Full Press Release Details
Biotherapeutics Reports First Quarter 2021
Financial Results and Corporate Updates
Expanding First-in-Class TIL Cell Therapy Platform
CARLOS, Calif., May 6, 2021 -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company
developing novel T cell-based cancer immunotherapies (tumor-infiltrating lymphocyte, TIL, and peripheral-blood lymphocyte, PBL), today
reported first quarter 2021 financial results and corporate updates.
Maria Fardis, Ph.D., President and Chief Executive Officer of Iovance,
stated, "During the first quarter of 2021 we continued to work on our potency assays in support of a BLA for lifileucel, which is
our top priority at Iovance. We continued developing multiple assays in parallel and submitted additional potency assay data to the FDA.
I am also very pleased to highlight the strength of clinical data for TIL being presented at the recent and upcoming medical meetings
and journal publications, including the first clinical data for TIL in combination with pembrolizumab in melanoma at the upcoming ASCO
Annual Meeting. We believe durable responses for Iovance TIL in relapsed or refractory metastatic melanoma, paired with data to be presented
for TIL in combination with anti-PD1 therapy in earlier treatment settings, solidify the broader potential for Iovance TIL and further
demonstrate our leadership in the development, manufacturing, and potential commercialization of TIL cell therapy."
First Quarter 2021 Highlights
and Recent Corporate Updates
First Quarter 2021 Financial Results
Iovance held $610.2 million in cash,
cash equivalents, investments and restricted cash at March 31, 2021 compared to $635.0 million at December 31, 2020. The
company anticipates that the year-end balance of cash, cash equivalents, investments and restricted cash will be sufficient into 2023.
Jean-Marc Bellemin, Chief Financial Officer, stated, "The continued
strength of our balance sheet puts Iovance in an excellent position to fulfill our operating plan and advance our pipeline. We are judicious
in our investments to maximize value and deliver on our commitments for patients and our shareholders."
Net loss for the first quarter ended March
31, 2021, was $75.4 million, or $0.51 per share, compared to a net loss of $69.6 million, or $0.55 per
share, for the first quarter ended March 31, 2020.
Research and development expenses were $55.9
million for the first quarter ended March 31, 2021, a decrease of $1.0 million compared to $57.0 million for
the first quarter ended March 31, 2020.
The decrease in research and development expenses
in the first quarter 2020 over the prior year period was primarily attributable to a decrease in manufacturing and clinical costs following
the completion of enrollment in the pivotal cohorts for melanoma and cervical cancer.
General and administrative expenses were $19.6
million for the first quarter ended March 31, 2021, an increase of $5.8 million compared to $13.9 million for
the first quarter ended March 31, 2020.
The increases in general and administrative
expenses in the first quarter 2021 compared to the prior year period was primarily attributable to growth of the internal general and
administrative team and higher stock-based compensation expenses.
will host a conference call today at 4:30 p.m. ET to discuss the first quarter 2021 financial results and corporate updates.
The conference call dial-in numbers are 1-800-773-2954 (domestic) or 1-847-413-3731 (international) and the access code is 50155289.
The live webcast can be accessed in the Investors section of the company's website at http://www.iovance.com.
The archived webcast will be available for a year in the Investors section at www.iovance.com.
About Iovance Biotherapeutics, Inc.
Biotherapeutics aims to improve patient care by making T cell-based immunotherapies broadly accessible for the treatment of patients
with solid tumors and blood cancers. Tumor infiltrating lymphocyte (TIL) therapy uses a patient's own immune cells to attack cancer.
TIL cells are extracted from a patient's own tumor tissue, expanded through a proprietary process, and infused back into the patient.
