Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology
company developing novel cancer immunotherapies based on
tumor-infiltrating lymphocyte (TIL) technology, today reported its
second quarter 2017 financial results and provided a corporate
update.
“During the second quarter of 2017, we made significant progress
with our robust immuno-oncology pipeline based on our TIL
technology, and reached important milestones. Patient dosing is now
ongoing in two of our three Phase 2 programs and we initiated
dosing patients in cohort 2 of our C-144-01 metastatic melanoma
study, which allows for administration of LN-144 generated through
a shorter manufacturing process,” said Dr. Maria Fardis, Ph.D.,
MBA, Chief Executive Officer of Iovance Biotherapeutics. “In
addition, we presented encouraging interim data at ASCO in June
from cohort 1 of our ongoing C-144-01 Phase 2 study in metastatic
melanoma. The responses were presented by overall response rate and
disease control rate in a heavily pre-treated patient population.
This data also demonstrated that we can manufacture TIL at our
central GMP facilities and treat a patient population with a high
unmet medical need at multiple clinical sites. We plan on selecting
the optimal manufacturing process for our clinical programs based
on the available data from the C-144-01 study, by the end of
2017.
Second Quarter 2017 and Recent Highlights and
Anticipated Milestones
Corporate News:
- Corporate name changed to Iovance
Biotherapeutics: In June, the Company changed its
corporate name from Lion Biotechnologies, Inc. to Iovance
Biotherapeutics, Inc. This new name better represents the company’s
leadership in the field of immuno-oncology and reflects the recent
advancements in evaluating TIL therapy in new indications as well
as initiatives to begin trials in Europe.
- Seeking patents for recent advancements in TIL
technology: Iovance has filed for patent protection on its
generation 2 TIL manufacturing process, methods of using TIL
therapies, as well as other technologies that can lead to
production of better TIL products.
Clinical Trial Progress:
- Patient dosing began in second cohort of C-144-01 Phase
2 metastatic melanoma study: In May,
the Company began patient dosing in the second cohort of its
ongoing Phase 2 trial investigating LN-144 for the treatment of
patients with metastatic melanoma. This cohort has a shorter
manufacturing process, and reduces the time from excision to
infusion from approximately six weeks to just over three weeks, by
utilizing the company’s generation 2 manufacturing process which
includes cryopreservation of the outbound products.
Cryopreservation of the product offers greater flexibility for
physicians and patients in scheduling the time of the infusion, and
the shorter process increases the manufacturing flexibility leading
to lower production costs.
- Two Phase 2 trials
investigating LN-145 are underway: In June, the
Company began patient dosing in its Phase 2 trial of LN-145 for the
treatment of patients with recurrent and/or metastatic squamous
cell carcinoma of the head and neck. The Company is also actively
screening patients in the Phase 2 trial for LN-145 in cervical
cancer.
- New Clinical Grant Agreement with Moffitt Cancer Center
for trial in lung cancer: In July, Iovance entered into a
new Clinical Grant Agreement with the Moffitt Cancer Center to fund
a Phase 1 clinical trial of TIL therapy in combination with
nivolumab in metastatic non-small cell lung cancer (NSCLC) in an
effort to continue to understand the potential power of TIL
technology to treat various cancers in areas of high unmet medical
need.
Manufacturing Updates:
- Technology transfer initiated at PharmaCell in the
Netherlands (now Lonza) for generation 1 and 2 TIL manufacturing
processes: In anticipation of the initiation of clinical
studies in Europe in early 2018, a technology transfer for both the
generation 1 and 2 TIL manufacturing processes was commenced at
PharmaCell.
- Increasing manufacturing capacity:
Manufacturing at Wuxi, in suites capable of manufacturing
late-stage clinical and commercial products, was initiated in May.
Regulatory News:
- Expansion of clinical trials globally: The
Company engaged local health authorities in Europe to seek feedback
in support of submission of a Clinical Trial Authorisation for
melanoma and cervical cancer studies in that region.
Data Presentations:
- Interim data presented at ASCO highlighting first
cohort in ongoing C-144-01 study: The Company presented a
poster at the 2017 American Society of Clinical Oncology (ASCO)
Annual Meeting in June 2017 with data from 16 patients enrolled in
the first cohort of its ongoing Phase 2 study of LN-144 for the
treatment of metastatic melanoma. The data reported showed
clinically-meaningful outcomes, of the evaluable patients, with a
29% ORR including one complete response continuing beyond 15 months
post-administration of a single TIL treatment, and 77% of patients
reported a reduction in target tumor size. The Phase 2 study was
conducted in a heavily pre-treated patient group, all of which had
received prior anti-PD-1 therapy and 88% with prior anti-CTLA-4
checkpoint inhibitors, with a median of three prior therapies. For
the full data, please view the release here.
