Full Press Release Details
Iovance Biotherapeutics Reports First Quarter
Financial Results and Corporate Updates
First Biologics License Application (BLA) Submission
Completed in March 2023
Commercial Readiness Activities on track to
Support Potential Commercial Launch of Lifileucel in 2023
SAN CARLOS, Calif., May 9, 2023 -- 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 2023 financial results and corporate updates.
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive
Officer of Iovance, stated, "Since the beginning of 2023, we have completed our first BLA for lifileucel in advanced melanoma, and
continue to execute our commercial readiness activities to launch lifileucel in 2023, while advancing our immuno-oncology pipeline. We
are also on track with our integration activities for the planned acquisition of Proleukin , which will provide revenue, streamline
our supply chain and logistics, reduce our future cost of goods and lower expenses for IL-2 used with TIL therapies. Our top priorities
in 2023 are to gain FDA approval and successfully launch lifileucel, continue to develop our pipeline in multiple solid tumor indications
and present new data from our clinical programs."
Recent and First Quarter 2023
Highlights and Corporate Updates
Acquisition of Proleukin
Iovance TIL Therapy (Lifileucel) in Advanced Melanoma
Manufacturing and Commercial Preparations
Research Programs for Next-Generation TIL Therapies and
Related Technologies
American Society of Clinical Oncology (ASCO) Annual Meeting,
First Quarter 2023 Financial Results
Iovance had $632.7 million in cash, cash equivalents, investments
and restricted cash at March 31, 2023, compared to $478.3 million at December 31, 2022. With the net proceeds from the
ATM equity financing facility of approximately $260.1 million raised during the first quarter of 2023, the cash position is expected to
be sufficient to fund current and planned operations into the second half of 2024.
Jean-Marc Bellemin, Chief Financial Officer of Iovance, said, "Iovance
is committed to prioritizing our investments and effectively managing expenses. We expect that our current cash position is sufficient
to fund our operating plan into the second half of 2024, including our planned acquisition of Proleukin , commercial launch preparations,
internal manufacturing and clinical pipeline expansion."
Net loss for the first quarter ended March
31, 2023, was $107.4 million, or $0.50 per share, compared to a net loss of $91.6 million, or $0.58 per share, for
the first quarter ended March 31, 2022.
Research and development expenses were $82.7
million for the first quarter ended March 31, 2023, an increase of $14.4 million compared to $68.3
million for the first quarter of 2022. The increase in research and development expenses in the first quarter 2023 over the
prior year period was primarily attributable to growth of the internal research and development team, as well as clinical trial
costs, manufacturing costs to support commercial manufacturing readiness, and facility-related costs, which were partially offset by
lower stock-based compensation expense.
General and administrative expenses were $28.1
million for the first quarter ended March 31, 2023, an increase of $4.7 million compared to $23.4 million for
the first quarter of 2022. The increase in general and administrative expenses in the first quarter of 2023 compared to the prior year
period was primarily attributable to growth of the internal general and administrative and commercial teams in preparation for launch,
fees to support the Proleukin acquisition, as well as costs associated with pre-commercial activities, which were partially offset by
lower stock-based compensation and marketing expenses.
For additional information, please see the
Company's Selected Condensed Consolidated Balance Sheet and Statement of Operations below.
Webcast and Conference Call
To participate in the conference call at 4:30 p.m. ET today, please
dial 1-800-715-9871 (domestic) or 1-646-307-1963 (international) and reference the access code 8957192. The live and archived webcast
can be accessed in the Investors section of the Company's website, IR.Iovance.com. The
archived webcast will also be available for one year.
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; whether clinical trial results from our pivotal studies and cohorts, and
meetings with the FDA, may support registrational studies and subsequent approvals by the FDA; 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 (including from the recent pre-BLA meeting with the FDA); the risk that the rolling BLA submission
for lifileucel in metastatic melanoma may take longer than expected; 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 the acquisition
of Proleukin may not be completed in a timely manner or at all; the failure to satisfy
the closing conditions to the consummation of the Proleukin acquisition, including the