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 second quarter
2021 financial results and corporate updates.
Frederick Vogt, Ph.D., J.D., Interim President and Chief
Executive Officer of Iovance, stated, “During the first half of
2021 we advanced our TIL pipeline and presented clinical data
across multiple solid tumor indications and treatment settings,
including single-agent TIL in metastatic non-small cell lung cancer
and melanoma, as well as initial clinical data for TIL in
combination with pembrolizumab in early line melanoma. Our top
priority remains our ongoing work to address FDA feedback regarding
the potency assays for lifileucel to support our planned BLA
submission. We are increasingly confident in the broad potential
for TIL as the next class of paradigm-shifting therapy for cancer
patients with significant unmet need.”
Second Quarter 2021 Highlights and Recent Corporate
Updates
Regulatory
- Potency assays for lifileucel: Following FDA
feedback regarding the potency assays for lifileucel, Iovance will
continue ongoing work developing and validating its potency assays
and plans to submit additional assay data and anticipates meeting
with the FDA before the end of 2021. The company's biologics
license application (BLA) submission for lifileucel is now expected
to occur during the first half of 2022. Resolution of the potency
assay for lifileucel in melanoma is also a key step towards our
regulatory plans in other indications.
Clinical
- TIL therapy in melanoma:
- Metastatic melanoma: follow up data from
Cohort 2 in the C-144-01 study of lifileucel in advanced melanoma
were presented at the American Society for Clinical Oncology (ASCO)
2021 Annual Meeting. As of the April 2021 data cutoff for the
presentation, the overall response rate (ORR) was 36.4% (4.5%
complete response rate and 31.8% partial response rate) and median
duration of response (DOR) was not reached at 33.1 months of median
study follow up as assessed by investigators (n=66). Detailed
Cohort 2 data were also published in a manuscript in the Journal of
Clinical Oncology, an ASCO journal.
- Anti-PD-1 naïve melanoma: initial clinical
data for lifileucel in combination with pembrolizumab were
presented in a poster at ASCO 2021. The ORR was 86% and the
complete response rate was 43% at a median follow up of 8.2 months
in anti-PD-1 naïve melanoma patients in Cohort 1A in the
IOV-COM-202 basket study (n=7).
- TIL therapy in non-small cell lung
cancer (NSCLC):
- LN-145 clinical data in metastatic NSCLC
(mNSCLC): clinical data for LN-145 showed a 21.4% ORR and
64.3% disease control rate in mNSCLC patients from Cohort 3B in the
IOV-COM-202 study (n=28), including two responders with PD-L1
negative tumors. All Cohort 3B patients had received one or more
prior systemic therapies, including anti-PD-1 therapy, and all
responders also received prior chemotherapy. Detailed results are
anticipated at a medical meeting in 2021.
- LN-145 in second-line mNSCLC: the first
patient was dosed and more than 15 U.S. clinical sites have been
activated in the registration-supporting IOV-LUN-202 study of
LN-145 in patients with mNSCLC.
Research
- Iovance is committed to advancing the next generation of TIL
and related therapies and technologies. Late preclinical programs
in IND-enabling studies include a novel IL-2 analog (IOV-3001) as
well as a genetically modified TIL (IOV-4001). IOV-4001 leverages
TALEN technology licensed from Cellectis S.A. to genetically knock
out PD-1 in TIL cells.
Manufacturing
- TIL manufacturing success: to date, nearly 500
patients have been dosed with Iovance TIL products with more than a
90 percent manufacturing success rate.
- Iovance Cell Therapy Center
(iCTC): the
investigational new drug (IND) application amendment has been
cleared and clinical manufacturing of TIL is expected to commence
at the iCTC in the near future. Commercial manufacturing remains on
track to commence with a potential regulatory approval.
Corporate
- Cash position of $708.7 million on June 30, 2021 is expected to
be sufficient well into 2023.
- A strong organization of nearly 270 employees with an average
of more than 3.5 years 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 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.
Second Quarter and First Half 2021 Financial
Results
Iovance held $708.7 million in cash, cash equivalents,
investments and restricted cash at June 30, 2021 compared
to $635.0 million at December 31, 2020. The cash
position as of the second quarter is expected to be sufficient for
more than two years based on the current operating plan.
Jean-Marc Bellemin, Chief Financial Officer, stated, “Our
balance sheet remains strong to advance our operating plan,
including launch preparations and pipeline development, with no
immediate need to raise additional capital.”
