Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel T cell-based cancer
immunotherapies (tumor-infiltrating lymphocyte, TIL, and
peripheral-blood lymphocyte, PBL), today reported fourth quarter
and full year 2020 financial results and corporate updates.
Dr. Maria Fardis, Ph.D., President and Chief Executive Officer
of Iovance, stated, “During 2020 we continued to advance our TIL
cell therapies in metastatic melanoma, cervical, head and neck, and
non-small cell lung cancers. We believe that the growing body of
TIL clinical data across multiple late-stage indications in cancer,
coupled with combination of TIL and checkpoint inhibitors in
earlier stages of disease, validate the significant potential for
TIL as a treatment option in multiple solid tumors and stages of
cancer. In 2021, our top priority is to continue the dialogue with
FDA regarding our potency assays to support a potential BLA
submission for lifileucel. We are excited about many opportunities
to further strengthen the Iovance leadership in development of TIL
cell therapy, manufacturing, and potential commercialization.”
Full Year 2020 Highlights and Recent Corporate
Updates
Clinical:
- TIL therapy, lifileucel, in melanoma: as of a
January 2021 corporate update, median duration of response has not
been reached at 28.1 months of median study follow up in metastatic
melanoma patients from Cohort 2 in the C-144-01 clinical study.
Available care for Cohort 2 patients is chemotherapy, with an
overall response rate of four to ten percent and overall survival
of only seven to eight months.
- TIL therapy, lifileucel, in cervical cancer:
The C-145-04 study of lifileucel, formerly LN-145, is intended to
support a BLA submission for metastatic cervical cancer. Inclusion
of both pivotal cohort 1 (post-chemotherapy) and cohort 2
(post-anti-PD-1/PDL-1) in the BLA may strengthen the potential
label and reflect the expected upcoming treatment landscape in
cervical cancer. Enrollment in both Cohorts 1 and 2 has been
completed.
- TIL therapy in non-small cell lung
cancer (NSCLC): H. Lee Moffitt Cancer Center presented
data for Moffitt’s TIL from a Phase 1 lung cancer trial at the
American Association for Cancer Research (AACR) Virtual Annual
Meeting I. Iovance initiated a potential registration-directed
study, IOV-LUN-202, to investigate LN-145 in patients with
recurrent or metastatic NSCLC, without driver mutations, who
previously received a single line of approved systemic therapy
(combined checkpoint inhibitor (CPI) plus chemotherapy). The
company continues to investigate LN-145 in several additional NSCLC
populations with unmet need across three cohorts in the IOV-COM-202
basket study, including a recently added cohort for LN-145 in
combination with ipilimumab/nivolumab.
- TIL therapy LN-145 in head and neck squamous cell
carcinoma (HNSCC): Initial data for TIL in combination
with pembrolizumab in earlier lines of therapy were presented for
the first time at the Society for Immunotherapy of
Cancer (SITC) Annual Meeting. Patients from Cohort 2A in the
IOV-COM-202 study with HNSCC who received LN-145 in combination
with pembrolizumab showed an overall response rate (ORR) of 44% and
median duration of response had not been reached at 8.6 months of
median study follow up (n=9). The company subsequently expanded
enrollment in Cohort 2A to gather data in additional patients. In
study C-145-03, target enrollment was achieved, and the study was
closed to enrollment.
- TIL clinical study enrollment updates: To
date, over 400 patients have been dosed with Iovance TIL products
with more than a 90 percent manufacturing success rate. Recruitment
continues in C-145-04 study in cervical cancer, the IOV-COM-202
study in solid tumors, the IOV-LUN-202 study in NSCLC and the
IOV-CLL-01 study in CLL/SLL. The COVID-19 pandemic may impact the
pace of enrollment and site activities in ongoing clinical studies,
particularly in cohorts with earlier line patients. Recruitment may
improve as the COVID-19 pandemic abates.
Regulatory
- Potency assays for lifileucel: during a Type B
meeting in the fourth quarter of 2020, Iovance and the U.S. Food
and Drug Administration (FDA) did not reach agreement on the
potency assays to define TIL. FDA and Iovance reached agreement on
duration of follow up for the pivotal cohort for the planned BLA
for lifileucel in metastatic melanoma. Additional work and dialogue
with FDA continue regarding current and new potency assays in
support of the BLA. The BLA submission is anticipated during 2021.
