On May 7, 2026 Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) reported financial results for the three months ended March 31, 2026, and provided an operating forecast and business update. Ligand management will host a conference call and webcast today at 8:30 a.m. Eastern Time to discuss the results and answer questions.
"The first few months of 2026 have already proven to be highly productive and transformative for Ligand," said Todd Davis, CEO of Ligand. "In April, we announced a definitive agreement to acquire XOMA Royalty Corporation ("XOMA Royalty" or "XOMA"), a highly complementary business that we expect to accelerate both near and long-term growth. Upon closing, the transaction will add more than 120 commercial, clinical and preclinical-stage assets to our royalty portfolio, including seven commercial assets and 14 late-stage programs, and meaningfully diversify Ligand across therapeutic areas, stages of development, and biopharma partners. We were also pleased to see the full FDA approval of Filspari in focal segmental glomerulosclerosis ("FSGS"), a transformative milestone that further strengthens one of our most valuable royalty assets. Filspari is now the largest royalty contributor within our commercial portfolio and, as the first and only FDA-approved medicine for this rare and serious kidney disease, is well positioned to be a key driver of long-term royalty growth."

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First Quarter 2026 Financial Results

First-quarter 2026 results reflect continued strong momentum in the royalty business, with royalty revenue growing 56% year-over-year. Total revenues and income for the first quarter of 2026 were $51.7 million, compared with $45.3 million for the same period in 2025, with the 14% increase primarily driven by higher royalty revenue. Royalties for the first quarter of 2026 were $43.0 million, compared with $27.5 million for the same period in 2025, with the 56% increase primarily attributable to royalties earned on Travere Therapeutics’ Filspari and Merck’s Ohtuvayre and Capvaxive. Captisol sales were $8.7 million for the first quarter of 2026, compared with $13.5 million for the same period in 2025, with the decrease due to the timing of customer orders.
Cost of Captisol for the first quarter of 2026 was $3.3 million, compared with $4.8 million for the same period in 2025, with the change due to a decrease in Captisol sales. Amortization of intangibles was $8.1 million for the first quarter of 2026, compared with $8.3 million for the same period in 2025. Research and development expenses were $2.1 million for the first quarter of 2026, compared with $50.1 million for the same period in 2025. The first quarter of 2025 included a $44.3 million one-time charge in connection with the royalty financing agreement with Castle Creek Biosciences to fund the Phase 3 clinical study of D-Fi (FCX-007), which was accounted for as a research and development funding agreement under ASC 730-20, Research and Development Arrangements, and $2.7 million research and development expenses of our former Pelthos business. General and administrative expenses were $20.8 million for the first quarter of 2026, compared with $18.8 million for the same period in 2025. The increase primarily reflects higher employee-related costs, including increased headcount and share-based compensation, consistent with the Company’s continued investment in its business development and portfolio management functions.
Non-operating expense, net, was $41.6 million for the first quarter of 2026, compared with $14.0 million for the same period in 2025. The change was primarily attributable to a $49.2 million non-cash loss from changes in the

fair value of the Company’s equity-method investment in Pelthos Therapeutics and Pelthos Series A Preferred Shares, partially offset by a $3.9 million gain from short-term investments and $4.9 million of net interest income.
GAAP net loss was $13.3 million, or $0.67 per share for the first quarter of 2026, compared with GAAP net loss of $42.5 million, or $2.21 per share, for the same period in 2025. Adjusted net income for the first quarter of 2026 was $34.6 million, or $1.63 per diluted share, representing growth of 30% and 23%, respectively, compared with $26.6 million, or $1.33 per diluted share, for the same period in 2025. The increase was primarily driven by the 56% year-over-year growth in royalty revenue. Adjusted net income represents a non-GAAP financial measure. See the table below for a reconciliation of net loss to adjusted net income.
As of March 31, 2026, Ligand had cash, cash equivalents, and short-term investments of $779.4 million, compared with $733.5 million at December 31, 2025.
2026 Financial Guidance Update
Ligand is reaffirming its 2026 full-year financial guidance, which was raised on April 27, 2026 in connection with the announced entry into a definitive agreement to acquire XOMA. The transaction is expected to close in the third quarter of 2026, subject to customary closing conditions, including approval by XOMA stockholders, and certain entity restructuring. The previously announced increase to guidance is entirely attributable to the anticipated partial-year contribution from XOMA and reflects: (i) incremental royalty revenue of approximately $25 million generated from XOMA’s commercial-stage portfolio, principally Vabysmo, Ojemda and Miplyffa; (ii) anticipated cost synergies resulting from the XOMA acquisition that are expected to substantially offset incremental operating expenses associated with the acquired business; partially offset by (iii) modestly lower other income, reflecting capital deployed to fund the XOMA acquisition and the related reduction in interest income on cash balances. The Company continues to expect adjusted earnings per diluted share1 of approximately $8.50 to $9.50 and full-year 2026 royalty revenue to be in the range of $225 million to $250 million. Revenue from sales of Captisol is unchanged at $35 million to $40 million and contract revenue is unchanged at $10 million to $20 million, resulting in total revenue of $270 million to $310 million.
First Quarter 2026 Corporate Highlights and Portfolio Updates

