On November 6, 2025 Vizgen, Inc., a spatial multi-omics innovator accelerating biological discovery and new drug development, reported that it will present new spatial multi-omics data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting on November 7-10, 2025 in National Harbor, Maryland. The company will showcase how researchers can generate a combination of high-quality RNA and protein data via Vizgen’s bioinformatics technology.

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Vizgen combined results from MERFISH 2.0 gene expression data generated on the MERSCOPE Ultra with data collected from InSituPlex (ISP) multiplex immunofluorescence (mIF) in sequential sections to decode the complexity of the tumor-immune microenvironment (TiME). In its session on November 7th at SITC (Free SITC Whitepaper), Vizgen will delve into how to co-register two established high-quality datasets to fuel multi-omic research.

"Vizgen is empowering researchers to use the power of spatial multi-omics to gain valuable new insights, and we’re excited to share the latest data at SITC (Free SITC Whitepaper) to demonstrate what is possible to significantly advance research," said Jiang He, VP & Portfolio Owner, Reagents & Sci. Affairs, at Vizgen. "The scientific community in attendance at SITC (Free SITC Whitepaper) 2025 will get a first look at data that improves the understanding of the tumor-immune microenvironment through a unified approach with spatial multi-omics. Vizgen offers a complete solution to study the tumor microenvironment."

POSTERS
Details of the posters at the Gaylord National Resort and Convention Center at SITC (Free SITC Whitepaper) 2025 are as follows:

Abstract Number: 101
Title: Combining Vizgen’s MERSCOPE gene expression profiling and InSituPlex multiplex immunofluorescence (mIF) to reveal functional compartmentalization within the tumor microenvironment (TME)
Session Date: Friday, November 7, 2025
Session Time: Between 12:15 p.m. and 1:45 p.m. ET (Lunch session) and between 5:35 p.m. and 7 p.m. (PM reception)
Presenter: Angela Vasaturo, Director of Scientific Affairs at Vizgen

Abstract Number: 102
Title: New developments in spatial transcriptomics using MERFISH 2.0 unlock insights into the tumor microenvironment
Session Date: Saturday, November 8, 2025
Session Time: Between 12:15 p.m. and 1:45 p.m. ET (Lunch session) and between 5:35 p.m. and 7 p.m. (PM reception)
Presenter: Amanda Burke, PhD, Field Application Scientist, Vizgen

Abstract Number: 84
Title: Enabling scalable tumor microenvironment (TME) profiling with 8-plex InSituPlex multiplex immunofluorescence (mIF) on ZEISS Axioscan 7 spatial biology
Session Date: Saturday, November 8, 2025
Session Time: Between 12:15 p.m. and 1:45 p.m. ET (Lunch session) and between 5:10 p.m. and 6:35 p.m. (PM reception)
Presenter: Kevin Hwang, Ph.D., Senior Scientist, Research at Vizgen

Abstract Number: 88
Title: Establishing a robust and reproducible automated mIF workflow for spatial biology using ZEISS SlideStream and Ultivue by Vizgen’s InSituPlex assays
Session Date: Saturday, November 8, 2025
Session Time: Between 12:15 p.m. and 1:45 p.m. ET (Lunch session) and between 5:35 p.m. and 7 p.m. (PM reception)
Presenter: Cassandra Kysilovsky, Ph.D., Associate Scientist at Vizgen

In exhibit hall booth #838, Vizgen representatives will be showcasing a spatial multi-omic workflow that combines spatial transcriptomics, spatial proteomics, and AI-enhanced data science.

(Press release, Vizgen, NOV 6, 2025, View Source [SID1234659619])

On November 6, 2025 Genmab reported Financial Results for the Nine Months of 2025 (Press release, Genmab, NOV 6, 2025, View Source [SID1234661304]).

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On November 6, 2025 Cerus Corporation (Nasdaq: CERS) reported financial results for the third quarter ended September 30, 2025, and provided a business update.

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"We continue to make great strides in improving the safety and availability of transfused blood components around the globe and the record quarterly product revenue results reflect that progress. Product revenue growth was driven by strong global commercial execution and growing awareness of the benefits conferred by our INTERCEPT Blood System. Furthermore, hospital demand for INTERCEPT fibrinogen complex or IFC in the U.S. continues to increase, bolstered by the many positive case studies from large academic hospitals that have implemented IFC in routine use," said William "Obi" Greenman, Cerus’ president and chief executive officer.

Additional highlights include:

Third-quarter 2025 total revenue comprised of (in millions, except percentages):
Three Months Ended

Nine Months Ended

September 30,

Change

September 30,

Change

2025

2024

$

%

2025

2024

$

%

Product Revenue

$52.7

$46.0

$6.7

15%

$148.4

$129.5

$18.9

15%

Government Contract Revenue

7.5

4.6

2.9

63%

20.8

15.1

5.7

38%

Total Revenue

$60.2

$50.7

$9.6

19%

$169.2

$144.6

$24.6

17%

Numbers may not sum due to rounding. Percentages calculated from unrounded figures.

