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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (date of earliest event reported): May 9, 2024
IOVANCE BIOTHERAPEUTICS, INC.
(Exact Name of Registrant as Specified in
Charter)
Delaware |
(State of Incorporation) |
|
001-36860 |
|
75-3254381 |
Commission File Number |
|
(I.R.S. Employer Identification No.) |
|
|
|
825
Industrial Road, 4th Floor |
|
|
San Carlos, California |
|
94070 |
(Address of Principal Executive Offices) |
|
(Zip Code) |
|
|
|
(650) 260-7120 |
(Registrant’s Telephone Number, Including Area Code) |
|
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425). |
| ¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12). |
| ¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)). |
| ¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)). |
Indicate
by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act
of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading
Symbol(s) |
Name of each exchange on which
registered |
Common stock, par value $0.000041666 per share |
IOVA |
The Nasdaq Stock Market LLC |
Item 2.02. |
Results of Operations and Financial Condition. |
On May 9, 2024, Iovance Biotherapeutics, Inc. (the
“Company”) issued a press release announcing its financial results for the first quarter ended March 31, 2024 and an update
on recent developments. A copy of that press release is furnished as Exhibit 99.1.
The information furnished under this Item 2.02,
including the accompanying Exhibit 99.1, shall not be deemed to be “filed” for the purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of such section, nor shall such
information be deemed to be incorporated by reference in any subsequent filing by the Company under the Securities Act of 1933, as amended,
or the Exchange Act, regardless of the general incorporation language of such filing, except as specifically stated in such filing.
Item 9.01. |
Financial Statements and Exhibits. |
(d) Exhibits.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
Iovance Biotherapeutics, Inc. |
|
|
|
Dated: May 9, 2024 |
By: |
/s/ Frederick G. Vogt |
|
Name: |
Frederick G. Vogt, Ph.D., J.D. |
|
Title: |
Interim CEO and President, and General Counsel |
Exhibit 99.1
Iovance Biotherapeutics Reports First Quarter
2024
Financial Results and Corporate Updates
Strong Momentum for Amtagvi™ (Lifileucel)
U.S. Launch
Following U.S. Food and Drug Administration
(FDA) Approval
100+ Amtagvi Patients Enrolled Across More
Than 40 Current Authorized Treatment Centers
(ATCs), with ~50 Total ATCs On Track by End of May and 70+ Total ATCs by Year-End 2024
Amtagvi Regulatory Submissions on Track in
the European Union (EU),
United Kingdom (UK), and Canada in 2024
SAN CARLOS, Calif., May 9, 2024
-- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating,
developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today reported first
quarter 2024 financial results and corporate updates.
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive
Officer of Iovance, stated, “The first quarter of 2024 was transformative for Iovance following our first FDA approval and our
strong start for the U.S. commercial launch of Amtagvi™ for patients with advanced melanoma. Immediate demand for Amtagvi is very
high and continues to significantly increase across initial ATCs. As of today, more than 100 patients have already enrolled for Amtagvi
therapy. We have successfully manufactured and delivered Amtagvi to many ATCs where commercial patients are being treated. We expect
our launch momentum to remain strong and continue to build as we ramp up the U.S. launch throughout 2024 with the authorization of additional
ATCs. We also continue to execute across our broad clinical pipeline. As a fully integrated company, Iovance is well positioned
to remain the global leader in innovating, developing, and delivering TIL cell therapy for patients with cancer.”
