Full Press Release Details
Iovance Biotherapeutics Reports First Quarter
Financial Results and Corporate Updates
First Biologics License Application (BLA) Submission
Planned in August 2022
SAN CARLOS, Calif., May 5, 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 first quarter 2022 financial results and corporate updates.
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive
Officer of Iovance, stated, "Iovance had a positive start to the year across our lead program lifileucel in metastatic melanoma
as well as our growing TIL pipeline. We recently reported favorable feedback from the FDA on our potency assays and assay matrix, which
brings us a step closer to our planned BLA submission for lifileucel in metastatic melanoma. We continue to enroll patients in clinical
studies to investigate our TIL therapies in multiple solid tumors, with plans to initiate a Phase 3 clinical trial of lifileucel in
combination with pembrolizumab in frontline melanoma. In addition, the FDA has allowed an IND to proceed with a clinical trial of our
PD-1 inactivated, gene-edited TIL therapy, IOV-4001. Our TIL platform, clinical data, and people are a solid foundation to establish TIL
as the next class of paradigm-shifting therapy for cancer patients with significant unmet need."
First Quarter 2022 Highlights
and Recent Corporate Updates
Next-Generation Research Programs
First Quarter 2022 Financial Results
Iovance had $516.0 million in cash,
cash equivalents, investments and restricted cash at March 31, 2022, compared to $602.1 million at December 31, 2021. The
cash position is expected to be sufficient to fund current and planned operations into 2024.
Jean-Marc Bellemin, Chief Financial Officer of Iovance, said, "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 mission to innovate, develop and deliver TIL therapy for patients with cancer while enhancing shareholder value."
Net loss for the first quarter ended March
31, 2022, was $91.6 million, or $0.58 per share, compared to a net loss of $75.4 million, or $0.51 per share,
for the first quarter ended March 31, 2021.
Research and development expenses were $68.3 million for
the first quarter ended March 31, 2022, an increase of $12.4 million compared to $55.9 million for the first
quarter ended March 31, 2021. The increase in research and development expenses in the first quarter 2022 over the prior year period
was primarily attributable to growth of the internal research and development team, including stock-based compensation expense, as well
as facility-related costs.
General and administrative expenses were $23.4
million for the first quarter ended March 31, 2022, an increase of $3.8 million compared to $19.6 million for
the first quarter ended March 31, 2021. The increase in general and administrative expenses in the first quarter 2022 compared to
the prior year period was primarily attributable to growth of the internal general and administrative and commercial teams, including
stock-based compensation expense, facility-related costs associated with the build out of the new corporate headquarters, increases in
intellectual property filing and legal expenses and enhancements to the information technology infrastructure.
For additional information, please see the
Company's Selected Condensed Consolidated Balance Sheet and Statement of Operations below.
Webcast and Conference Call
Iovance will host a conference call today
at 4:30 p.m. ET to discuss first quarter 2022 financial results and corporate updates. The conference call dial-in numbers
are 1 (844) 646-4465 (domestic) or 1 (615) 247-0257 (international), the conference ID is #4655146. 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
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. 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 Condensed Consolidated Balance Sheets
| March 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| (Unaudited) | ||||||||
| Cash, cash equivalents, and investments | $ | 509,890 | $ | 595,998 | ||||
| Restricted cash | $ | 6,084 | $ | 6,084 | ||||
| Total assets | $ | 701,251 | $ | 777,333 | ||||
| Stockholders' equity | $ | 551,992 | $ | 621,659 |
(Unaudited, in thousands, except per share information)
| For the Three Months Ended March 31, | ||||||||
| 2022 | 2021 | |||||||
| Costs and expenses* | ||||||||
| Research and development | $ | 68,300 | $ | 55,949 | ||||
| General and administrative | 23,413 | 19,621 | ||||||
| Total costs and expenses | 91,713 | 75,570 | ||||||
| Loss from operations | (91,713 | ) | (75,570 | ) | ||||
| Other income | ||||||||
| Interest income, net | 106 | 121 | ||||||
| Net Loss | $ | (91,607 | ) | $ | (75,449 | ) | ||
| Net Loss Per Common Share, Basic and Diluted | $ | (0.58 | ) | $ | (0.51 | ) | ||
| Weighted-Average Common Shares Outstanding, Basic and Diluted | 157,113 | 147,370 | ||||||
| *Includes stock-based compensation as follows | ||||||||
| Research and development | $ | 13,651 | $ | 9,202 | ||||
| General and administrative | 8,614 | 7,739 | ||||||
| $ | 22,265 | $ | 16,941 |
Iovance Biotherapeutics, Inc.:
Sara Pellegrino, IRC
Vice President, Investor Relations & Public Relations
650-260-7120 ext. 264
Director, Investor Relations & Public Relations