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 third quarter
2020 financial results and provided a corporate update.
“Subsequent to meeting with FDA, we have moved the BLA
submission date for lifileucel to 2021 in order to reach agreement
on the required potency assays to fully define TIL,” said Maria
Fardis, PhD, President and CEO of Iovance. “In additional
indications, we look forward to starting our registration-directed
study in non-small cell lung cancer, and to presenting initial
clinical data of TIL in combination with anti-PD-1 therapy in head
and neck cancer. Our financial strength also allows us to advance
our clinical programs and continue our operating plans. Overall, I
believe that Iovance is well-positioned to be the leader in
development, manufacturing and commercialization of TIL cell
therapy for cancer.”
Third Quarter
2020 and Recent
Corporate
Updates
Clinical:
- TIL therapy,
lifileucel, in
melanoma: Iovance and the U.S. Food and
Drug Administration (FDA) reached agreement on duration of follow
up for pivotal data for the biologics license application (BLA) for
lifileucel in metastatic melanoma. Additional work is underway on
current and new potency assays in support of the BLA. Dialogue with
FDA about the assays is expected to continue with BLA submission
anticipated to occur in 2021.
- TIL therapy,
lifileucel, in
cervical cancer: the
last patient was dosed in the pivotal Cohort 1 of the C-145-04
study of lifileucel, formerly LN-145, for metastatic cervical
cancer.
- TIL therapy in non-small cell lung
cancer (NSCLC): the protocol was
finalized for 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). Cohorts 1 and 3 have patients
with TPS score of less than one percent, and Cohort 2 will enroll
patients with TPS score of greater than or equal to one
percent.
- TIL therapy, LN-145,
in head and neck squamous cell carcinoma
(HNSCC): in the abstract for the
upcoming Society for Immunotherapy of Cancer (SITC) Annual
Meeting, patients 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 6.9 months of
median study follow up (n=9). Updated data will be presented at
SITC.
- Iovance development program: to date, over 400
patients have been dosed with Iovance TIL products with more than
90 percent manufacturing success rate.
Manufacturing:
- Construction of the Iovance Cell Therapy Center (iCTC) is
advancing as planned at the Navy Yard in Philadelphia. Clean rooms
are expected to be completed in late 2020 with clinical activities
to initiate in early 2021. Commercial manufacturing is on track for
2022.
Corporate:
- Cash position of $719.7 million at September 30 is sufficient
for Iovance to execute commercial launch and pipeline programs,
including the IOV-LUN-202 study in NSCLC.
- A strong organization of over 200 employees is in place across
multiple locations to advance research, development, manufacturing
and commercial launch preparations.
- Iovance has been granted or allowed a total of 20 U.S. patents
for compositions and methods of treatment in using Iovance TIL in a
broad range of cancers related to its 22-day second generation (Gen
2) manufacturing process.
Upcoming Data in Head
and Neck Cancer at SITC Annual Meeting (November
9-14, 2020):
- Poster Presentation (Abstract #353): Safety
and efficacy of tumor infiltrating lymphocytes (TIL; LN-145) in
combination with pembrolizumab for advanced, recurrent or
metastatic HNSCC
- Authors: A Jimeno, et al.
- Presentation Times: Wednesday, Nov. 11, from
5:15-5:45 p.m. EST and Friday, Nov. 13, from 4:40-5:10 p.m.
EST.
- Location: Virtual Poster Hall
Third Quarter
and September Year-to-Date
Financial Results
Iovance held $719.7 million in cash, cash equivalents,
short-term investments and restricted cash at September 30, 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 may be over $630
million.
Net loss for the third quarter ended September 30,
2020, was $58.6 million, or $0.40 per share,
compared to a net loss of $49.5 million,
or $0.40 per share, for the third quarter
ended September 30, 2019. Net loss for the nine months
ended September 30, 2020, was $191.2 million,
or $1.41 per share, compared to a net loss of $134.0
million, or $1.08 per share, for the same period
ended September 30, 2019.
Research and development expenses were $43.1
million for the third quarter ended September 30, 2020,
an increase of $1.5 million compared to $41.6
million for the third quarter ended September 30, 2019.
Research and development expenses were $149.3 million for
the nine months ended September 30, 2020, an increase
of $37.5 million compared to $111.8 million for
the same period ended September 30, 2019.
