Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology
company developing novel cancer immunotherapies based on
tumor-infiltrating lymphocyte (TIL) technology, today reported its
third quarter 2017 financial results and provided a corporate
update.
“In the third quarter of 2017 we continued to make significant
progress in the clinic as the first patient was dosed with LN-145
in the Phase 2 trial for cervical cancer. Regulatory progress was
demonstrated with the FDA granting Fast Track designation for
LN-144 for the treatment of advanced melanoma and approval of a CTA
by the competent authority in the Netherlands for the Phase 2 trial
of LN-145 in cervical carcinoma,” said Dr. Maria Fardis, Ph.D.,
MBA, President and Chief Executive Officer of Iovance
Biotherapeutics. “On the corporate front, we successfully completed
a common stock offering adding approximately $54.0 million in net
proceeds to the cash reserves. In the fourth quarter of 2017, we
look forward to sharing new clinical data from Cohort 2 of the
C-144-01 metastatic melanoma trial and nonclinical data at the
upcoming SITC meeting.”
Third Quarter 2017 and Recent Highlights and Anticipated
Milestones
Corporate News:
- Appointed New Chief Financial Officer
(CFO): In August, Tim Morris was
appointed CFO of Iovance. Mr. Morris brings over 22 years of
experience related to the biopharmaceutical industry.
- Completion of Public Offering: In September,
the Company completed a public offering of 8,846,154 shares of its
common stock at a price of $6.50 per share, before
underwriting discounts. The shares of common stock issued and sold
in the offering at the closing include 1,153,846 shares issued upon
the exercise in full by the underwriters of their option to
purchase additional shares. The net proceeds from the offering,
after deducting the underwriting discounts and commissions and
other estimated offering expenses payable by Iovance, are
approximately $54.0 million.
Clinical Trial Progress:
- C-144-01 Phase 2 Trial in Metastatic Melanoma:
In October, preliminary data from Cohort 2 of the ongoing C-144-01
Phase 2 trial of LN-144 was accepted as a late-breaking abstract to
be presented at the Society for Immunotherapy of Cancer (SITC) 2017
Annual Meeting.
- First Patient Dosed in C-145-04 Phase 2 Trial in
Cervical Cancer: In August, the first patient was
dosed in the C-145-04 Phase 2 trial of LN-145 for the treatment of
patients with recurrent, metastatic or persistent cervical
carcinoma.
Manufacturing Updates:
- Partnership with TrakCel for Personalized Patient
Product Management: In September, Iovance commenced a
partnership with TrakCel Ltd. to build a scheduling and logistics
tool that automates the supply chain for Iovance’s adoptive cell
therapy products that utilize its TIL technology. The TrakCel
Solution will electronically link Iovance with clinical sites,
contract manufacturing organizations and couriers to schedule and
track TIL therapies for each patient. The TrakCel Solution is
intended to help manage capacity utilization and throughput as well
as providing efficiencies in the delivery of TIL treatment.
Regulatory Updates:
- Fast Track Designation Granted for LN-144: In
August, the U.S. Food and Drug Administration (FDA) granted Fast
Track designation for LN-144, the Company’s adoptive cell therapy
using its TIL technology, for the treatment of advanced
melanoma.
- European Clinical Trial Applications (CTAs):
Iovance initiated the submission of CTAs in multiple countries
in Europe starting in August 2017 in support of
Phase 2 clinical trials of LN-145 in cervical carcinoma and LN-144
in metastatic melanoma. In September, the Company received the
first approval from the competent authority in the
Netherlands, for LN-145 for the treatment of patients with cervical
carcinoma. Subsequent to the end of the quarter, the Company
received CTA approvals in Hungary for metastatic melanoma and the
United Kingdom for cervical carcinoma and metastatic melanoma.
Research Update and Data Presentations:
- Research Collaboration Agreement with Ohio State
University: In September, the Company entered into a
collaboration with the Ohio State University. The collaboration
will initially focus on hematologic malignancies in areas of poor
prognostic cancers with high unmet medical need, which include
acute myeloid leukemia (AML) and chronic lymphocytic leukemia
(CLL).
- Poster Presentation at European Society for Medical
Oncology (ESMO): In August, the Company announced a poster
presentation at the ESMO 2017 Congress in September with data that
demonstrates the ability to produce TIL from lymphoma that have
similar functionality as TIL generated from melanoma.
Third Quarter 2017 Financial and Operating
Results
As of September 30, 2017, the Company held $163.4 million in
cash and cash equivalents and short-term investments, compared to
$166.5 million as of December 31, 2016.
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 Attributable to Common
Stockholders
GAAP net loss attributable to common stockholders for the
quarter ended September 30, 2017 was $22.1 million, or ($0.35) per
share, compared to GAAP net loss of $68.2 million or ($1.15) per
share for the quarter ended September 30, 2016.
