Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage
biotechnology company developing novel cancer immunotherapies based
on tumor-infiltrating lymphocyte (TIL) technology, today reported
first quarter 2019 financial results and provided a corporate
update.
“We have made great progress in recent months in advancing TIL
therapy toward commercialization. In April, we dosed the first
patient in the pivotal study, Cohort 4 of the innovaTIL-01 melanoma
trial, bringing us a step closer to our goal of filing for
regulatory approval of lifileucel in 2020,” commented Maria Fardis,
Ph.D., MBA, president and chief executive officer of Iovance
Biotherapeutics. “We are pleased that three Iovance abstracts
submitted to ASCO have been accepted, two of which include data
updates from our fully enrolled Cohort 2 of our melanoma program
and data from our ongoing LN-145 cervical study being presented for
the first time in a medical conference at the 2019 meeting.”
Recent Achievements and Upcoming Milestones
Clinical
- In April 2019, the company announced that the first patient was
dosed in Cohort 4 of the pivotal innovaTIL-01 study of lifileucel
in metastatic melanoma.
- New interim data from Cohort 2 of the innovaTIL-01 melanoma
study and data from the ongoing innovaTIL-04 cervical cancer study
will be presented on June 1, 2019 at the American Society of
Clinical Oncology (ASCO) annual meeting.
- The company closed the IOV-LUN-201 study and instead will add
an additional arm to the IOV-COM-202 study, adapting clinical
development plans to reflect advances in the treatment landscape
for non-small cell lung cancer.
- The protocol for innovaTIL-04, the Phase 2 study in cervical
cancer, was amended to increase the sample size to 59 and to modify
the primary endpoint of Objective Response Rate (ORR) to be
determined by a Blinded Independent Review Committee (BIRC). The
company made the changes in anticipation of a meeting with the U.S.
Food and Drug Administration (FDA) planned for later this year to
discuss the registration pathway for LN-145 in cervical
cancer.
Regulatory
- In February 2019, LN-145 received Fast Track designation from
the FDA for the cervical cancer indication.
Research
- In April 2019, persistence and biomarker data from Cohort 2 of
the innovaTIL-01 study of lifileucel in the treatment of advanced
melanoma were presented at the American Association for Cancer
Research (AACR) annual meeting. The presentation described results
of an analysis of circulating T cells at 42 days post-infusion,
highlighting the uniqueness of clonal profiles in TIL therapy in
melanoma. The results support potential use of a polyclonal product
such as Iovance bulk TIL in the treatment of melanoma and likely
other cancers with high mutational load solid tumors.
- Researchers at Iovance have generated data in collaboration
with Roswell Park Cancer Center from the 22-day Gen 2 process of
generating TIL from patient derived bladder cancer tumor tissue. An
abstract describing the data has been accepted for presentation at
the upcoming AACR “Bladder Cancer: Transforming the Field”
conference taking place May 18-21, 2019.
Corporate
- In May 2019, the company opened a satellite office in
Philadelphia, Pennsylvania. The office will house various
functions including members of the Iovance legal and manufacturing
teams.
First Quarter 2019 Financial Results
Net loss for the quarter ended March 31, 2019 was $37.0 million,
or $0.30 per share, compared to net loss of $26.5 million, or $0.31
per share for the quarter ended March 31, 2018.
Research and development expenses were $30.9 million for the
quarter ended March 31, 2019, an increase of $11.0 million,
compared to $19.9 million for the same period ended March 31, 2018.
The increase in research and development expenses was primarily
attributable to an increase in the total number of patients in our
clinical studies which in turn results in higher manufacturing and
clinical study costs, technology transfer expenses and an increase
in research and development headcount.
General and administrative expenses were $9.1 million for the
quarter ended March 31, 2019, an increase of $2.1 million compared
to $7.0 million for the same period ended March 31, 2018. The
increase was primarily attributable to an increase in general and
administrative headcount and higher stock based
compensation.
