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 fourth quarter
and year-end 2019 financial results and provided a corporate
update.
“During 2019 we made tremendous progress in advancing Iovance
TIL and PBL products,” said Maria Fardis, Ph.D., MBA, Iovance
President and Chief Executive Officer. “We conducted two planned
pivotal programs for lifileucel in melanoma and LN-145 in cervical,
initiated patient dosing in earlier lines of therapy and received
clearance from FDA on a new IND to proceed to dose patients with
our PBL product, IOV-2001. In anticipation for commercialization of
Iovance TIL, we are building our internal manufacturing capability
and expanding our commercial team and infrastructure. With the
first potential cell therapy in solid tumors, as well as a broad
TIL platform, Iovance is poised to become the leader in
development, manufacturing, and commercialization of TIL cell
therapy for solid tumors.”
2019 Highlights and 2020 Updates
Clinical
- Initiation and completion of patient dosing in the
pivotal melanoma program, cohort 4 in the C-144-01 trial:
Patient dosing in the pivotal cohort 4 of the C-144-01 study was
initiated in March 2019 and completed in January 2020, three months
ahead of schedule. Iovance intends to submit a biologics license
application (BLA) to FDA subsequent to consultation with the agency
in 2020.
- Presentation of data for lifileucel in metastatic
melanoma and LN-145 for metastatic cervical cancer at major medical
meetings: Several clinical data presentations continued to
demonstrate efficacy and safety of lifileucel in metastatic
melanoma (from C-144-01 study) and LN-145 in recurrent, metastatic,
or persistent cervical cancer (from C-145-04 study). --
Melanoma update - The data for the C-144-01
study in melanoma demonstrated a 36.4% ORR by investigator as
presented at ASCO.1 - In a recent data cut for
the C-144-01 study, a median duration of response (DOR) was not
reached at 15.5 months of median study follow up (Jan. 2020).2
- Expansion of TIL treatment to earlier lines of therapy
for melanoma, head and neck, and non-small cell lung cancer (NSCLC)
patients. Patient dosing in the IOV-COM-202 clinical study
was initiated in May 2019 to evaluate TIL plus pembrolizumab in
patients with immune checkpoint inhibitor naïve melanoma, squamous
cell carcinoma of the head and neck (HNSCC), and NSCLC. In the
fourth cohort, LN-145 alone is offered to relapsed/refractory NSCLC
patients.
Regulatory
- Receipt of Breakthrough Therapy designation (BTD), Fast
Track designation and holding End of Phase 2 Meeting for LN-145 in
cervical cancer: LN-145 was granted Fast Track and BTD
from FDA in recurrent, metastatic or persistent cervical cancer
with disease progression on or after chemotherapy. Following an end
of Phase 2 meeting, the ongoing C-145-04 clinical study was
expanded to dose 75 patients to support registration of LN-145.
Additional cohorts in earlier and later line cervical cancer
patients were added to study C-145-04 in anticipation of a changing
landscape in this indication, specifically, a cohort allowing
patients post anti-PD-1 was added.
- Clearance of the investigational new drug (IND)
application by FDA and initiation of patient dosing for PBL
(IOV-2001) therapy in the first hematologic indication,
CLL: An IND application for IOV-2001 was accepted by FDA
in the blood cancer indication, relapsed or refractory CLL or small
lymphocytic lymphoma (SLL). The first patient was dosed in a Phase
1/2 study (IOV-CLL-01 study).
Manufacturing
- Continuation of high manufacturing success
rate: The Gen 2 TIL therapy manufacturing process
continues to be robust with a demonstrated success rate, as
measured from the receipt of the starting material to the shipment
of TIL product, of well over 90 percent in approximately 300
patients.
- Clinical introduction of Gen 3 TIL therapy: A
proprietary 16-day, third generation TIL therapy manufacturing
process (Gen 3) entered the clinic for initial evaluation in the
expanded C-145-03 clinical study in head and neck cancer patients
with significant unmet need, for which shorter time to TIL infusion
may offer a potential benefit.
- Clinical introduction of PD-1 selected TIL therapy
(LN-145-S1): A proprietary, selected TIL product
LN-145-S1, aimed at taking further advantage of TIL’s ability to
recognize the tumor, is also entering the clinic for initial
evaluation in the expanded C-145-03 study in head and neck cancer,
and subsequently in a new cohort in the IOV-COM-202 study.
Corporate
- Iovance manufacturing facility on track for commercial
production in 2022: Iovance began construction of a
state-of-the-art, 136,000 square foot commercial-scale production
facility in Philadelphia for its TIL therapies in June 2019. The
new facility is expected to be completed by year-end 2021 to
support commercial supply in 2022, with capacity to meet demand for
thousands of patients in multiple cancers. Iovance expects to
invest approximately $85 million over three years for equipment and
construction of the facility.
- The National Cancer Institute (NCI), with support from
Iovance, received an award for TIL therapy technology
transfer: NCI won the Federal Laboratory Consortium’s 2020
Excellence In Technology Transfer Award for “New, First-in-class
Immunotherapy, for Treatment of Recurrent, Metastatic Cervical
Cancer” for its collaboration with Iovance. Iovance supported NCI’s
application for the award and remains a CRADA partner for ongoing
research in TIL therapy.3
- New Iovance patents issued: Iovance has been
granted or allowed a total of 10 U.S. patents for compositions and
methods of treatment in a broad range of cancers related to its
22-day Gen 2 manufacturing process.