Non-GAAP net loss attributable to common stockholders for the
quarter ended September 30, 2017 was $19.5 million, or ($0.31) per
share, compared to non-GAAP net loss of $10.1 million, or ($0.17)
per share for the quarter ended September 30, 2016. The non-GAAP
net loss for the quarters ended September 30, 2017 and September
30, 2016 excludes $2.6 million and $8.6 million of non-cash
stock-based compensation, and a non-cash deemed dividend of $49.5
million which was recorded in the quarter ended September 30, 2016.
The deemed dividend will only impact the prior years’ quarter’s
financial statements.
GAAP net loss attributable to common stockholders for the nine
months ended September 30, 2017 was $66.2 million, or ($1.06) per
share, compared to GAAP net loss attributable to common
stockholders of $86.7 million or ($1.64) per share for the nine
months ended September 30, 2016. Non-GAAP net loss for the nine
months ended September 30, 2017 was $57.0 million, or ($0.91) per
share, compared to non-GAAP net loss of $21.4 million or ($0.40)
per share for the nine months ended September 30, 2016.
GAAP and Non-GAAP Expenses GAAP
research and development (R&D) expenses were $17.8 million for
the quarter ended September 30, 2017, an increase of $9.3 million
compared to the quarter ended September 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 $1.1 million for the three months ended September 30,
2017 and $4.3 million for the nine months ended September 30, 2017.
Non-GAAP R&D expenses were $16.7 million for the quarter ended
September 30, 2017, an increase of $8.9 million, compared to $7.8
million for the quarter ended September 30, 2016.
GAAP general and administrative (G&A) expenses were $4.6
million for the quarter ended September 30, 2017, a decrease of
$5.9 million compared to the quarter ended September 30, 2016.
Non-GAAP G&A expenses were $3.0 million for the quarter ended
September 30, 2017, an increase of $0.5 million, compared to $2.5
million for the quarter ended September 30, 2016.
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 items included in GAAP presentations but excluded for purposes
of determining non-GAAP financial measures for the periods
presented in this press release are: (i) 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, and (ii) the one-time
non-cash deemed dividend related to the conversion feature of the
Series B Preferred Stock. 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.
2017 Year End Guidance for Cash, Cash Equivalents and
Short-Term Investments
Iovance anticipates the cash, cash equivalents and short-term
investments as of December 31, 2017, to be in excess of $141.0
million.
Webcast and Conference Call
Iovance will host a conference call today at 4:30 p.m. ET to
discuss these third 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
1423064. 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:
https://edge.media-server.com/m6/p/q7762k6j.
A replay of the call will be available one hour after the end of
the call on October 31, 2017 until 8:00 p.m. ET on November 30,
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 1423064. 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.
Investor Relations Contact: Sarah McCabeStern
Investor Relations, Inc.212-362-1200sarah@sternir.com
Media Relations Contact:Evan SmithFTI
Consulting212-850-5622 evan.smith@fticonsulting.com
Iovance Biotherapeutics,
Inc.Selected Consolidated Balance Sheet
Data(unaudited; in thousands) |
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
Cash, cash equivalents
and short-term investments |
|
$ |
163,380 |
|
|
$ |
166,470 |
Total assets |
|
$ |
173,970 |
|
|
$ |
171,886 |
Stockholders'
equity |
|
$ |
165,441 |
|
|
$ |
166,918 |
Condensed Consolidated Statements of
Operations(unaudited; in thousands, except per share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended
September 30, |
|
|
For the Nine Months Ended
September 30, |
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and
expenses* |
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
17,753 |
|
|
|
8,481 |
|
|
|
54,029 |
|
|
|
17,200 |
|
General
and administrative |
|
4,590 |
|
|
|
10,498 |
|
|
|
12,777 |
|
|
|
20,517 |
|
Total
costs and expenses |
|
22,343 |
|
|
|
18,979 |
|
|
|
66,806 |
|
|
|
37,717 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(22,343 |
) |
|
|
(18,979 |
) |
|
|
(66,806 |
) |
|
|
(37,717 |
) |
Other
income |
|
|
|
|
|
|
|
|
|
|
|
Interest
income |
|
194 |
|
|
|
221 |
|
|
|
596 |
|
|
|
511 |
|
Net
Loss |
$ |
(22,149 |
) |
|
$ |
(18,758 |
) |
|
$ |
(66,210 |
) |
|
$ |
(37,206 |
) |
Deemed
dividend related to beneficial conversion feature of convertible
preferred stock |
|
- |
|
|
|
(49,454 |
) |
|
|
- |
|
|
|
(49,454 |
) |
Net Loss
Attributable to Common Stockholders |
|
(22,149 |
) |
|
|
(68,212 |
) |
|
|
(66,210 |
) |
|
|
(86,660 |
) |
Net Loss Per
Common Share, Basic and Diluted |
$ |
(0.35 |
) |
|
$ |
(1.15 |
) |
|
$ |
(1.06 |
) |
|
$ |
(1.64 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average Common Shares Outstanding,
Basic and Diluted |
|
63,332 |
|
|
|
59,113 |
|
|
|
62,697 |
|
|
|
52,963 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Includes
stock-based compensation as follows |
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
$ |
1,053 |
|
|
$ |
640 |
|
|
$ |
4,336 |
|
|
$ |
1,818 |
|
General
and administrative |
|
1,566 |
|
|
|
8,005 |
|
|
|
4,872 |
|
|
|
13,963 |
|
|
$ |
2,619 |
|
|
$ |
8,645 |
|
|
$ |
9,208 |
|
|
$ |
15,781 |
|
Iovance Biotherapeutics, Inc.
