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 first quarter
2021 financial results and corporate updates.
Maria Fardis, Ph.D., President and Chief Executive Officer of
Iovance, stated, “During the first quarter of 2021 we continued to
work on our potency assays in support of a BLA for lifileucel,
which is our top priority at Iovance. We continued developing
multiple assays in parallel and submitted additional potency assay
data to the FDA. I am also very pleased to highlight the strength
of clinical data for TIL being presented at the recent and upcoming
medical meetings and journal publications, including the first
clinical data for TIL in combination with pembrolizumab in melanoma
at the upcoming ASCO Annual Meeting. We believe durable responses
for Iovance TIL in relapsed or refractory metastatic melanoma,
paired with data to be presented for TIL in combination with
anti-PD1 therapy in earlier treatment settings, solidify the
broader potential for Iovance TIL and further demonstrate our
leadership in the development, manufacturing, and potential
commercialization of TIL cell therapy.”
First Quarter 2021 Highlights and Recent Corporate
Updates
Clinical:
- TIL therapy, lifileucel, in
melanoma: Updated data from Cohort 2 in the C-144-01
study of lifileucel in advanced melanoma were presented at the
American Association for Cancer Research (AACR) 2021 Annual
Meeting. As of the December 2020 data cutoff for the presentation,
lifileucel showed a 36.4% overall response rate (4.5% complete
responses and 31.8% partial responses); median duration of response
(DOR) was not reached at 28.1 months of median study follow up as
assessed by investigators (n=66). Available care for Cohort 2
patients is chemotherapy, with an overall response rate of four to
10 percent and overall survival of only seven to eight months.
Updated Cohort 2 data has been accepted for an oral presentation at
the upcoming American Society of Clinical Oncology (ASCO) Annual
Meeting. A manuscript of the Cohort 2 data has also been accepted
for a forthcoming publication in a high impact oncology
journal.
- 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. Patient dosing is
complete in both Cohorts 1 and 2, and enrollment continues in
Cohort 3 (lifileucel in combination with pembrolizumab in cervical
cancer patients who are naïve to anti-PD-1 therapy).
- TIL therapy in non-small cell lung
cancer (NSCLC): Iovance has activated 10 U.S.
clinical sites and patients have consented in the 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 also continues to investigate LN-145 in
several additional NSCLC populations with unmet need across three
cohorts in the IOV-COM-202 basket study.
- TIL therapy in combination with pembrolizumab in
melanoma and head and neck squamous cell carcinoma
(HNSCC): Iovance is investigating TIL in combination
with pembrolizumab in earlier treatment settings in melanoma and
HNSCC. Initial data from Cohort 1A in the IOV-COM-202 study, which
is evaluating lifileucel in combination with pembrolizumab in
melanoma, will be presented at the upcoming ASCO Annual Meeting.
Patients with HNSCC continue to enroll in the expanded Cohort 2A in
the IOV-COM-202 study to receive LN-145 in combination with
pembrolizumab.
- TIL clinical program updates: To date,
over 450 patients have been dosed with Iovance TIL products with
more than a 90 percent manufacturing success rate.
Regulatory
- Potency assays for lifileucel: Iovance
recently submitted additional potency assay data to the FDA, while
continuing to evaluate additional assays as backup options in
support of the BLA. Submission of the BLA is anticipated during
2021. Expeditious 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): Activities
at the iCTC have commenced to support start of clinical
manufacturing in late 2021. The expected commercial manufacturing
remains on track to start in 2022.
- Generation 3 (Gen 3) manufacturing: A
shorter 16-day third generation manufacturing process is being
explored in a cohort of metastatic melanoma patients in the
IOV-COM-202, where patient dosing has initiated using Gen 3. In
addition, a cohort of NSCLC patients in the IOV-LUN-202 study will
receive product manufactured by this Gen 3 process.
Corporate:
- Cash position of $610.2 million on March 31, 2021 is expected
to be sufficient into 2023 to deliver on pipeline programs.
- A strong organization of more than 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.
- On May 6, 2021, Iovance entered into an amended license
agreement with the National Institutes of Health (NIH), which adds
additional exclusive, worldwide patent rights in certain
indications to cytokine-tethered TIL technology and expands the
non-exclusive, worldwide field of use to all cancers.
