1stOncology™: Cancer Intelligence Service – Page 903 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Ligand Reports Second Quarter 2025 Financial Results and Raises Guidance

On August 7, 2025 Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) reported financial results for the three and six months ended June 30, 2025, and provided an operating forecast and business update (Press release, Ligand, AUG 7, 2025, View Source [SID1234654989]). Ligand management will host a conference call and webcast today at 8:30 a.m. Eastern Time to discuss the results and answer questions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"We are pleased to announce an increase to our 2025 guidance reflecting the continued strength and growth of our commercial-stage royalty portfolio." said Todd Davis, CEO of Ligand. "This quarter there were several key milestones across our portfolio including the commercial launch of Zelsuvmi by our partner Pelthos and Merck’s recently announced acquisition of our partner, Verona, which is expected to further accelerate the launch trajectory of Ohtuvayre in COPD and its clinical development in other indications. These achievements reflect the significant value of our partnerships and our comprehensive asset selection process, which continue to validate our robust and differentiated royalty aggregation model."

Second Quarter 2025 Financial Results

Total revenues and other income for the second quarter of 2025 were $47.6 million, compared with $41.5 million for the same period in 2024, with the 15% increase primarily attributable to an increase in royalty revenue. Royalties for the second quarter of 2025 were $36.4 million, compared with $23.2 million for the same period in 2024, with the 57% increase primarily attributable to royalties earned on Recordati’s Qarziba, and Travere Therapeutics’ Filspari. Captisol sales were $8.3 million for the second quarter of 2025, compared with $7.5 million for the same period in 2024, with the change due to the timing of customer orders. Contract revenue and other income was $2.9 million for the second quarter of 2025, compared with $10.9 million for the same period in 2024, with the difference due to the timing of partner milestone events.

Cost of Captisol was $2.9 million and amortization of intangibles was $8.3 million for each of the second quarters of 2025 and 2024. Research and development expenses were $6.6 million for the second quarter of 2025, compared with $5.4 million for the same period in 2024, with the increase primarily attributable to expenses incurred by Pelthos in preparation for the commercial launch of Zelsuvmi. General and administrative expenses were $20.2 million for the second quarter of 2025, compared with $17.6 million for the same period in 2024, with the increase primarily attributable to employee related costs and operating costs associated with incubating the Pelthos business. Fair value adjustment to partner program derivatives was $1.3 million for the second quarter of 2025 primarily due to mark to market adjustments to certain Agenus partnered programs. In the second quarter of 2024 Ligand recorded a $26.5 million financial asset impairment tied to Takeda’s Soticlestat program which resulted from missing its Phase 3 clinical trial primary endpoint.

GAAP net income was $4.8 million, or $0.24 per diluted share for the second quarter of 2025, compared with GAAP net loss of $51.9 million, or $2.88 per share, for the same period in 2024. Core adjusted net income for the second quarter of 2025 was $32.0 million, or $1.60 per diluted share, compared to $25.8 million, or $1.40 per diluted share, for the same period in 2024. The increase in core adjusted net income was driven primarily by the

15% increase in revenue and other income. Core adjusted net income represents a non-GAAP financial measure. See the table below for a reconciliation of net income (loss) to core adjusted net income.
As of June 30, 2025, Ligand had cash, cash equivalents and short-term investments of $245.0 million, which includes $26.5 million in Viking Therapeutics common stock.

Year-to-Date Financial Results

Total revenues and other income for the six months ended June 30, 2025 were $93.0 million, compared with $72.5 million for the same period in 2024, with the 28% increase primarily attributable to an increase in royalty revenue and Captisol sales. Royalties for the six months ended June 30, 2025 were $63.9 million, compared with $42.3 million for the same period in 2024, with the 51% increase primarily attributable to royalties earned on Recordati’s Qarziba, and Travere Therapeutics’ Filspari. Captisol sales were $21.7 million for the six months ended June 30, 2025, compared with $16.7 million for the same period in 2024, with the change due to the timing of customer orders. Contract revenue and other income was $7.3 million for the six months ended June 30, 2025, compared with $13.5 million for the same period in 2024, with the difference due to the timing of partner milestone events.
Cost of Captisol was $7.8 million for the six months ended June 30, 2025, compared with $5.8 million for the same period in 2024, with the change due to an increase in Captisol sales. Amortization of intangibles was $16.5 million for the six months ended June 30, 2025, compared with $16.4 million for the same period in 2024. Research and development expenses were $56.7 million for the six months ended June 30, 2025, compared with $11.3 million for the same period in 2024, with the increase primarily attributable to a $44.3 million one-time charge in connection with Ligand’s previously announced 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 arrangement under ASC 730-20, Research and Development Arrangements. General and administrative expenses were $39.0 million for the six months ended June 30, 2025, compared with $28.6 million for the same period in 2024, with the increase primarily attributable to employee related costs and operating costs associated with incubating the Pelthos business. Fair value adjustment to partner program derivatives was $0.8 million for the six months ended June 30, 2025 primarily due to mark to market adjustments to certain Agenus partnered programs. Financial royalty assets impairment was $26.5 million for the six months ended June 30, 2024 due to Takeda’s Soticlestat missing its Phase 3 clinical trial primary endpoint of reducing the frequency of convulsive seizures for patients with Dravet Syndrome.
GAAP net loss was $37.6 million, or $1.95 per share for the six months ended June 30, 2025, compared with GAAP net gain of $34.2 million, or $1.87 per diluted share, for the same period in 2024. Core adjusted net income for the six months ended June 30, 2025 was $58.6 million, or $2.94 per diluted share, compared to $47.6 million, or $2.61 per diluted share, for the same period in 2024. Core adjusted net income excluded gains from the sale of Viking Therapeutics common stock during the six months ended June 30, 2024. Ligand did not sell any shares of Viking Therapeutics common stock during the six months ended June 30, 2025. The increase in core adjusted net income was driven primarily by the 28% increase in revenue and other income. Core adjusted net income represents a non-GAAP financial measure. See the table below for a reconciliation of net income (loss) to core adjusted net income.