Net loss for the second quarter ended June 30,
2021, was $81.4 million, or $0.53 per share,
compared to a net loss of $63.0 million, or $0.47 per share,
for the second quarter ended June 30, 2020. Net loss for
the six months ended June 30, 2020, was $156.8 million, or $1.04
per share, compared to a net loss of $132.6 million, or $1.02 per
share, for the same period ended June 30, 2020.
Research and development expenses were $62.1
million for the second quarter ended June 30, 2021, an
increase of $12.8 million compared to $49.3
million for the second quarter ended June 30, 2020.
Research and development expenses were $118.1 million for the six
months ended June 30, 2021, an increase of $11.8 million compared
to $106.2 million for the same period ended June 30, 2020.
The increase in research and development expenses in the second
quarter 2021 over the prior year period was primarily attributable
to an increase in costs associated with growth of the internal
research and development team and increases in manufacturing and
iCTC facility related costs. The increase in research and
development expenses in the first half of 2021 over the prior year
period was primarily attributable to growth of the internal
research and development team, an increase in iCTC facility related
costs, which were partially offset by lower manufacturing and
clinical costs following the completion of enrollment in the
pivotal cohorts for melanoma and cervical cancer.
General and administrative expenses were $19.3
million for the second quarter ended June 30, 2021, an
increase of $5.0 million compared to $14.4
million for the second quarter ended June 30, 2020.
General and administrative expenses were $38.9 million for the six
months ended June 30, 2021, an increase of $10.7 million compared
to $28.2 million for the same period ended June 30, 2020.
The increases in general and administrative expenses in the
second quarter and first half of 2021 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 CallIovance will host a
conference call today at 4:30 p.m. ET to discuss the
second quarter 2021 financial results and corporate updates. The
conference call dial-in numbers are 1-(844) 646-4465 (domestic) or
1-(615) 247-0257 (international) and the access code is 1489438.
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
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 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
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) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
2021 |
|
|
2020 |
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and
investments |
$ |
702,656 |
|
$ |
629,437 |
Restricted cash |
$ |
6,084 |
|
$ |
5,525 |
Total assets |
$ |
852,790 |
|
$ |
768,458 |
Stockholders' equity |
$ |
744,413 |
|
$ |
656,498 |
IOVANCE BIOTHERAPEUTICS, INC. |
|
Condensed Consolidated Statements of
Operations |
|
(unaudited, in thousands, except per share
information) |
|
|
|
|
|
|
For the Three Months EndedJune
30, |
|
|
For the Six Months EndedJune
30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
$ |
- |
|
$ |
- |
|
$ |
- |
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and
expenses* |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
62,119 |
|
|
49,274 |
|
|
118,068 |
|
|
106,226 |
|
|
General and
administrative |
|
19,307 |
|
|
14,353 |
|
|
38,928 |
|
|
28,211 |
|
|
Total costs and
expenses |
|
81,426 |
|
|
63,627 |
|
|
156,996 |
|
|
134,437 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(81,426 |
) |
|
(63,627 |
) |
|
(156,996 |
) |
|
(134,437 |
) |
Other
income |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
75 |
|
|
609 |
|
|
196 |
|
|
1,824 |
|
Net
Loss |
$ |
(81,351 |
) |
$ |
(63,018 |
) |
$ |
(156,800 |
) |
$ |
(132,613 |
) |
Net Loss
Per Share of Common Stock, Basic and Diluted |
$ |
(0.53 |
) |
$ |
(0.47 |
) |
$ |
(1.04 |
) |
$ |
(1.02 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average Shares of Common Stock
Outstanding, Basic and Diluted |
|
153,751 |
|
|
133,162 |
|
|
150,571 |
|
|
129,848 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Includes
stock-based compensation as follows |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
8,585 |
|
$ |
5,465 |
|
$ |
17,787 |
|
$ |
9,783 |
|
|
General and
administrative |
|
5,829 |
|
|
5,072 |
|
|
13,568 |
|
|
10,166 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
14,414 |
|
$ |
10,537 |
|
$ |
31,355 |
|
$ |
19,949 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
Iovance Biotherapeutics (NASDAQ:IOVA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Iovance Biotherapeutics (NASDAQ:IOVA)
Historical Stock Chart
From Apr 2023 to Apr 2024