Full Press Release Details
Iovance Biotherapeutics Reports Fourth Quarter
Financial Results and Corporate Updates
Expanding TIL Platform in Multiple Solid Tumors
and Treatment Settings
SAN CARLOS, Calif., February 24, 2022 -- 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 fourth quarter and full year 2021 financial results
and corporate updates.
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive
Officer of Iovance, stated, "Throughout 2021, we continued to build upon the strength of clinical data for Iovance TIL therapy
in multiple solid tumor types and treatment settings. Highlights included long-term clinical data for one-time treatment with lifileucel
in metastatic melanoma, the potential to increase response rates for TIL therapy in combination with pembrolizumab as an earlier treatment
for melanoma, cervical and head and neck cancers, as well as an important proof-of-concept for Iovance TIL therapy in non-small cell
lung cancer. We also advanced our genetically modified TIL pipeline and expect to initiate our first clinical study of a gene-edited
TIL product candidate later this year. Our top priority remains our ongoing work to address feedback from the U.S. Food and Drug Administration
(FDA) regarding the potency assays for lifileucel to support our planned biologics license application (BLA) submission in the first
half of this year. We remain increasingly confident in the broad potential for TIL as the next class of paradigm-shifting therapy for
cancer patients with significant unmet need."
Full Year 2021 Highlights and Recent Corporate Updates
Next-Generation Genetically Modified TIL Products and
Fourth Quarter and Full Year 2021 Financial Results
Iovance had $602.1 million in cash,
cash equivalents, investments and restricted cash at December 31, 2021 compared to $635.0 million at December 31, 2020.
The cash position is expected to be sufficient to fund current and planned operations into 2024.
Jean-Marc Bellemin, Chief Financial Officer, stated, "With late-stage
clinical assets in our pipeline, as well as a strong balance sheet and investments focused on launch preparations, we are well positioned
to execute our operating plan. We are confident in our prospects to deliver new treatment options to patients with great unmet need while
enhancing shareholder value."
Net loss for the fourth quarter ended December
31, 2021, was $99.3 million, or $0.63 per share, compared to a net loss of $68.4 million, or $0.47 per share,
for the fourth quarter ended December 31, 2020. Net loss for the full year period ended December 31, 2021, was $342.3 million,
or $2.23 per share, compared to a net loss of $259.6 million, or $1.88 per share, for the full year period ended December 31, 2020.
Research and development expenses were $75.6
million for the fourth quarter ended December 31, 2021, an increase of $23.1 million compared to $52.5 million for
the fourth quarter ended December 31, 2020. Research and development expenses were $259.0 million for the full year period ended
December 31, 2021, an increase of $57.3 million compared to $201.7 million for the full year ended December 31, 2020.
The increase in research and development expenses in the fourth quarter
2021 over the prior year period was primarily attributable to an increase in costs associated with growth of the internal research and
development team, including stock-based compensation expense, and increases in clinical trial costs and facility related costs associated
with the iCTC. The increase in research and development expenses in the full year 2021 over the prior full year period was primarily
attributable to growth of the internal research and development team and an increase in clinical trial costs and facility related costs
associated with the iCTC.
General and administrative expenses were $23.8
million for the fourth quarter ended December 31, 2021, an increase of $7.7 million compared to $16.1 million for
the fourth quarter ended December 31, 2020. General and administrative expenses were $83.7 million for the full year period ended
December 31, 2021, an increase of $23.5 million compared to $60.2 million for the full year ended December 31, 2020.
The increases in general and administrative
expenses in the fourth quarter and full year 2021 compared to the prior year periods were primarily attributable to an increase in costs
associated with growth of the internal general and administrative team, including stock-based compensation expense, and an increase in
intellectual property filing related costs.
Webcast and Conference Call
Iovance will host a conference call today
at 4:30 p.m. ET to discuss the fourth quarter and full year 2021 financial results and corporate updates. The conference call
dial-in numbers are 1-(844) 646-4465 (domestic) or 1-(615) 247-0257 (international) and the access code is 2877242. 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.
Iovance Biotherapeutics aims to be the global leader in innovating,
developing and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational
approach to cure cancer by harnessing the human immune system's ability to recognize and destroy diverse cancer cells in each patient.
Our lead late-stage TIL product candidate, lifileucel for metastatic melanoma, has the potential to become the first approved one-time
cell therapy for a solid tumor cancer. The Iovance TIL platform has demonstrated promising clinical data across multiple solid
We are committed to continuous innovation in cell therapy, including
gene-edited cell therapy, that may extend and improve life for patients with cancer. 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 or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups
within these trials or in other prior trials or cohorts; 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 changing landscape of care for cervical cancer patients may impact
our clinical trials in this indication; 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 forecasts and increase our estimated capital requirements; and other
factors, including general economic conditions and regulatory developments, not within our control.
| IOVANCE BIOTHERAPEUTICS, INC. | ||||||||
| Selected Consolidated Balance Sheet Information | ||||||||
| (In thousands) | ||||||||
| December 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Cash, cash equivalents, and investments | $ | 595,998 | $ | 629,437 | ||||
| Restricted cash | $ | 6,084 | $ | 5,525 | ||||
| Total assets | $ | 777,333 | $ | 768,458 | ||||
| Stockholders' equity | $ | 621,659 | $ | 656,498 |
| IOVANCE BIOTHERAPEUTICS, INC. | ||||||||||||||||
| Consolidated Statements of Operations | ||||||||||||||||
| (In thousands, except per share information) | ||||||||||||||||
| For the Three Months Ended December 31, | For the Years Ended December 31, | |||||||||||||||
| 2021 (Unaudited) | 2020 (Unaudited) | 2021 | 2020 | |||||||||||||
| Costs and expenses* | ||||||||||||||||
| Research and development | $ | 75,616 | $ | 52,451 | $ | 259,039 | $ | 201,727 | ||||||||
| General and administrative | 23,849 | 16,083 | 83,664 | 60,210 | ||||||||||||
| Total costs and expenses | 99,465 | 68,534 | 342,703 | 261,937 | ||||||||||||
| Loss from operations | (99,465 | ) | (68,534 | ) | (342,703 | ) | (261,937 | ) | ||||||||
| Other income | ||||||||||||||||
| Interest income, net | 135 | 137 | 451 | 2,356 | ||||||||||||
| Net Loss | $ | (99,330 | ) | $ | (68,397 | ) | $ | (342,252 | ) | $ | (259,581 | ) | ||||
| Net Loss Per Share of Common Stock, Basic and Diluted | $ | (0.63 | ) | $ | (0.47 | ) | $ | (2.23 | ) | $ | (1.88 | ) | ||||
| Weighted Average Shares of Common Stock Outstanding, Basic and Diluted | 156,923 | 146,738 | 153,406 | 138,301 | ||||||||||||
| * Includes stock-based compensation as follows: | ||||||||||||||||
| Research and development | $ | 11,542 | $ | 4,662 | $ | 40,833 | $ | 19,727 | ||||||||
| General and administrative | 7,562 | 5,570 | 28,932 | 21,160 | ||||||||||||
| $ | 19,104 | $ | 10,232 | $ | 69,765 | $ | 40,887 |