2025 Financial Guidance

Ligand is increasing its 2025 full year financial guidance. The Company now expects total revenue of $200 million to $225 million (previously $180 million to $200 million) and is raising its guidance on adjusted earnings per diluted share1 to $6.70 to $7.00 (previously $6.00 to $6.25).
Royalties are now expected to be in the range of $140 million to $150 million (previously $135 million to $140 million). Sales of Captisol are unchanged from $35 million to $40 million and contract revenue is now in the range of $25 million to $35 million (previously $10 million to $20 million).

Second Quarter 2025 and Corporate Highlights

Pelthos Therapeutics Transaction
On July 2, 2025, Ligand announced the completion of its previously announced merger between the Company’s wholly owned subsidiary, LNHC, Inc., and CHRO Merger Sub Inc., a wholly owned subsidiary of Channel Therapeutics Corporation ("Channel"). The combined company operates under the name Pelthos Therapeutics Inc. ("Pelthos") and trades on the NYSE American exchange under the ticker symbol "PTHS".
Concurrent with the merger, Pelthos raised $50.1 million of equity capital, including a private placement from a group of strategic investors led by Murchinson ("Investor Group" and together with Ligand, the "Investors"). The

Investor Group invested $32 million and Ligand invested $18 million in the combined company, respectively. The capital was invested into Pelthos’ Series A Convertible Preferred Stock ("Series A") and common stock and includes cancellation of approximately $18.8 million in bridge capital that was advanced to Pelthos by several of the Investors (including Ligand) since the beginning of 2025 to support the commercial launch of Zelsuvmi.
On July 10, 2025, Pelthos commercially launched Zelsuvmi (berdazimer) topical gel 10.3%, the first and only U.S. Food and Drug Administration (FDA) approved at-home treatment for molluscum contagiosum. Ligand earned a $5 million milestone payment from Pelthos following the commercial launch of Zelsuvmi. Ligand is also entitled to a 13% royalty on worldwide sales of Zelsuvmi, excluding Japan, and up to an additional $5 million in commercial sales milestones.

New Royalty Investment in Orchestra BioMed

On August 4, 2025, Ligand invested $25 million in strategic capital to fund Orchestra BioMed’s late-stage partnered cardiology programs with an additional $15 million to be funded, subject to certain conditions precedent, at the nine-month anniversary of the transaction closing date. Ligand’s investment included a $20 million cash payment and an additional $5 million in an equity private placement at the public offering price of $2.75 per share in Orchestra BioMed’s public offering. In exchange, Ligand will receive a low double-digit royalty on the first $100 million in commercial revenues from Orchestra’s AVIM therapy and Virtue SAB programs in all indications. Ligand will also earn a mid-single-digit royalty on annual revenues exceeding $100 million in commercial revenues from AVIM therapy in the uncontrolled hypertension and increased cardiovascular risk indication and Virtue SAB in coronary artery disease indications.

Portfolio Updates

On July 9, 2025, Merck and Verona announced a definitive agreement under which Merck, through a subsidiary, will acquire Verona for $107 per American Depository Share (ADS), each of which represents eight Verona ordinary shares, for a total transaction value of approximately $10 billion. Verona’s portfolio includes Ohtuvayre, which was approved by the FDA in June 2024 for the maintenance treatment of COPD in adult patients. Ligand receives a 3% royalty on Ohtuvayre sales.

On July 7, 2025, Agenus announced that its botensilimab and balstilimab (BOT/BAL) combination achieved a two-year survival rate of 42% along with a more mature 21-month median overall survival in an expanded cohort of 123 patients with microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases (NLM). Agenus also confirmed that it has reached agreement with the FDA on the design of the global BATTMAN Phase 3 trial. The FDA waived the need for a BOT monotherapy arm, allowing for a simple two-arm study design.

On June 23, 2025, Palvella Therapeutics announced the full enrollment in SELVA, a Phase 3 trial of Qtorin 3.9% rapamycin anhydrous gel (Qtorin rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs). The Phase 3 trial enrolled 51 subjects, exceeding the original target of 40 subjects by over 25%. Top-line results from SELVA are expected in the first quarter of 2026, with a New Drug Application (NDA) submission planned for the second half of 2026.