(1)Reconciliation of Selected GAAP Measures to
Non-GAAP (unaudited; in thousands, except per share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended
September 30, |
|
|
For the Nine Months Ended
September 30, |
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
Reconciliation
of GAAP to non-GAAP Research and development |
|
|
|
|
|
|
|
|
|
|
|
GAAP Research and
development |
$ |
17,753 |
|
|
$ |
8,481 |
|
|
$ |
54,029 |
|
|
$ |
17,200 |
|
Less: |
|
|
|
|
|
|
|
|
|
|
|
Non-cash
stock-based compensation (2) |
|
(1,053 |
) |
|
|
(640 |
) |
|
|
(4,336 |
) |
|
|
(1,818 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Research and
development |
$ |
16,700 |
|
|
$ |
7,841 |
|
|
$ |
49,693 |
|
|
$ |
15,382 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation
of GAAP to non-GAAP General and administrative |
|
|
|
|
|
|
|
|
|
|
|
GAAP General and
administrative |
$ |
4,590 |
|
|
$ |
10,498 |
|
|
$ |
12,777 |
|
|
$ |
20,517 |
|
Less: |
|
|
|
|
|
|
|
|
|
|
|
Non-cash
stock-based compensation (2) |
|
(1,566 |
) |
|
|
(8,005 |
) |
|
|
(4,872 |
) |
|
|
(13,963 |
) |
Non-GAAP General and
administrative |
$ |
3,024 |
|
|
$ |
2,493 |
|
|
$ |
7,905 |
|
|
$ |
6,554 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Net
loss reconciliation |
|
|
|
|
|
|
|
|
|
|
|
GAAP Net loss |
$ |
(22,149 |
) |
|
$ |
(68,212 |
) |
|
$ |
(66,210 |
) |
|
$ |
(86,660 |
) |
Add back: |
|
|
|
|
|
|
|
|
|
|
|
Non-cash
stock-based compensation (2) |
|
2,619 |
|
|
|
8,645 |
|
|
|
9,208 |
|
|
|
15,781 |
|
Non-cash
Deemed dividend related to beneficial conversion feature of
convertible preferred stock (3) |
|
- |
|
|
|
49,454 |
|
|
|
- |
|
|
|
49,454 |
|
Non-GAAP Net loss |
$ |
(19,530 |
) |
|
$ |
(10,113 |
) |
|
$ |
(57,002 |
) |
|
$ |
(21,425 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended
September 30, |
|
|
For the Nine Months Ended
September 30, |
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
Non-GAAP net
loss per share reconciliation |
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss per basic
and diluted share: |
$ |
(0.35 |
) |
|
$ |
(1.15 |
) |
|
$ |
(1.06 |
) |
|
$ |
(1.64 |
) |
Add back: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash
stock-based compensation (2) |
|
0.04 |
|
|
|
0.15 |
|
|
|
0.15 |
|
|
|
0.30 |
|
Non-cash
Deemed dividend related to beneficial conversion feature of
convertible preferred stock (3) |
|
- |
|
|
|
0.83 |
|
|
|
- |
|
|
|
0.94 |
|
Non-GAAP net loss per
basic and diluted share |
$ |
(0.31 |
) |
|
$ |
(0.17 |
) |
|
$ |
(0.91 |
) |
|
$ |
(0.40 |
) |
Weighted-Average Common Shares Outstanding,
Basic and Diluted |
|
63,332 |
|
|
|
59,113 |
|
|
|
62,697 |
|
|
|
52,963 |
|
|
- 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.
- The deemed dividend related to the conversion feature of the
Series B Preferred Stock was excluded for non-GAAP analysis.
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