Resolution of the potency assay for lifileucel in melanoma is also
a key step towards BLA submission plans in cervical cancer.
Manufacturing:
- Iovance Cell Therapy Center
(iCTC): construction is
advancing as planned at the Navy Yard in Philadelphia. Construction
of the clean rooms were completed in late 2020 and activities in
support of clinical manufacturing are expected to initiate in the
coming weeks. Commercial manufacturing is on track for start in
2022.
- Generation 3 (Gen 3) manufacturing: a shorter
16-day third generation manufacturing process will be explored in a
cohort of metastatic melanoma patients in the IOV-COM-202 study as
well as a cohort of NSCLC patients in the IOV-LUN-202 study.
Corporate:
- Cash position of $635.0 million on December 31, 2020 is
expected to be sufficient into 2023 to deliver on our pipeline
programs.
- A strong organization of nearly 250 employees, of which 76
percent have more than a year of cell therapy experience, is in
place to advance research, development, manufacturing, and
commercial launch preparations.
- Iovance continues to expand its intellectual property portfolio
and currently owns more than 20 granted or allowed U.S. and
international patents for compositions and methods of treatment in
a broad range of cancers relating to the Gen 2 manufacturing
process. Iovance’s portfolio also includes patent applications and
granted patents directed towards Gen 3 manufacturing, selected TIL
products, stable and transient genetic TIL modifications, and
combinations of checkpoint inhibitors and TIL products.
Fourth Quarter and Full Year 2020 Financial
Results
Iovance held $635.0 million in cash, cash equivalents,
short-term investments and restricted cash at December 31, 2020
compared to $312.5 million at December 31, 2019. The
current cash position includes net proceeds of $567.0 million from
a common stock public offering in June 2020. The company
anticipates that the year-end balance of cash, cash equivalents,
short-term investments and restricted cash will be sufficient into
2023.
Jean-Marc Bellemin, Chief Financial Officer, stated, “I am
confident that Iovance is in a strong position to continue to
execute our operating plan and advance our portfolio in 2021. Our
healthy balance sheet will help us deliver on our commitments, both
to patients and to our shareholders.”
Net loss for the fourth quarter ended December 31,
2020, was $68.4 million, or $0.47 per share,
compared to a net loss of $63.6 million,
or $0.50 per share, for the fourth quarter
ended December 31, 2019. Net loss for full year
ended December 31, 2020, was $259.6 million,
or $1.88 per share, compared to a net loss of $197.6
million, or $1.59 per share, for the full year
ended December 31, 2019.
Research and development expenses were $52.4
million for the fourth quarter ended December 31, 2020, a
decrease of $1.8 million compared to $54.2
million for the fourth quarter ended December 31, 2019.
Research and development expenses were $201.7 million for
the 12 months ended December 31, 2020, an increase
of $35.7 million compared to $166.0 million for
the full year ended December 31, 2019.
The decrease in research and development expenses in the fourth
quarter 2020 over the prior year period was primarily attributable
to a decrease in manufacturing and clinical costs following the
completion of enrollment in the pivotal cohorts for melanoma and
cervical cancer. The increase in research and development expenses
in the full year 2020 over the prior full year period was primarily
attributable to higher clinical costs, licensing fees and growth of
the internal research and development team.
General and administrative expenses were $16.1
million for the fourth quarter ended December 31, 2020,
an increase of $5.2 million compared to $10.9
million for the fourth quarter ended December 31, 2019.
General and administrative expenses were $60.2
million for the full year ended December 31, 2020, an
increase of $19.3 million compared to $40.9
million for the same period ended December 31, 2019.
The increases in general and administrative expenses in the
fourth quarter and full year of 2020 compared to the prior year
periods were primarily attributable to growth of the internal
general and administrative team and higher stock-based compensation
expenses.
Webcast and Conference Call
Iovance will host a conference call today at 4:30 p.m.
