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]).

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"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.

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]).

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"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:

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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.

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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.
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A TROP2-TRACTr added a first-in-class opportunity targeting multiple solid tumors with preclinical data supporting differentiated safety and efficacy potential.
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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.

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

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

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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:

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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.

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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.

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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.

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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.

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]).

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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.

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]).

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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 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.

On August 7, 2025 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, reported operational highlights and financial results for the second quarter ended June 30, 2025 (Press release, Intellia, AUG 7, 2025, View Source [SID1234654984]).

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"We are exceeding many of our internal expectations," said Intellia President and Chief Executive Officer John Leonard, M.D. "The enthusiasm from both patients and physicians for Intellia’s late-stage programs has resulted in strong enrollment numbers that allow us to plan to enhance the Phase 3 MAGNITUDE trial in ATTR-CM and accelerate completion of the Phase 3 HAELO study in HAE ahead of our original plans. We are full steam ahead in achieving our mission of getting one-time therapies to more patients."

Second Quarter 2025 and Recent Operational Highlights

Hereditary Angioedema (HAE)

Lonvoguran ziclumeran (lonvo-z, also known as NTLA-2002): Lonvo-z is a wholly owned, investigational in vivo CRISPR-based therapy designed to knock out the KLKB1 gene in the liver, with the goal of lifelong control of HAE attacks after a single dose.
Recruitment ended earlier than expected during the second quarter and the Company now expects to complete randomization in the global Phase 3 HAELO study during the third quarter 2025.
Intellia presented three-year follow-up data from the Phase 1 portion of the ongoing Phase 1/2 study after receiving a single dose of lonvo-z. Results were shared in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025 on June 15 in Glasgow, United Kingdom. In the Phase 1 portion of the study, a one-time dose of 25 mg (N=3), 50 mg (N=4) or 75 mg (N=3) of lonvo-z was administered via intravenous infusion and plasma kallikrein protein levels were measured along with HAE attacks. At the time of the February 12, 2025 data cutoff, all 10 patients were attack-free and treatment-free for a median of nearly two years. With up to three years of follow-up, a single dose of lonvo-z led to a mean reduction in monthly HAE attack rate of 98% over the study period, compared to pre-treatment baseline. For all 10 patients, deep, dose-dependent and durable reductions in plasma kallikrein protein continued to be observed through the latest assessment. Across all three dose levels, lonvo-z was generally well tolerated and showed a safety profile consistent with earlier data presented at EAACI in 2024. The most frequent adverse events during the study period were infusion-related reactions (IRRs). IRRs were mostly Grade 1 and resolved with all patients receiving the full dose. With up to three years of follow-up, no treatment-emergent serious adverse events were observed, and no treatment-related adverse events were observed during the period following 28 days after dosing.
Intellia expects to present additional data from the ongoing Phase 1/2 study in the second half of 2025.
The Company is on track to submit a Biologics License Application (BLA) in the second half of 2026.

Transthyretin (ATTR) Amyloidosis

Nexiguran ziclumeran (nex-z, also known as NTLA-2001): Nex-z is an investigational in vivo CRISPR-based therapy designed to inactivate the TTR gene in liver cells, thereby preventing the production of transthyretin (TTR) protein for the treatment of ATTR amyloidosis. Nex-z offers the possibility of halting and reversing the disease by driving a deep, consistent and potentially lifelong reduction in TTR protein after a single dose. Intellia leads development and commercialization of nex-z in collaboration with Regeneron Pharmaceuticals, Inc.
ATTR Amyloidosis with Cardiomyopathy (ATTR-CM):
Enrollment in the global Phase 3 MAGNITUDE trial is progressing ahead of the Company’s projections and the Company is tracking to enroll at least 650 patients cumulatively by year-end. Intellia is amending the MAGNITUDE study to expand enrollment to approximately 1,200 patients from 765 patients, subject to health authority review. Expanding the patient number in the study would provide a more robust dataset, particularly in the stabilizer stratum, which we believe will be very important to patients, clinicians, and payers. This change has no expected impact on previously projected enrollment timelines or the Company’s projected cash runway.
In May 2025, the Company presented Phase 1 wild-type vs. variant ATTR-CM data at the Heart Failure 2025 Meeting in Belgrade, Serbia. The data showed that nex-z reduced TTR production and showed promise for treating both wild-type (ATTRwt) and variant (ATTRv) ATTR-CM with a favorable safety profile. Absolute TTR levels dropped from 222.4 to 16.5 μg/mL (ATTRwt) and 132.0 to 16.6 μg/mL (ATTRv). Functional capacity and clinical biomarkers were favorably impacted in both patient groups. Evidence of stability or improvement in disease progression markers were observed across both populations at similar rates. The most commonly reported treatment-related adverse events were IRR, which were mild or moderate, and did not result in any discontinuations. Observed liver enzyme abnormalities were not considered serious, were asymptomatic and resolved spontaneously without medical intervention or sequelae.
Intellia expects to present longer-term data from ATTR-CM patients in the Phase 1 study in the second half of 2025. The data will include updated measures of clinical efficacy and safety.
Hereditary ATTR Amyloidosis with Polyneuropathy (ATTRv-PN):
Enrollment is ahead of schedule in the global Phase 3 MAGNITUDE-2 study. Intellia now expects enrollment to be completed in the first half of 2026.
In May 2025, the Company presented positive two-year follow-up Phase 1 data in an oral presentation at the 2025 Peripheral Nerve Society (PNS) Annual Meeting in Edinburgh, United Kingdom. Across patients who received a one-time dose of 0.3 mg/kg or higher (n=33), the mean serum TTR reduction by Day 28 was 90% (corresponding mean absolute serum TTR level of 23.8 µg/mL), with levels remaining virtually unchanged through at least 24 months. Among the 18 patients with 24 month mNIS+7 endpoint assessments, 13 showed improvements of ≥ 4 points, which is considered to be a clinically meaningful threshold. Most of the patients in the cohort who had progressed on patisiran improved, and only a single patient among the 18 had a deterioration of ≥ 4. Nex-z was generally well tolerated across all patients and at all dose levels tested. Treatment-related adverse events were consistent with those described for the cardiomyopathy population.
In September 2025, the Company will present interim Phase 1 extended data in a symposium at the 5th International ATTR Amyloidosis Meeting for Patients and Doctors in Baveno, Italy.