- Data to be presented at the upcoming European Society
for Medical Oncology (ESMO) 2017 Congress in Madrid, Spain in
September 2017: Data will be presented at the upcoming
ESMO congress demonstrating phenotypic and functional
characterization of TIL grown from lymphoma tumors.
Second Quarter 2017 Financial and Operating
Results
As of June 30, 2017, the Company held $129.0 million in cash and
cash equivalents and short-term investments, compared to $166.5
million as of December 31, 2016.
In connection with hiring Maria Fardis Ph.D. as the new Chief
Executive Officer, on June 1, 2016 the Company granted to Dr.
Fardis 550,000 non-transferrable restricted stock units as an
inducement of employment pursuant to the exception to The NASDAQ
Global Market rules. The 550,000 restricted stock units vest in
installments as follows: (i) 137,500 restricted stock units vested
June 1, 2017; (ii) 275,000 restricted stock units vested upon the
satisfaction of certain clinical and manufacturing milestones; and
(iii) the remaining 137,500 restricted stock units will vest in
equal monthly installments over the 36-month period after June 1,
2017.
The Company is providing both GAAP and non-GAAP financial
information. All non-GAAP information excludes amounts related to
stock-based compensation. See “Use of Non-GAAP Financial Measures”
below for a description of the Company’s non-GAAP Financial
Measures. Reconciliation between certain GAAP and non-GAAP measures
is provided at the end of this press release.
GAAP and Non-GAAP Net Loss
GAAP net loss for the quarter ended June 30, 2017 was $23.4
million, or ($0.37) per share, compared to GAAP net loss of $11.6
million or ($0.23) per share for the quarter ended June 30,
2016.
Non-GAAP net loss for the quarter ended June 30, 2017 was $20.1
million, or ($0.32) per share, compared to non-GAAP net loss of
$6.2 million, or ($0.13) per share for the quarter ended June 30,
2016. The non-GAAP net loss for the quarters ended June 30, 2017
and June 30, 2016 excludes $3.3 million and $5.4 million of
non-cash stock-based compensation, respectively.
GAAP net loss for the six months ended June 30, 2017 was $44.1
million, or ($0.71) per share, compared to GAAP net loss of $18.5
million or ($0.37) per share for the six months ended June 30,
2016. Non-GAAP net loss for the six months ended June 30, 2017 was
$37.5 million, or ($0.60) per share, compared to non-GAAP net loss
of $11.3 million or ($0.23) per share for the six months ended June
30, 2016.
GAAP and Non-GAAP Expenses GAAP
research and development (R&D) expenses were $19.7 million for
the quarter ended June 30, 2017, an increase of $15.2 million
compared to the quarter ended June 30, 2016. The increase in
R&D expense is due to increased spending on clinical activities
and manufacturing. In addition, R&D-associated stock based
expenses were $1.9 million for the three months ended June 30, 2017
and $3.3 million for the six months ended June 30, 2017. Non-GAAP
R&D expenses were $17.8 million for the quarter ended June 30,
2017, an increase of $13.9 million, compared to $3.9 million for
the quarter ended June 30, 2016.
GAAP general and administrative (G&A) expenses were $3.9
million for the quarter ended June 30, 2017, a decrease of $3.4
million compared to the quarter ended June 30, 2016. Non-GAAP
G&A expenses for both quarters ended June 30, 2017 and June 30,
2016 remained unchanged at $2.5 million.
Use of Non-GAAP Financial Measures
This press release contains non-GAAP financial measures,
including expenses adjusted to exclude certain non-cash expenses.
These measures are not in accordance with, or an alternative to,
generally accepted accounting principles, or GAAP, and may be
different from non-GAAP financial measures used by other companies.
The item included in GAAP presentations but excluded for purposes
of determining non-GAAP financial measures for the periods
presented in this press release relates to the non-cash stock-based
compensation expense which may fluctuate from period to period
based on factors including the timing and accounting of grants for
stock options and changes in the Company’s stock price which
impacts the fair value of options granted. The Company believes the
presentation of non-GAAP financial measures provides useful
information to management and investors regarding various financial
and business trends relating to the Company’s financial condition
and results of operations. When GAAP financial measures are viewed
in conjunction with non-GAAP financial measures, investors are
provided with a more meaningful understanding of Iovance’s ongoing
operating performance. In addition, these non-GAAP financial
measures are among those indicators the Company uses as a basis for
evaluating operational performance, allocating resources and
planning and forecasting future periods. Non-GAAP financial
measures are not intended to be considered in isolation or as a
substitute for GAAP financial measures. To the extent this release
contains historical or future non-GAAP financial measures, the
Company has also provided corresponding GAAP financial measures for
comparative purposes. Reconciliation between certain GAAP and
non-GAAP measures is provided at the end of this press release.