On April 27, 2026, Ligand and XOMA, both biotechnology royalty aggregators, announced that the companies entered into a definitive agreement under which Ligand will acquire XOMA for $39.00 per share of common stock in cash. XOMA stockholders are expected to separately receive one non-transferable Contingent Value Right ("CVR") per share entitling the holders to receive a portion of 75% of the net proceeds that may result from certain pending litigation at XOMA. The cash purchase price at close represents an approximately 14% premium to XOMA’s 30 trading day volume weighted average price as of April 24, 2026, the last trading day prior to announcement of the transaction. The transaction is expected to close in the third quarter of 2026, subject to customary closing conditions. Ligand intends to fund the transaction through a combination of cash on hand and borrowings under its existing revolving credit facility, and expects to retain sufficient capital capacity to continue executing its capital deployment strategy of investing approximately $150 million to $250 million annually in high-value royalty assets.
The acquisition further diversifies Ligand’s royalty portfolio across therapeutic areas such as ophthalmology, oncology, CNS and rare diseases and across stages of development and biopharma partners. The anticipated XOMA acquisition will add over 120 commercial, clinical, and preclinical-stage assets to Ligand’s broad and growing royalty portfolio, highlighted by Roche’s Vabysmo (faricimab-svoa), Day One Pharmaceuticals’, now Servier’s, Ojemda (tovorafenib), Zevra Therapeutics’ Miplyffa (arimoclomol), and 14 programs in late-stage development, highlighted by Takeda’s mezagitamab and certain assets from Takeda’s externalized asset portfolio, including osavampator, volixibat and OHB-607.

Filspari
1 The financial outlook, expectations and other forward-looking statements provided by Ligand for 2026 and beyond reflect Ligand’s judgment based on the information available at the time of this release. Please see the "Cautionary Note Regarding Forward-looking Statements" section in this release for factors that may impact Ligand’s ability to meet expectations. A reconciliation of forward-looking non-GAAP core adjusted earnings per diluted share for 2026 to the most directly comparable GAAP measures was provided in Ligand’s Acquisition of XOMA Royalty presentation on April 27, 2026, which is available on Ligand’s investor relations website.

On April 13, 2026, Travere announced the U.S. Food and Drug Administration (FDA) approved Filspari to reduce proteinuria in adult and pediatric patients aged 8 years and older with FSGS, in patients without nephrotic syndrome. Filspari is currently the first and only medicine approved by the FDA for the treatment of FSGS, marking its expansion beyond IgA nephropathy (IgAN) into a second rare kidney disease.
People with FSGS who do not have nephrotic syndrome span across different types of FSGS and represent a population aligned with the KDIGO guidelines for treating glomerular diseases. Travere estimates that the addressable population in the U.S. is more than 30,000 individuals with FSGS who do not have nephrotic syndrome.
On May 4, 2026, Travere announced first quarter results and recent business highlights:
•Filspari achieved record 993 new patient start forms for IgAN in the U.S. in the first quarter; U.S. net product sales grew 88% year over year to $105 million
•The first FSGS patients were treated within one week of approval
•The SPARX Study evaluating Filspari in post-transplant patients with recurrent IgAN or FSGS is on track to complete enrollment in the second quarter of 2026

Qtorin rapamycin

On February 24, 2026, Palvella announced positive topline results from its Phase 3 SELVA study of Qtorin rapamycin for the treatment of microcystic lymphatic malformations (MLMs). The Phase 3 trial met its primary endpoint with statistically significant improvement on the Microcystic LM Investigator Global Assessment and achieved statistical significance on its pre-specified key secondary endpoint and all four secondary efficacy endpoints. Qtorin rapamycin was well tolerated, with no drug-related serious adverse events reported and systemic rapamycin levels below 2 ng/mL at all timepoints for all participants. 98% of participants who completed the efficacy evaluation period elected to continue to receive Qtorin rapamycin in the ongoing treatment extension period.
On March 31, 2026, Palvella announced fourth quarter results and recent business highlights:
•NDA for Qtorin rapamycin for the treatment of MLM is on track for planned submission in second half of 2026
•Accelerating U.S. launch readiness for Qtorin rapamycin for MLMs; potential to become the first FDA-approved therapy and first-line, standard-of-care treatment for this serious, lifelong disease affecting an estimated more than 30,000 diagnosed patients in the U.S.
•Initiation of the Phase 3 trial of Qtorin rapamycin for the treatment of cutaneous venous malformations is planned for second half of 2026
•Initiation of the Phase 2 trial of Qtorin rapamycin for the treatment of clinically significant angiokeratomas is planned for second quarter of 2026

