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:
On November 5, 2026, Iovance Biotherapeutics,
Inc. (the “Company”) issued a press release announcing its financial results for the third quarter ended September 30, 2026,
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.
(d) Exhibits.
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.
Exhibit 99.1
Iovance Biotherapeutics Reports Record Third
Quarter 2026
Revenue of ~$122M,
Business Achievements, and Corporate Updates
Total Revenue Increased ~80% and U.S. Amtagvi
Revenue Increased ~77% Year-over-Year,
and Gross Margin Increased to ~60%
24.6% Objective Response Rate (ORR) in 69 Patients
with Non-Squamous Metastatic Non-Small-Cell Lung Cancer (mNSCLC)
59.1% ORR in Biomarker-Selected mNSCLC Subgroup
with POSITILITY Trial Underway
55.6% ORR in Undifferentiated Pleomorphic Sarcoma
(UPS)
and Dedifferentiated Liposarcoma (DDLPS) with
SARATOGA Registrational Trial Underway
PHILADELPHIA, November 5, 2026 -- 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 third quarter 2026 financial results, business achievements, and corporate
updates.
“Third quarter revenue reached a new record of ~$122 million
with our highest gross margin ever, driven by continued U.S. Amtagvi demand,” said Frederick Vogt, Ph.D., J.D., Interim Chief Executive
Officer and President. “We remain on track to achieve our full-year 2026 total revenue guidance of $410 to $420 million and recently
marked the tremendous milestone of more than 1,000 commercially treated Amtagvi patients. We released our positive results for Cohorts
1 and 2 of our ongoing IOV-LUN-202 trial with a 24.6% ORR in 69 patients and excellent durability that is much greater than current standard
of care. We are completing enrollment in Cohorts 1 and 2 and preparing for a supplemental Biologics License Application (sBLA) submission,
while adding the new POSITILITY and OPTILISM trials supported by a remarkable 59.1% ORR in biomarker-selected patients.
We also recently presented best-in-class data for lifileucel in chemotherapy-refractory UPS and DDLPS in support of our SARATOGA registrational
trial, where our confirmed ORR has now increased to 55.6% in 9 patients with strong durability.”
Third Quarter 2026 Financial
Highlights
Second Consecutive Record Quarter in Revenue and High Margin Driven
by Volume and Cost Discipline
| · | Total product revenue was ~$122 million, an increase of ~80% from ~$67 million
in 3Q25 and ~22% from ~$99 million in 2Q26. |
| · | U.S. Amtagvi revenue was ~$102 million, up ~77% from 3Q25 and ~12% from 2Q26.
Global Proleukin revenue was ~$20 million in 3Q26. |
| · | Gross margin1 was ~60%, compared to 56% in 2Q26, reflecting higher
Amtagvi sales volume and effective internal cost optimization programs spanning all of product production. |
| · | Research and Development (R&D) expenses decreased by ~16% compared to
2Q26, driven by operational efficiencies, marking the fifth straight quarter of improvements, and allowing pipeline growth in additional
indications with significant market opportunity. |
Full Year 2026 Outlook
Third Quarter Performance and Demand Growth Support Guidance
| · | Iovance
remains on track towards achieving its guidance range of $410 to $420 million in total
product revenue in 2026. |
| · | Improvements in gross margin are expected to continue, excluding occasional
one-time items. |
Amtagvi Commercial Business
Sustained U.S. Commercial Business Growth and Upcoming Milestones
in Global Expansion
| · | Authorized treatment center (ATC) network: The network has grown to more than 100 U.S., Canadian, and Australian
ATCs, with at least 110 ATCs expected to be active by the end of 2026. Community ATCs continue to represent a third of the network and
are expected to increase significantly over the next several quarters. |
| · | Real-world
experience: Numerous real-world studies by Iovance and ATCs using commercial Amtagvi
continue to highlight efficacy and safety, with objective response rates (ORRs) of 50% or
greater in second-line patients, supporting earlier adoption of Amtagvi with rapid patient
referrals and access. In a poster at the European Society for Medical Oncology Congress
2026 (ESMO 2026), an indirect comparison suggested that lifileucel may approximately double
four-year overall survival (OS) rates compared with standard-of-care therapies in anti-PD-1-resistant
advanced melanoma. |
| · | Manufacturing turnaround time: Amtagvi turnaround time for the majority
of lots is about 30 days or less using the only scaled, centralized commercial manufacturing process approved by the U.S. Food and Drug
Administration (FDA) for TIL therapy. |
| · | United Kingdom (UK): The Marketing Authorization Application (MAA)
was resubmitted and is undergoing expedited review by the Medicines and Healthcare products Regulatory Agency for potential approval by
1Q27. Advanced melanoma causes more than 2,500 deaths annually in the UK. |
| · | Switzerland: A potential MAA approval by Swissmedic is expected in
1Q27, and the process is moving smoothly, opening a second market opportunity in Europe with the added potential for medical tourism.