Webcast and Conference Call
Iovance will host a conference call today at 5:00 p.m. ET to
discuss these second quarter 2017 results. 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
47307932. The live webcast can be accessed under “News &
Events” in the “Investors” section of the Company’s website at
http://www.iovance.com/ or you may use the link:
http://edge.media-server.com/m/p/so22t2sr.
A replay of the call will be available one hour after the end of
the call on August 1, 2017 until 8:00 p.m. ET on August 31, 2017.
To access the replay, please dial 1-855-859-2056 (domestic) or
1-404-537-3406 (international). The conference ID number for the
replay is 47307932. The archived webcast will be available for
thirty days in the Investors section of Iovance Biotherapeutics’
website at http://www.iovance.com/
About Iovance Biotherapeutics, Inc. (formerly
Lion Biotechnologies, Inc.)Iovance Biotherapeutics, Inc. is a
clinical-stage biotechnology company focused on the development of
cancer immunotherapy products for the treatment of various cancers.
The Company's lead product candidate is an adoptive cell therapy
using tumor-infiltrating lymphocyte (TIL) technology being
investigated for the treatment of patients with metastatic
melanoma, recurrent and/or metastatic squamous cell carcinoma of
the head and neck and recurrent and metastatic or persistent
cervical cancer. For more information, please
visit http://www.iovance.com.
Forward-Looking Statements Certain matters
discussed in this press release are “forward-looking statements”.
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. In particular, the
Company’s statements regarding trends and potential future results
are examples of such forward-looking statements. The
forward-looking statements include risks and uncertainties,
including, but not limited to, the success, timing and cost of our
ongoing clinical trials and anticipated clinical trials for our
current product candidates, including statements regarding the
timing of initiation and completion of the 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
Company’s product pipeline; the successful implementation of the
Company’s research and development programs and collaborations; the
success of the Company’s 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. 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 circumstance.
|
|
|
|
|
|
|
|
Iovance Biotherapeutics, Inc. |
Selected Consolidated Balance Sheet
Data |
(unaudited; in thousands) |
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
December 31, |
|
|
|
2017 |
|
|
|
2016 |
Cash, cash equivalents
and short-term investments |
|
$ |
129,017 |
|
|
$ |
166,470 |
Total assets |
|
$ |
138,012 |
|
|
$ |
171,886 |
Stockholders'
equity |
|
$ |
129,152 |
|
|
$ |
166,918 |
|
|
|
|
|
|
|
|
|
Condensed Consolidated Statements of Operations |
(in thousands, except per share
information) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended
June 30, |
|
|
For the Six Months Ended June
30, |
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and
expenses* |
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
19,653 |
|
|
|
4,463 |
|
|
|
36,276 |
|
|
|
8,655 |
|
General
and administrative |
|
3,928 |
|
|
|
7,264 |
|
|
|
8,188 |
|
|
|
10,082 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
costs and expenses |
|
23,581 |
|
|
|
11,727 |
|
|
|
44,464 |
|
|
|
18,737 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(23,581 |
) |
|
|
(11,727 |
) |
|
|
(44,464 |
) |
|
|
(18,737 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income |
|
|
|
|
|
|
|
|
|
|
|
Interest
income |
|
204 |
|
|
|
164 |
|
|
|
403 |
|
|
|
290 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss |
$ |
(23,377 |
) |
|
$ |
(11,563 |
) |
|
$ |
(44,061 |
) |
|
$ |
(18,447 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss Per
Common Share, Basic and Diluted |
$ |
(0.37 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.71 |
) |
|
$ |
(0.37 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average Common Shares Outstanding,
Basic and Diluted |
|
62,457 |
|
|
|
51,082 |
|
|
|
62,371 |
|
|
|
49,807 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Includes
stock-based compensation as follows |
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
$ |
1,896 |
|
|
$ |
593 |
|
|
$ |
3,283 |
|
|
$ |
1,178 |
|
General
and administrative |
|
1,397 |
|
|
|
4,764 |
|
|
|
3,306 |
|
|
|
5,958 |
|
|
$ |
3,293 |
|
|
$ |
5,357 |
|
|
$ |
6,589 |
|
|
$ |
7,136 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Iovance Biotherapeutics, Inc.