On May 4, 2026, Palvella announced the first patients have been dosed in LOTU, a Phase 2 clinical trial designed to evaluate the safety and efficacy of Qtorin rapamycin for the treatment of clinically significant angiokeratomas. Clinically significant angiokeratomas represent a rare, chronic and debilitating lymphatic malformation with no FDA approved therapies and an estimated more than 50,000 diagnosed patients in the U.S. Topline results from the Phase 2 trial are expected in the second half of 2027.
Lasofoxifene

On March 26, 2026, LeonaBio announced fourth quarter results and recent business highlights:
•Lasofoxifene is currently in a Phase 3 clinical trial in combination with abemaciclib, a CDK4/6 inhibitor, as a targeted therapy for estrogen receptor-positive (ER+), HER2-negative, ESR1-mutated metastatic breast cancer, a population with limited treatment options following progression on aromatase inhibitors and CDK4/6 inhibitors. The primary endpoint of the study is statistically significant improvement in progression free survival (PFS) as determined by blinded, independent central review (BICR). The ongoing Phase 3 trial aims to establish a new standard of care for this genetically defined patient group

•LeonaBio is amending the ELAINE-3 trial protocol to increase the sample size from 500 participants to up to 600 participants. The primary goal of the amendment is to help ensure that the trial will have the appropriate number of disease progression events. The Company expects to complete enrollment of the

Phase 3 ELAINE-3 clinical trial in the fourth quarter of 2026 and to have topline data in the second half of 2027
AVIM Therapy/Virtue SAB

On March 12, 2026, Orchestra BioMed announced fourth quarter results and recent business highlights:
•Accelerated patient enrollment of the BACKBEAT global pivotal study, in collaboration with Medtronic, evaluating the efficacy and safety of AVIM Therapy for the treatment of uncontrolled hypertension in patients indicated for a pacemaker

•Initiated patient enrollment in the Virtue SAB U.S. pivotal trial, a randomized head-to-head IDE registrational clinical trial comparing Virtue SAB with the commercially available AGENT paclitaxel-coated balloon for the treatment of coronary in-stent restenosis

On April 30, 2026, Orchestra BioMed announced that the FDA has granted Breakthrough Device Designation ("BDD") for AVIM Therapy specific to patients with uncontrolled hypertension despite the use of anti-hypertensive medications, and an indication for a pacemaker.

Together, the two BDD’s for AVIM Therapy cover indications that encompass both the broader population of patients with uncontrolled hypertension despite medication and increased cardiovascular risk as well as the specific pacemaker-indicated population with uncontrolled hypertension being evaluated in the BACKBEAT global pivotal trial, which Orchestra BioMed is conducting in collaboration with Medtronic. This additional BDD supports strategic optionality for the clinical, regulatory and commercial reimbursement strategies for AVIM Therapy.

Bot/Bal
On April 1, 2026, Agenus announced the first patient enrolled in the landmark global Phase 3 BATTMAN trial. This study is evaluating Agenus’ immunotherapy combination of botensilimab plus balstilimab ("Bot/Bal") versus best supportive care in patients with refractory, unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC), a population long considered resistant to immunotherapy. The BATTMAN trial serves as the registrational-enabling study for Bot/Bal, enrolling approximately 830 patients and is expected to complete global enrollment quickly, reflecting the unprecedented investigator and patient enthusiasm worldwide.

Tzield
On April 22, 2026, Sanofi announced the FDA approved the supplemental biologic license application for Tzield, expanding the indication from eight years and older to as young as one year of age to delay the onset of stage 3 type 1 diabetes (T1D) in patients diagnosed with stage 2 T1D. The approval was granted under a priority review process and is supported by one-year data from the PETITE-T1D Phase 4 study, evaluating safety and pharmacokinetics in young children.

Adjusted Financial Measures
Ligand reports adjusted net income from continuing operations, adjusted net income per diluted share and adjusted earnings per diluted share in addition to, and not as a substitute for, financial measures calculated in accordance with GAAP, and does not consider such measures superior to GAAP results. The Company also reports "core" versions of these measures, which exclude any realized gains from the sale of Viking Therapeutics common stock.
Adjusted earnings per diluted share is a key component of the financial metrics utilized by the Company’s board of directors to evaluate management performance and determine certain elements of management compensation. GAAP results include items such as share‑based compensation expense, amortization of acquisition‑related and intangible assets, changes in contingent liabilities, mark‑to‑market adjustments on investments in public companies, transaction‑related costs and related tax effects, which are excluded from adjusted results and are detailed in the reconciliations included at the end of this press release.