Recent and First Quarter
2024 Highlights and Corporate Updates
Amtagvi™ (Lifileucel) U.S. Approval and Launch Highlights
in Advanced Melanoma
| · | The
U.S. FDA approved Amtagvi (lifileucel) on February 16, 2024, as the first treatment
option for advanced melanoma after anti-PD-1 and targeted therapy. Amtagvi is also the
first and only FDA-approved T cell therapy for a solid tumor indication. |
| · | Since
approval, more than 100 patients have enrolled for Amtagvi therapy. The first patients have
been successfully treated and the balance are moving through the stages of the journey, which
includes surgery for cell collection, manufacturing, and the Amtagvi treatment regimen. |
| · | Onboarding
is complete at more than 40 U.S. ATCs, up from 30 initial ATCs at approval. Iovance remains
on track to onboard approximately 50 ATCs by the end of May 2024 and expects to have
more than 70 ATCs onboarded by the end of 2024. |
| · | Manufacturing
turnaround time has been on-target with initial launch expectations of approximately 34 days
from inbound to return shipment to ATCs. The commercial manufacturing experience to date
is consistent with prior clinical experience. |
| · | The
U.S. launch of Amtagvi, and additional sales of Proleukin® used with the treatment regimen,
are expected to drive significant revenue for Iovance in 2024. |
| · | Amtagvi
was added as a preferred second-line or subsequent therapy in the National Comprehensive
Cancer Network® guidelines for treatment of cutaneous melanoma. |
| · | Reimbursement
remains strong and on track at the ATCs with progress toward coverage policies successful
in many cases. As anticipated, more than 75% of enrolled Amtagvi patients are covered by
private payers. To date, payers covering more than 200 million lives have already authorized
Amtagvi treatment for their patients, setting a strong precedent for reimbursement success. |
Lifileucel Launch Expansion into New Markets
and Indications
| · | Geographic
expansion can more than double the total addressable patient population for Amtagvi in advanced
melanoma. Regulatory dossiers remain on track for submission in the following markets with
significant populations of advanced melanoma patients: |
| o | EU in the second quarter of 2024 |
| o | UK and Canada in the second half
of 2024 |
| o | Australia and additional countries
in 2025 |
Iovance TIL Cell Therapy Pipeline Highlights
| · | Lifileucel
in Frontline Advanced Melanoma |
| o | The registrational Phase 3 TILVANCE-301
trial is well underway to support accelerated and full U.S. approvals of Amtagvi in combination
with pembrolizumab in frontline advanced melanoma as well as regular approval of Amtagvi
in post-anti-PD-1 melanoma. |
| o | Global site activation and patient
enrollment continue with strong momentum in the U.S., Europe, Australia, Canada, and additional
countries. |
| o | An oral presentation of updated
clinical data from Cohort 1A of the IOV-COM-202 trial, which strongly supports the rationale
for TILVANCE-301 and the frontline melanoma opportunity, will be presented at the American
Society of Clinical Oncology (ASCO) Annual Meeting on May 31, 2024. |
| · | Lifileucel
in Non-Small Cell Lung Cancer (NSCLC) |
| o | Enrollment resumed for new patients
in the IOV-LUN-202 registrational Phase 2 trial in post-anti-PD-1 NSCLC soon after the U.S.
FDA lifted a partial clinical hold in the first quarter. The IOV-LUN-202 trial includes clinical
sites in the U.S., Canada, and Europe, with plans to include additional regions with strong
track records for enrollment in lung cancer studies over the next few months. Enrollment
has restarted with high demand and the registrational cohorts are expected to be fully enrolled
in 2025. |
| o | At a recent Type D meeting, the
FDA provided positive regulatory feedback on the proposed potency matrix for lifileucel in
NSCLC. The FDA previously provided positive regulatory feedback that the design of the single-arm
IOV-LUN-202 trial may be acceptable for approval of lifileucel in post-anti-PD-1 NSCLC. |
| · | Lifileucel
in Endometrial Cancer |
| o | A Phase 2 trial of lifileucel
in advanced endometrial cancer patients is on track to initiate in the second quarter of
2024. The trial will enroll patients with advanced endometrial cancer who progressed after
platinum-based chemotherapy and anti-PD-(L)1 therapy regardless of mismatch repair (MMR)
status. This clinical program and trial design are supported by preclinical and manufacturing
success data to be presented at a conference in 2024 and has received positive feedback from
gynecological oncology experts. |
| o | In 2024, an estimated 67,880
new cases of uterine cancer (>90% of which are endometrial cancer) are expected to be
diagnosed, with 13,250 deaths expected in the US.1 There are no currently approved
therapies in the emerging second-line setting after frontline post-anti-PD1 therapy and chemotherapy.