On June 3, 2025, Agenus announced it entered into a partnership agreement with Zydus designed to accelerate clinical development, scale global manufacturing, and expand patient access to BOT/BAL. The strategic collaboration includes an exchange of Agenus’ state-of-the-art biologics CMC facilities in Emeryville, CA and Berkeley, CA for an upfront consideration of $75 million. Moreover, Agenus will receive up to an additional $50 million in contingent payments triggered by BOT/BAL production orders. This collaboration enables Agenus to unlock the value of its manufacturing assets and secure strategic capital to drive BOT/BAL toward global regulatory engagement and commercialization.

On May 23, 2025, CSL Vifor announced that the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending that Filspari can be used in the NHS in England as an option to treat primary IgA nephropathy in adults with a urine protein excretion of 1.0 g/day or more, or a urine protein-to-creatinine ratio of 0.75 g/g or more.

On May 16, 2025, Nuance announced top-line results from the Phase 3 ENHANCE-CHINA trial which evaluated nebulized ensifentrine (marketed as Ohtuvayre in the U.S.) for the maintenance treatment of chronic obstructive pulmonary disease (COPD). The ENHANCE-CHINA trial successfully met its primary endpoint, as well as secondary endpoints demonstrating improvements in lung function.

On May 15, 2025, Travere announced that the FDA accepted its supplemental New Drug Application (sNDA) for traditional approval of Filspari (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026, and has indicated that it is currently planning to hold an advisory committee meeting to discuss the application. Additionally, Travere continues to expect a PDUFA target action date of August 28, 2025 for its sNDA requesting modification of liver monitoring and removal of embryo-fetal toxicity monitoring REMS for Filspari for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

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, not as a substitute for, and does not consider such measures superior to, financial measures calculated in accordance with GAAP. The Company also reports a core calculation for each of the foregoing measures which excludes any realized gain from sales of Viking Therapeutics common stock. Additionally, adjusted earnings per diluted share is a key component of the financial metrics utilized by the Company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation. The Company’s financial measures under GAAP include share-based compensation expense, amortization of debt-related costs, amortization related to acquisitions and intangible assets, changes in contingent liabilities, mark-to-market adjustments for amounts relating to its equity investments in public companies, excess tax benefit from share-based compensation, transaction costs, income tax effect of adjusted reconciling items and others that are listed in the itemized reconciliations between GAAP and non-GAAP adjusted financial measures included at the end of this press release. A reconciliation of forward-looking non-GAAP adjusted earnings per diluted share to the most directly comparable GAAP measures is not available without unreasonable effort, as certain items cannot be reasonably predicted because of their high variability, complexity and low visibility. Specifically, non-cash adjustments that could be made for changes in contingent liabilities, changes in the market value of its investments in public companies, share-based compensation expense and the effects of any discrete income tax items, directly impact the calculations of our adjusted earnings per diluted share, which we expect to have a significant impact on our future GAAP financial results.

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 this announcement and answer questions. To participate via telephone, please dial (800) 715-9871 using the conference ID 3661098. International participants outside of Canada may use the toll number +1(646) 307-1963. To participate via live or replay webcast, a link is available at www.ligand.com.

Kura Oncology Reports Second Quarter 2025 Financial Results

On August 7, 2025 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported second quarter 2025 financial results and provided a corporate update (Press release, Kura Oncology, AUG 7, 2025, View Source [SID1234654988]).

"FDA’s acceptance of our NDA for ziftomenib represents another important step toward addressing a high unmet need in patients with relapsed or refractory NPM1-mutant AML," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "As a menin inhibitor, ziftomenib targets a fundamental disease driver in certain genetically defined subsets of AML, and along with our partners at Kyowa Kirin, we are committed to advancing ziftomenib as a potential therapy for patients throughout the continuum of care. With preparations underway for commercialization, upcoming initiation of two registrational trials of ziftomenib in the frontline setting and a strong pipeline to support future growth, we believe Kura is well-positioned to deliver meaningful benefit to patients and long-term value to stakeholders."