Cash, Cash Equivalents and Short-term
Investments
At March 31, 2019, the company held $440.0 million in cash, cash
equivalents, and short-term investments compared to $468.5 million
at December 31, 2018.
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 7393657. The live webcast can be accessed
under “News & Events: Investor Calendar” in the Investors
section of the Company’s website at www.iovance.com or at the
link: https://edge.media-server.com/m6/p/ika42eku. An archived
webcast will be available in the Investors section of
www.iovance.com for thirty days following the call.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics intends to commercialize lifileucel, an
autologous cell therapy product using TIL technology that amplifies
the body’s own immune response to eradicate solid tumors or attack
blood cancers. The company is currently conducting the pivotal
study innovaTIL-01 in patients with metastatic melanoma. In
addition, the company’s TIL therapies are being investigated for
the treatment of patients with locally advanced, recurrent or
metastatic cancers including cervical, head and neck, and non-small
cell lung cancer. 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,”
“likely,” “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 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 obtain and maintain
U.S. Food and Drug Administration or other regulatory authority
approval of, or other action with respect to, our product
candidates; the strength of the Company’s product pipeline; the
successful implementation of the Company’s research and development
programs and collaborations; 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 FDA may
not agree with the Company’s interpretation of the results of its
clinical trials; later developments with the FDA that may be
inconsistent with already completed FDA meetings; the preliminary
clinical results, including efficacy and safety results, from
ongoing Phase 2 studies may not be reflected in the final analyses
of these trials, including new cohorts within these trials, and may
not be supportive of product approval; the FDA or other regulatory
authorities may potentially delay the timing of their approval of,
or other action with respect to, the Company’s product candidates
(specifically, the Company’s description of FDA interactions are
subject to FDA’s interpretation, as well as FDA’s authority to
request new or additional information); 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 and safety requirements as
well as manufacturing and control requirements; risks related to
the Company’s accelerated FDA review designations, including the
Company’s ability to maintain and benefit from such designations;
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) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and short-term
investments |
$ |
440,018 |
|
$ |
468,523 |
Total assets |
$ |
461,502 |
|
$ |
480,821 |
Stockholders' equity |
$ |
434,932 |
|
$ |
466,193 |
|
|
|
Consolidated Statements of Operations |
(Unaudited, in thousands, except per share
data) |
|
|
|
|
|
|
|
|
|
|
|
For the Three Months March 31, |
|
|
|
|
2019 |
|
|
2018 |
|
Revenues |
$ |
- |
|
$ |
- |
|
|
|
|
|
|
|
|
|
Costs and
expenses |
|
|
|
|
|
|
|
Research and development
expenses |
|
30,905 |
|
|
19,912 |
|
|
General and administrative
expenses |
|
9,081 |
|
|
6,965 |
|
|
Total costs and
expenses |
|
39,986 |
|
|
26,877 |
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(39,986 |
) |
|
(26,877 |
) |
Other
income |
|
|
|
|
|
|
|
Interest income, net |
|
3,036 |
|
|
362 |
|
Net
Loss |
$ |
(36,950 |
) |
$ |
(26,515 |
) |
|
|
|
|
|
|
|
|
Net Loss
Per Common Share, Basic and Diluted |
$ |
(0.30 |
) |
$ |
(0.31 |
) |
|
|
|
|
|
|
|
|
Weighted-Average Common Shares Outstanding, Basic and
Diluted |
|
123,415 |
|
|
84,350 |
|
|
|
|
|
|
|
|
|
* Includes
stock-based compensation as follows |
|
|
|
|
|
|
|
Research and development |
$ |
2,701 |
|
$ |
2,000 |
|
|
General and
administrative |
|
3,145 |
|
|
2,104 |
|
|
|
|
|
|
|
|
|
|
|
$ |
5,846 |
|
$ |
4,104 |
|
|
|
|
|
|
|
|
|
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