ET to discuss the fourth quarter and year-to-date 2020
financial results and to provide a corporate update. The conference
call dial-in numbers are 1-844-646-4465 (domestic) or
1-615-247-0257 (international). The conference ID access number for
the call is 9075827. The live webcast can be accessed in the
Investors section of the company’s website
at http://www.iovance.com. The archived webcast will be
available for a year in the Investors section at
www.iovance.com.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics aims to improve patient care by making T
cell-based immunotherapies broadly accessible for the treatment of
patients with solid tumors and blood cancers. Tumor infiltrating
lymphocyte (TIL) therapy uses a patient’s own immune cells to
attack cancer. TIL cells are extracted from a patient’s own tumor
tissue, expanded through a proprietary process, and infused back
into the patient. Upon infusion, TIL reach tumor tissue, where they
attack cancer cells. The company has completed dosing in pivotal
programs in patients with metastatic melanoma and cervical cancer.
In addition, the company’s TIL therapy is being investigated in a
registration-supporting study for the treatment of patients with
locally advanced, recurrent or metastatic non-small cell lung
cancer. Clinical studies are also underway to evaluate TIL in
earlier stage cancers in combination with currently approved
treatments, and to investigate Iovance peripheral blood lymphocyte
(PBL) T cell therapy for blood cancers. 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 and
maintain U.S. Food and Drug Administration (“FDA”) 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
approval; preliminary and interim clinical results, which may
include efficacy and safety results, from ongoing clinical trials
may not be reflected in the final analyses of our ongoing clinical
trials or subgroups within these trials; 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 new
version of the protocol which further defines the patient
population to include more advanced patients in our cervical cancer
trial may have an adverse effect on the results reported to date;
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 or other regulatory authorities; the risk
that our interpretation of the results of our clinical trials or
communications with the FDA may differ from the interpretation of
such results or communications by the FDA; the acceptance by the
market of our product candidates and their potential reimbursement
by payors, if approved; 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
that unanticipated expenses may decrease our estimated cash
balances and increase our estimated capital requirements; and other
factors, including general economic conditions and regulatory
developments, not within our control.
CONTACTS
Iovance Biotherapeutics, Inc:Sara Pellegrino,
IRCVice President, Investor Relations & Public
Relations650-260-7120 ext. 264Sara.Pellegrino@iovance.com
Solebury Trout:Chad Rubin
(investors)646-378-2947crubin@troutgroup.com
Zara Lockshin (media)646.378.2960zlockshin@troutgroup.com
|
IOVANCE BIOTHERAPEUTICS, INC. |
Selected Consolidated Balance Sheet Data |
(In thousands) |
|
December 31, |
|
December 31, |
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents,
short-term investments, and restricted cash |
$ |
634,962 |
|
|
$ |
312,531 |
|
Total assets |
$ |
768,458 |
|
|
$ |
344,655 |
|
Stockholders' equity |
$ |
656,420 |
|
|
$ |
298,971 |
|
|
|
|
|
|
|
|
|
IOVANCE BIOTHERAPEUTICS, INC. |
|
Consolidated Statements of Operations |
|
(In thousands, except per share information) |
|
|
|
|
|
|
|
|
|
For the Three Months EndedDecember
31, |
|
|
For the Years EndedDecember
31, |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
$ |
- |
|
$ |
- |
|
$ |
- |
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and
expenses* |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
52,451 |
|
|
54,238 |
|
|
201,727 |
|
|
166,023 |
|
General and administrative |
|
16,083 |
|
|
10,872 |
|
|
60,210 |
|
|
40,849 |
|
Total costs and expenses |
|
68,534 |
|
|
65,110 |
|
|
261,937 |
|
|
206,872 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(68,534 |
) |
|
(65,110 |
) |
|
(261,937 |
) |
|
(206,872 |
) |
Other
income |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
137 |
|
|
1,542 |
|
|
2,356 |
|
|
9,316 |
|
Net
Loss |
$ |
(68,397 |
) |
$ |
(63,568 |
) |
$ |
(259,581 |
) |
$ |
(197,556 |
) |
Net Loss
Per Common Share, Basic and Diluted |
$ |
(0.47 |
) |
$ |
(0.50 |
) |
$ |
(1.88 |
) |
$ |
(1.59 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average Common Shares Outstanding,
Basic and Diluted |
|
146,738 |
|
|
126,273 |
|
|
138,301 |
|
|
124,336 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Includes
stock-based compensation as follows |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
4,662 |
|
$ |
2,629 |
|
$ |
19,727 |
|
$ |
11,936 |
|
General and administrative |
|
5,570 |
|
|
2,778 |
|
|
21,160 |
|
|
12,881 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
10,232 |
|
$ |
5,407 |
|
$ |
40,887 |
|
$ |
24,277 |
|
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