Recent Highlights

FDA Priority Review of New Drug Application for ziftomenib with PDUFA target action date of November 30, 2025 – In June 2025, Kura and Kyowa Kirin Co., Ltd. (Kyowa Kirin) announced the U.S. Food and Drug Administration (FDA) accepted Kura’s NDA seeking full approval for ziftomenib as a treatment for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a nucleophosmin 1 mutation (NPM1-m). Ziftomenib is the only menin inhibitor to receive Breakthrough Therapy Designation (BTD) for this indication. The application has been granted Priority Review and assigned a PDUFA target action date of November 30, 2025.
Commercial readiness activities advancing in line with the regulatory review timeline – Pre-launch efforts by medical affairs, market access, patient support, and sales continue. Hiring and onboarding of U.S. field sales team are now complete. Pre-approval information exchange with key stakeholders across the AML ecosystem is ongoing.
Presentation of positive results from the KOMET-001 pivotal trial of ziftomenib in R/R NPM1-m AML at 2025 ASCO (Free ASCO Whitepaper) Annual Meeting – The study achieved a complete remission (CR) plus CR with partial hematologic recovery (CRh) rate of 23%, an improvement over historical controls in a heavily pretreated patient population with limited survival and few treatment options. Key safety and tolerability measures, including manageable differentiation syndrome, low rates of ziftomenib-related myelosuppression and treatment discontinuation, absence of clinically significant QTc prolongation and minimal drug-drug interactions highlighted a potentially favorable benefit-risk profile for ziftomenib.
Presentation of clinical data from the Phase 1b expansion cohort of KOMET-007 evaluating ziftomenib in combination with intensive chemotherapy (7+3) in newly diagnosed NPM1-m and KMT2A-rearranged AML at 2025 EHA (Free EHA Whitepaper) Congress – High rates of CR and measurable residual disease (MRD) negativity with ziftomenib in combination with intensive chemotherapy in newly diagnosed NPM1-m and KMT2A-rearranged (KMT2A-r) AML were reported. Among patients achieving a composite CR, 68% of NPM1-m and 83% of KMT2A-r patients reached MRD-negative status at a median of ~4–5 weeks. At a median follow-up of 25 and 16 weeks, 96% and 88% of patients in the respective cohorts remained alive and on study. Ziftomenib was well tolerated, enabling patients to remain on treatment through consolidation and maintenance, without interruption, dose reduction, or added myelosuppression.
Nomination of next-generation menin inhibitor designed for the treatment of Type 1 and Type 2 diabetes and menin-dependent cardiometabolic indications – In preclinical models of type 2 diabetes, ziftomenib has been shown to improve glucose control, enhance insulin production, reduce insulin resistance, and selectively induce beta-cell proliferation, supporting menin as a therapeutic target for beta-cell regeneration. Kura has nominated a next-generation menin inhibitor for evaluation in diabetes. Development plans and timelines will be announced in a future update.
Three clinical abstracts from Kura’s farnesyl transferase inhibitor (FTI) program accepted for presentation at the 2025 ESMO (Free ESMO Whitepaper) Congress – The presentations will include the first clinical data on Kura’s lead investigational FTI therapy, KO-2806, in combination with cabozantinib in renal cell carcinoma (Poster #2604P), as well as KO-2806 monotherapy in advanced RAS-mutant solid tumors (Poster #981P). An additional abstract will highlight clinical data from the combination of the FTI tipifarnib and alpelisib in patients with PIK3CA-mutant head and neck squamous cell carcinoma (HNSCC) (Poster #1349P).
Financial Results

Collaboration revenue from our Kyowa Kirin partnership for the second quarter of 2025 was $15.3 million, compared to no revenue for the second quarter of 2024.
Research and development expenses for the second quarter of 2025 were $62.8 million, compared to $39.7 million for the second quarter of 2024.
General and administrative expenses for the second quarter of 2025 were $25.2 million, compared to $16.7 million for the second quarter of 2024.
Net loss for the second quarter of 2025 was $66.1 million, compared to a net loss of $50.8 million for the second quarter of 2024. Net loss for the second quarter included non-cash share-based compensation expense of $6.9 million, compared to $8.4 million for the same period in 2024.
As of June 30, 2025, Kura had cash, cash equivalents and short-term investments of $630.7 million, compared to $727.4 million as of December 31, 2024.
Based on our current plans, we believe that our cash, cash equivalents and short-term investments as of June 30, 2025 will be sufficient to enable us to fund our current operating expenses into 2027, and, combined with anticipated funding under our collaboration agreement with Kyowa Kirin, should support our ziftomenib AML program through commercialization in the frontline combination setting.
Forecasted Milestones

Continued regulatory interactions with the FDA ahead of the November 30, 2025 PDUFA target action date for ziftomenib as a monotherapy for adult patients with relapsed or refractory NPM1-m AML.
Initiate KOMET-017, two independent Phase 3 registration-enabling trials in frontline intensive chemotherapy and non-intensive chemotherapy AML settings, in the second half of 2025.
Present preliminary clinical data from the KOMET-007 Phase 1b expansion cohort evaluating ziftomenib in combination with venetoclax and azacitidine in the second half of 2025.
Initiate one or more FIT-001 expansion cohorts of KO-2806 and cabozantinib in patients with advanced renal cell carcinoma in the second half of 2025.
Present data from the FIT-001 Phase 1 trial evaluating KO-2806 and cabozantinib in patients with renal cell carcinoma at the 2025 ESMO (Free ESMO Whitepaper) Congress in October 2025.
Present data from the FIT-001 Phase 1 monotherapy dose escalation of KO-2806 in patients with RAS-mutant solid tumors at the 2025 ESMO (Free ESMO Whitepaper) Congress in October 2025.
Present data from the KURRENT-HN trial evaluating tipifarnib and alpelisib in PIK3CA-dependent HNSCC at the 2025 ESMO (Free ESMO Whitepaper) Congress in October 2025.
Conference Call and Webcast

Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, August 7, 2025, to discuss the financial results for the second quarter of 2025 and to provide a corporate update. The live call may be accessed by dialing (800) 579-2543 for domestic callers and (785) 424-1789 for international callers and entering the conference ID: KURAQ2. A live webcast and archived replay of the event will be available here or online from the investor relations section of the Company’s website at www.kuraoncology.com.

Janux Therapeutics Reports Second Quarter 2025 Financial Results and Business Highlights

On August 7, 2025 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technologies to its Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, reported financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, Janux Therapeutics, AUG 7, 2025, View Source [SID1234654987]).