Conference Call and Webcast
Ligand management will host a conference call today beginning at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss its results and answer questions. To participate via telephone, please dial (833) 461-5787 using the conference ID 304603090. International participants outside of Canada may use the toll number +1(585) 542-9983. To participate via live or replay webcast, a link is available at www.ligand.com.

(Press release, Ligand, MAY 7, 2026, View Source [SID1234665334])

On May 7, 2026 Lantheus Holdings, Inc. (Lantheus or the Company) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported financial results for its first quarter ended March 31, 2026.

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"Our first quarter results demonstrate disciplined execution across the business, with strong performance from PYLARIFY, Neuraceq, and DEFINITY, and continued progress against the priorities that underpin our long-term strategy," said Mary Anne Heino, Chief Executive Officer of Lantheus. "During the quarter, we secured FDA approval for PYLARIFY TruVu and achieved tentative approval for PNT2003. For the remainder of 2026, we are focused on sustaining our leadership in PSMA PET as we prepare for the PYLARIFY TruVu conversion later this year, expanding our Alzheimer’s imaging portfolio, and advancing our prioritized pipeline. At the same time, we will remain disciplined in our capital deployment, prioritizing radiodiagnostics while evaluating the best path to maximize value from our radiotherapeutic assets – all as we lay the groundwork for growth acceleration beginning in 2027."

Summary Financial Results

Three Months Ended
March 31,
(in millions, except per share data – unaudited) 2026 2025 % Change
Worldwide revenue $ 377.3 $ 372.8 1.2 %
GAAP net income $ 118.4 $ 72.9 62.3 %
GAAP fully diluted earnings per share $ 1.80 $ 1.02 76.5 %
Adjusted net income (non-GAAP) $ 95.8 $ 109.5 (12.5 %)
Adjusted fully diluted earnings per share (non-GAAP) $ 1.46 $ 1.53 (4.6 %)

First Quarter 2026

Worldwide revenue increased 1.2% to $377.3 million compared to the same period in 2025.
Sales of PYLARIFY were $240.9 million, a decrease of 6.5%.
Sales of Neuraceq were $35.4 million.
Sales of DEFINITY were $84.6 million, an increase of 6.8%.
Operating income decreased 20.3% to $81.3 million. Adjusted operating income (non-GAAP) decreased 10.5% to $129.1 million.
Fully diluted earnings per share increased 76.5% to $1.80, compared to fully diluted earnings per share of $1.02 in the prior year period. Adjusted fully diluted earnings per share (non-GAAP) decreased 4.6% to $1.46, compared to $1.53 in the prior year period.
Net cash provided by operating activities and free cash flow were $125.1 million and $121.9 million, respectively.
Balance Sheet

At March 31, 2026, the Company’s cash and cash equivalents were $498.6 million, including proceeds of $31.4 million from the sale of the Company’s single-photon emission computerized tomography ("SPECT") business to SHINE Technologies, LLC ("SHINE") on January 1, 2026, compared to $359.1 million at December 31, 2025.
The Company currently has access to up to $750.0 million from a revolving line of credit.
Recent Business Highlights

Received FDA approval for PYLARIFY TruVuTM (piflufolastat F18), a new formulation of PYLARIFY, the Company’s market-leading PSMA PET imaging agent, designed to enhance manufacturing efficiency and supply flexibility; a phased geographic commercial launch is planned to begin in the fourth quarter of 2026 to align with coding, coverage, payment, and customer and PMF readiness.
Completed the divestiture of the legacy SPECT business to SHINE (effective January 1, 2026), a decisive action taken to focus on PET radiodiagnostics and simplify the Company’s operating model. 
Achieved FDA tentative approval for PNT2003, which upon full approval would be the first radioequivalent to Lutetium Lu 177 Dotatate for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs); launch timing will consider the following factors: the timing of FDA approval, the expiration of the 30-month Hatch-Waxman stay and disposition of the related legal proceedings, as well as manufacturing and commercial strategy to ensure launch success.
The FDA extended the PDUFA date for LNTH-2501(Ga 68 edotreotide), the Company’s PET diagnostic imaging kit for somatostatin receptor-positive neuroendocrine tumors (NETs), by three months to June 29, 2026, to allow additional time to review manufacturing-related information. This standard review extension is not related to the efficacy or safety data of LNTH-2501.
Full Year 2026 Financial Guidance

Guidance Issued May 7, 2026 Guidance Issued February 26, 2026
FY 2026 Revenue $1.4 billion – $1.45 billion $1.4 billion – $1.45 billion
FY 2026 Adjusted fully diluted EPS $5.00 – $5.25 $5.00 – $5.25

On a forward-looking basis, the Company does not provide GAAP income per common share guidance or a reconciliation of GAAP income per common share to adjusted fully diluted EPS because the Company is unable to predict with reasonable certainty business development and acquisition related expenses, purchase accounting fair value adjustments, and any one-time, non-recurring charges. These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP. As a result, it is the Company’s view that a quantitative reconciliation of adjusted fully diluted EPS on a forward-looking basis is not available without unreasonable effort.

