Full Press Release Details
Biotherapeutics Reports Third Quarter and Year-to-Date 2021
Financial Results and Corporate Updates
Advancing TIL Platform in Multiple Solid Tumors
and Treatment Settings
CARLOS, Calif., November 4, 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 third quarter and year-to-date 2021 financial results and corporate updates.
Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "During 2021, we have continued to report
long-term clinical data demonstrating the durability of one-time treatment with lifileucel in metastatic melanoma while broadening the
potential for TIL cell therapy to address more patients in additional indications and treatment settings. We look forward to highlighting
our TIL cell therapy platform at the upcoming Society for Immunotherapy of Cancer annual meeting. 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. 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."
Third Quarter 2021 Highlights
and Recent Corporate Updates
Third Quarter and Year-to-Date 2021 Financial Results
has $660.8 million in cash, cash equivalents, investments and restricted cash at September 30, 2021 compared to $635.0
million at December 31, 2020. The cash position is expected to be sufficient to fund current and planned operations well
Jean-Marc Bellemin, Chief Financial Officer, stated, "With the
continued strength of our balance sheet and focused investment on pipeline development and launch preparations, we are well positioned
to execute our operating plan with no immediate need to raise additional capital. Following completion of the iCTC, we have also
concluded our initial $85 million investment in constructing the facility."
Net loss for the third quarter ended September 30,
2021, was $86.1 million, or $0.55 per share, compared to a net loss of $58.6 million, or $0.40 per share, for
the third quarter ended September 30, 2020. Net loss for the nine months ended September 30, 2021, was $242.9 million,
or $1.60 per share, compared to a net loss of $191.2 million, or $1.41 per share, for the same period ended September 30, 2020.
Research and development expenses were $65.4
million for the third quarter ended September 30, 2021, an increase of $22.3 million compared to $43.1 million for
the third quarter ended September 30, 2020. Research and development expenses were $183.4 million for the nine months ended
September 30, 2021, an increase of $34.1 million compared to $149.3 million for the same period ended September 30, 2020.
The increase in research and development expenses in the third 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 and increases in clinical trial costs and iCTC facility related costs. The increase in research and development
expenses in the first nine months of 2021 over the prior year period was primarily attributable to growth of the internal research and
development team and an increase in iCTC facility related costs.
General and administrative expenses were $20.9
million for the third quarter ended September 30, 2021, an increase of $5.0 million compared to $15.9 million for
the third quarter ended September 30, 2020. General and administrative expenses were $59.8 million for the nine months ended
September 30, 2021, an increase of $15.7 million compared to $44.1 million for the same period ended September 30, 2020.
The increases in general and administrative
expenses in the third quarter and first nine months of 2021 compared to the prior year periods were primarily attributable to growth of
the internal general and administrative team and higher stock-based compensation expenses.
Webcast and Conference Call
will host a conference call today at 4:30 p.m. ET to discuss the third quarter 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 7286232.
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 be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) cell
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 tumors. We are committed to continuous innovation in cell therapy, including
gene-edited cell therapy, that may extend and improve life for patients with cancer.
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
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 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 Condensed Consolidated Balance Sheets
| September 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| (Unaudited) | ||||||||
| Cash, cash equivalents, and investments | $ | 654,696 | $ | 629,437 | ||||
| Restricted cash | $ | 6,084 | $ | 5,525 | ||||
| Total assets | $ | 828,825 | $ | 768,458 | ||||
| Stockholders' equity | $ | 698,330 | $ | 656,498 |
IOVANCE BIOTHERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(unaudited, in thousands, except per share information)
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Costs and expenses* | ||||||||||||||||
| Research and development | $ | 65,355 | $ | 43,050 | $ | 183,423 | $ | 149,276 | ||||||||
| General and administrative | 20,887 | 15,916 | 59,815 | 44,127 | ||||||||||||
| Total costs and expenses | 86,242 | 58,966 | 243,238 | 193,403 | ||||||||||||
| Loss from operations | (86,242 | ) | (58,966 | ) | (243,238 | ) | (193,403 | ) | ||||||||
| Other income | ||||||||||||||||
| Interest income, net | 120 | 395 | 316 | 2,219 | ||||||||||||
| Net Loss | $ | (86,122 | ) | $ | (58,571 | ) | $ | (242,922 | ) | $ | (191,184 | ) | ||||
| Net Loss Per Share of Common Stock, Basic and Diluted | $ | (0.55 | ) | $ | (0.40 | ) | $ | (1.60 | ) | $ | (1.41 | ) | ||||
| Weighted-Average Shares of Common Stock Outstanding, Basic and Diluted | 155,508 | 146,492 | 152,221 | 135,457 | ||||||||||||
| * Includes stock-based compensation as follows | ||||||||||||||||
| Research and development | $ | 11,504 | $ | 5,282 | $ | 29,291 | $ | 15,065 | ||||||||
| General and administrative | 7,802 | 5,424 | 21,370 | 15,590 | ||||||||||||
| $ | 19,306 | $ | 10,706 | $ | 50,661 | $ | 30,655 |
Biotherapeutics, Inc.:
Sara Pellegrino, IRC