Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology
company focused on innovating, developing and delivering novel
polyclonal tumor infiltrating lymphocyte (TIL) therapies for
patients with cancer, today reported second quarter and first half
2023 financial results and corporate updates.
Frederick Vogt, Ph.D., J.D., Interim President and
Chief Executive Officer of Iovance, stated, “Iovance is making
significant progress in executing on our goals. The Priority Review
of our BLA for lifileucel in advanced melanoma remains on track and
continues to progress well as we work collaboratively with FDA and
approach a potential approval and launch this year. We acquired
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. We are also excited about our
NSCLC pipeline, with a registrational trial and positive
preliminary data in post-anti-PD-1 patients and the upcoming full
data presentation for TIL therapy in combination with pembrolizumab
in ICI naïve patients. We are well positioned to execute on our
regulatory, pipeline, manufacturing and commercial launch
activities to advance our mission to be the global leader in TIL
therapy.”
Recent and Second Quarter 2023 Highlights
and Corporate Updates
Iovance TIL Therapy (Lifileucel) in
Advanced MelanomaRegulatory
Highlights
- The U.S. Food and Drug Administration (FDA) accepted the
Biologics License Application (BLA) for lifileucel for patients
with advanced melanoma. The FDA granted lifileucel Priority Review
and assigned November 25, 2023, as the target action date for a
decision under the Prescription Drug User Fee Act (PDUFA).
- The first patient was randomized in the registrational Phase 3
global TILVANCE-301 trial to support accelerated and full
approvals of lifileucel in combination with pembrolizumab in
frontline advanced melanoma. TILVANCE-301, which is also a
confirmatory trial to support full approval of lifileucel in
post-anti-PD-1 advanced melanoma, is expected to be well underway
at the time of potential accelerated approval for lifileucel in
this initial indication.
Manufacturing and Commercial
Preparations
- To date, more than 600 patients have been treated with Iovance
TIL therapy manufactured using proprietary Iovance processes, with
a manufacturing success rate of more than 90%.
- The Iovance Cell Therapy Center (iCTC) is currently
manufacturing TIL therapies for clinical trials while executing
activities to support BLA review, including pre-approval inspection
readiness, in preparation for initiating commercial supply.
- The iCTC facility currently has annual capacity to supply
TIL therapies for 2,000+ patients, with buildable shell space to
ultimately supply TIL therapies for 5,000+ patients from this
facility. Iovance has additional flexibility and capacity through
contract manufacturers to meet potential commercial and clinical
demand.
- Several initiatives are underway ahead of potential
commercialization, including on-boarding and personnel training at
Authorized Treatment Centers (ATCs), patient access, education and
awareness, and other commercial launch readiness activities.
Iovance TIL Therapy Programs in Advanced
Non-Small Cell Lung Cancer (NSCLC)
- Registrational Phase 2 Trial IOV-LUN-202 in
Post-Anti-PD- 1 NSCLC:
- At a Type B Pre-Phase 3 meeting, the FDA provided positive
regulatory feedback that the design of the single-arm Phase 2
IOV-LUN-202 trial may be acceptable for approval of LN-145 TIL
therapy in post-anti-PD-1 NSCLC. Based on the regulatory
discussions, Iovance completed a preliminary analysis and plans to
enroll a total of approximately 120 patients into the
registrational IOV-LUN-202 trial.
- In a preliminary analysis of IOV-LUN-202, ORR was 26.1% by
RECIST v1.1 (n=6, one complete response and five partial
responses). All responses remained ongoing at the data cut off and
the median duration of response (DOR) was not reached (1.4+ to 9.7+
months).
- Enrollment in IOV-LUN-202 is ongoing at more than 40 active
clinical sites in the U.S., Canada and Europe,
and is expected to complete in the second half of 2024.
- Iovance TIL Therapy in combination with anti-PD-1 in
frontline advanced NSCLC:
- Detailed results from Cohort 3A of the IOV-COM-202 clinical
trial will be presented at an oral session during the IASLC 2023
World Congress on Lung Cancer (WCLC 2023). Cohort 3A explores the
combination of TIL therapy (LN-145) and pembrolizumab in anti-PD-1
naïve advanced NSCLC patients.