"The recent expansion of our TRACTr, TRACIr, and ARM development programs displays our ability to enact a strategy that attempts to both maximize the benefit and value of our current clinical programs, including JANX007, while continuing to advance other differentiated candidates in oncology and autoimmune disease," said David Campbell, Ph.D., President and CEO of Janux. "We look forward to additional clinical data from JANX007 and JANX008 expected in the second half of 2025."

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

•
R&D Day highlighted pipeline progress and novel bispecific platform in autoimmune disease.
In July 2025, Janux management presented multiple product candidates identified from its preclinical pipeline to move towards clinical trials.

•
A PSMA-TRACIr designed to be combined with potentially best-in-treatment asset, JANX007, and provide CD28 co-stimulation to further differentiate depth and durability of patient responses.
•
A TROP2-TRACTr added a first-in-class opportunity targeting multiple solid tumors with preclinical data supporting differentiated safety and efficacy potential.
•
A CD19-ARM displayed rapid, deep and durable B-cell depletion in periphery and tissues with a prolonged memory B cell reset while maintaining a large safety window in non-human primates.

•
JANX007 continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC (NCT05519449).

•
JANX008 continues to enroll in the first-in-human Phase 1 clinical trial in advanced or metastatic solid tumors (NCT05783622).

•
Clinical milestone payment of $10 million from Merck recently triggered by first patient dosed in the lead collaboration program under the companies’ 2020 Research Collaboration and Exclusive License Agreement.

Additional data from JANX007 and JANX008 will be presented at future Janux events in the second half of 2025.

SECOND QUARTER 2025 FINANCIAL RESULTS:

•
Cash and cash equivalents and short-term investments: As of June 30, 2025, Janux reported cash and cash equivalents and short-term investments of $996.0 million, compared to $1.03 billion at December 31, 2024.

•
Research and development expenses: Research and development expenses for the quarter ended June 30, 2025 were $34.7 million, compared to $14.9 million for the comparable period in 2024.

•
General and administrative expenses: General and administrative expenses for the quarter ended June 30, 2025 were $10.5 million, compared to $7.8 million for the comparable period in 2024.

•
Net loss: For the quarter ended June 30, 2025, Janux reported a net loss of $33.9 million, compared to a net loss of $6.0 million for the comparable period in 2024.

Janux’s TRACTr, TRACIr and ARM Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with mCRPC. Janux’s second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. Janux is also advancing additional CD3-based TRACTr and CD28-based TRACIr programs for future clinical development, including a PSMA-TRACIr for use in combination with our PSMA-TRACTr JANX007, and a TROP2-TRACTr for the treatment of TROP2+ solid tumors. Janux is advancing its first ARM platform program candidate, a CD19-ARM for the potential treatment of autoimmune diseases toward clinical trials. Janux is also generating a number of additional TRACTr, TRACIr and ARM programs for potential future development.

Iovance Biotherapeutics Reports Financial Results and Corporate Updates for Second Quarter and First Half 2025

On August 7, 2025 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 second quarter and first half 2025 financial results and corporate updates (Press release, Iovance Biotherapeutics, AUG 7, 2025, View Source [SID1234654986]).

Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "In the first half of 2025, we continued to drive U.S. adoption for Amtagvi in advanced melanoma, surpassing more than 100 patients treated within a single quarter. Growth for Amtagvi and Proleukin will continue in the second half of 2025 as existing ATC growth continues and large community practices begin treating patients. We expect our first ex-U.S. regulatory approval imminently and remain on track to provide updates on our clinical programs."

Second Quarter and First Half 2025 Financial Results, Corporate Guidance and Updates

Product Revenue and Guidance

Second Quarter 2025 Total Product Revenue: Iovance recognized total product revenue of $60.0 million from Amtagvi and Proleukin during the second quarter ended June 30, 2025. Year-over-year product revenue increased by 93% compared to $31.1 million in the second quarter of 2024. The U.S. FDA approved Amtagvi (lifileucel) on February 16, 2024, as the first treatment option for patients with advanced (unresectable or metastatic) melanoma after anti-PD-1 and targeted therapy.
2Q25 Amtagvi Revenue: Product revenue from U.S. Amtagvi sales was $54.1 million, representing 102 commercial patients treated. Infusion growth was a direct result of increased field activities in existing ATCs and contributions from new ATCs treating patients.
2Q25 Proleukin Revenue: Product revenue also included $5.9 million in Proleukin sales, reflecting restocking orders from two major U.S. wholesalers to keep pace with increasing Amtagvi utilization. Strong growth in Proleukin revenue in the second half of 2025 is expected to align with Amtagvi demand and year-end restocking patterns at U.S. distributors. In addition to the Amtagvi treatment regimen, Proleukin revenue is recognized from other commercial, clinical, manufacturing, and research sales.
Full Year 2025 Total Product Revenue Guidance: Iovance is reiterating total product revenue guidance within the range of $250 to $300 million in the first full calendar year of Amtagvi sales. The forecast continues to track in line with current and expected ATC growth trajectories, including large community practices and community referral activities. Proleukin sales are also expected to accelerate in the second half of 2025 from restocking at U.S. distributors, ex-U.S. demand, and sales growth for clinical and manufacturing uses. Iovance expects continued growth in total product revenue for the full year 2026 and beyond. Gross margins are expected to increase through near-term optimization of manufacturing capacity utilization over the next several years.

