Following strategic portfolio
prioritization, as well as completion of many one-time commercial
and manufacturing readiness activities, quarterly and annual
operating expenses are expected to be reduced in the remainder of
2023 and 2024, while continuing all key clinical programs and
utilizing internal manufacturing capabilities.
- Iovance currently owns more than 60 granted or
allowed U.S. and international patents for 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. More information on Iovance’s patent
portfolio is available on the Intellectual Property page
on www.iovance.com.
Third Quarter and Year-to-Date Financial
Results
Iovance had $427.8 million in cash, cash equivalents,
investments and restricted cash at September 30, 2023, compared to
$478.3 million at December 31, 2022. The combined net proceeds in
the third quarter of 2023 from the Company’s public offering in
July 2023 and the at-the market (ATM) equity financing facility
were approximately $203.2 million. The current cash position and
anticipated revenue in 2024 from lifileucel and Proleukin® is
expected to be sufficient to fund current and planned operations
into 2025.
Net loss for the third quarter ended September 30,
2023, was $113.8 million, or $0.46 per share,
compared to a net loss of $99.6 million, or $0.63 per share,
for the third quarter ended September 30, 2022. Net loss
for the nine months ended September 30, 2023, was $327.7 million,
or $1.44 per share, compared to a net loss of $290.6 million, or
$1.85 per share, for the same period ended September 30, 2022.
Revenue for the third quarter and nine months ended September
30, 2023, was $0.5 million and $0.7 million, respectively, and
comprised of product sales following the Proleukin® acquisition in
May 2023. There was no revenue for the third quarter and nine
months ended September 30, 2022. Cost of sales for the third
quarter and nine months ended September 30, 2023, was $4.3 million
and $6.4 million, respectively, and comprised of cost of inventory
associated with sales of Proleukin® as well as $4.0 million and
$5.9 million, respectively, of non-cash amortization expenses of
the acquired intangible asset for developed technology. There was
no cost of revenues for the third quarter and nine months ended
September 30, 2022.
Research and development expenses were $87.5
million for the third quarter ended September 30, 2023,
an increase of $15.0 million compared to $72.5
million for the same period ended September 30, 2022.
Research and development expenses were $256.6 million for the nine
months ended September 30, 2023, an increase of $42.4 million
compared to $214.2 million for the same period ended September 30,
2022.
The increases in research and development expenses in the third
quarter and the nine months ended September 30, 2023, over the
prior year periods were primarily attributable to growth of the
internal research and development team, as well as higher costs
related to facilities and the initiation of new clinical trials,
including the Phase 3 TILVANCE trial, which were partially offset
by a decrease in stock-based compensation expense.
Selling, general and administrative expenses were $27.0
million for the third quarter ended September 30, 2023, a
decrease of $0.9 million compared to $27.9
million for the same period ended September 30, 2022.
Selling, general and administrative expenses were $77.0 million for
the nine months ended September 30, 2023, a decrease of $0.6
million compared to $77.6 million for the same period ended
September 30, 2022.
The decrease in selling, general and administrative expenses in
the third quarter and the nine months ended September 30, 2023,
compared to prior year periods was primarily attributable to the
decrease in stock-based compensation expense and other costs
related to the timing of spend compared to the prior year period,
including marketing, advertising, and legal costs, partially offset
by costs associated with the growth in the overall
business. For additional information, please see the Company’s
Selected Condensed Consolidated Balance Sheet and Statement of
Operations below.
Webcast and Conference CallTo participate in
the conference call Q&A and live audio webcast, please register
at
https://register.vevent.com/register/BIfd1787749ef747f19a491cb371d60fab.
To listen to the live or archived webcast, please register at
https://edge.media-server.com/mmc/p/n9gmq93h. The live and archived
webcast can be accessed in the Investors section of the Company’s
website, IR.Iovance.com. The archived webcast will be available for
one year.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics 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. Our lead late-stage TIL product candidate,
lifileucel for metastatic melanoma, has the potential to become the
first approved one-time cell therapy for a solid tumor cancer. The
Iovance TIL platform has demonstrated promising clinical data
across multiple solid tumors. 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.