- Iovance plans a meeting with the FDA in 2023 to discuss Cohort
3A results and a potential registrational trial of lifileucel in
combination with pembrolizumab after standard of care chemotherapy
to support accelerated approval in frontline advanced NSCLC and to
serve as the confirmatory trial for IOV-LUN-202.
Additional Clinical Pipeline
Highlights
- Iovance PD-1 inactivated TIL therapy (IOV-4001) in
previously treated advanced melanoma or mNSCLC: The
ongoing IOV-GM1-201 trial of Iovance’s first genetically
modified TIL therapy, IOV-4001, is among the first clinical trials
of a genetically modified TIL cell therapy for solid tumors.
- Lifileucel in advanced cervical
cancer: Additional patients continued to enroll in
pivotal Cohort 2 in the ongoing C-145-04 trial to support
a BLA in cervical cancer following progression on or after
chemotherapy and pembrolizumab.
Research Programs for Next-Generation TIL
Therapies and Related Technologies
- Additional programs using the gene editing TALEN® technology
are on track to enter clinical development in 2024, including
genetically modified TIL therapy with multiple inactivated
checkpoint targets.
- Additional research and preclinical studies are
exploring approaches to increase TIL potency using CD39/69
double negative TILs and stable gene incorporation
enhancements such as tethered cytokines.
- A novel interleukin-2 (IL-2) analog (IOV-3001) is in
IND-enabling studies supporting its use as part of the TIL
treatment regimen following TIL infusion.
Corporate Updates
- Iovance completed the acquisition of worldwide rights to
Proleukin® (aldesleukin) from Clinigen Limited in May of 2023.
Proleukin is an interleukin-2 (IL-2) product with uses that include
administration following TIL infusion to promote T-cell activity.
Iovance expects Proleukin to provide revenue, secure the IL-2
supply chain and logistics surrounding TIL therapy administration,
and lower cost of goods and clinical trial expenses for Proleukin
used with TIL therapies.
- As of June 30, 2023, Iovance’s cash position was
approximately $317.3 million. In July of 2023, Iovance raised
estimated net proceeds from a common stock public offering of
approximately $161.4 million. Inclusive of the net proceeds
from the offering, the current cash position is expected to fund
Iovance’s operating plan into the end of 2024.
- Iovance currently owns more than 60 granted or
allowed U.S. and international patents for TIL
compositions and methods of treatment and manufacturing in a broad
range of cancers, with Gen 2 patent rights expected to provide
exclusivity into 2038. More information on Iovance’s patent
portfolio is available on the Intellectual Property page
on www.iovance.com.
Upcoming Medical Conferences
- IASLC 2023 World Conference on Lung Cancer hosted by
the International Association for the Study of Lung Cancer
(WCLC 2023), September 9-12,
2023, Singapore
- Mini Oral Presentation: MA15.08 – Multicenter
phase II trial of LN-145 TIL cell therapy plus pembrolizumab in
patients with ICI-naïve metastatic NSCLC
- Presenter: Adam J. Schoenfeld, MD, Medical
Oncologist, Memorial Sloan Kettering Cancer Center
- Session: MA15 - Bringing New Discoveries into
Early Phase Clinical Trials
- Session Date & Time: Tuesday, Sep 12,
2023, 11:15 AM - 11:20 AM SST (Monday, September 11, 2023, 11:15 –
11:20 PM EDT)
- Poster Presentation: P2.18-02 – Successful
generation of tumor-infiltrating lymphocytes (TIL) for adoptive
cell therapy from mesothelioma
- Presenter: Professor Dean Fennell FRCP Ph.D.,
Melanoma Research Programme, University of Leicester
- Session: P2.18 - Mesothelioma, Thymoma, and
Other Thoracic Tumors - Clinical
- Session Date & Time: Monday, September 11,
2023, 6:00 PM - 7:30 PM SST (Monday, September 11, 2023, 6:00 –
7:30 AM EDT)
- European Society for Medical Oncology
ESMO CONGRESS 2023, October 20-24, 2023,
Madrid, Spain
- Mini Oral Presentation: 1086MO – Lifileucel