Conference Call and Webcast

As previously announced, the Company will host a conference call and webcast on Thursday, May 7, 2026, at 8:00 a.m. ET. To access the conference call or webcast, participants should register online at View Source

A replay will be available approximately two hours after completion of the webcast and will be archived on the same web page for at least 30 days.

The conference call will include a discussion of non-GAAP financial measures. Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this press release, our Form 8-K filed with the SEC today, or otherwise available in the Investor Relations section of our website located at www.lantheus.com.

The conference call may include forward-looking statements. See the cautionary information about forward-looking statements in the safe-harbor section of this press release.

(Press release, Lantheus, MAY 7, 2026, View Source [SID1234665333])

On May 7, 2026 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies, reported financial results for the quarter ended March 31, 2026, and provided a business update.

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"Our commitment to advancing a prostate cancer franchise is demonstrated by our continued progress with JANX007, clinical initiation of JANX014, and advancement of JANX013 toward the clinic," said David Campbell, Ph.D., President and CEO of Janux. "Our ongoing clinical study with JANX011 has been designed to support our emerging autoimmune disease opportunity."

BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS:

Clinical & Pipeline Progress

•
JANX007 (PSMA-TRACTr) continues to enroll in its Phase 1b trial in metastatic castration-resistant prostate cancer (mCRPC), with ongoing dose optimization and expansion in taxane-naïve patients.
•
An expansion cohort evaluating JANX007 in combination with darolutamide, an androgen receptor pathway inhibitor, is actively enrolling in taxane-naïve mCRPC.
•
JANX014 (PSMA-TRACTr), a double masked tumor-activated T cell engager, has initiated clinical evaluation.
•
Following the completion of the Phase 1a portion of the study and internal review of the data, the Company has discontinued further clinical development of JANX008 (EGFR-TRACTr) and is prioritizing resources toward other pipeline opportunities.
•
JANX011 (CD19-ARM) is actively enrolling in its Phase 1 clinical trial in healthy volunteers.
•
The Company continues to advance additional TRACTr, TRACIr and ARM programs for potential future development.

Strategic Collaborations

•
Janux announced a collaboration and exclusive worldwide license agreement with Bristol Myers Squibb to develop a novel tumor-activated therapeutic targeting a validated solid tumor antigen, utilizing Janux’s TRACTr platform.
•
Recently announced development candidate nomination, triggering a $35 million milestone payment.

Corporate & Leadership

•
Janux announced the appointment of William Go, M.D., Ph.D. as Chief Medical Officer, supporting the Company’s continued clinical advancement as additional programs enter the clinic in 2026.

Upcoming Milestones

•
Janux expects to provide additional clinical data for JANX007 at a future medical congress in the first half of 2027.
•
Janux plans to announce an initial clinical update from the Phase 1 study of JANX011 in healthy volunteers in the second half of 2026.
•
Janux plans to initiate clinical development of JANX013, a PSMA-targeted CD28 costimulatory TRACIr, in the second half of 2026.

FIRST QUARTER 2026 FINANCIAL RESULTS:

•
Cash and cash equivalents and short-term investments: As of March 31, 2026, Janux reported cash and cash equivalents and short-term investments of $956.4 million, compared to $966.6 million on December 31, 2025.
•
Research and development expenses: Research and development expenses were $26.8 million for the quarter ended March 31, 2026, compared to $25.1 million for the comparable period in 2025. The change was primarily driven by manufacturing.
•
General and administrative expenses: General and administrative expenses were $11.1 million for the quarter ended March 31, 2026, compared to $9.8 million for the comparable period in 2025.
•
Net loss: Net loss was $24.4 million for the quarter ended March 31, 2026, compared to $23.5 million for the comparable period in 2025.

(Press release, Janux Therapeutics, MAY 7, 2026, View Source [SID1234665332])

On May 7, 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, reported first quarter 2026 financial results, business achievements, and corporate updates.