Upon infusion, TIL reach tumor tissue, where they attack cancer cells. The company has completed dosing in pivotal programs in patients
with metastatic melanoma and cervical cancer. In addition, the company's TIL therapy is being investigated in a registration-supporting
study for the treatment of patients with locally advanced, recurrent or metastatic non-small cell lung cancer. Clinical studies are also
underway to evaluate TIL in earlier stage cancers in combination with currently approved treatments, and to investigate Iovance peripheral
blood lymphocyte (PBL) T cell therapy for blood cancers. For more information, please visit 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") within the meaning of the Private Securities Litigation Reform Act of 1995 (the
"PSLRA"). All such written or oral statements made in this press release, other than statements of historical fact, are forward-looking
statements and are intended to be covered by the safe harbor for forward-looking statements provided by the PSLRA. Without limiting the
foregoing, we may, in some cases, use terms such as "predicts," "believes," "potential," "continue,"
"estimates," "anticipates," "expects," "plans," "intends," "forecast,"
"guidance," "outlook," "may," "could," "might," "will," "should"
or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking
statements are based on assumptions and assessments made in light of management's experience and perception of historical trends,
current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press
release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a
result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject
to risks, uncertainties and other factors, many of which are outside of our control, that may cause actual results, levels of activity,
performance, achievements and developments to be materially different from those expressed in or implied by these forward-looking statements.
Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements
are described in the sections titled "Risk Factors" in our filings with the Securities and Exchange Commission, including our
most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial
known and unknown risks and uncertainties inherent in our business: the effects of the COVID-19 pandemic; risks related to the timing
of and our ability to successfully develop, submit, obtain and maintain U.S. Food and Drug Administration ("FDA") or other
regulatory authority approval of, or other action with respect to, our product candidates, and our ability to successfully commercialize
any product candidates for which we obtain FDA approval; preliminary and interim clinical results, which may include efficacy and safety
results, from ongoing clinical trials may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these
trials; the risk that enrollment may need to be adjusted for our trials and cohorts within those trials based on FDA and other regulatory
agency input; the new version of the protocol which further defines the patient population to include more advanced patients in our cervical
cancer trial may have an adverse effect on the results reported to date; the risk that we may be required to conduct additional clinical
trials or modify ongoing or future clinical trials based on feedback from the FDA or other regulatory authorities; the risk that our interpretation
of the results of our clinical trials or communications with the FDA may differ from the interpretation of such results or communications
by the FDA; the acceptance by the market of our product candidates and their potential reimbursement by payors, if approved; our ability
or inability to manufacture our therapies using third party manufacturers or our own facility may adversely affect our potential commercial
launch; the results of clinical trials with collaborators using different manufacturing processes may not be reflected in our sponsored
trials; the risk that unanticipated expenses may decrease our estimated cash balances and increase our estimated capital requirements;
and other factors, including general economic conditions and regulatory developments, not within our control.
IOVANCE BIOTHERAPEUTICS, INC.
Selected Condensed Consolidated Balance
| March 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| (Unaudited) | ||||||||
| Cash, cash equivalents, and investments | $ | 604,157 | $ | 629,437 | ||||
| Restricted cash | $ | 6,084 | $ | 5,525 | ||||
| Total assets | $ | 750,573 | $ | 768,458 | ||||
| Stockholders' equity | $ | 647,431 | $ | 656,498 |
IOVANCE BIOTHERAPEUTICS, INC.
Condensed Consolidated Statements
(Unaudited, in thousands, except per
| For the Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| Costs and expenses | ||||||||
| Research and development expenses | 55,949 | 56,952 | ||||||
| General and administrative expenses | 19,621 | 13,858 | ||||||
| Total costs and expenses | 75,570 | 70,810 | ||||||
| Loss from operations | (75,570 | ) | (70,810 | ) | ||||
| Other income | ||||||||
| Interest income, net | 121 | 1,215 | ||||||
| Net Loss | $ | (75,449 | ) | $ | (69,595 | ) | ||
| Net Loss Per Common Share, Basic and Diluted | $ | (0.51 | ) | $ | (0.55 | ) | ||
| Weighted-Average Common Shares Outstanding, Basic and Diluted | 147,370 | 126,568 | ||||||
| * Includes stock-based compensation as follows | ||||||||
| Research and development | $ | 9,202 | $ | 4,318 | ||||
| General and administrative | 7,739 | 5,094 | ||||||
| $ | 16,941 | $ | 9,412 |
Biotherapeutics, Inc:
Sara Pellegrino, IRC
Vice President, Investor Relations & Public Relations
650-260-7120 ext. 264