Iovance Biotherapeutics Reports Record Third Quarter 2026 Revenue of ~$122M, Business Achievements, and Corporate Updates
Lower research spending accompanied revenue growth, while Iovance maintained its 2026 outlook and advanced additional cancer trials.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Iovance Biotherapeutics (NASDAQ: IOVA) reported third-quarter 2026 revenue of $121.469 million, up from $67.455 million a year earlier. U.S. Amtagvi revenue reached approximately $102 million. Gross margin, excluding depreciation and amortization, rose to approximately 60% from 56% in the second quarter. Iovance maintained its $410–$420 million full-year revenue outlook and expects its approximately $382 million cash position to fund operations well into 2029.
Lifileucel produced a 24.6% objective response rate, meaning measurable tumor shrinkage, in 69 lung cancer patients, including two unconfirmed responses. A biomarker-selected subgroup achieved 59.1%; a related trial is beginning enrollment. Updated sarcoma results showed a 55.6% confirmed response rate in nine patients. Iovance plans a 2027 lung cancer approval submission and anticipates potential UK and Swiss melanoma approvals in the first quarter of 2027.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointThird-quarter revenue of $121.469 million increased from $67.455 million in 2025.
- Moderate pointGross margin, excluding depreciation and amortization, reached approximately 60%, versus 56% in second-quarter 2026.
- Moderate pointThird-quarter research and development expense fell to $49.337 million from $75.174 million a year earlier.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Cash position was approximately $382 million at September 30; Iovance expects funding well into 2029.
- Moderate pointIOV-LUN-202 response rate reached 24.6% in 69 patients, including two unconfirmed responses.
- Moderate point. Forward-looking: it has not happened yet and may not happen.UK and Swiss approvals are potentially expected in first-quarter 2027, expanding planned international access.
21 minor points
- Minor pointU.S. Amtagvi revenue of approximately $102 million rose approximately 77% year-over-year and 12% sequentially.
- Minor point. Forward-looking: it has not happened yet and may not happen.2026 product revenue guidance remains $410–$420 million; Iovance expects further margin improvement, excluding occasional one-time items.
- Minor pointResearch and development expense decreased approximately 16% sequentially, marking five consecutive quarters of improvement.
- Minor pointNine-month revenue increased to $292.212 million from $176.731 million in 2025.
- Minor pointNine-month research and development expense declined to $170.675 million from $229.067 million in 2025.
- Minor pointFDA Fast Track designation granted for lifileucel in metastatic non-small-cell lung cancer.
- Minor pointBiomarker-selected lung cancer subgroup achieved a 59.1% response rate, supporting the new POSITILITY trial.
- Minor point. Forward-looking: it has not happened yet and may not happen.POSITILITY enrollment begins this month, targeting 80 biomarker-selected lung cancer patients with registration intent.
- Minor point. Forward-looking: it has not happened yet and may not happen.Lung cancer approval submission planned in 2027, based on cohorts targeting approximately 80 patients.
- Minor point. Forward-looking: it has not happened yet and may not happen.OPTILISM initiation planned in 2027 for biomarker-selected patients receiving initial lung cancer treatment.
- Minor pointSARATOGA is enrolling approximately 40 patients per indication, with FDA-aligned design and a potential accelerated approval pathway.
- Minor pointSarcoma confirmed response rate increased to 55.6% (5/9), including two responses ongoing beyond one year.
- Minor pointPhase 2 melanoma combination response rate was 62.5%, with 29.2% complete responses in 24 patients.
- Minor pointMedian overall survival was not reached after median follow-up exceeding four years in the melanoma combination study.
- Minor pointTILVANCE-301 enrollment continues, testing lifileucel plus pembrolizumab and supporting confirmatory and potential frontline approval submissions.
- Minor point. Forward-looking: it has not happened yet and may not happen.ENDURANCE enrollment will restart in serous endometrial cancer; Iovance plans FDA discussions on expedited approval.
- Minor pointPOTENTIL and IOV-GM1-201 are enrolling, advancing separate next-generation TIL therapies in solid tumors.
- Minor pointIOV-3001 safety testing is advancing through multiple dose levels in its Phase 1/2 trial.
- Minor point. Forward-looking: it has not happened yet and may not happen.Kidney cancer investigator-sponsored trial commenced; skin cancer trial initial results are expected in first-half 2027.