Switzerland’s domestic melanoma burden causes several hundred deaths annually. |
| · | Other markets and indications: Iovance is planning to submit an MAA
for Amtagvi in advanced melanoma to the Brazilian Health Regulatory Agency (ANVISA) in 2027. An MAA resubmission for Amtagvi to the European
Medicines Agency is on track for 2027. Other regulatory submissions are planned in international markets with a high prevalence of advanced
melanoma, lung cancer, and soft tissue sarcomas. |
Clinical and Regulatory Pipeline Updates
Progress Across a Deep Pipeline of Registrational
Programs
| · | IOV-LUN-202,
POSITILITY, and OPTILISM: Iovance recently reported a 24.6%
ORR in 69 patients with non-squamous mNSCLC, including two unconfirmed responses, consistent
with previously reported results. IOV-LUN-202 Cohorts 1 and 2 are completing enrollment.
An sBLA for lifileucel based on Cohorts 1 and 2, with a target of approximately 80 patients,
is planned in 2027. Independent review committee assessments, FDA discussions, and other
pre-submission activities, including confirmatory trial preparation, are ongoing. |
| - | Efficacy results are potentially best-in-class, with durability continuing to mature and already much greater than standard of care,
including docetaxel, which offers an ORR of only 12.8%, a durability of only 5.6 months, and median overall survival of 12.3 months.2 |
| - | The safety profile remains consistent with lifileucel regimen experience and was improved after switching to reduced-dose lymphodepletion. |
| - | The FDA awarded Fast Track Designation (FTD) on the strength of the clinical data and the high unmet medical need of mNSCLC patients. |
| - | A novel biomarker-enriched subgroup within IOV-LUN-202 achieved a 59.1% ORR, leading to the start of POSITILITY, a first-in-class
biomarker-enriched cohort with registrational intent, with enrollment beginning this month and a target of 80 patients. |
| - | Iovance plans to initiate OPTILISM, an innovative frontline trial in biomarker-enriched non-squamous mNSCLC, in 2027. The U.S.
market opportunity in frontline and second-line non-squamous mNSCLC in the biomarker-selected cohort is about ten times that of advanced
melanoma. |
| - | Translational data in a poster at ESMO 2026 showed enrichment
over time of putative tumor-reactive clones in mNSCLC patients responding to lifileucel in
IOV-LUN-202. |
| · | SARATOGA
(IOV-SAR-201): A registrational trial in UPS and DDLPS, with approximately 40 patients
in each indication, is actively enrolling patients refractory to at least one prior line
of anthracycline chemotherapy. Iovance has aligned with the FDA on the registrational trial
design and potential accelerated approval pathway. The FDA granted FTD in both indications
in 2Q26. |
| - | Results of lifileucel in heavily pretreated UPS and DDLPS, with 84%
of patients receiving two or more prior lines of therapy, were highlighted in a Rapid Oral
presentation at ESMO 2026. |
| - | In an updated data analysis conducted after ESMO, the confirmed ORR by RECIST v1.1 increased to 55.6% (5/9) with multiple durable
responses observed, including two responses ongoing more than a year from infusion. |
| - | The U.S. market opportunity in UPS and DDLPS is approximately the same size as the current second-line metastatic melanoma opportunity
for Amtagvi. |
| · | TILVANCE-301:
A Phase 3 randomized trial of lifileucel and pembrolizumab is enrolling patients with frontline
advanced melanoma across a broad global footprint.