Platform and Company Updates

Intellia is pioneering novel CRISPR-based gene editing technologies, such as gene writing and extrahepatic lipid nanoparticle (LNP) delivery technologies, to create highly differentiated in vivo and ex vivo product candidates. The Company’s proprietary platform technologies are being researched and developed to expand therapeutics opportunities to support the mission of transforming lives of people with severe diseases, including the possibility of curative genome editing therapeutics.
Intellia has expanded its commercial and medical affairs teams to build a strong foundation for commercial readiness. Since the beginning of the year, the company welcomed two key leaders: Jim McNinch, Vice President, U.S. Head of Sales and Ben Newman, Vice President, Commercial Operations, as well as several additional senior leaders with responsibilities for commercial data and field operations, marketing, pricing, patient services, market access, forecasting and medical communications. The company has largely completed the buildout of the commercial and medical affairs leadership teams.

Upcoming Events

The Company will participate in the following events during the third quarter of 2025:

Citi 2025 Biopharma Back to School Conference, Sept. 3, Boston
Wells Fargo Health Care Conference, Sept. 4, Boston
Bernstein Healthcare Forum, Sept. 23, New York
5th International ATTR Amyloidosis Meeting for Patients and Doctors, Sept. 25-26, Baveno, Italy

Second Quarter 2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $630.5 million as of June 30, 2025, compared to $861.7 million as of December 31, 2024. The decrease in cash, cash equivalents and marketable securities includes approximately $65.0 million of non-recurring cash payments in the first half of 2025 associated with the Company’s previously announced portfolio prioritization, workforce reduction, and real estate consolidation. The Company’s cash, cash equivalents and marketable securities as of June 30, 2025 are expected to fund operations into the first half of 2027 and into the anticipated first commercial launch.
Collaboration Revenue: Collaboration revenue was $14.2 million during the second quarter of 2025, compared to $6.9 million during the second quarter of 2024. The $7.3 million increase was mainly driven by cost reimbursements related to our collaboration with Regeneron Pharmaceuticals, Inc.
R&D Expenses: Research and development (R&D) expenses were $97.0 million during the second quarter of 2025, compared to $114.2 million during the second quarter of 2024. The $17.2 million decrease was primarily driven by employee-related expenses, stock-based compensation, research materials and contracted services offset by an increase in the advancement of our lead programs. Stock-based compensation expense included in R&D expenses was $14.1 million for the second quarter of 2025.
G&A Expenses: General and administrative (G&A) expenses were $27.2 million during the second quarter of 2025, compared to $31.8 million during the second quarter of 2024. The $4.6 million decrease was primarily related to lower stock-based compensation, offset in part by increased expenses related to the ongoing buildout of our commercial infrastructure. Stock-based compensation expense included in G&A expenses was $8.0 million for the second quarter of 2025.
Net Loss: Net loss was $101.3 million for the second quarter of 2025, compared to $147.0 million during the second quarter of 2024.

Conference Call to Discuss Second Quarter 2025 Results

The Company will discuss these results on a conference call today, Thursday, August 7 at 8 a.m. ET.
To join the call:

U.S. callers should dial 1-833-316-0545 and international callers should dial 1-412-317-5726, approximately five minutes before the call. All participants should ask to be connected to the Intellia Therapeutics conference call.
Please visit this link for a simultaneous live webcast of the call.

A replay of the call will be available through the Events and Presentations page of the Investors & Media section on Intellia’s website at intelliatx.com, beginning on August 7 at 12 p.m. ET.