Amtagvi (Lifileucel) Monotherapy U.S. Launch Highlights in Advanced Melanoma

Real-World Retrospective Study for Commercial Amtagvi
The physician-assessed objective response rate (ORR) was 48.8% (20 out of 41 evaluable patients treated with commercial Amtagvi).
ORR was higher with earlier Amtagvi monotherapy:
60.9% (14/23) in third-line or earlier patients
33.3% (6/18) in patients following three or more prior lines of therapy
Iovance plans to present detailed data at an upcoming medical meeting in 2025.
Authorized Treatment Centers (ATCs)
The Amtagvi treatment network includes more than 80 U.S. ATCs across 35 states and 95% of addressable patients live within 200 miles of an ATC.
New ATCs continue to be onboarded as the network expands beyond top academic centers.
U.S. community referral activities are accelerating to drive earlier treatment with Amtagvi.
Iovance has entered into a specialty pharmacy agreement with Biologics by McKesson, a key offering within InspiroGene, McKesson’s suite of CGT commercialization solutions. This new access channel, added in direct response to requests from large community practices, will be another option for providers to acquire Amtagvi, alongside the traditional direct purchase channel.
Commercial Manufacturing
Manufacturing turnaround time has improved to 33 days from inbound to return shipment to ATCs.
The overall commercial manufacturing experience remains consistent with prior clinical experience.

Launch Expansion into New Markets
Amtagvi has the opportunity to address more than 30,000 patients globally with previously treated advanced melanoma.1 Iovance is gaining momentum to address adult patients with previously treated advanced melanoma in new markets.

Health Canada is expected to approve Amtagvi monotherapy in the coming weeks as the first T cell therapy for a solid tumor cancer and first treatment option in Canada for previously treated advanced melanoma. Iovance is preparing for a commercial launch in Canada over the next few months.
Iovance recently withdrew a marketing authorization application (MAA) from the European Medicines Agency (EMA) following interactions with EMA’s Committee for Medicinal Products for Human Use. A new strategy is in development to make Amtagvi and TIL therapy broadly accessible to patients in the EU.
Iovance expects Amtagvi approval in three additional markets:
Review in the United Kingdom is on track for potential approval and launch in the first half of 2026.
Australia’s Therapeutic Goods Administration granted Priority Review with a decision anticipated in early 2026.
Swiss Medic recommended Priority Review ahead of the Swiss regulatory submission planned in the fourth quarter of 2025.

Recent Iovance TIL Cell Therapy Pipeline Highlights

Lifileucel Franchise in Solid Tumors: Priority Programs
Combination Therapy in Frontline Advanced Melanoma: The registrational TILVANCE-301 trial continues with strong momentum to support U.S. approval of Amtagvi in combination with pembrolizumab in frontline advanced melanoma, and full approval in post-anti-PD-1 melanoma. The trial was designed with FDA and EMA input to show the contribution of components for Amtagvi in combination with pembrolizumab compared to pembrolizumab alone.
Lifileucel Monotherapy in Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC): Iovance remains on track to share additional data in the second half of 2025 from the IOV-LUN-202 registrational Phase 2 trial to support a potential U.S. accelerated approval of lifileucel monotherapy in post-anti-PD-1 NSCLC in 2027. The FDA previously provided positive regulatory feedback on the IOV-LUN-202 clinical trial design and proposed potency assay matrix to support registration. The single-arm IOV-LUN-202 trial is investigating lifileucel monotherapy in a defined patient population with limited options after approved standard of care. This trial design aligns with FDA guidance for single-arm trials to support accelerated approvals in conditions with unmet medical need.
Lifileucel Monotherapy in Endometrial Cancer: Iovance is actively enrolling in the IOV-END-201 Phase 2 trial for advanced endometrial cancer, a significant unmet medical need. The trial is investigating lifileucel after platinum-based chemotherapy and anti-PD-1 therapy regardless of mismatch repair (MMR) status, with initial results on track for the second half of 2025.
Next Generation TIL Pipeline
PD-1 Inactivated TIL Cell Therapy (IOV-4001): Results are anticipated in the second half of 2025 from the Phase 2 efficacy portion of the IOV-GM1-201 trial in previously treated advanced melanoma.
Next Generation Interleukin-2 (IL-2) for TIL Treatment Regimen (IOV-3001): Patient enrollment continues in a Phase 1/2 clinical trial, IOV-IL2-101, to investigate IOV-3001, a second-generation, modified IL-2 analog for use in the TIL therapy treatment regimen. Preclinical studies of IOV-3001 demonstrated the potential for improved safety, convenience of less frequent dosing and strong effector T cell expansion.
Next Generation, Cytokine-Tethered TIL Therapy (IOV-5001): IND-enabling studies are proceeding for IOV-5001, a genetically engineered, inducible, and tethered interleukin-12 TIL cell therapy, in support of an IND in early 2026 for clinical development for multiple indications.
Publications and Presentations
The Journal of Clinical Oncology published the final five-year analysis from the Phase 2 C-144-01 clinical trial evaluating one-time lifileucel monotherapy, which represents unprecedented durability and duration of follow-up in previously treated advanced melanoma patients. The ORR was 31.4% and nearly one third of responders (31.3%) had ongoing responses. Median duration of response (mDOR) was 36.5 months, median overall survival (OS) was 13.9 months and five-year OS was 19.7%. These data were simultaneously presented at the ASCO (Free ASCO Whitepaper) 2025 annual meeting.
Cancer Communications published a peer-reviewed letter about C-144-01 patients with previously treated advanced mucosal melanoma. Following one-time lifileucel monotherapy in this difficult to treat subgroup, ORR was 50% and mDOR was not reached at a median follow up of 35.7 months.

