IOVA — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-06

• Globally, Amtagvi® has the potential to address more than 30,000 previously treated advanced melanoma patients annually. We plan to launch into additional markets with a high prevalence of advanced melanoma. On June 4, 2026, we received marketing authorization with conditions from the Therapeutic Go…

• The current iCTC facility has the potential capacity to supply TIL cell therapies for more than 5,000 cancer patients annually. To utilize our internal manufacturing suites at greater scale, improve gross margin and reduce operating expenses, we transitioned all manufacturing for clinical and commer…

• cell therapy and manufacturing; stable and transient genetically-modified TIL cell therapies, including genetic knockouts of immune checkpoints; cytokine-tethered TIL cell therapies; methods of using immune checkpoint inhibitor, or ICIs, in combination with TIL cell therapies; TIL selection technolo…

• Revenues for the three and six months ended June 30, 2026 represents product sales of Amtagvi®, as well as Proleukin®, primarily driven from sales in the U.S. to support the ongoing commercial launch of Amtagvi®, which received FDA approval in February 2024. Proleukin®, which we acquired the worldwi…

• costs, number of sites included in the trial, discontinuation rates of patients, duration of patient follow-up, efficacy and safety profile of the product candidate, and the length of time required to enroll eligible patients.

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• Globally, Amtagvi® has the potential to address more than 30,000 previously treated advanced melanoma patients annually. We plan to launch into additional markets with a high prevalence of advanced melanoma. Potential approvals are pending in Australia in the first half of 2026 and Switzerland in 20…

• The current iCTC facility has the potential capacity to supply TIL cell therapies for more than 5,000 cancer patients annually. To utilize our internal manufacturing suites at greater scale, improve gross margin and reduce operating expenses, we transitioned all

• manufacturing for clinical and commercial Iovance TIL cell therapies to the iCTC and terminated an agreement with a contract manufacturer in the first quarter of 2026 to manage and reduce long-term product manufacturing costs. We have full control of manufacturing capacity and product quality, suppl…

• Revenue for the three months ended March 31, 2026 represents product sales of Amtagvi®, as well as Proleukin®, primarily driven from sales in the U.S. to support the ongoing commercial launch of Amtagvi®, which received FDA approval in February 2024. Proleukin®, which we acquired the worldwide right…

• Research and development expense for the three months ended March 31, 2026 decreased by $13.5 million, or 18%, compared to the same period in 2025. The decrease was primarily attributable to (i) a $4.9 million decrease in outside services cost driven by a decrease in the number of consultants, (ii) …

Text added vs the prior filing · source: 10-Q · 2026-08-06

• Our operations have consumed substantial amounts of cash since inception. From our inception to June 30, 2026, we have an accumulated deficit of $2.9 billion. In addition, our research and development and our operating costs have also been substantial and

• are expected to increase. As of June 30, 2026, we had $303.7 million in cash, cash equivalents, short-term investments, and restricted cash ($110.8 million of cash and cash equivalents, $186.9 million in short-term investments, and $6.0 million in restricted cash).

• Our net operating loss carryforwards and any future research and development tax credits may expire and not be used. As of December 31, 2025, we had U.S. federal net operating loss carryforwards of approximately $1.7 billion. Our net operating loss carryforwards arising in taxable years ending on or…

• codependency. Additionally, Proleukin® revenues are dependent upon continued use in manufacturing and clinical settings by Iovance and other cell therapy companies.

• Currently, our products and product candidates are manufactured at our internal facility, the iCTC, and by CMOs, using processes developed or modified by us or by our third-party research institution collaborators that we may not intend to use for more advanced clinical trials or commercialization. …

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• Our operations have consumed substantial amounts of cash since inception. From our inception to March 31, 2026, we have an accumulated deficit of $2.9 billion. In addition, our research and development and our operating costs have also been substantial and are expected to increase. As of March 31, 2…

• Our net operating loss carryforwards and any future research and development tax credits may expire and not be used. As of December 31, 2025, we had U.S. federal net operating loss carryforwards of approximately $1.7 billion. Our net operating loss

• carryforwards arising in taxable years ending on or prior to December 31, 2017 will begin expiring in 2027 if we have not used them prior to that time. Net operating loss carryforwards arising in taxable years ending after December 31, 2017, are no longer subject to expiration under the Internal Rev…

• deductions or other tax allocations, which may adversely affect our results of operations and financial position. In addition, given our current net loss and net loss carryforwards, we may not be able to realize the full benefit of these tax advantages before they expire.

• Currently, our products and product candidates are manufactured at our internal facility, the iCTC, and by CMOs, using processes developed or modified by us or by our third-party research institution collaborators that we may not intend to use for more