The increase in research and development expenses in the third
quarter 2020 over the prior year period was primarily attributable
to growth of the internal research and development team and higher
stock-based compensation, partially offset by a decrease in
manufacturing costs. The increase in research and development
expenses in the first nine months of 2020 over the prior year
period was primarily attributable to higher patient enrollment in
clinical trials, licensing fees and growth of the internal research
and development team.
General and administrative expenses were $15.9
million for the third quarter ended September 30, 2020,
an increase of $5.9 million compared to $10.0
million for the third quarter ended September 30, 2019.
General and administrative expenses were $44.1
million for the nine months ended September 30, 2020, an
increase of $14.2 million compared to $30.0
million for the same period ended September 30, 2019.
The increases in general and administrative expenses in the
third quarter and first nine months 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 CallIovance will host a
conference call today at 4:30 p.m. ET to discuss the
third 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 1190777. 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 (“Iovance” or the “Company”) 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. After
infusion, TIL reach tumor tissue, where they attack tumor cells.
The Company has completed dosing in the pivotal study in patients
with metastatic melanoma and is currently conducting a pivotal
study in patients with metastatic cervical cancer. In addition, the
Company’s TIL therapy is being investigated for the treatment of
patients with locally advanced, recurrent or metastatic cancers
including head and neck and non-small cell lung cancer. A clinical
study to investigate Iovance T cell therapy for blood cancers
called peripheral blood lymphocyte (PBL) therapy is open to
enrollment. 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, filings with
the Securities and Exchange Commission (“SEC”), reports
to stockholders and in meetings with investors and analysts, 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. These forward-looking
statements include, but are not limited to, statements regarding
the success, timing, projected enrollment, manufacturing and
production capabilities, and cost of our ongoing clinical trials
and anticipated clinical trials for our current product candidates
(including both Company-sponsored and collaborator-sponsored trials
in both the U.S. and Europe), such as statements
regarding the timing of initiation and completion of these trials;
the strength of the Company’s product pipeline; and the guidance
provided for the Company’s future cash, cash equivalents,
short-term investments, restricted cash balances and forecasted
operating expenses, including our statements regarding the
sufficiency of our cash reserves to execute commercial launch and
pipeline programs, which assumes no material change in liabilities.
These statements involve risks, uncertainties and other factors
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,
including, without limitation, the following substantial known and
unknown risks and uncertainties inherent in the Company’s business:
the COVID-19 pandemic may have an adverse effect on the Company and
its clinical trials, including potential slower patient
recruitment, inability of clinical trial sites to collect data,
inability of the Company or its contract research organizations to
monitor patients, as well as U.S. Food and Drug
Administration (“FDA”) availability due to competing
priorities; our ability to achieve long-term profitability and
successfully commercialize our products alone or with third
parties, as well as our history of operating losses and our
expectations that we will continue to incur significant operating
losses; our limited operating history in our current line of
business, which makes it difficult to evaluate our prospects, our
business plan or the likelihood of our successfully implementing
such business plan; risks related to the timing of and our ability
to successfully develop, submit, obtain and maintain FDA or other
regulatory authority approval of, or other action with respect to,
our product candidates (including with respect to lifileucel for
the treatment of metastatic melanoma, for which we currently expect
to submit a biologics licensing application (“BLA”) to the FDA
during 2021), and our ability to successfully commercialize any
product candidates for which we obtain FDA approval; our limited
history in conducting clinical trials, on which our future
profitability is substantially dependent, and our need to rely on
third parties, including contract research organizations, contract
manufacturing organizations and consultants, in connection with the
conduct, supervision and monitoring of our clinical trials for our
product candidates; preliminary and interim clinical results, which
may include efficacy and safety results, from ongoing Phase 2
studies may not be reflected in the final analyses of our ongoing
clinical trials or subgroups within these trials; the risk that a
slower rate of enrollment may delay the Company’s clinical trial
timelines or otherwise adversely impact our clinical development
activities; the risk that enrollment may need to be adjusted for