Corporate Updates

Business Optimization: Iovance is implementing a strategic restructuring to optimize business performance, resulting in more than $100 million in annual cost savings starting in the fourth quarter of 2025 and extending cash runway into the fourth quarter of 2026. No significant changes to the pipeline are expected, and all registrational and early-phase programs remain on track. Net cash burn for the next four quarters through the second quarter of 2026 is expected to be less than $245 million, excluding one-time charges associated with the strategic restructuring. The restructuring includes a workforce reduction of approximately 19% in the third quarter of 2025. Iovance will continue to optimize and refine its cost structure through operational excellence initiatives over the next two to three quarters.
Cash Position: As of June 30, 2025, Iovance had cash, cash equivalents, investments, and restricted cash of approximately $307.1 million. The current cash position and anticipated product revenue, including cost savings from the strategic restructuring, are expected to be sufficient to fund current and planned operations into the fourth quarter of 2026.
New Leadership Appointments: Iovance recently appointed Corleen Roche as Chief Financial Officer and Marc R. Theoret, M.D. as Senior Vice President, Regulatory Strategy.
Intellectual Property: Iovance currently owns approximately 280 granted or allowed U.S. and international patents and patent rights for Amtagvi and other TIL-related technologies that are expected to provide exclusivity through at least 2042. This patent portfolio covers TIL compositions and methods of treatment and manufacturing in a broad range of cancers, with Gen 2 patent rights expected to provide exclusivity for Amtagvi into 2038 and additional patent rights, including methods of treating melanoma and compositions and methods for potency assays, expected to provide exclusivity into 2039 and 2042, respectively. Iovance also owns an industry-leading patent portfolio covering TIL products produced with genetic engineering, using core biopsies and peripheral blood as starting material, and using combinations of TIL products with checkpoint inhibitors, as well as Iovance’s proprietary IovanceCares system. More information on Iovance’s patent portfolio is available on the Intellectual Property page on www.iovance.com.

Second Quarter and First Half 2025 Financial Results

Net loss for the second quarter of 2025 was $111.7 million, or $0.33 per share, compared to a net loss of $97.1 million, or $0.34 per share, for the second quarter of 2024. Net loss for the first half of 2025 was $227.8 million, or $0.69 per share, compared to a net loss of $210.1 million, or $0.76 per share, for the first half of 2024.

Revenue consists of product revenue from Amtagvi and Proleukin. Revenue was $60.0 million for the second quarter of 2025, a 22% increase from $49.3 million in the first quarter of 2025 and a 93% increase over revenue of $31.1 million in the second quarter of 2024. Product revenue was $54.1 million for Amtagvi and $5.9 million for Proleukin in the second quarter of 2025 compared to $12.8 million for Amtagvi and $18.3 million for Proleukin in the second quarter of 2024.

Revenue was $109.3 million for the first half of 2025, an increase of 243% over revenue of $31.8 million in the prior year six-month period. Product revenue from Amtagvi and Proleukin was $97.7 million and $11.6 million, respectively, in the first half of 2025 compared to $12.8 million and $19.0 million, respectively, in the first half of 2024.

The increase in revenue in the second quarter and first half 2025 over the prior year periods was primarily attributable to the U.S. launch and product revenue growth from Amtagvi.

Cost of sales includes inventory, overhead and related cash and non-cash expenses that are directly associated with sales of Amtagvi and Proleukin, as well as manufacturing costs for Amtagvi.

Cost of sales was $56.7 million for the second quarter 2025, including $19.0 million for period costs associated with patient drop off and manufacturing success rates, $5.9 million for non-cash amortization expense for intangible assets and fair value mark up of inventory, $2.1 million for non-cash stock-based compensation, and $1.2 million in royalties payable on product sales. Cost of sales was $31.4 million in the second quarter of 2024. Cost of sales was $106.4 million for the first half of 2025 compared to $38.6 million in the first half of 2024.

The increase in cost of sales in the second quarter and first half of 2025 over the prior year periods was associated with the initiation and growth of product sales, certain costs associated with patient drop-off and manufacturing success rates, and related cash and non-cash expenses tied to the U.S. launch of Amtagvi that began during the first quarter of 2024.

Research and development expenses were $79.4 million for the second quarter of 2025, an increase of 28% compared to $62.1 million for the second quarter of 2024. Research and development expenses were $156.2 million for the first half of 2025, an increase of 10% compared to $141.9 million for the first half of 2024.

The increases in research and development expenses in the second quarter and first half of 2025 over the prior year periods were primarily attributable to higher headcount and related costs, offset by reductions in stock-based compensation, and clinical trial costs resulting from continued enrollment in existing trials and the resumption of the LUN-202 study. The increases for the first half of 2025 were offset by the transition of Amtagvi to commercial manufacturing.

