Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel cancer immunotherapies based
on tumor-infiltrating lymphocyte (TIL) technology, today reported
financial results from second quarter and first six months of 2019
and provided a corporate update.
“We have had a highly productive second quarter
at Iovance,” commented Maria Fardis, Ph.D., MBA, president and
chief executive officer of Iovance Biotherapeutics. “We presented
data for both melanoma and cervical programs at ASCO, met with the
FDA to define our registration path for LN-145, received
Breakthrough Therapy Designation for LN-145, and broke ground for
our commercial manufacturing facility. Based on FDA feedback, we
expect to submit a Biologics License Application (BLA) for LN-145
for advanced cervical cancer in late 2020. This time frame
potentially overlaps with the expected timing of a submission in
the advanced melanoma indication. In addition, we continue to
expand the Iovance team and build our corporate infrastructure in
anticipation of making TIL therapy broadly accessible to all
patients that may benefit from this treatment approach.”
Recent Achievements and Upcoming
Milestones
Clinical
- Data from the C-144-01 melanoma study and from the C-145-04
cervical cancer study were presented in June 2019 at the American
Society of Clinical Oncology (ASCO) annual meeting. Data from the
C-145-04 study in 27 patients demonstrated an objective response
rate (ORR) of 44 percent. At 7.4-month median follow-up, the median
duration of response (DOR) had not been reached. Interim results
from the C-144-01 study in 66 patients demonstrated an ORR of 38
percent. At 8.8-month median follow-up, median DOR had not been
reached.
- Enrollment for Cohort 4, the pivotal cohort of the C-144-01, is
on target for completion of enrollment in the first quarter of
2020.
- Study C-145-04 has been expanded to dose 75 patients to address
the expected sample size in anticipation of a BLA submission in
late 2020.
- The first patient has been dosed in the IOV-COM-202 study
evaluating TIL monotherapy or TIL plus pembrolizumab in patients
with melanoma, head and neck cancer, or non-small cell lung cancer
(NSCLC). The company has amended the protocol for IOV-COM-202 to
add an additional cohort to treat PD-1 naive NSCLC patients with
TIL and pembrolizumab. The total number of patients expected to
enroll in the study was increased to 48. This study has received
regulatory approval for conduct in EU and Canada.
- To date, over 200 patients have been treated with TIL therapy
at Iovance.
Regulatory
- In May 2019, LN-145 was granted Breakthrough Therapy
designation from the U.S. Food and Drug Administration (FDA) for
the treatment of advanced cervical cancer patients who have
progressed during or after chemotherapy.
- At an End of Phase 2 meeting, the FDA acknowledged that the
ongoing C-145-04 study of TIL therapy LN-145 may be sufficient to
support registration in the treatment of patients with advanced
cervical cancer. We plan to include in the BLA, patients who have
progressed following initial systemic therapy for recurrent or
metastatic disease, which constitutes almost all of the more
advanced patients enrolled to date. The protocol may further be
amended to enroll additional patients in order to support a BLA
submission.
Research
- A poster entitled “Iovance Peripheral Blood Lymphocytes (PBL):
A Potential Cell Therapy Strategy for the Treatment of Chronic
Lymphocytic Leukemia” was presented at the 24th Congress of
European Hematology Association in June 2019. The poster described
the company’s nine-day manufacturing process and preclinical
results for IOV-2001, PBL for chronic lymphocytic leukemia, created
from 50 mL of blood.
- In July 2019, the company entered into a clinical trial
agreement with the University of Montreal Health Centre (CHUM),
under which CHUM will conduct a clinical study that it has designed
using PD-1 positive selected TIL. The PD-1 positive TIL to be used
in the study will be manufactured by a GMP cell processing facility
within the University of Montreal network using a process developed
by CHUM. Iovance also has an option to negotiate an exclusive
license to the technology from CHUM. Iovance is expanding its
footprint in Canada with this collaboration.
Corporate
- In May 2019, the company entered into a long-term lease
agreement to build an approximately 136,000 square foot
commercial-scale production facility in Philadelphia for commercial
and clinical production of autologous TIL products. The company and
its partners began construction of the facility in June 2019.
- Friedrich Graf Finckenstein, M.D., joined the company as chief
medical officer.
- Athena Countouriotis, M.D., was appointed to the company’s
board of directors.
- The company currently owns seven recently granted or allowed
U.S. patents for compositions and methods of treatment in a broad
range of cancers relating to its Gen 2 manufacturing process,
including U.S. Patent Nos. 10,166,257, 10,130,659, and 10,272,113.
The company’s owned and licensed intellectual property portfolio
also includes patent applications relating to TIL, marrow
infiltrating lymphocyte, and PBL therapies; methods of
manufacturing; the use of costimulatory molecules in TIL therapy
and manufacturing; stable and transient genetically-modified TIL
therapies; and methods of treating patient subpopulations.
Second Quarter 2019 Financial
Results
Net loss for the second quarter ended June 30,
2019, was $47.6 million, or $0.38 per share, compared to net loss
of $30.7 million, or $0.34 per share for the second quarter ended
June 30, 2018.
Research and development expenses were $39.3
million for the second quarter of 2019, an increase of $14.7
million compared to $24.6 million for the second quarter of 2018.
The increase in research and development expenses was primarily
attributable to costs associated with the transfer of the
manufacturing process to additional facilities to increase our
manufacturing capacity, an increase in total patients in our
clinical studies which in turn resulted in higher study costs, and
an increase in research and development employees.