The TILVANCE-301 trial includes an early interim analysis based on ORR for a potential sBLA
for frontline advanced melanoma. The trial also serves as the confirmatory study for the
accelerated approval of lifileucel in second-line advanced melanoma. |
| - | An oral presentation at ESMO 2026 reinforced the rationale
for TILVANCE-301 with Phase 2 results of the combination of lifileucel and pembrolizumab
as a potential best-in-class option for frontline advanced melanoma. The confirmed ORR was
62.5%, the complete response rate was 29.2%, and median OS was not reached at a median follow-up
of more than four years in the IOV-COM-202 trial (n=24). |
| - | Enrollment momentum in TILVANCE-301 is accelerating at more than 80 sites in the U.S., Canada, Europe, and Asia-Pacific. The clinical
site network is expanding into new regions, contributing to ongoing robust enrollment. |
| · | ENDURANCE
(IOV-END-201): Positive initial data in previously treated metastatic serous endometrial
cancer using a biomarker strategy based on histology were reported in 1Q26. Enrollment of
serous endometrial patients in ENDURANCE will restart, and discussion with the FDA is planned
on an expedited approval pathway to focus on this population. |
Next-Generation Pipeline Updates
First-in-Class Immuno-Oncology Technologies
Target New Indications
| · | POTENTIL
(IOV-GE1-201): A Phase 1/2 trial is actively enrolling
using IOV-5001, a second-generation IL-12 tethered TIL therapy designed to remodel the suppressive
tumor microenvironment (TME) and activate immunologically “cold tumors” to support
TIL responses and boost response rates.3 Cohorts include metastatic colorectal
cancer, triple-negative and estrogen receptor-low breast cancers, and other solid tumors
causing more than 100,000 annual U.S. deaths.4 |
| | · |
IOV-GM1-201:
A Phase 1/2 trial investigating IOV-4001, a PD-1 inactivated TIL therapy, is enrolling patients
with previously treated metastatic melanoma and mNSCLC. IOV-4001 is engineered to resist
inhibitory signals and enhance the ability of TIL therapies to fight and kill cancer in the
TME. |
| · | IOV-IL2-101:
A Phase 1 safety cohort is advancing through multiple dose levels in the Phase 1/2 trial
of IOV-3001, a second-generation modified IL-2 analog for the TIL treatment regimen. IOV-3001
selectively expands effector T cells while avoiding activation of regulatory T cells with
the potential for a lower-dose IL-2 regimen with reduced adverse events. IOV-3001 is expected
to be superior to Proleukin as a component of future TIL regimens. |
| · | Investigator-sponsored trials (ISTs): Iovance continues to advance
its broad IST portfolio in multiple new indications for lifileucel. A new IST of lifileucel in clear cell renal cell carcinoma (ccRCC)
recently commenced. An ongoing IST of lifileucel in cutaneous squamous cell carcinoma (CSCC) and Merkel cell carcinoma (MCC) is accelerating.
