Full Press Release Details
Iovance Biotherapeutics Reports Third
Quarter 2017 Financial Results
- Company to Host Conference Call at 4:30pm
SAN CARLOS, CA - October 31, 2017 -- 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."
and Recent Highlights and Anticipated Milestones
Clinical Trial Progress:
Manufacturing Updates:
Research Update and Data Presentations:
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
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,
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