- Iovance continues to expand its intellectual property portfolio
and currently owns more than 25 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 Gen 2 patent rights are expected to provide
exclusivity through 2038. Iovance’s portfolio also includes patent
applications and granted patents directed towards Gen 3
manufacturing, selected TIL products, stable and transient genetic
TIL modifications, tumor digest and fragment compositions and
methods (including cryopreservation), and combinations of
checkpoint inhibitors and TIL products.
First Quarter 2021 Financial Results
Iovance held $610.2 million in cash, cash equivalents,
investments and restricted cash at March 31, 2021 compared
to $635.0 million at December 31, 2020. The company
anticipates that the year-end balance of cash, cash equivalents,
investments and restricted cash will be sufficient into 2023.
Jean-Marc Bellemin, Chief Financial Officer, stated, “The
continued strength of our balance sheet puts Iovance in an
excellent position to fulfill our operating plan and advance our
pipeline. We are judicious in our investments to maximize value and
deliver on our commitments for patients and our shareholders.”
Net loss for the first quarter ended March 31,
2021, was $75.4 million, or $0.51 per share,
compared to a net loss of $69.6 million,
or $0.55 per share, for the first quarter
ended March 31, 2020.
Research and development expenses were $55.9
million for the first quarter ended March 31, 2021, a
decrease of $1.0 million compared to $57.0
million for the first quarter ended March 31, 2020.
The decrease in research and development expenses in the first
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.
General and administrative expenses were $19.6
million for the first quarter ended March 31, 2021, an
increase of $5.8 million compared to $13.9
million for the first quarter ended March 31, 2020.
The increases in general and administrative expenses in the
first quarter 2021 compared to the prior year period was primarily
attributable to growth of the internal general and administrative
team and higher stock-based compensation expenses.
Webcast and Conference CallIovance will host a
conference call today at 4:30 p.m. ET to discuss the
first quarter 2021 financial results and corporate updates. The
conference call dial-in numbers are 1-800-773-2954 (domestic) or
1-847-413-3731 (international) and the access code is 50155289. 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.
IOVANCE BIOTHERAPEUTICS, INC. |
Selected Condensed Consolidated Balance
Sheets |
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
2021 |
|
|
2020 |
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and
investments |
$ |
604,157 |
|
$ |
629,437 |
Restricted cash |
$ |
6,084 |
|
$ |
5,525 |
Total assets |
$ |
750,573 |
|
$ |
768,458 |
Stockholders’ equity |
$ |
647,431 |
|
$ |
656,498 |
IOVANCE BIOTHERAPEUTICS, INC. |
Condensed Consolidated Statements of
Operations |
(Unaudited, in thousands, except per share
information) |
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
Costs and
expenses |
|
|
|
|
|
|
|
|
Research and development
expenses |
|
55,949 |
|
|
|
56,952 |
|
|
General and administrative
expenses |
|
19,621 |
|
|
|
13,858 |
|
|
Total costs and expenses |
|
75,570 |
|
|
|
70,810 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(75,570 |
) |
|
|
(70,810 |
) |
Other
income |
|
|
|
|
|
|
|
|
Interest income, net |
|
121 |
|
|
|
1,215 |
|
Net
Loss |
$ |
(75,449 |
) |
|
$ |
(69,595 |
) |
|
|
|
|
|
|
|
|
|
Net Loss
Per Common Share, Basic and Diluted |
$ |
(0.51 |
) |
|
$ |
(0.55 |
) |
|
|
|
|
|
|
|
|
|
Weighted-Average Common Shares Outstanding,
Basic and Diluted |
|
147,370 |
|
|
|
126,568 |
|
|
|
|
|
|
|
|
|
|
* Includes
stock-based compensation as follows |
|
|
|
|
|
|
|
|
Research and development |
$ |
9,202 |
|
|
$ |
4,318 |
|
|
General and
administrative |
|
7,739 |
|
|
|
5,094 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
16,941 |
|
|
$ |
9,412 |
|
CONTACTS
Iovance Biotherapeutics, Inc:Sara Pellegrino,
IRCVice President, Investor Relations & Public
Relations650-260-7120 ext. 264Sara.Pellegrino@iovance.com
Solebury Trout:Zara
Lockshin646.378.2960zlockshin@soleburytrout.com
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