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Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "We are accelerating the adoption and commercial expansion for Amtagvi after record high demand. Iovance is well positioned through 2026 for long-term revenue growth, while advancing multiple ongoing and new clinical trials, including our registrational trial in advanced sarcomas now underway and encouraging initial data reported today for lifileucel in metastatic serous endometrial cancer. Internal manufacturing efficiencies, operational improvements, and cost reductions will benefit gross margin and propel future profitability, sustainable growth, and long-term value for patients and shareholders."

First Quarter 2026 Financial Highlights
Continued Strength in Execution and Cost Discipline

Total product revenue of ~$71 million increased by ~45% over 1Q25, reflecting significant performance improvements over the prior annual maintenance period.
U.S. Amtagvi revenue was ~$60 million.
Global Proleukin revenue was ~$11 million.
Gross margin of 41% absorbed one-time costs for the annual maintenance period and the recent internal facility expansion.
Consistent with 1Q25, revenue was affected by maintenance of the Iovance Cell Therapy Center (iCTC). The facility has now been expanded to ensure continuous supply going forward during future maintenance periods.
Research and Development (R&D) expenses decreased by 12% compared to 4Q25, driven by operational efficiencies and marking the third consecutive quarter of improvements.
Successful centralization of manufacturing at iCTC, significant operational excellence initiatives focused on Amtagvi production, and R&D optimization should further reduce costs and improve gross margins in 2026 and 2027.
Second Quarter 2026 and Full Year 2026 Guidance
Strong Growth in Amtagvi Forecast for 2026

Total product revenue guidance for 2Q26 is $86 million to $88 million and for FY26 is $350 million to $370 million.
U.S. Amtagvi revenue for 2Q26 is expected to be $79 million to $81 million, reflecting an expected ~23% increase over 4Q25 (the quarter prior to iCTC maintenance).
Amtagvi Commercial Business
Strong U.S. Commercial Business to Deliver Strong Growth in 2026

Increasing Amtagvi demand, catalyzed by real-world data, is driven by adoption and referrals toward earlier treatment. Recently published real world objective response rates were 52% in patients with two or fewer prior lines of therapy. Five-year follow-up clinical data demonstrated deep and durable responses in heavily pretreated patients, with a median duration of response of 3 years.
Demand and referral patterns are accelerating across a growing network of more than 90 U.S. and Canadian academic and community authorized treatment centers (ATCs). By year-end 2026, at least 110 ATCs will be activated.
Amtagvi turnaround time is 32 days or less with the first scaled, centralized commercial manufacturing process for TIL therapy. This is significantly faster than any other TIL therapy in development.
Amtagvi global expansion is advancing:
Decisions on marketing authorization application (MAA) approvals are expected in Australia in the first half of 2026 and in Switzerland in the first half of 2027.
In the United Kingdom, Iovance withdrew its initial MAA for lifileucel in May 2026 for procedural reasons. With the full agreement of the Medicines and Healthcare products Regulatory Agency (MHRA), Iovance will promptly resubmit the MAA with updated information for an expedited review by the MHRA, which is expected to be completed over the coming months.
Iovance is working to resubmit an MAA to the European Medicines Agency (EMA) in 2026.
Other regulatory submissions are planned in markets with a high prevalence of advanced melanoma, non-small cell lung cancer (NSCLC), and soft tissue sarcomas.
Pipeline Updates
New Data Across Several Pipeline Programs Anticipated Throughout 2026