tumor-infiltrating lymphocyte (TIL) cell therapy in patients (pts)
with advanced mucosal melanoma after progression on immune
checkpoint inhibitors (ICI): Results from the phase 2 C-144-01
study
- Presenter: Götz-Ulrich Grigoleit, Head of
Department Hematology, Oncology and Immunology at Helios Hospital
Duisburg
- Session: Mini Oral Session – Melanoma and
Other Skin Tumours
- Session Date & Time: Saturday, October 21,
3:20 PM - 3:25 PM CEST (9:20 AM – 9:25 AM EDT)
Second Quarter and First Half 2023
Financial Results
Iovance had $317.3 million in cash, cash
equivalents, investments and restricted cash at June 30, 2023,
compared to $478.3 million at December 31, 2022. With the estimated
net proceeds from the common stock public offering of approximately
$161.4 million raised in July of 2023, the cash position is
expected to be sufficient to fund current and planned operations
into the end of 2024.
Net loss for the second quarter ended June 30,
2023, was $106.5 million, or $0.47 per share,
compared to a net loss of $99.3 million, or $0.63 per share,
for the second quarter ended June 30, 2022. Net loss for
the six months ended June 30, 2023, was $213.9 million, or $0.98
per share, compared to a net loss of $191.0 million, or $1.21 per
share, for the same period ended June 30, 2022.
Revenue for the six months ended June 30, 2023, was
$0.2 million, comprised of product sales following the Proleukin
acquisition in May of 2023. There was no revenue for six months
ended June 30, 2022. Cost of sales for the six months ended June
30, 2023, was $2.1 million, including $1.9 million of non-cash
amortization of the acquired intangible asset for developed
technology during the second quarter. There was no cost of revenues
for the six months ended June 30, 2022.
Research and development expenses were $86.3
million for the second quarter ended June 30, 2023, an
increase of $12.9 million compared to $73.4
million for the same period ended June 30, 2022. Research
and development expenses were $169.1 million for the six months
ended June 30, 2023, an increase of $27.4 million compared to
$141.7 million for the same period ended June 30, 2022.
The increases in research and development expenses
in the second quarter and first half of 2023 over the prior year
periods were primarily attributable to growth of the internal
research and development team, as well as higher costs related to
facilities, internal research programs and the Phase 3 TILVANCE
trial, which were partially offset by a decrease in stock-based
compensation expense.
Selling, general and administrative expenses
were $21.9 million for the second quarter ended June
30, 2023, a decrease of $4.4 million compared
to $26.3 million for the same period ended June 30,
2022. Selling, general and administrative expenses were $50.0
million for the six months ended June 30, 2023, an increase of $0.3
million compared to $49.7 million for the same period ended June
30, 2022.
The decrease in selling, general and administrative expenses in
the second quarter of 2023 compared to prior year period was
primarily attributable to the capitalization of expenses associated
with the Proleukin acquisition upon the transaction close.
Decreases in other costs are related to the timing of spend
compared to the prior year period, including marketing,
advertising, licensing and insurance costs, partially offset by
costs associated with the growth in the overall business. The
increase in selling, general and administrative expenses in the
first half of 2023 compared to the prior year period was primarily
attributable to growth of the internal general and administrative
and commercial teams, offset by a decrease in legal fees and other
costs.
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 and live
audio webcast at 5:00 p.m. ET, please register at
https://register.vevent.com/register/BI83559f749d674b71bae2cbaeb65d484b.