Endometrial cancer represents a significant opportunity for TIL cell therapy to address an
additional unmet medical need in the post-anti-PD-1 treatment setting and may address both
MMR deficient and proficient patients. |
| · | Next
Generation TIL Pipeline |
| o | IOV-4001 (PD-1 Inactivated
TIL Cell Therapy): The Phase 1 safety portion concluded in the first in human IOV-GM1-201 trial
to investigate PD-1 inactivated TIL cell therapy (IOV-4001) in previously treated advanced
melanoma and NSCLC, and the trial is progressing successfully into the multi-center Phase
2 efficacy stage. Iovance continues to utilize the TALEN® technology licensed from Cellectis
to develop other investigational gene-edited TIL cell therapies with multiple knockout targets
to potentially improve efficacy. |
| o | Next Generation IL-2 for TIL
Treatment Regimen: Iovance plans to submit an Investigational New Drug application (IND)
for a Phase 1/2 clinical trial of IOV-3001, a modified interleukin-2 (IL-2) fusion protein,
for use in the TIL therapy treatment regimen in the third quarter of 2024. Results from non-human
primate and IND-enabling studies of IOV-3001 will be presented in a poster at ASCO 2024 and
demonstrate the potential for improved safety with strong effector T cell expansion. |
| o | Next
Generation, Cytokine-Tethered TIL Therapy: A genetically engineered, inducible, and tethered
IL-12 TIL cell therapy, designated IOV-5001, is in IND-enabling studies. In preclinical studies, IOV-5001
augmented anti-tumor activity in vitro, and a clinical trial of a prior generation
IL-12 TIL therapy at the National Cancer Institute showed improved efficacy. An
INTERACT meeting is planned with the FDA to discuss IOV-5001 in the third quarter of 2024,
followed by an IND submission in early 2025. |
Manufacturing
Capacity Expansion
| · | The
Iovance Cell Therapy Center (iCTC), and a nearby FDA-approved contract manufacturer,
are built today for capacity for several thousands of patients annually. Capacity expansion
is currently underway at iCTC to supply TIL cell therapies for more than 5,000 patients
annually in the next few years. |
Upcoming ASCO 2024 Highlights for Iovance
| · | Oral
Presentation: Efficacy and safety of lifileucel, an autologous tumor-infiltrating lymphocyte
cell therapy, and pembrolizumab in patients with immune checkpoint inhibitor-naive unresectable
or metastatic melanoma: updated results from IOV-COM-202 Cohort 1A |
| o | Session: Melanoma/Skin Cancers,
Friday, May 31, 2024, 2:45 - 5:45 p.m. CDT |
| · | Poster:
IOV-3001, a modified interleukin-2 fusion protein, for potential use in tumor-infiltrating
lymphocyte cell therapy regimens |
| o | Session: Developmental Therapeutics
– Immunotherapy - Saturday, June 1, 2024; 9:00 a.m. – 12:00 p.m. CDT |
| · | Poster:
Dynamics of circulating cytokines and chemokines during and after tumor-infiltrating lymphocyte
cell therapy with lifileucel in advanced melanoma patients |
| o | Session: Melanoma/Skin Cancers:
Saturday, June 1, 2024, 1:30-4:30 p.m. CDT |
Corporate Updates
| · | As
of March 31, 2024, Iovance had cash, cash equivalents, investments, and restricted
cash of approximately $362.6 million, compared to $346.3 million at December 31, 2023.
