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Iovance Biotherapeutics Reports Second Quarter and First Half 2022 Financial Results and Corporate Updates First Biologics License Application (BLA) Submission on Track in August 2022

Key Takeaway: Biotherapeutics Reports Second Quarter and First Half 2022 Financial Results and Corporate Updates First Biologics License Application (BLA) Submission on Track in August 2022 CARLOS, Calif., August 4, 2022 -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotech

Full Press Release Details

Biotherapeutics Reports Second Quarter and First Half 2022
Financial Results and Corporate Updates
First Biologics License Application (BLA) Submission
on Track in August 2022
CARLOS, Calif., August 4, 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 second quarter and first half 2022 financial results and corporate updates.
Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "Iovance continues to solidify our global leadership
across all three aspects of our mission to innovate, develop and deliver TIL therapy for patients with cancer. During the second quarter
we executed toward our top priority, to submit the BLA for lifileucel in metastatic melanoma, while preparing for commercialization and
advancing our robust immuno-oncology pipeline. Following our recent pre-BLA meeting in late July, we are finalizing our BLA to
begin submission this month. With many opportunities to create significant value for cancer patients and our shareholders, Iovance is
a true pioneer in the industry, driven by our experienced executive leadership team and talented organization with deep cell therapy experience."
Second Quarter 2022 Highlights
and Recent Corporate Updates
Research Programs for Next-Generation TIL Therapies and
Related Technologies
Second Quarter and First Half 2022 Financial Results
had $430.9 million in cash, cash equivalents, investments and restricted cash at June 30, 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, "As
a late-stage oncology company approaching potential commercialization, we continue to maintain a strong balance sheet through prudent
investments in commercial launch preparations, internal manufacturing and pipeline expansion. Our cash position is expected to take us
through several milestones to create value for patients and shareholders."
Net loss for the second quarter ended June
30, 2022, was $99.3 million, or $0.63 per share, compared to a net loss of $81.4 million, or $0.53 per share,
for the second quarter ended June 30, 2021. Net loss for the six months ended June 30, 2022, was $191.0 million, or $1.21 per
share, compared to a net loss of $156.8 million, or $1.04 per share, for the same period ended June 30, 2021.
Research and development expenses were $73.4 million for
the second quarter ended June 30, 2022, an increase of $11.3 million compared to $62.1 million for the same period
ended June 30, 2021. Research and development expenses were $141.7 million for the six months ended June 30, 2022, an increase of
$23.6 million compared to $118.1 million for the same period ended June 30, 2021.
The increases in research and development expenses in the second quarter
and first half of 2022 over the prior year periods were primarily attributable to growth of the internal research and development team,
including stock-based compensation expense, as well as facility-related and internal research program costs, which were partially offset
by lower clinical and manufacturing costs driven by completion of enrollment of pivotal clinical trials.
General and administrative expenses were $26.3
million for the second quarter ended June 30, 2022, an increase of $7.0 million compared to $19.3 million for
the same period ended June 30, 2021. General and administrative expenses were $49.7 million for the six months ended June 30, 2022,
an increase of $10.8 million compared to $38.9 million for the same period ended June 30, 2021.
The increase in general and administrative
expenses in the second quarter and first half of 2022 compared to the prior year periods were 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, as well as costs associated with pre-commercial activities.
For additional information, please see the
Company's Selected Condensed Consolidated Balance Sheet and Statement of Operations below.
participate in the conference call, please register at https://register.vevent.com/register/BI25a798dba7074946a0aa3082d603bf41.
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.
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
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 may support registration and approval 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 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.
Condensed Consolidated Balance Sheet Data
June 30, 2022 (Unaudited) December 31, 2021
Cash, cash equivalents, and investments $ 424,458 $ 595,998
Restricted cash $ 6,430 $ 6,084
Total assets $ 610,878 $ 777,333
Stockholders' equity $ 472,690 $ 621,659
IOVANCE BIOTHERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(unaudited, in thousands, except per share information)
For the Three Months Ended For the Six Months Ended
June 30, June 30,
2022 2021 2022 2021
Costs and expenses*
Research and development $ 73,406 $ 62,119 $ 141,706 $ 118,068
General and administrative 26,328 19,307 49,741 38,928
Total costs and expenses 99,734 81,426 191,447 156,996
Loss from operations (99,734 ) (81,426 ) (191,447 ) (156,996 )
Other income
Interest income, net 385 75 491 196
Net Loss $ (99,349 ) $ (81,351 ) $ (190,956 ) $ (156,800 )
Net Loss Per Share of Common Stock, Basic and Diluted $ (0.63 ) $ (0.53 ) $ (1.21 ) $ (1.04 )
Weighted-Average Shares of Common Stock Outstanding, Basic and Diluted 157,274 153,751 157,194 150,571
*Includes stock-based compensation as follows:
Research and development $ 13,940 $ 8,585 $ 27,591 $ 17,787
General and administrative 8,528 5,829 17,142 13,568
Total costs and expenses $ 22,468 $ 14,414 $ 44,733 $ 31,355
Biotherapeutics, Inc.:
Last updated: Aug 4, 2022