Research and Development
- Licensing of novel IL-2 analog (IOV-3001):
Iovance obtained a license from Novartis to develop and
commercialize an expectedly better IL-2 analog, an antibody
cytokine engrafted protein, referred to as IOV-3001, as a targeted
and selective IL-2 analog.
- Licensing of TALEN® technology to develop gene edited
TIL: Under a research collaboration and exclusive
worldwide license agreement with Cellectis, Iovance licensed
certain Cellectis TALEN technology to develop genetically edited
TIL to potentially create more potent therapeutics in several
cancer indications. The worldwide exclusive license enables
Iovance’s use of TALEN technology addressing multiple gene targets
to modify TIL for therapeutic use.
Anticipated 2020 Milestones
- Last patient dosed in the pivotal program of LN-145 for
cervical cancer
- Pre-BLA Meeting with U.S. FDA
- Melanoma top-line pivotal data
- BLA submission
Fourth Quarter and Full-Year 2019 Financial
Results
Net loss for the fourth quarter ended December 31,
2019, was $63.6 million, or $0.50 per share,
compared to a net loss of $32.6 million,
or $0.27 per share, for the fourth quarter
ended December 31, 2018. Net loss for the full-year
ended December 31, 2019, was $197.6 million,
or $1.59 per share, compared to a net loss of $123.6
million, or $1.27 per share, for the full-year
ended December 31, 2018.
Research and development expenses were $54.2
million for the fourth quarter ended December 31, 2019,
an increase of $26.8 million compared to $27.4
million for the fourth quarter ended December 31, 2018.
Research and development expenses were $166.0 million for
the 12 months ended December 31, 2019, an increase
of $66.2 million compared to $99.8 million for
the prior year period. The increases in fourth quarter and full
year 2019 over the prior year periods were primarily attributable
to an increase in costs associated with manufacturing activities
and capacity, clinical trials due to higher enrollment, and growth
of the internal research and development team.
General and administrative expenses were $10.9
million for the fourth quarter 2019, an increase of $3.4
million compared to $7.5 million for the fourth
quarter 2018. General and administrative expenses were $40.8
million for the 12 months ended December 31, 2019, an
increase of $12.4 million compared to $28.4
million for the full year ended December 31, 2018. The
increases in fourth quarter and full year 2019 over the prior year
periods were primarily attributable to growth of the internal
general and administrative team, as well as higher intellectual
property legal costs and market research activities in preparation
for commercialization.
Cash, cash equivalents, short term investments and
restricted cash
At December 31, 2019, the company held $312.5
million in cash, cash equivalents, short-term investments and
restricted cash compared to $468.5
million at December 31, 2018.
Webcast and Conference Call
Iovance will host a conference call today at 4:30 p.m.
ET to discuss fourth quarter and full-year 2019 results and
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 4693108. 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”).
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 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; 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.
1Sarnaik, et al. ASCO 2019 -
Safety and efficacy of cryopreserved autologous tumor infiltrating
lymphocyte therapy (LN-144, lifileucel) in advanced metastatic
melanoma patients who progressed on multiple prior therapies
including anti-PD-1
2Iovance Corporate Overview -
https://ir.iovance.com/presentations
3https://techtransfer.cancer.gov/news
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 Consolidated Balance Sheet Data |
(In thousands) |
|
|
December 31, |
|
|
December 31, |
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, short-term investments, and restricted
cash |
$ |
312,531 |
|
$ |
468,523 |
Total assets |
$ |
344,655 |
|
$ |
480,821 |
Stockholders' equity |
$ |
298,971 |
|
$ |
466,193 |
IOVANCE BIOTHERAPEUTICS, INC. |
|
Consolidated Statements of Operations |
|
(In thousands, except per share information) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended December
31, |
|
|
For the Years Ended December
31, |
|
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
$ |
- |
|
$ |
- |
|
$ |
- |
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and
expenses* |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
54,238 |
|
|
27,418 |
|
|
166,023 |
|
|
99,828 |
|
|
General and
administrative |
|
10,872 |
|
|
7,525 |
|
|
40,849 |
|
|
28,430 |
|
|
Total costs and expenses |
|
65,110 |
|
|
34,943 |
|
|
206,872 |
|
|
128,258 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(65,110 |
) |
|
(34,943 |
) |
|
(206,872 |
) |
|
(128,258 |
) |
Other
income |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
1,542 |
|
|
2,368 |
|
|
9,316 |
|
|
4,678 |
|
Net
Loss |
$ |
(63,568 |
) |
$ |
(32,575 |
) |
$ |
(197,556 |
) |
$ |
(123,580 |
) |
Net Loss
Per Common Share, Basic and Diluted |
$ |
(0.50 |
) |
$ |
(0.27 |
) |
$ |
(1.59 |
) |
$ |
(1.27 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average Common Shares Outstanding, Basic and
Diluted |
|
126,273 |
|
|
119,085 |
|
|
124,336 |
|
|
97,277 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Includes
stock-based compensation as follows |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
2,629 |
|
$ |
2,669 |
|
$ |
11,396 |
|
$ |
9,305 |
|
|
General and
administrative |
|
2,778 |
|
|
2,516 |
|
|
12,881 |
|
|
10,722 |
|
|
|
$ |
5,407 |
|
$ |
5,185 |
|
$ |
24,277 |
|
$ |
20,027 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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