Full Press Release Details
Iovance Biotherapeutics Reports Second
Quarter 2017 Financial Results
- Company to Host Conference Call at 5:00pm
SAN CARLOS, CA - August 1, 2017 -- 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.
and Recent Highlights and Anticipated Milestones
Clinical Trial Progress:
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.
Manufacturing Updates:
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,
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