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
2020 financial results and provided a corporate update.
“We continue making strong progress toward commercializing
Iovance TIL for melanoma and cervical cancer indications,” said
Maria Fardis, Ph.D., MBA, Iovance President and Chief Executive
Officer. “While COVID-19 has impacted healthcare systems globally,
we have been able to continue our key business operations due to
dedication from our employees and through close collaboration with
our clinical sites and other business partners. Cancer patients are
still in critical need of access to therapy and a one-time
treatment may offer an attractive therapeutic option to patients
and treating physicians. With the first potential cell therapy in
solid tumors and a broad TIL platform, Iovance remains
well-positioned to become the leader in development, manufacturing,
and commercialization of TIL cell therapy for cancer.”
First Quarter 2020 Updates
Clinical:
- Melanoma: the last patient in the pivotal
Cohort 4 of C-144-01 melanoma study was dosed in January 2020. The
enrollment of this cohort was completed approximately three months
ahead of schedule with over-enrollment due to increased demand for
participation.
- Cervical: enrollment in the cervical study
C-145-04 continues and completion of enrollment in the pivotal
program is on track for approximately mid-2020.
Regulatory:
- Iovance continues preparing for submission of a Biologics
License Application (BLA) in late 2020 through data compilation as
well as internal readiness activities.
Manufacturing:
- Manufacturing at all manufacturing organizations continues as
planned for ongoing clinical studies.
- Construction of the Iovance manufacturing facility at the Navy
Yard in Philadelphia continues with initiation of the build of
clean rooms in April 2020, ahead of schedule.
Corporate:
- Iovance continues to build a strong team with approximately 190
employees across multiple locations and an experienced commercial
team in place preparing for launch of lifileucel.
- Iovance has been granted or allowed a total of 12 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.
Clinical Data Presentations:
- Oral presentation of updated data from Cohort 2 in the
C-144-01 trial in metastatic melanoma at upcoming ASCO
2020: the abstract #10006 is titled “Long-term follow up
of lifileucel (LN-144) cryopreserved autologous tumor infiltrating
lymphocyte therapy in patients with advanced melanoma progressed on
multiple prior therapies.” The virtual scientific program of the
American Society of Clinical Oncology (ASCO) will be held May
29-31, 2020.
- H. Lee Moffit Cancer Center’s TIL data from Phase 1
lung cancer study presented at American Association for Cancer
Research (AACR) Virtual Annual Meeting I: Moffit’s
presentation demonstrated the potential clinical benefit for TIL in
non-small cell lung cancer (NSCLC), including two durable complete
responses lasting beyond 12 months, in a Phase 1 study supported by
Iovance Biotherapeutics, a Stand Up To Cancer Catalyst® grant, and
other partners.
First Quarter 2020 Financial Results
Net loss for the first quarter ended March 31,
2020, was $69.6 million, or $0.55 per share,
compared to a net loss of $37.0 million,
or $0.30 per share, for the first quarter
ended March 31, 2019.
Research and development expenses were $57.0
million for the first quarter ended March 31, 2020, an
increase of $26.1 million compared to $30.9
million for the first quarter ended March 31, 2019. The
increase in first quarter 2020 over the prior year period was
primarily attributable to an increase in costs associated with the
license to the IOV-3001 IL-2 analog from Novartis, clinical trials
due to higher enrollment, growth of the internal research and
development team, and increased manufacturing activities.
General and administrative expenses were $13.9
million for the first quarter 2020, an increase of $4.8
million compared to $9.1 million for the first
quarter 2019. The increase in first quarter 2020 over the prior
year period was primarily attributable to growth of the internal
general and administrative team, higher stock-based compensation
expenses, as well as higher legal costs.
At March 31, 2020, the company held $251.2
million in cash, cash equivalents, short-term investments and
restricted cash compared to $312.5
million at December 31, 2019. The first quarter 2020
spend included upfront license payments and the purchase of
clinical materials.
