Full Press Release Details
Biotherapeutics Reports Second Quarter and First Half 2021
Financial Results and Corporate Updates
Expanding Leadership for TIL Cell Therapy in
CARLOS, Calif., August 5, 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 second quarter 2021 financial results and corporate updates.
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive
Officer of Iovance, stated, "During the first half of 2021 we advanced our TIL pipeline and presented clinical data across multiple
solid tumor indications and treatment settings, including single-agent TIL in metastatic non-small cell lung cancer and melanoma, as well
as initial clinical data for TIL in combination with pembrolizumab in early line melanoma. Our top priority remains our ongoing work to
address FDA feedback regarding the potency assays for lifileucel to support our planned BLA submission. We are increasingly confident
in the broad potential for TIL as the next class of paradigm-shifting therapy for cancer patients with significant unmet need."
Second Quarter 2021 Highlights
and Recent Corporate Updates
| TIL manufacturing success: To date, nearly 500 patients have been dosed with Iovance TIL products with more than a 90 percent manufacturing success rate. | ||
| Iovance Cell Therapy Center ( i CTC) : the investigational new drug (IND) application amendment has been cleared and clinical manufacturing of TIL is expected to commence at the i CTC in the near future. Commercial manufacturing remains on track to commence with a potential regulatory approval. |
| Cash position of $708.7 million on June 30, 2021 is expected to be sufficient well into 2023. | ||
| A strong organization of nearly 270 employees with an average of more than 3.5 years of cell therapy experience is in place to advance research, development, manufacturing, and commercial launch preparations. | ||
| Iovance continues to expand its intellectual property portfolio and currently owns more than 25 granted or allowed U.S. and international patents for compositions and methods of treatment in a broad range of cancers relating to the Gen 2 manufacturing process . Iovance's Gen 2 patent rights are expected to provide exclusivity through 2038. Iovance's portfolio also includes patent applications and granted patents directed towards Gen 3 manufacturing, selected TIL products, stable and transient genetic TIL modifications, tumor digest and fragment compositions and methods (including cryopreservation), and combinations of checkpoint inhibitors and TIL products. |
Second Quarter and First Half 2021 Financial Results
held $708.7 million in cash, cash equivalents, investments and restricted cash at June 30, 2021 compared to $635.0
million at December 31, 2020. The cash position as of the second quarter is expected to be sufficient for more than two
years based on the current operating plan.
Jean-Marc Bellemin, Chief Financial Officer, stated, "Our balance
sheet remains strong to advance our operating plan, including launch preparations and pipeline development, with no immediate need to
raise additional capital."
Net loss for the second quarter ended June 30,
2021, was $81.4 million, or $0.53 per share, compared to a net loss of $63.0 million, or $0.47 per share, for
the second quarter ended June 30, 2020. Net loss for the six months ended June 30, 2020, was $156.8 million, or $1.04
per share, compared to a net loss of $132.6 million, or $1.02 per share, for the same period ended June 30, 2020.
Research and development expenses were $62.1
million for the second quarter ended June 30, 2021, an increase of $12.8 million compared to $49.3 million for
the second quarter ended June 30, 2020. Research and development expenses were $118.1 million for the six months ended June 30,
2021, an increase of $11.8 million compared to $106.2 million for the same period ended June 30, 2020.
The increase in research and development expenses in the second 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 manufacturing and iCTC facility related costs. The increase in research and development expenses in
the first half of 2021 over the prior year period was primarily attributable to growth of the internal research and development team,
an increase in iCTC facility related costs, which were partially offset by lower manufacturing and clinical costs following the completion
of enrollment in the pivotal cohorts for melanoma and cervical cancer.
General and administrative expenses were $19.3
million for the second quarter ended June 30, 2021, an increase of $5.0 million compared to $14.4 million for
the second quarter ended June 30, 2020. General and administrative expenses were $38.9 million for the six months ended June 30,
2021, an increase of $10.7 million compared to $28.2 million for the same period ended June 30, 2020.
The increases in general and administrative
expenses in the second quarter and first half 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 second 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 1489438.
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
About Iovance Biotherapeutics, Inc.
Biotherapeutics aims to improve patient care by making T cell-based immunotherapies broadly accessible for the treatment of patients
with solid tumors and blood cancers. Tumor infiltrating lymphocyte (TIL) therapy uses a patient's own immune cells to attack cancer.
TIL cells are extracted from a patient's own tumor tissue, expanded through a proprietary process, and infused back into the patient.
Upon infusion, TIL reach tumor tissue, where they attack cancer cells. The company has completed dosing in pivotal programs in patients
with metastatic melanoma and cervical cancer. In addition, the company's TIL therapy is being investigated in a registration-supporting
study for the treatment of patients with locally advanced, recurrent or metastatic non-small cell lung cancer. Clinical studies are also
underway to evaluate TIL in earlier stage cancers in combination with currently approved treatments, and to investigate Iovance peripheral
blood lymphocyte (PBL) T cell therapy for blood cancers. 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
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
| June 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| (Unaudited) | ||||||||
| Cash, cash equivalents, and investments | $ | 702,656 | $ | 629,437 | ||||
| Restricted cash | $ | 6,084 | $ | 5,525 | ||||
| Total assets | $ | 852,790 | $ | 768,458 | ||||
| Stockholders' equity | $ | 744,413 | $ | 656,498 |
IOVANCE BIOTHERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
(unaudited, in thousands, except per share information)
| For the Three Months Ended June 30, | For the Six Months Ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenues | $ | - | $ | - | $ | - | $ | - | ||||||||
| Costs and expenses* | ||||||||||||||||
| Research and development | 62,119 | 49,274 | 118,068 | 106,226 | ||||||||||||
| General and administrative | 19,307 | 14,353 | 38,928 | 28,211 | ||||||||||||
| Total costs and expenses | 81,426 | 63,627 | 156,996 | 134,437 | ||||||||||||
| Loss from operations | (81,426 | ) | (63,627 | ) | (156,996 | ) | (134,437 | ) | ||||||||
| Other income | ||||||||||||||||
| Interest income, net | 75 | 609 | 196 | 1,824 | ||||||||||||
| Net Loss | $ | (81,351 | ) | $ | (63,018 | ) | $ | (156,800 | ) | $ | (132,613 | ) | ||||
| Net Loss Per Share of Common Stock, Basic and Diluted | $ | (0.53 | ) | $ | (0.47 | ) | $ | (1.04 | ) | $ | (1.02 | ) | ||||
| Weighted-Average Shares of Common Stock Outstanding, Basic and Diluted | 153,751 | 133,162 | 150,571 | 129,848 | ||||||||||||
| * Includes stock-based compensation as follows | ||||||||||||||||
| Research and development | $ | 8,585 | $ | 5,465 | $ | 17,787 | $ | 9,783 | ||||||||
| General and administrative | 5,829 | 5,072 | 13,568 | 10,166 | ||||||||||||
| $ | 14,414 | $ | 10,537 | $ | 31,355 | $ | 19,949 |