Full Press Release Details
Iovance Biotherapeutics Reports Third
Quarter 2018 Financial Results and Provides Corporate Update
- Company to Host Conference Call at 4:30pm
SAN CARLOS, CA - November 6, 2018 -- Iovance Biotherapeutics,
Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL)
technology, today reported its third quarter 2018 financial results and provided a corporate update.
"We have made tremendous progress in the last several
months. Following our recent end of Phase 2 meeting with the FDA, we released information about the meeting outcome and our US
registration path, receipt of RMAT designation for metastatic melanoma, an abbreviated set of our latest clinical data, and conducted
a successful round of financing. The company is now in a very strong financial position which will allow us to pursue our registration
program to commercialize our TIL therapy," said Dr. Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance
Biotherapeutics. "We intend to recruit a new cohort of patients in the C-144-01 study to support registration of lifileucel,
build a commercial manufacturing facility as well as a commercial team to support our plans to bring lifileucel to patients, while
we continue advancing our existing clinical programs and expand our TIL therapy into new indications."
Third Quarter 2018 Financial Results
Net loss for the third quarter ended September 30, 2018 was
$33.8 million, or $0.36 per share, compared to a net loss of $22.1 million, or $0.35 per share for the same period ended September
Research and development expenses were $27.9 million for the
third quarter ended September 30, 2018, an increase of $11.3 million compared to $16.7 million for the third quarter ended September
30, 2017. The increase was primarily attributable to a $4.8 million increase in clinical trial costs due to; higher patient enrollment
and an increase in the number of sites in the clinical trial of lifileucel for the treatment of metastatic melanoma, increased
enrollment in the cervical and head and neck LN-145 clinical trials and the initiation of clinical trials in 2018 for new indications.
Further, payroll and related expenses, including stock-based compensation expenses increased by $4.4 million due to a higher number
of full time employees and dedicated consultants as the company expanded its internal research efforts and clinical development
programs. In addition, research and alliance costs increased by $1.4 million for clinical trials run by Iovance's alliance
partners and new research initiatives and $0.7 million for the expansion of manufacturing capacity at the company's Clinical
Manufacturing Organizations (CMOs).
General and administrative expenses were $7.1 million for the
third quarter ended September 30, 2018, an increase of $1.4 million compared to $5.7 million for the third quarter ended September
30, 2017. The increase was primarily attributable to a $1.5 million increase in stock-based compensation expenses due to an increase
in the number of full time employees and higher stock prices during the quarter as compared to the same period in 2017.
Nine Months Ended September 30, 2018 Financial Results
Net loss for the nine months ended September 30, 2018 was $91.0
million, or $1.01 per share, compared to a net loss of $66.2 million, or $1.06 per share for the same period ended September 30,
Research and development expenses were $72.4 million for the
nine months ended September 30, 2018, an increase of $21.5 million compared to $50.9 million for the same period ended September
30, 2017. The increase was primarily attributable to a $11.9 million increase in the company's clinical trial costs for ongoing
and newly initiated studies and a $10.1 million increase in payroll and related expenses, including stock-based compensation expenses,
for a higher number of full time employees and expenses for services performed by third parties in support of the company's
clinical studies. Further, research and research alliance costs increased by $1.1 million as Iovance expanded its research efforts
and the number of clinical development programs run by its collaborators. These increases were partially offset by a $1.5 million
decrease in manufacturing costs due to higher costs in 2017 related to technical transfer activities.
General and administrative expenses were $20.9 million for the
nine months ended September 30, 2018, an increase of $5.0 million compared to $15.9 million for the same period ended September
30, 2017. The increase was primarily attributable to a $4.3 million increase in payroll and related expenses, including stock-based
compensation expenses, due to a higher number of full time employees and higher stock prices during 2018 and a $0.6 million increase
in professional service and legal expenses.
At September 30, 2018, the company held $260 million in cash,
cash equivalents, and short-term investments compared to $276.1 million at June 30, 2018. During the third quarter the company
used $28.2 million for operating-related activities and received $12.1 million of proceeds from the exercise of warrants and stock
options. In October 2018 the company received $236.6 in net proceeds from the issuance of common stock. The company anticipates
that the year-end balance of cash, cash equivalents and short-term investments may be between $460 to $465 million.
Webcast and Conference Call
Iovance will host a conference call today at 4:30 p.m. ET to
discuss these third quarter 2018 results and provide a corporate update. 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 8718039. 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/bdn8vp67.
A replay of the call will be available
from November 6, 2018 at 7:30 p.m. ET to November 13, 2018 at 8:30 p.m. ET. To access the replay, please dial 1-855-859-2056
(domestic) or 1-404-537-3406 (international) and reference the access code 8718039. 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.
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 TIL technology being investigated for
the treatment of patients with metastatic melanoma, recurrent and/or metastatic squamous cell carcinoma of the head and neck,
recurrent, metastatic or persistent cervical cancer and locally advanced or metastatic non-small cell lung cancer. For more information,
please visit http://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," "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 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 described above may not be reflected in the final analyses of these trials including new cohorts within these trials;
the results obtained in the Company's ongoing clinical trials, such as the studies and trials referred to in this release,
may not be indicative of results obtained in future clinical trials or supportive of product approval; regulatory authorities
may potentially delay the timing of FDA or other regulatory authority 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 may
not be able to obtain or maintain FDA or other regulatory authority approval of its product candidates; 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; the ability of the Company
to manufacture its therapies using third party manufacturers; the ability of the Company to obtain and maintain intellectual property