Registrational Trials of Lifileucel Treatment in Solid Tumors
IOV-END-201: Positive initial data in previously treated metastatic serous endometrial cancer:
The confirmed objective response rate (cORR) by RECIST v1.1 was 40% and disease control rate was 100% in the first five evaluable patients with a median of 2 prior lines of therapy.
All five patients were mismatch repair proficient and progressed on prior chemotherapy and checkpoint inhibitor therapy.
These initial responses build on established differentiation of lifileucel from immune checkpoint inhibitors, including in melanoma, and demonstrate its advantages for solid tumor indications.
Serous endometrial cancer is a difficult to treat subtype accounting for ~40% of the approximately 12,500 annual U.S. endometrial cancer deaths.1 The second line setting represents an area of unmet medical need, with no therapy approved by FDA specifically for patients with serous endometrial carcinoma or for patients who have received prior PD-1 blocking antibodies.
Engagement on an expedited approval pathway with the ongoing IOV-END-201 trial is planned with the U.S. Food and Drug Administration (FDA).
IOV-LUN-202: initial results in previously treated, metastatic non-squamous NSCLC supported FDA Fast Track Designation, reflecting the high unmet medical need in this population. Upcoming milestones include:
Updated data at a major medical meeting in 2026.
Completion of enrollment in 2026 to support a supplemental Biologics License Application (sBLA).
Potential for a U.S. accelerated approval and launch in the second half of 2027.
IOV-SAR-201: a new registrational trial in undifferentiated pleomorphic sarcoma (UPS) and dedifferentiated liposarcoma (DDLPS) is now underway, driven by positive early data with a cORR of 50% in the first six evaluable patients.
Site activation and enrollment are on track to begin in the third quarter of 2026.
Iovance is actively engaging with FDA on a path to expedited approval for lifileucel in UPS and DDLPS.
TILVANCE-301: A Phase 3 randomized trial of lifileucel and pembrolizumab in frontline advanced melanoma.
Sites are actively enrolling patients across a broad global footprint.
An early interim analysis based on cORR is intended for a potential sBLA in frontline advanced melanoma.
TILVANCE-301 is also the confirmatory trial to support full approval in second line advanced melanoma.
Next Generation Pipeline
An Investigational New Drug (IND) application was submitted to FDA for a Phase 1/2 basket trial of IOV-5001, a second-generation IL-12 tethered TIL therapy, to begin enrolling in 2H 2026. Cohorts include advanced colorectal cancer, triple negative and estrogen receptor low breast cancers, and other highly prevalent solid tumors representing more than 100,000 U.S. deaths annually.2 IOV-5001 is designed to remodel the suppressive tumor microenvironment (TME) and activate immunologically cold tumors to support TIL responses. A first-generation IL-12 secreted TIL therapy showed a cORR of 63% in 16 melanoma patients at cell doses much lower than used with typical TIL therapies as well as those safely achievable with IOV-5001.3
A Phase 1/2 trial, IOV-GM1-201, is enrolling using IOV-4001, a PD-1 inactivated TIL therapy, in previously treated advanced melanoma and NSCLC. IOV-4001 is engineered to resist inhibitory signals and enhance the ability of TIL therapies to fight and kill cancer in the TME.
A Phase 1 safety cohort using IOV-3001 is advancing through multiple dose levels in the Phase 1/2 trial of our 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 exhibits favorable pharmacokinetics and is expected to be superior to Proleukin as a component of future TIL regimens.
Multiple investigator-sponsored clinical trials of lifileucel are enrolling in cutaneous squamous and Merkel cell carcinomas as well as other new solid tumor indications.
Corporate Updates

Iovance currently owns or licenses nearly 400 granted or allowed U.S. and international patents and patent rights for Amtagvi and other TIL-related technologies, as well as more than 1,000 patent applications worldwide, which are expected to provide exclusivity into 2042 for Amtagvi and beyond for pipeline therapies.
Dr. Friedrich Graf Finckenstein, Chief Medical Officer, will retire from Iovance in June 2026. The company thanks Dr. Finckenstein for his service and contributions to the development of Amtagvi and other pipeline products. A new Chief Medical Officer is expected to be announced in the near term.
Iovance’s cash position was ~$319 million on March 31, 2026.4 The current cash position, bolstered by expense reductions, is expected to fund operations well into 2028.
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 View Source The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.Iovance.com, for one year.

1.Hamilton, C., Cheung, M., Osann, K. et al. Uterine papillary serous and clear cell carcinomas predict for poorer survival compared to grade 3 endometrioid corpus cancers. Br J Cancer 94, 642–646
2. Surveillance, Epidemiology, and End Results Program Cancer Stat Facts (accessed May 2026).
3. Zhang L, Rosenberg SA, et al, Clin Cancer Res 2015;21(10):2278–2288.
4. Cash, cash equivalents, short-term investments, and restricted cash as of March 31, 2026.

(Press release, Iovance Biotherapeutics, MAY 7, 2026, View Source [SID1234665331])

On May 7, 2026 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, reported first quarter 2026 financial results and provides a corporate update.

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Corporate Update

INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the SOC treatment in patients with early-stage, operable triple negative breast cancer and SOC alone.
In March 2026, the Company reported the following:
•Preliminary observations of the INVINCIBLE-4 Study showed that five (5) out of seven (7) patients (71.4%) who received INT230-6 prior to SOC ("Cohort A") achieved a pathological complete response ("pCR") whereas two (2) out of six (6) (33%) patients in the SOC arm alone ("Cohort B") achieved a pCR, with one patient still to be evaluated.
•Forty-four percent (44%) fewer grade 3 or higher adverse events were observed in Cohort A compared to Cohort B.
•A protocol amendment was submitted to Swissmedic, Switzerland’s regulatory authority, and the Switzerland Ethics Committee to resume enrollment. Full approval to resume enrollment was granted on March 26, 2026. The Company plans to resume enrollment in the second quarter of 2026.
The Company expects presentation of more detailed results for the seven (7) Cohort A patients at a future oncology conference.

INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second- and third-line treatment for specific soft tissue sarcoma subtypes.
In March 2025, the Company paused new site activations and patient enrollments due to funding constraints. Before this pause, the trial had enrolled 21 patients. The Company has continued to treat patients enrolled in this study, maintain the database, conduct pharmacovigilance, and conduct other study-related activities in cooperation with its third-party contract research organizations at significantly reduced ongoing costs during this pause. In April 2026, the Company decided to resume enrollment in the INVINCIBLE-3 Study in a limited number of U.S. sites by the third quarter of 2026, and has prioritized commencing full patient enrollment and site activations in this study once sufficient incremental funding is obtained.

Lewis H. Bender, Founder, President, and CEO, stated, "The Company made excellent progress in the first quarter. We announced early data from the INVINCIBLE-4 Study, our randomized controlled study in TNBC, showing the possibilities for INT230-6 to increase efficacy while also potentially improving safety. We are now seeking additional patients in our INVINCIBLE-4 Study in Switzerland and expect to initiate enrollment in France in the second or third quarter of 2026. Further, after a successful funding campaign in 2025 and the establishment of a $60 million ATM facility in March 2026, we have made the decision to reinitiate enrollment of our INVINCIBLE-3 Study and plan to manage our cash burn judiciously. Both of our clinical trials focus on indications with high unmet medical need."

First Quarter 2026 Financial Results

Research and development expenses were $1.2 million for the three months ended March 31, 2026, compared to $2.2 million for the same period in 2025. The decrease was primarily due to lower INVINCIBLE-3 Study costs. In March 2025, the Company paused new site activations and patient enrollments in the INVINCIBLE-3 Study due to funding constraints. Prior to this pause, the trial had enrolled 21 patients. The Company has continued to treat all patients enrolled in this study in cooperation with our third-party contract research organizations during this pause. The Company plans to resume enrollment in the INVINCIBLE-3 Study in a limited number of U.S. sites by the third quarter of 2026, and has prioritized commencing full patient enrollment and site activations once sufficient funding is obtained. In addition, lower headcount-related costs in 2026 were entirely offset by an estimated bonus accrual during the three months ended March 31, 2026 compared to no bonus accrual during the three months ended March 31, 2025.

General and administrative expenses were $1.3 million for the three months ended March 31, 2026, compared to $1.2 million for the same period in 2025. The increase was due to an estimated bonus accrual during the three months ended March 31, 2026 compared to no bonus accrual during the three months ended March 31, 2025. This increase was partially offset by lower stock-based compensation and one-time expenses related to our reverse stock split in February 2026.

Overall, net loss was $2.4 million for the three months ended March 31, 2026, compared to a net loss of $3.3 million for the three months ended March 31, 2025.

As of March 31, 2026, cash and cash equivalents totaled $10.2 million.

About Triple Negative Breast Cancer in the Presurgical Setting
Women with aggressive forms of breast cancer, such as Triple Negative Breast Cancer ("TNBC"), are often counseled to undergo pre-surgical (neoadjuvant) systemic therapy in advance to reduce the risk of the disease returning. Having a pathological complete response, meaning the absence of live cancer at the time of surgery, has been shown to result in a lower risk of disease recurrence from 50% to 16% at 5 years. Approximately 11 to 17% of breast cancers test negative for estrogen receptors ("ER"), progesterone receptors (PR), and overexpression of human epidermal growth factor receptor 2 ("HER2") protein, qualifying them as triple negative. There are approximately 56,000 new cases of TNBC in the US and 420,000 worldwide diagnosed each year, 85% of which are local to the breast. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, because there are fewer available targeted medicines. Most patients with local TNBC typically receive immunochemotherapy before surgery. Since the publication of Keynote-522, the standard neoadjuvant treatment for TNBC includes systemic chemotherapy (anthracyclines, cyclophosphamide, paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody pembrolizumab. pCR rates range from 50 to 65%, depending on tumor size. Rates are generally lower in the larger-sized tumors or with lymph node metastasis. The toxicity of the Keynote-522 regimen is high, with 77% of patients experiencing grade 3 or higher treatment-related AEs, including treatment-related adverse events that lead to death in 0.5% of patients.

About Sarcoma

Soft tissue sarcoma is a rare type of cancer that starts with the growth of cells in the body’s soft tissue, such as muscle, fat, blood vessels, nerves, tendons, and linings of the joints. The disease mostly occurs in the arms, legs and belly. There are 197,000 patients in the US living with sarcoma and more than 100 types of soft tissue sarcoma, the treatment of which first involves surgery. Other treatments might include radiation therapy and then chemotherapy. Using the U.S. SEER database, the Company estimated that 14,400 patients have regional or distal (metastatic) leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma.

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

(Press release, Intensity Therapeutics, MAY 7, 2026, View Source [SID1234665330])