Confirmed clinical activity in both CSCC and MCC was observed, and initial results are expected in 1H27. With a lack of effective therapies
after failure of checkpoint inhibitors and other frontline combinations, lifileucel could address a large CSCC, MCC, and ccRCC population
suffering from thousands of annual deaths in the U.S. alone. |
Corporate Updates
| · | Iovance
currently owns or licenses more than 400 granted or allowed U.S. and international patents
and patent rights for Amtagvi and other TIL-related technologies, including patent rights
directed to its biomarker-directed strategy, and has filed more than 1,000 additional patent
applications worldwide. This broad patent portfolio is expected to provide patent exclusivity
through at least 2042 and beyond. |
| · | Iovance entered into a contract research agreement with Cell and Gene Therapy
Catapult, a UK independent innovation and technology organization advancing cell and gene therapies, with an option to license a next-generation
smart manufacturing platform. |
| · | As of September 30, 2026, Iovance’s cash position5 was ~$382
million, and current cash is expected to fund operations well into 2029. |
Webcast and Conference Call
Management will host a conference call and live audio webcast to discuss
these results and provide a corporate update today at 8:30 a.m. ET. To listen to the live or archived audio webcast, please register
at https://edge.media-server.com/mmc/p/j9pwh6ke. The live and archived webcast can be accessed in the Investors section of the
Company’s website, iovance.com, for one year.
1. Excludes depreciation and amortization.
2. Ahn MJ, Tanaka K, et al., J Clin Oncol 2025;43:260–272.
3. Zhang L, Rosenberg SA, et al., Clin Cancer Res 2015;21(10):2278–2288.
4. Surveillance, Epidemiology, and End Results Program Cancer Stat
Facts (accessed November 2026).
5. Cash, cash equivalents, short-term investments, and restricted cash
as of September 30, 2026.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. is the global leader in innovating,
developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi®
(lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets
and available at more than 100 authorized treatment centers (ATCs). The Iovance TIL platform spans registrational trials
and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2,
and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial
treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that
is scaled to serve thousands of cancer patients worldwide each year. Headquartered in Pennsylvania with offices and laboratories in California
and Florida, Iovance serves patients at ATCs and clinical sites across almost the entire U.S. and in many countries around the world. 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.
Information on Iovance’s broad, industry-leading patent portfolio
is available on the Intellectual Property page on 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”).
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,” “can,” “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 ATC network
expansion and new markets; the size of the addressable patient populations for, and the acceptance by the market of, our products and
product candidates, if approved, and their potential pricing and/or reimbursement by payors, and whether such acceptance is sufficient
to support continued commercialization or development of our products or product candidates; the risk regarding our ability to manufacture
our therapies at our iCTC facility, including the risk that our ability to increase manufacturing capacity at our facility may
adversely affect our commercial supply or clinical supply; the risks related to our ability to obtain, maintain, and enforce patent and
other intellectual property protection for our products and product candidates, including our biomarker-directed strategy; 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 at all; the risks related to the timing of and our ability to successfully develop, submit, obtain,
or maintain regulatory authority approval of our product candidates; whether clinical trial results from our clinical studies and cohorts,
and meetings with regulatory authorities, may support registrational studies, including biomarker-selected studies, and subsequent approvals
by regulatory authorities, and the risk that our clinical trials, including registrational and investigator-sponsored trials, may experience
delays in site activation, enrollment, or data readouts, may not meet their primary endpoints, or may not support approval; clinical results,
whether preliminary, interim, or final, which may include efficacy and safety results, from clinical trials or cohorts may not be confirmed
or reflected in independent review assessments or the final analyses of our ongoing clinical trials or subgroups within these trials or
in other prior or future trials or cohorts; the risk that we may be required to conduct additional clinical trials or modify ongoing or
future clinical trials based on feedback from regulatory authorities; the risk that our interpretation of the results of our clinical
trials, including comparisons to other therapies, or communications with regulatory authorities may differ from the interpretation of
such results or communications by such regulatory authorities or others; 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 risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues, and other factors such as the
number of ATCs, may not serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial
performance, including our financial guidance and projections; the effects of global and domestic geopolitical factors or public health
events; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance
provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change
in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the
period covered by this press release; and no material fluctuation in exchange rates.
IOVANCE BIOTHERAPEUTICS,
INC.