(1) |
Reconciliation of Selected GAAP Measures to
Non-GAAP |
(unaudited; in thousands, except per share
data) |
|
|
|
For the Three Months Ended
June 30, |
|
|
For the Six Months Ended June
30, |
|
|
|
2017 |
|
|
|
|
2016 |
|
|
|
|
2017 |
|
|
|
|
2016 |
|
Reconciliation
of GAAP to non-GAAP Research and development |
|
|
|
|
|
|
|
|
|
|
|
GAAP Research and
development |
$ |
|
19,653 |
|
|
$ |
|
4,463 |
|
|
$ |
|
36,276 |
|
|
$ |
|
8,655 |
|
Less: |
|
|
|
|
|
|
|
|
|
|
|
Non-cash
stock-based compensation (2) |
|
|
(1,896 |
) |
|
|
|
(593 |
) |
|
|
|
(3,283 |
) |
|
|
|
(1,178 |
) |
Non-GAAP Research and
development |
$ |
|
17,757 |
|
|
$ |
|
3,870 |
|
|
$ |
|
32,993 |
|
|
$ |
|
7,477 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation
of GAAP to non-GAAP General and administrative |
|
|
|
|
|
|
|
|
|
|
|
GAAP General and
administrative |
$ |
|
3,928 |
|
|
$ |
|
7,264 |
|
|
$ |
|
8,188 |
|
|
$ |
|
10,082 |
|
Less: |
|
|
|
|
|
|
|
|
|
|
|
Non-cash
stock-based compensation (2) |
|
|
(1,397 |
) |
|
|
|
(4,764 |
) |
|
|
|
(3,306 |
) |
|
|
|
(5,958 |
) |
Non-GAAP General and
administrative |
$ |
|
2,531 |
|
|
$ |
|
2,500 |
|
|
$ |
|
4,882 |
|
|
$ |
|
4,124 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Net
loss reconciliation |
|
|
|
|
|
|
|
|
|
|
|
GAAP Net loss |
$ |
|
(23,377 |
) |
|
$ |
|
(11,563 |
) |
|
$ |
|
(44,061 |
) |
|
$ |
|
(18,447 |
) |
Add back: |
|
|
|
|
|
|
|
|
|
|
|
Non-cash
stock-based compensation (2) |
|
|
3,293 |
|
|
|
|
5,357 |
|
|
|
|
6,589 |
|
|
|
|
7,136 |
|
Non-GAAP Net loss |
$ |
|
(20,084 |
) |
|
$ |
|
(6,206 |
) |
|
$ |
|
(37,472 |
) |
|
$ |
|
(11,311 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended
June 30, |
|
|
For the Six Months Ended June
30, |
|
|
|
2017 |
|
|
|
|
2016 |
|
|
|
|
2017 |
|
|
|
|
2016 |
|
Non-GAAP net
loss per share reconciliation |
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss per basic
and diluted share: |
$ |
|
(0.37 |
) |
|
$ |
|
(0.23 |
) |
|
$ |
|
(0.71 |
) |
|
$ |
|
(0.37 |
) |
Add back: |
|
|
|
|
|
|
|
|
|
|
|
Non-cash
stock-based compensation (2) |
|
|
0.05 |
|
|
|
|
0.10 |
|
|
|
|
0.11 |
|
|
|
|
0.14 |
|
Non-GAAP net loss per
basic and diluted share |
$ |
|
(0.32 |
) |
|
$ |
|
(0.13 |
) |
|
$ |
|
(0.60 |
) |
|
$ |
|
(0.23 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average Common Shares Outstanding,
Basic and Diluted |
|
|
62,457 |
|
|
|
|
51,082 |
|
|
|
|
62,371 |
|
|
|
|
49,807 |
|
|
|
|
|
|
|
|
|
|
|
|
|
- This presentation includes non-GAAP measures. The Company’s
non-GAAP measures are not meant to be considered in isolation or as
a substitute for comparable GAAP measures and should be read only
in conjunction with its financial statements prepared in accordance
with GAAP.
- All stock-based compensation was excluded for the non-GAAP
analysis.
Investor Relations Contact:
Sarah McCabe
Stern Investor Relations, Inc.
212-362-1200
sarah@sternir.com
Media Relations Contact:
Evan Smith/Kotaro Yoshida
FTI Consulting
212-850-5622/212-850-5690
evan.smith@fticonsulting.com
kotaro.yoshida@fticonsulting.com
Iovance Biotherapeutics (NASDAQ:IOVA)
Historical Stock Chart
From Feb 2024 to Mar 2024
Iovance Biotherapeutics (NASDAQ:IOVA)
Historical Stock Chart
From Mar 2023 to Mar 2024