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
2020 financial results and provided a corporate update.
“During a strong first half of 2020 we completed dosing and
reported early data for our pivotal melanoma program for
lifileucel, announced data at AACR for our collaborator Moffitt’s
TIL in non-small cell lung cancer, presented updated Cohort 2 data
for lifileucel at ASCO, and successfully completed a public
financing,” said Maria Fardis, Ph.D., MBA, Iovance President and
Chief Executive Officer. “Iovance is now in an excellent position
to execute our planned commercial launch while broadening our
pipeline programs. The cumulative set of positive clinical data for
lifileucel continue to support our planned BLA submission for this
one-time treatment for metastatic melanoma. We are also pleased to
report that our cervical cancer pivotal program has recently
completed enrollment in Cohort 1, and we look forward to dosing the
last few patients in the coming weeks. With the first potential
cell therapy in solid tumors and a broadening TIL platform, we
believe Iovance is the leader in development, manufacturing, and
commercialization of TIL cell therapy for cancer.”
Second Quarter 2020 Updates
Clinical:
- TIL therapy, lifileucel, in Melanoma: updated
data from the C-144-01 trial continue to support the potential for
lifileucel as a one-time treatment for advanced melanoma.-
Updated Cohort 2 data presented at ASCO 2020 showed an ORR of 36.4%
with median duration of response not reached at 18.7 months of
median study follow up (n=66).- Early Cohort 4 data showed
32.4% ORR at 5.3 months of median study follow up (n=68).
- TIL therapy, lifileucel, in Cervical cancer:
enrollment in the pivotal Cohort 1 is complete in the C-145-04
study of lifileucel, previously known as LN-145, for advanced
cervical cancer.
- TIL therapy in non-small cell lung
cancer (NSCLC): active planning is underway for a
registration-directed study, IOV-LUN-202, for LN-145 in NSCLC
patients with defined unmet medical need.
- T-cell based therapies in additional
indications: patient recruitment continues in the
IOV-COM-202 basket study in solid tumors as well as the C-145-03
study in squamous cell carcinoma of the head and neck (SCCHN).
Additional sites are being activated for the IOV-CLL-01 study in
relapsed or refractory chronic lymphocytic leukemia and small
lymphocytic lymphoma (CLL/SLL).
Regulatory:
- Iovance continues preparing for submission of a Biologics
License Application (BLA) in late 2020 through data compilation and
internal readiness activities.
- Iovance scheduled a meeting with U.S. FDA Division of
Manufacturing and Product Quality (DMPQ) to align on the commercial
manufacturing facility design and capacity. Full alignment was
reached with the DMPQ prior to the upcoming scheduled meeting with
the division.
- United States Adopted Names (USAN) council accepted and
published the use of the name “lifileucel” to describe Iovance TIL
therapy for cervical cancer in addition to melanoma. Lifileucel
will replace the former product code LN-145 for the cervical cancer
indication.
Commercial Launch Planning:
- Iovance is committed to providing individualized support for a
personalized therapy through IovanceCaresTM, a program that will
allow communication and coordination with health care providers
(HCPs) for patient care throughout the lifileucel journey. All
elements of the system will be managed by dedicated Iovance case
managers to handle the needs of HCPs and patients. This platform
will allow the hospitals to place orders for lifileucel, with
Iovance to monitor and track patients’ cells during the
manufacturing process through the delivery of lifileucel to the
hospitals. The system will also include reimbursement support for
sites.
Manufacturing:
- Construction of the Iovance Cell Therapy Center (iCTC) at the
Navy Yard in Philadelphia remains on schedule. 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.
Research:
- Entered into an agreement with Avid Bioservices for the GLP and
GMP manufacturing of novel IL-2 analog IOV-3001.
Corporate:
- Cash position of $777.4 million at June 30 includes net
proceeds of $567.4 million from a common stock public offering in
June 2020. The current cash position is sufficient for Iovance to
execute commercial launch and pipeline activities including a
clinical program in NSCLC.
- A strong and growing organization of over 200 employees is in
place across multiple locations, including an experienced
commercial team with extensive cell therapy experience preparing
for launch of lifileucel.