the Company’s 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 the Company’s cervical cancer trial may have
an adverse effect on the results reported to date; the risk that
the results obtained in our ongoing clinical trials may not be
indicative of results obtained in future clinical trials or that
data within these trials may not be supportive of product approval,
including that later developments with the FDA may be inconsistent
with already completed FDA meetings; the risk that the FDA
may not agree with our approach to expand our cervical cancer trial
to include Cohort 2 of the C-145-04 trial; the risk that changes in
patient populations may result in changes in preliminary clinical
results; the Company’s ability or inability to address FDA or other
regulatory authority requirements relating to its clinical programs
and registrational plans, such requirements including, but not
limited to, clinical, safety, manufacturing and control
requirements; the risk that regulatory authorities may potentially
delay the timing of FDA or other regulatory approval of, or other
action with respect to, our product candidates, or 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 the Company’s interpretation
of the results of its clinical trials or communications with the
FDA may differ from the interpretation of such results or
communications by the FDA; our ability to obtain and maintain
intellectual property rights related to our product pipeline; our
ability to successfully implement our research and development
programs and collaborations; the acceptance by the market of our
product candidates and their potential reimbursement by payors, if
approved; our ability to obtain tax incentives and credits and the
risk that our existing net operating loss carryforwards and
research tax credits may expire or otherwise be limited in use; the
success of our manufacturing, license or development agreements;
risks related to the Company’s ability to maintain and benefit from
accelerated FDA review designations, including breakthrough therapy
designation or regenerative medicine advanced therapy designation,
which may not result in a faster development process or review of
the Company’s product candidates (and which may later be rescinded
by the FDA), and which does not assure approval of such product
candidates by the FDA or the ability of the Company to obtain FDA
approval in time to benefit from commercial opportunities; the
ability or inability of the Company to manufacture its therapies
using third party manufacturers or its own facility may adversely
affect the Company’s potential commercial launch; the results of
clinical trials with collaborators using different manufacturing
processes may not be reflected in the Company’s sponsored trials;
our dependence on additional financing to fund our operations and
complete the development and commercialization of our product
candidates, and the risks that raising such additional capital may
restrict our operations or require us to relinquish rights to our
technologies or product candidates; 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
the Company’s 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
Rich Allan (media)646-378-2958rallan@troutgroup.com
IOVANCE BIOTHERAPEUTICS, INC. |
Selected
Condensed Consolidated Balance Sheets |
(in
thousands) |
|
|
September 30, |
|
|
December 31, |
|
|
2020(unaudited) |
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and short-term
investments |
$ |
714,148 |
|
$ |
307,081 |
Restricted cash |
$ |
5,525 |
|
$ |
5,450 |
Total assets |
$ |
782,294 |
|
$ |
344,655 |
Stockholders' equity |
$ |
711,841 |
|
$ |
298,971 |
|
|
|
|
IOVANCE BIOTHERAPEUTICS,
INC. |
|
Condensed Consolidated
Statements of Operations |
|
(unaudited, in thousands, except per share
information) |
|
|
|
|
|
|
For the Three Months
EndedSeptember 30, |
|
|
For the Nine Months
EndedSeptember 30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
$ |
- |
|
$ |
- |
|
$ |
- |
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and
expenses* |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
43,050 |
|
|
41,582 |
|
|
149,276 |
|
|
111,785 |
|
|
General and
administrative |
|
15,916 |
|
|
10,029 |
|
|
44,127 |
|
|
29,977 |
|
|
Total costs and expenses |
|
58,966 |
|
|
51,611 |
|
|
193,403 |
|
|
141,762 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(58,966 |
) |
|
(51,611 |
) |
|
(193,403 |
) |
|
(141,762 |
) |
Other
income |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
395 |
|
|
2,124 |
|
|
2,219 |
|
|
7,774 |
|
Net
Loss |
$ |
(58,571 |
) |
$ |
(49,487 |
) |
$ |
(191,184 |
) |
$ |
(133,988 |
) |
Net Loss
Per Share of Common Stock, Basic
and Diluted |
$ |
(0.40 |
) |
$ |
(0.40 |
) |
$ |
(1.41 |
) |
$ |
(1.08 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average Shares of Common
Stock Outstanding, Basic and
Diluted |
|
146,492 |
|
|
124,035 |
|
|
135,457 |
|
|
123,674 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Includes
stock-based compensation as follows |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
5,282 |
|
$ |
3,346 |
|
$ |
15,065 |
|
$ |
8,767 |
|
|
General and
administrative |
|
5,424 |
|
|
3,252 |
|
|
15,590 |
|
|
10,103 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
10,706 |
|
$ |
6,598 |
|
$ |
30,655 |
|
$ |
18,870 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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