- Minor point. Forward-looking: it has not happened yet and may not happen.Brazil submission and European resubmission are planned for 2027 for Amtagvi in advanced melanoma.
- Minor pointCell and Gene Therapy Catapult research agreement signed, including an option to license a manufacturing platform.
Negative
- Moderate pointThird-quarter operating loss was $23.968 million, despite increased revenue.
- Minor pointUK and Swiss marketing approvals remain pending; UK expedited review is underway.
- Minor pointLung cancer submission preparation remains ongoing, including independent assessments, FDA discussions and confirmatory trial preparation.
- Minor pointThird-quarter cost of sales rose to $48.028 million from $38.477 million in 2025.
- Minor pointThird-quarter selling, general and administrative expense rose to $38.575 million from $34.555 million in 2025.
4 minor points
- Minor pointThird-quarter depreciation and amortization increased to $9.497 million from $9.007 million in 2025.
- Minor pointNine-month cost of sales increased to $134.121 million from $130.073 million in 2025.
- Minor pointNine-month selling, general and administrative expense increased to $116.796 million from $115.922 million in 2025.
- Minor pointNine-month depreciation and amortization increased to $27.536 million from $26.422 million in 2025.
Details
Market move: IOVA +6.44% vs previous close. 3Q26 earnings report
On Nov 5, the day this news came out, the latest delayed price for IOVA is 6.44% above the previous close. Our momentum scanner has recorded 3 alerts for this stock so far that day. The latest delayed price is $9.26. Relative volume is exceptionally heavy at 8.9x what this stock usually trades by this time of day.
Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.
Key Figures
- Total product revenue
- $121,469 thousand
- 3Q26; compared with $67,455 thousand in 3Q25
- 2026 total product revenue guidance
- $410 million to $420 million
- Full-year 2026; company said it remained on track
- Net loss
- $22,271 thousand
- 3Q26
- Objective response rate
- 24.6% in 69 patients
- IOV-LUN-202, non-squamous mNSCLC
- Objective response rate
- 59.1%
- Biomarker-selected mNSCLC subgroup
- Confirmed objective response rate
- 55.6% (5/9)
- SARATOGA, UPS and DDLPS
- Confirmed objective response rate
- 62.5%
- IOV-COM-202, lifileucel plus pembrolizumab
- Complete response rate
- 29.2%
- IOV-COM-202, lifileucel plus pembrolizumab
Historical Context
-
Reported 24.6% ORR and a 59.1% biomarker subgroup result in IOV-LUN-202.
-
Reported 50% confirmed ORR in soft-tissue sarcoma ahead of the SARATOGA update.
-
Reported 62.5% confirmed ORR for lifileucel plus pembrolizumab in IOV-COM-202.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
objective response rate medical
recist v1.1 medical
fast track designation regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Total Revenue Increased ~
and Gross Margin Increased to ~
and Dedifferentiated Liposarcoma (DDLPS) with SARATOGA Registrational Trial Underway
PHILADELPHIA, Nov. 05, 2026 (GLOBE NEWSWIRE) -- 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 ~
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 to56% 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 t o$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.
- 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
- 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.
- Results of lifileucel in heavily pretreated UPS and DDLPS, with
- 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 was29.2% , 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.
- 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
- 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
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were Iovance's third-quarter 2026 revenue and full-year guidance?
Iovance reported $121.469 million in third-quarter revenue and maintained its $410–$420 million full-year 2026 product revenue guidance. Third-quarter revenue compared with $67.455 million a year earlier.
What did Iovance's lifileucel lung cancer trial show?
IOV-LUN-202 showed a 24.6% objective response rate in 69 patients with non-squamous metastatic non-small-cell lung cancer, including two unconfirmed responses. A biomarker-selected subgroup achieved a 59.1% response rate. Iovance plans a supplemental approval submission in 2027 based on Cohorts 1 and 2.
How does Iovance's TILVANCE-301 trial support Amtagvi's melanoma approvals?
TILVANCE-301 serves as the confirmatory study for lifileucel's accelerated approval in second-line advanced melanoma. The randomized Phase 3 trial also tests lifileucel plus pembrolizumab in frontline advanced melanoma and includes an early response-rate analysis for a potential supplemental approval application.