Selling, general and administrative expenses were $37.7 million for the second quarter of 2025, a decrease of 5% compared to $39.6 million for the second quarter of 2024. The decrease in selling, general and administrative expenses in the second quarter of 2025 compared to the prior year period was primarily attributable to a decrease in stock-based compensation, partially offset by increases in headcount and related costs to support the growth in the overall business and related corporate infrastructure and costs related to the marketing and advertising of Amtagvi.

Selling, general and administrative expenses were $81.6 million for the first half of 2025, an increase of 15% compared to $71.0 million for the first half of 2024. The increase in selling, general and administrative expenses in the first half of 2025 compared to the prior year period was primarily attributable to increases in headcount and related costs, offset by reductions in stock-based compensation, to support the growth in the overall business and related corporate infrastructure, as well as costs incurred to support the distribution and commercialization of Amtagvi and Proleukin.

For additional information, please see the Company’s Selected Consolidated Balance Sheets and Statements of Operations below.

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 4:30 p.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.

Intensity Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update

On August 7, 2025 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 second quarter 2025 financial results and provides a corporate update (Press release, Intensity Therapeutics, AUG 7, 2025, View Source [SID1234654985]).

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 standard of care ("SOC") treatment in patients with early-stage, operable triple-negative breast cancer and SOC alone. The primary endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone. In April, the European Medicines Agency authorized the initiation of the INVINCIBLE-4 Study in France in collaboration with Unicancer (UCBG), the French referent cooperative group in breast cancer accredited by the French National Cancer Institute (INCa).

The INVINCIBLE-4 Study is currently recruiting patients in Switzerland and France. The expected total is 54 patients. In June 2025 we showed images from the trial of a patient who received two doses of INT230-6. Prior to the injections, the tumor was active. In the post INT230-6 injection scans, the tumor became dark with only diminished live cancer observed at the interface of the healthy tissue and necrotic tumor.

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. This study has been authorized by the US FDA, Health Canada, the European Medicines Agency (for France, Germany, Italy, Poland, and Spain), and Australia’s Therapeutic Goods Administration. The primary endpoint in the INVINCIBLE-3 Study is overall survival. In March 2025, new patient enrollment and site activations were paused due to funding issues; however, patients who were already enrolled continue to be dosed, followed and monitored.

Capital Raises and Cash Runway: Since the beginning of the second quarter of 2025, the Company has raised an aggregate of $11.3 million, with net proceeds of approximately $10.1 million in two public offerings and At-the Market offerings (the "ATM"), and has extended its cash runway into the second half of 2026.
•In April 2025, the Company entered into a Securities Purchase Agreement with certain institutional investors participating in a public offering and raised an aggregate of $2.35 million, with net proceeds after deducting the fees and expenses of approximately $1.9 million.
•In June 2025, the Company entered into an Underwriting Agreement with ThinkEquity LLC in a public offering and raised an aggregate of $2.3 million, with net proceeds after deducting the fees and expenses of approximately $1.8 million.
•In July 2025, the Company raised an aggregate of $6.6 million via its ATM, with net proceeds after deducting the fees and expenses of approximately $6.3 million.

"In a challenging financial market, we were able to raise capital and lower our burn rate during the second quarter to continue to treat patients in our two studies, and in July 2025, high liquidity in our stock allowed us to raise additional gross proceeds of $6.6 million at a lower incremental cost. This new capital extends our operating runway considerably, with the remaining capacity under the ATM facility to be used selectively and strategically. Given the capital raised to date, we also believe that we are now compliant with Nasdaq’s minimum stockholders’ equity listing requirements, pending Nasdaq’s confirmation," stated Lewis H. Bender, Intensity Founder, President, and CEO. "In the INVINCIBLE-4 Study, scan images indicate a substantial decrease in tumor activity following two doses of our drug as patients begin their immune-chemo regimen. Based on our prior studies, we believe this effect should be beneficial in increasing the pathological response rate in the cohort of patients receiving our drug and expect to obtain pathology data in 2H of 2026. Lastly, as always, the Company is driven by a focus on patients. This quarter, we strengthen that commitment by forming a collaboration with the author, model, executive producer, speaker, and breast cancer survivor Christine Handy to raise patient awareness of new treatment options on the horizon for patients with early-stage disease."

Second Quarter 2025 Financial Results

Research and development expenses were $1.5 million for the three months ended June 30, 2025, compared to $3.6 million for the same period in 2024. Clinical trial expenses decreased $1.5 million 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 23 patients. The Company will continue to treat all patients enrolled in this study in cooperation with our third-party contract research organizations during this pause, and once sufficient funding is obtained, the Company plans to restart site activations and patient enrollment.

General and administrative expenses were $1.2 million for the three months ended June 30, 2025, compared to $1.5 million for the same period in 2024. Insurance expense decreased due to the favorable directors and officers insurance renewal terms compared to the prior policy year, and legal and other expenses decreased as a result of cost saving from the integration of new systems in the administrative areas.

Overall, net loss was $2.5 million for the three months ended June 30, 2025, compared to a net loss of $5.0 million for the three months ended June 30, 2024.

As of June 30, 2025, cash and cash equivalents totaled $2.2 million.

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 facilitates the dispersion of potent cytotoxic drugs throughout tumors, 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.