Selected Condensed
Consolidated Balance Sheets
(in thousands)
| | |
September 30, 2026 | | |
December 31, 2025 | |
| | |
(unaudited) | | |
| |
| Cash, cash equivalents, and investments | |
$ | 376,320 | | |
$ | 296,980 | |
| Restricted cash | |
$ | 6,018 | | |
$ | 5,980 | |
| Total assets | |
$ | 991,214 | | |
$ | 913,170 | |
| Stockholders’ equity | |
$ | 812,662 | | |
$ | 698,583 | |
Condensed Consolidated Statements
of Operations
(unaudited; in thousands, except per
share information)
| | |
For the Three Months Ended | | |
For the Nine Months Ended | |
| | |
September 30, | | |
September 30, | |
| | |
2026 | | |
2025 | | |
2026 | | |
2025 | |
| Revenue | |
| | |
| | |
| | |
| |
| Product revenue, net | |
$ | 121,469 | | |
$ | 67,455 | | |
$ | 292,212 | | |
$ | 176,731 | |
| Total revenue | |
| 121,469 | | |
| 67,455 | | |
| 292,212 | | |
| 176,731 | |
| | |
| | | |
| | | |
| | | |
| | |
| Costs and expenses* | |
| | | |
| | | |
| | | |
| | |
| Cost of sales ** | |
$ | 48,028 | | |
$ | 38,477 | | |
$ | 134,121 | | |
$ | 130,073 | |
| Research and development ** | |
| 49,337 | | |
| 75,174 | | |
| 170,675 | | |
| 229,067 | |
| Selling, general, and administrative ** | |
| 38,575 | | |
| 34,555 | | |
| 116,796 | | |
| 115,922 | |
| Depreciation and amortization | |
| 9,497 | | |
| 9,007 | | |
| 27,536 | | |
| 26,422 | |
| Restructuring charges | |
| - | | |
| 5,143 | | |
| - | | |
| 5,143 | |
| Total costs and expenses | |
| 145,437 | | |
| 162,356 | | |
| 449,128 | | |
| 506,627 | |
| Loss from operations | |
| (23,968 | ) | |
| (94,901 | ) | |
| (156,916 | ) | |
| (329,896 | ) |
| Other income | |
| | | |
| | | |
| | | |
| | |
| Interest and other income, net | |
| 2,311 | | |
| 1,243 | | |
| 6,861 | | |
| 8,567 | |
| Net Loss before income taxes | |
$ | (21,657 | ) | |
$ | (93,658 | ) | |
$ | (150,055 | ) | |
$ | (321,329 | ) |
| Income tax benefit (expense) | |
| (614 | ) | |
| 2,405 | | |
| 1,424 | | |
| 2,255 | |
| Net Loss | |
$ | (22,271 | ) | |
$ | (91,253 | ) | |
$ | (148,631 | ) | |
$ | (319,074 | ) |
| Net Loss Per Share of Common Stock, Basic and Diluted | |
$ | (0.05 | ) | |
$ | (0.25 | ) | |
$ | (0.34 | ) | |
$ | (0.94 | ) |
| Weighted Average Shares of Common Stock Outstanding, Basic and Diluted | |
| 455,919 | | |
| 364,037 | | |
| 442,683 | | |
| 340,623 | |
| | |
| | | |
| | | |
| | | |
| | |
| *Non-cash stock-based compensation included in cost of sales and operating expenses | |
| | | |
| | | |
| | | |
| | |
| Cost of sales | |
$ | 1,721 | | |
$ | 1,408 | | |
$ | 4,276 | | |
$ | 5,977 | |
| Research and development | |
| 4,771 | | |
| 5,011 | | |
| 14,966 | | |
| 21,287 | |
| Selling, general, and administrative | |
| 5,341 | | |
| 5,481 | | |
| 15,593 | | |
| 22,494 | |
| | |
$ | 11,833 | | |
$ | 11,900 | | |
$ | 34,835 | | |
$ | 49,758 | |
** Excludes depreciation and amortization
CONTACTS
Investors
IR@iovance.com
650-260-7120 ext. 150
Media
PR@iovance.com
650-260-7120 ext. 150