The current cash position and anticipated revenue from Amtagvi and Proleukin are expected
to be sufficient to fund current and planned operations well into the second half of 2025. |
| · | Iovance
is now recognizing all Proleukin revenues for commercial and clinical use and has recently
commenced significant sales to distributors. In the first quarter of 2024, Iovance completed
the transfer of marketing authorizations and began distribution of Proleukin. Beginning in
the second quarter of 2024, Iovance expects to recognize significant incremental revenues
for Proleukin as part of the Amtagvi treatment regimen. |
| · | Iovance
currently owns more than 120 granted or allowed U.S. and international patents
for TIL-related technologies, including 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 and additional patent rights, including patents related to potency assays expected to
provide exclusivity into 2042. More information on Iovance’s patent portfolio is available
on the Intellectual Property page on www.iovance.com. |
First quarter 2024 Financial Results
Net loss for the first quarter ended March 31,
2024, was $113.0 million, or $0.42 per share, compared to a net loss of $107.4 million, or $0.50 per share, for the first quarter ended
March 31, 2023. The net loss for the first quarter 2024 includes amortization of intangible assets acquired as part of the Proleukin
transaction.
Revenue for the first quarter ended March 31,
2024, was $0.7 million from sales of Proleukin® in licensed markets outside of the U.S. Cost of sales was $7.3 million, primarily
related to inventoriable costs associated with sales of Proleukin and non-cash amortization expense for the acquired intangible asset
for developed technology during the first quarter of 2024. No revenue or cost of sales were incurred for the first quarter ended March 31,
2023.
Research and development expenses were $79.8
million for the first quarter ended March 31, 2024, a decrease of $2.9 million compared to $82.7 million for the first quarter of
2023. The decrease was primarily attributable to the transition to commercial Amtagvi manufacturing in the most recent quarter, partially
offset by increased costs associated with the purchases of raw materials, clinical trials driven primarily by the Phase 3 TILVANCE-301
clinical trial, and the planned EU regulatory submissions for lifileucel.
Selling, general and administrative expenses
were $31.4 million for the first quarter ended March 31, 2024, an increase of $3.3 million compared to $28.1 million for the first
quarter of 2023. The increase was primarily attributable to increases in headcount and related costs, including stock-based compensation,
to support the growth in the overall business and related corporate infrastructure, as well as costs incurred to support the commercialization
of Amtagvi and Proleukin, partially offset by a decrease in legal costs.
For additional information, please see the
Company’s Selected Condensed Consolidated Balance Sheet and Statement of Operations below.
Webcast
and Conference Call
To listen to the live or archived audio
webcast, please register at https://edge.media-server.com/mmc/p/m4tigan7. The live and archived webcast can be accessed in
the Investors section of the Company’s website, IR.Iovance.com for one year.
1. National Cancer Institute Surveillance,
Epidemiology and End Results (SEER) Program. 2024 Estimates. https://seer.cancer.gov
About Iovance
Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc.
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. The Iovance TIL platform has demonstrated promising clinical data across multiple
solid tumors. Iovance’s Amtagvi™ is the first FDA-approved T cell therapy for a solid tumor indication. 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.
Amtagvi™ and its accompanying design marks, Proleukin®, Iovance®,
and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries.
All other trademarks and registered trademarks are the property of their respective owners.