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”). All such written or oral statements made in
this press release, other than statements of historical fact, are
forward-looking statements and are intended to be covered by the
safe harbor for forward-looking statements provided by 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 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
effects of the COVID-19 pandemic; risks related to the timing of
and our ability to successfully develop, submit, obtain, or
maintain U.S. Food and Drug Administration (“FDA”), European
Medicines Agency (“EMA”), or other regulatory authority approval
of, or other action with respect to, our product candidates, and
our ability to successfully commercialize any product candidates
for which we obtain FDA, EMA, or other regulatory authority
approval; 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 the
prior pre-BLA meeting with the FDA and/or regarding our prior
meetings with the FDA regarding our NSCLC clinical trials); the
risk that the FDA, EMA, or other regulatory authorities may not
approve or may delay approval for our BLA submission for lifileucel
in metastatic melanoma; the acceptance by the market of our product
candidates and their potential reimbursement by payors, if
approved, in the U.S. and other international markets; our ability
or inability to manufacture our therapies using third party
manufacturers or our own facility may adversely affect our
potential 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 may not generate sufficient revenue from product sales,
and we may not become profitable in the near term, or at all; the
risk that unanticipated expenses may decrease our estimated cash
balances and forecasts and increase our estimated capital
requirements; and other factors, including general economic
conditions and regulatory developments, not within our control.
IOVANCE BIOTHERAPEUTICS,
INC.Selected Condensed Consolidated Balance
Sheets(in thousands) |
|
September 30,
2023(unaudited) |
|
December 31,2022 |
Cash, cash equivalents, and investments |
$ |
361,374 |
|
$ |
471,845 |
Restricted cash |
$ |
66,430 |
|
$ |
6,430 |
Total assets |
$ |
852,315 |
|
$ |
663,982 |
Stockholders' equity |
$ |
674,008 |
|
$ |
499,638 |
Condensed Consolidated Statements of
Operations(unaudited; in thousands, except per share
information) |
|
For the Three Months Ended |
|
For the Nine Months Ended |
|
September 30, |
|
September 30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
Revenue |
|
|
|
|
|
|
|
|
|
|
|
Product revenue |
$ |
469 |
|
$ |
— |
|
$ |
707 |
|
$ |
— |
Total revenue |
|
469 |
|
|
— |
|
|
707 |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
Costs and
expenses* |
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
$ |
4,340 |
|
$ |
— |
|
$ |
6,390 |
|
$ |
— |
Research and development |
|
87,526 |
|
|
72,502 |
|
|
256,607 |
|
|
214,208 |
Selling, general and administrative |
|
26,964 |
|
|
27,893 |
|
|
77,013 |
|
|
77,634 |
Total costs and expenses |
|
118,830 |
|
|
100,395 |
|
|
340,010 |
|
|
291,842 |
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(118,361) |
|
|
(100,395) |
|
|
(339,303) |
|
|
(291,842) |
Other
income |
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
3,358 |
|
|
777 |
|
|
9,925 |
|
|
1,268 |
Net Loss before income
taxes |
$ |
(115,003) |
|
$ |
(99,618) |
|
$ |
(329,378) |
|
$ |
(290,574) |
Income tax benefit |
|
1,243 |
|
|
— |
|
|
1,720 |
|
|
— |
Net Loss |
$ |
(113,760) |
|
$ |
(99,618) |
|
$ |
(327,658) |
|
$ |
(290,574) |
Net Loss Per Share of
Common Stock, Basic and Diluted |
$ |
(0.46) |
|
$ |
(0.63) |
|
$ |
(1.44) |
|
$ |
(1.85) |
Weighted-Average
Shares of Common Stock Outstanding, Basic and Diluted |
|
245,817 |
|
|
157,817 |
|
|
228,115 |
|
|
157,404 |
|
|
|
|
|
|
|
|
|
|
|
|
*Includes stock-based
compensation as follows: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
8,787 |
|
$ |
11,272 |
|
$ |
27,036 |
|
$ |
38,863 |
Selling, general and administrative |
|
7,034 |
|
|
8,508 |
|
|
21,190 |
|
|
25,650 |
Total stock-based compensation included in costs and expenses |
$ |
15,821 |
|
$ |
19,780 |
|
$ |
48,226 |
|
$ |
64,513 |
CONTACTS
Iovance Biotherapeutics, Inc.:Sara Pellegrino,
IRCSVP, Investor Relations & Corporate
Communications650-260-7120 ext. 264Sara.Pellegrino@iovance.com
Jen SaundersDirector, Investor Relations & Public
Relations267-485-3119Jen.Saunders@iovance.com
1 American Cancer Statistics. Key Statistics for Endometrial
Cancer,
https://www.cancer.org/cancer/endometrial-cancer/about/key-statistics.html.
Iovance Biotherapeutics (NASDAQ:IOVA)
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Iovance Biotherapeutics (NASDAQ:IOVA)
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