- Iovance has been granted a total of 12 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 Presentations:
- Three Abstracts Accepted for ESMO Virtual Congress
2020: the following three posters will be highlighted at
the upcoming ESMO Virtual Congress 2020, Scientific Weekend, to be
held September 19-21, 2020- In vivo persistence of Iovance
tumor-infiltrating lymphocytes LN-145 in cervical cancer patients
(Abstract #3688)- Genetic Modification of Iovance’s TIL
through TALEN-mediated knockout of PD-1 as a strategy to empower
TIL therapy for cancer (Abstract #3721)- Iovance Generation-2
Tumor-infiltrating Lymphocyte (TIL) Product Is Reinvigorated During
the Manufacturing Process (Abstract #4229)
Second Quarter and First Half 2020 Financial
Results
At June 30, 2020, Iovance held $777.4 million in
cash, cash equivalents, short-term investments and restricted cash
compared to $312.5 million at December 31, 2019. The
current cash position includes net proceeds of $567.4 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. The operating expenses in the second half of 2020 are
forecasted to be in the same range as the first half of 2020.
Net loss for the second quarter ended June 30,
2020, was $63.0 million, or $0.47 per share,
compared to a net loss of $47.6 million,
or $0.38 per share, for the second quarter
ended June 30, 2019. Net loss for the six months
ended June 30, 2020, was $132.6 million,
or $1.02 per share, compared to a net loss of $84.5
million, or $0.68 per share, for the same period
ended June 30, 2019.
Research and development expenses were $49.3
million for the second quarter ended June 30, 2020, an
increase of $10.0 million compared to $39.3
million for the second quarter ended June 30, 2019.
Research and development expenses were $106.2 million for
the six months ended June 30, 2020, an increase of $36.0
million compared to $70.2 million for the same
period ended June 30, 2019.
The increase in research and development expenses in the second
quarter 2020 over the prior year period was primarily attributable
to an increase in costs associated with multiple clinical trials,
and growth of the internal research and development team. The
increase in research and development expenses in the first half
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 $14.4
million for the second quarter ended June 30, 2020, an
increase of $3.5 million compared to $10.9
million for the second quarter ended June 30, 2019.
General and administrative expenses were $28.2
million for the six months ended June 30, 2020, an
increase of $8.3 million compared to $19.9
million for the same period ended June 30, 2019.
The increases in general and administrative expenses in the
second quarter and first half 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 second quarter 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 7875997. 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. 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 investment, restricted cash balances, and forecasted operating
expenses. 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
expect to submit a biologics licensing application (“BLA”) to the
FDA during 2020), 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 additional
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:Annie Chang
(investors)646-378-2972achang@troutgroup.com
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) |
|
|
June 30, |
|
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and short-term
investments |
$ |
771,879 |
|
$ |
307,081 |
|
Restricted cash |
$ |
5,525 |
|
$ |
5,450 |
|
Total assets |
$ |
817,567 |
|
$ |
344,655 |
|
Stockholders' equity |
$ |
758,309 |
|
$ |
298,971 |
|
|
|
IOVANCE BIOTHERAPEUTICS, INC. |
Condensed Consolidated Statements of
Operations |
(unaudited, in thousands, except per share
information) |
|
|
|
For the Three Months Ended June 30, |
|
|
For the Six Months Ended June 30, |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
$ |
- |
|
$ |
- |
|
$ |
- |
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and
expenses* |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
49,274 |
|
|
39,298 |
|
|
106,226 |
|
|
70,203 |
|
General and administrative |
|
14,353 |
|
|
10,867 |
|
|
28,211 |
|
|
19,948 |
|
Total costs and expenses |
|
63,627 |
|
|
50,165 |
|
|
134,437 |
|
|
90,151 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(63,627 |
) |
|
(50,165 |
) |
|
(134,437 |
) |
|
(90,151 |
) |
Other
income |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
609 |
|
|
2,614 |
|
|
1,824 |
|
|
5,650 |
|
Net Loss |
$ |
(63,018 |
) |
$ |
(47,551 |
) |
$ |
(132,613 |
) |
$ |
(84,501 |
) |
Net Loss Per Share of
Common Stock, Basic and Diluted |
$ |
(0.47 |
) |
$ |
(0.38 |
) |
$ |
(1.02 |
) |
$ |
(0.68 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average
Shares of Common Stock Outstanding, Basic and Diluted |
|
133,162 |
|
|
123,567 |
|
|
129,848 |
|
|
123,491 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Includes stock-based
compensation as follows |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
5,465 |
|
$ |
2,720 |
|
$ |
9,783 |
|
$ |
5,421 |
|
General and administrative |
|
5,072 |
|
|
3,706 |
|
|
10,166 |
|
|
6,851 |
|
|
$ |
10,537 |
|
$ |
6,426 |
|
$ |
19,949 |
|
$ |
12,272 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Iovance Biotherapeutics (NASDAQ:IOVA)
Historical Stock Chart
From Aug 2024 to Sep 2024
Iovance Biotherapeutics (NASDAQ:IOVA)
Historical Stock Chart
From Sep 2023 to Sep 2024