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”). 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 U.S. 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 risks related to our ability to successfully commercialize our products, including Amtagvi, for which we have obtained
U.S. Food and Drug Administration (“FDA”) approval, and Proleukin, for which we have obtained FDA and European Medicines
Agency (“EMA”) approval; the risk that the EMA or other ex-U.S. regulatory authorities may not approve or may delay approval
for our marketing authorization application submission for lifileucel in metastatic melanoma; the acceptance by the market of our products,
including Amtagvi and Proleukin, and their potential pricing and/or reimbursement by payors, if approved (in the case of our product
candidates), in the U.S. and other international markets and whether such acceptance is sufficient to support continued commercialization
or development of our products, including Amtagvi and Proleukin, or product candidates, respectively; the risk whether the number of
patients treated and/or ATCs is an appropriate measure of commercial success and/or recognized revenue; future competitive or other market
factors may adversely affect the commercial potential for Amtagvi or Proleukin; the risk regarding our ability or inability to manufacture
our therapies using third party manufacturers or at our own facility, including our ability to increase manufacturing capacity at such
third party manufacturers and our own facility, may adversely affect our 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, including Amtagvi and
Proleukin, may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the
risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain FDA, EMA, or other regulatory authority
approval of, or other action with respect to, our product candidates; whether clinical trial results from our pivotal studies and cohorts,
and meetings with the FDA, EMA, or other regulatory authorities may support registrational studies and subsequent approvals by the FDA,
EMA, or other regulatory authorities, including the risk that the planned single arm Phase 2 IOV-LUN-202 trial may not support registration;
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 risk that 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, EMA, or other regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications
with the FDA, EMA, or other regulatory authorities may differ from the interpretation of such results or communications by such regulatory
authorities (including from our prior meetings with the FDA regarding our non-small cell lung cancer clinical trials); the risk that
clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not
support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances
and forecasts and increase our estimated capital requirements; the effects of the COVID-19 pandemic; and other factors, including general
economic conditions and regulatory developments, not within our control.
IOVANCE BIOTHERAPEUTICS, INC.
Selected Condensed Consolidated Balance Sheets
(in thousands)
| |
March 31, 2024 (unaudited) | | |
December 31, 2023 | |
Cash, cash equivalents, and investments | |
$ | 356,195 | | |
$ | 279,867 | |
Restricted cash | |
$ | 6,430 | | |
$ | 66,430 | |
Total assets | |
$ | 869,830 | | |
$ | 780,351 | |
Stockholders' equity | |
$ | 680,024 | | |
$ | 584,613 | |
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except per share information)
| |
For the Three Months Ended | |
| |
March 31, | |
| |
2024 | | |
2023 | |
Revenue | |
| | |
| |
Product revenue | |
$ | 715 | | |
$ | — | |
Total revenue | |
| 715 | | |
| — | |
| |
| | | |
| | |
Costs and expenses* | |
| | | |
| | |
Cost of sales | |
$ | 7,261 | | |
$ | — | |
Research and development | |
| 79,783 | | |
| 82,734 | |
Selling, general and administrative | |
| 31,393 | | |
| 28,122 | |
Total costs and expenses | |
| 118,437 | | |
| 110,856 | |
| |
| | | |
| | |
Loss from operations | |
| (117,722 | ) | |
| (110,856 | ) |
Other income | |
| | | |
| | |
Interest income, net | |
| 3,338 | | |
| 3,486 | |
Net loss before income taxes | |
$ | (114,384 | ) | |
$ | (107,370 | ) |
Income tax benefit | |
| 1,408 | | |
| — | |
Net Loss | |
$ | (112,976 | ) | |
$ | (107,370 | ) |
| |
| | | |
| | |
Net Loss Per Share of Common Stock, Basic and Diluted | |
$ | (0.42 | ) | |
$ | (0.50 | ) |
| |
| | | |
| | |
Weighted Average Shares of Common Stock Outstanding, Basic and Diluted | |
| 266,220 | | |
| 213,694 | |
| |
| | | |
| | |
*Includes stock-based compensation as follows: | |
| | | |
| | |
Research and development | |
$ | 8,915 | | |
$ | 8,859 | |
Selling, general and administrative | |
| 8,263 | | |
| 6,806 | |
Total stock-based compensation included in costs and expenses | |
$ | 17,178 | | |
$ | 15,665 | |
CONTACTS
Iovance Biotherapeutics, Inc.:
Sara Pellegrino, IRC
SVP, Investor Relations & Corporate Communications
650-260-7120
ext. 264
Sara.Pellegrino@iovance.com
Jen Saunders
Senior Director, Investor Relations & Corporate Communications
267-485-3119
Jen.Saunders@iovance.com
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