To view the live webcast, please register at
https://edge.media-server.com/mmc/p/nxy3p22t. The live and archived
webcast can be accessed in the Investors section of the Company’s
website, IR.Iovance.com. The archived webcast will 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:
preliminary and interim clinical results, which may include
efficacy and safety results, from ongoing clinical trials or
cohorts, including but not limited to our IOV-LUN-202 trial, 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; 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, including the risk that the planned single-arm Phase 2
IOV-LUN-202 trial may not support registration; 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 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 prior
pre-BLA meeting with the FDA and/or regarding our prior meetings
with the FDA regarding our NSCLC clinical trials); the risk that
the FDA may not approve our BLA submission for lifileucel
in metastatic melanoma; 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 regarding
the successful integration of the recent Proleukin acquisition; the
risk that the successful development or commercialization of our
products may not generate sufficient revenue from product sales,
and we may not become profitable in the near term or, if at all;
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(in thousands)
|
|
|
|
|
June 30, 2023(unaudited) |
|
December 31,2022 |
Cash, cash equivalents, and investments |
$ |
250,894 |
|
$ |
471,845 |
Restricted cash |
$ |
66,430 |
|
$ |
6,430 |
Total assets |
$ |
757,293 |
|
$ |
663,982 |
Stockholders' equity |
$ |
578,569 |
|
$ |
499,638 |
|
|
|
|
|
|
|
|
|
|
|
|
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, |
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
Product revenue |
$ |
238 |
|
|
$ |
— |
|
|
$ |
238 |
|
|
$ |
— |
|
Total revenue |
|
238 |
|
|
|
— |
|
|
|
238 |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and
expenses* |
|
|
|
|
|
|
|
|
|
|
|
Costs of sales |
$ |
2,050 |
|
|
$ |
— |
|
|
$ |
2,050 |
|
|
$ |
— |
|
Research and development |
|
86,347 |
|
|
|
73,406 |
|
|
|
169,081 |
|
|
|
141,706 |
|
Selling, general and administrative |
|
21,927 |
|
|
|
26,328 |
|
|
|
50,049 |
|
|
|
49,741 |
|
Total costs and expenses |
|
110,324 |
|
|
|
99,734 |
|
|
|
221,180 |
|
|
|
191,447 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(110,086 |
) |
|
|
(99,734 |
) |
|
|
(220,942 |
) |
|
|
(191,447 |
) |
Other
income |
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
3,081 |
|
|
|
385 |
|
|
|
6,567 |
|
|
|
491 |
|
Net Loss before income
taxes |
$ |
(107,005 |
) |
|
$ |
(99,349 |
) |
|
$ |
(214,375 |
) |
|
$ |
(190,956 |
) |
Income tax benefit |
|
477 |
|
|
|
— |
|
|
|
477 |
|
|
|
— |
|
Net Loss |
|
(106,528 |
) |
|
|
(99,349 |
) |
|
|
(213,898 |
) |
|
|
(190,956 |
) |
Net Loss Per Share of
Common Stock, Basic and Diluted |
$ |
(0.47 |
) |
|
$ |
(0.63 |
) |
|
$ |
(0.98 |
) |
|
$ |
(1.21 |
) |
Weighted-Average
Shares of Common Stock Outstanding, Basic and Diluted |
|
224,481 |
|
|
|
157,274 |
|
|
|
219,117 |
|
|
|
157,194 |
|
|
|
|
|
|
|
|
|
|
|
|
|
*Includes stock-based
compensation as follows: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
9,390 |
|
|
$ |
13,940 |
|
|
$ |
18,249 |
|
|
$ |
27,591 |
|
Selling, general and administrative |
|
7,350 |
|
|
|
8,528 |
|
|
|
14,156 |
|
|
|
17,142 |
|
Total stock-based compensation included in costs and expenses |
$ |
16,740 |
|
|
$ |
22,468 |
|
|
$ |
32,405 |
|
|
$ |
44,733 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONTACTS
Iovance Biotherapeutics, Inc.:Sara
Pellegrino, IRCSVP, Investor Relations & Corporate
Communications650-260-7120 ext. 264Sara.Pellegrino@iovance.com
Jen SaundersDirector, Investor Relations &
Public Relations267-485-3119Jen.Saunders@iovance.com
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