Webcast and Conference Call Iovance will host a
conference call today at 4:30 p.m. ET to discuss the
first 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 4564469. 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. We may, in some cases, use terms such as “predicts,”
“believes,” “potential,” “continue,” “estimates,” “anticipates,”
“expects,” “plans,” “intends,” “may,” “could,” “might,” “will,”
“should” or other words that convey uncertainty of future events or
outcomes to identify these forward-looking statements. The
forward-looking statements include, but are not limited to, risks
and uncertainties relating to 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 timing of and our ability to successfully submit,
obtain and maintain FDA or other regulatory authority approval of,
or other action with respect to, our product candidates, including
those product candidates that have been granted breakthrough
therapy designation (“BTD”) or regenerative medicine advanced
therapy designation (“RMAT”) by the FDA and new product candidates
in both solid tumor and blood cancers; the strength of the
Company’s product pipeline; the successful implementation of the
Company’s research and development programs and collaborations; the
Company’s ability to obtain tax incentives and credits; the
guidance provided for the Company’s future cash, cash equivalents,
short term investment and restricted cash balances; the success of
the Company’s manufacturing, license or development agreements; the
acceptance by the market of the Company’s product candidates, if
approved; and other factors, including general economic conditions
and regulatory developments, not within the Company’s control. The
factors discussed herein could cause actual results and
developments to be materially different from those expressed in or
implied by such statements. Actual results may differ from those
set forth in this press release due to the risks and uncertainties
inherent in the Company’s business, including, without limitation:
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 FDA availability due to competing
priorities; the preliminary clinical results, which may include
efficacy and safety results, from ongoing Phase 2 studies may not
be reflected in the final analyses of these trials or subgroups
within these trials; a slower rate of enrollment may impact the
Company’s clinical trial timelines; 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 data within these trials may not be supportive of product
approval; 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 Company’s interpretation of
communications with the FDA may differ from the interpretation of
such communications by the FDA; risks related to the Company’s
ability to maintain and benefit from accelerated FDA review
designations, including BTD and RMAT, 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 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; and
additional expenses may decrease our estimated cash balances and
increase our estimated capital requirements. A further list and
description of the Company’s risks, uncertainties and other factors
can be found in the Company’s most recent Annual Report on Form
10-K and the Company’s subsequent filings with the Securities and
Exchange Commission. Copies of these filings are available online
at www.sec.gov or www.iovance.com. The forward-looking statements
are made only as of the date of this press release and the Company
undertakes no obligation to publicly update such forward-looking
statements to reflect subsequent events or circumstances.
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) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
2020 |
|
|
2019 |
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and short-term investments |
$ |
245,652 |
|
$ |
307,081 |
Restricted cash |
$ |
5,525 |
|
$ |
5,450 |
Total assets |
$ |
288,298 |
|
$ |
344,655 |
Stockholders' equity |
$ |
243,313 |
|
$ |
298,971 |
|
IOVANCE BIOTHERAPEUTICS, INC. |
Condensed Consolidated Statements of
Operations |
(Unaudited, in thousands, except per share
information) |
|
|
|
|
|
|
|
|
|
|
|
For the Three Months March 31, |
|
|
|
|
2020 |
|
|
2019 |
|
Revenues |
$ |
- |
|
$ |
- |
|
|
|
|
|
|
|
|
|
Costs and
expenses |
|
|
|
|
|
|
|
Research and development
expenses |
|
56,952 |
|
|
30,905 |
|
|
General and administrative
expenses |
|
13,858 |
|
|
9,081 |
|
|
Total costs and
expenses |
|
70,810 |
|
|
39,986 |
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(70,810 |
) |
|
(39,986 |
) |
Other
income |
|
|
|
|
|
|
|
Interest income, net |
|
1,215 |
|
|
3,036 |
|
Net
Loss |
$ |
(69,595 |
) |
$ |
(36,950 |
) |
|
|
|
|
|
|
|
|
Net Loss
Per Common Share, Basic and Diluted |
$ |
(0.55 |
) |
$ |
(0.30 |
) |
|
|
|
|
|
|
|
|
Weighted-Average Common Shares Outstanding, Basic and
Diluted |
|
126,568 |
|
|
123,415 |
|
|
|
|
|
|
|
|
|
* Includes
stock-based compensation as follows |
|
|
|
|
|
|
|
Research and development |
$ |
4,318 |
|
$ |
2,701 |
|
|
General and
administrative |
|
5,094 |
|
|
3,145 |
|
|
|
$ |
9,412 |
|
$ |
5,846 |
|
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