General and administrative expenses were $10.9
million for the second quarter of 2019, an increase of $4.1 million
compared to $6.8 million for the second quarter of 2018. The
increase was primarily attributable to new general and
administrative employees and higher stock-based compensation, legal
expenses related to the intellectual property portfolio and real
estate and external market research costs as we prepare for
commercialization.
Six Months Ended June 30, 2019 Financial
Results
Net loss for the six months ended June 30, 2019,
was $84.5 million, or $0.68 per share, compared to net loss of
$57.2 million, or $0.65 per share for the same period ended June
30, 2018.
Research and development expenses were $70.2
million for the six months ended June 30, 2019, an increase of
$25.7 million compared to $44.5 million for the same period ended
June 30, 2018. The increase in research and development expenses
was primarily attributable to costs associated with the transfer of
the manufacturing process to additional facilities to increase our
manufacturing capacity, higher costs for drugs used in the clinical
studies, an increase in total patients in our clinical studies
which in turn resulted in higher study costs, and an increase in
the number of research and development employees.
General and administrative expenses were $19.9
million for the six months ended June 30, 2019, an increase of $6.1
million compared to $13.8 million for the same period ended June
30, 2018. The increase was primarily attributable to the addition
of general and administrative employees and higher stock-based
compensation, legal expenses related to intellectual property, and
external market research expenses.
Cash, Cash Equivalents, Short-Term
Investments and Restricted Cash
At June 30, 2019, the company held $409.6
million in cash, cash equivalents, short-term investments and
restricted cash as compared to $440.0 million at March 31, 2019.
During the second quarter the company used $33.8 million for
operating activities. The company anticipates that the year-end
balance of cash, cash equivalents, short-term investments and
restricted cash may be between $310 and $320 million.
Webcast and Conference Call
Iovance will host a conference call and live
audio webcast to discuss financial results and provide a corporate
update today at 4:30 p.m. EDT.
To participate in the conference call, please
dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international)
and reference the access code 7574927. A live and archived webcast
can be accessed in the Investors section of the company’s website
at www.iovance.com.
About Iovance Biotherapeutics,
Inc.
Iovance Biotherapeutics intends to commercialize
autologous cell therapy products for solid tumors and blood
cancers. Tumor infiltrating lymphocyte (TIL) therapy uses a
patient’s own cancer-fighting immune cells to attack solid tumors.
TIL are extracted from tumor cells, and once expanded through a
proprietary process are infused back into the patient. After
infusion, TIL enter tumor tissue, where they recognize, attack, and
destroy the tumor. The company is currently conducting pivotal
studies in patients with metastatic melanoma and advanced cervical
cancer. In addition, the company’s TIL therapies are being
investigated for the treatment of patients with locally advanced,
recurrent or metastatic cancers including head and neck and
non-small cell lung cancer. Iovance has also developed a T cell
therapy for blood cancers called peripheral blood lymphocyte (PBL)
and intends to bring that product to clinic to investigate utility
of PBL in chronic lymphocytic leukemia. 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 equivalent,
and short term investment positions; 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; the 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; the Company’s ability 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; 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; and the ability of
the Company to manufacture its therapies using third party
manufacturers. 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.
Investor Relations
Contacts: Annie ChangSolebury
Trout646-378-2972achang@troutgroup.com
Chad RubinSolebury
Trout646-378-2947crubin@troutgroup.com
Media Relations Contact: Rich
AllanSolebury Trout646-378-2958rallan@troutgroup.com
|
IOVANCE BIOTECHNOLOGIES, INC. |
Selected Consolidated Balance Sheet Data |
(Unaudited, in thousands) |
|
|
June 30, |
|
|
December 31, |
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and short-term investments |
$ |
404,153 |
|
$ |
468,523 |
Restricted cash |
$ |
5,450 |
|
$ |
- |
Total assets |
$ |
435,924 |
|
$ |
480,821 |
Stockholders' equity |
$ |
397,422 |
|
$ |
466,193 |
|
|
|
|
|
|
|
|
IOVANCE BIOTECHNOLOGIES, INC. |
|
Condensed Statements of Operations |
|
(unaudited, in thousands, except per share
information) |
|
|
|
|
|
For the Three Months Ended June 30, |
|
|
For the Six Months Ended June 30, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
$ |
- |
|
$ |
- |
|
$ |
- |
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and
expenses* |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
39,298 |
|
|
24,551 |
|
|
70,203 |
|
|
44,463 |
|
General and administrative |
|
10,867 |
|
|
6,827 |
|
|
19,948 |
|
|
13,792 |
|
Total costs and expenses |
|
50,165 |
|
|
31,378 |
|
|
90,151 |
|
|
58,255 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(50,165 |
) |
|
(31,378 |
) |
|
(90,151 |
) |
|
(58,255 |
) |
Other
income |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
2,614 |
|
|
718 |
|
|
5,650 |
|
|
1,080 |
|
Net Loss |
$ |
(47,551 |
) |
$ |
(30,660 |
) |
$ |
(84,501 |
) |
$ |
(57,175 |
) |
Net Loss Per Common
Share, Basic and Diluted |
$ |
(0.38 |
) |
$ |
(0.34 |
) |
$ |
(0.68 |
) |
$ |
(0.65 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average
Common Shares Outstanding, Basic and Diluted |
|
123,567 |
|
|
90,236 |
|
|
123,491 |
|
|
87,310 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Includes stock-based
compensation as follows |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
2,720 |
|
$ |
2,381 |
|
$ |
5,421 |
|
$ |
4,381 |
|
General and administrative |
|
3,706 |
|
|
2,841 |
|
|
6,851 |
|
|
4,945 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
6,426 |
|
$ |
5,222 |
|
$ |
12,272 |
|
$ |
9,326 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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