Hospital demand for IFC continues to increase with third quarter volumes (equivalent to FC15* therapeutic units) up approximately 110% compared to the prior year period. Q3 U.S. IFC sales totaled $3.9 million, up from $2.3 million during the prior year period.
Completed enrollment in the U.S. RedeS trial, the second pivotal U.S. Phase 3 clinical trial designed to evaluate the safety and efficacy of red blood cells prepared with the INTERCEPT Blood System for Red Blood Cells (RBCs) in patient populations requiring RBC transfusion for acute and chronic anemia. Study results are expected in the second half of 2026.
Third quarter GAAP net loss attributable to Cerus narrowed to $0.02 million, near breakeven. Third-quarter non-GAAP adjusted EBITDA totaled $5.0 million.
Cash, cash equivalents, and short-term investments were $78.5 million at September 30, 2025, supported by $1.9 million of operating cash flow generation for the quarter.
Revenue

Product revenue during the third quarter of 2025 was $52.7 million, compared to $46.0 million during the prior year period. This year-over-year increase of 15% was led by growth in IFC and global platelet sales.

Third-quarter 2025 government contract revenue was $7.5 million, compared to $4.6 million during the prior year period. Our government contract revenue was comprised of funding associated with research and development (R&D) activities related to the INTERCEPT RBC program as well as efforts related to the development of next-generation pathogen reduction technology to treat whole-blood and development of lyophilized IFC. The year-over-year increase was primarily driven by increasing enrollment in the Phase 3 RedeS trial for the INTERCEPT RBC system covered under the Company’s 2016 agreement with BARDA and the activities for the advancement of the INTERCEPT RBC system covered under the Company’s 2024 BARDA contract.

Product Gross Profit and Margin

Product gross profit for the third quarter of 2025 was $28.1 million, increasing by 7% over the prior year period. Product gross margin for the third quarter of 2025 was 53.4% compared to 56.9% for the third quarter of 2024. As contemplated in the Company’s previous remarks, import tariffs, inflationary pressure, and higher IFC production costs to meet increasing demand impacted product gross margin compared to the prior year period.

Operating Expenses

Total operating expenses for the third quarter of 2025 were $34.4 million compared to $31.8 million for the same period of the prior year, reflecting a year-over-year increase of 8%.

R&D expenses for the third quarter of 2025 were $15.8 million, compared to $14.0 million in the third quarter of 2024. The primary drivers for the increase in R&D expenses were higher government contract costs incurred to support our government research activities and the resulting government contract revenue, as well as enrollment in the Phase 3 RedeS trial and U.S. development costs on INT200, the new LED-based illumination device.

SG&A expenses totaled $18.6 million for the third quarter of 2025, compared to $17.8 million for the third quarter of 2024. Year-over-year SG&A expenses were relatively consistent due to multiple offsetting factors and reflect the Company’s ongoing focus on driving leverage.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for the third quarter of 2025 was $0.02 million, or $0.00 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $2.9 million, or $0.02 per basic and diluted share, for the same period of the prior year. Net loss attributable to Cerus Corporation for the first nine months of 2025 was $13.4 million compared to net loss attributable to Cerus Corporation of $18.4 million for the first nine months of 2024.

Non-GAAP Adjusted EBITDA

Non-GAAP adjusted EBITDA for the third quarter of 2025 rose to a positive $5.0 million, compared to non-GAAP adjusted EBITDA of positive $4.4 million for the same period of the prior year. Non-GAAP adjusted EBITDA for the first nine months of 2025 was a positive $6.1 million compared to non-GAAP adjusted EBITDA of positive $2.5 million for the first nine months of 2024.

The Company is well positioned to achieve its previously stated goal of positive full-year 2025 non-GAAP adjusted EBITDA. For additional information, please see definitions and the reconciliation of this non-GAAP measure to net loss attributable to Cerus Corporation accompanying this release.

Balance Sheet and Cash Flows

At September 30, 2025, the Company had cash, cash equivalents, and short-term investments of $78.5 million, compared to $80.5 million at December 31, 2024. The Company’s revolving line of credit allows for an additional $15.0 million as of September 30, 2025, which is dependent on eligible assets supporting the borrowing base.

For the third quarter of 2025, cash generated from operations totaled $1.9 million compared to $4.1 million generated during the same period of the prior year.

Raising Full-Year 2025 Product Revenue Guidance

The Company now expects full-year 2025 product revenue to be in the range of $202 million to $204 million, reflecting growth of 12% to 13% from 2024. Included in this range is full-year 2025 IFC revenue guidance between $16 million to $17 million. Previously, the Company’s 2025 product revenue guidance range was $200 million to $203 million, including IFC revenue guidance between $16 million to $18 million.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. ET this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at View Source

A replay will be available on Cerus’ website approximately three hours after the call through November 27, 2025.

(Press release, Cerus, NOV 6, 2025, View Source [SID1234659560])

On November 6, 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 third quarter and year-to-date 2025 financial results, business achievements, pipeline progress, and corporate updates.

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Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, "We continued to see revenue growth with significant gross margin improvement in the third quarter of 2025. Amtagvi demand is increasing as we integrate our community treatment centers to drive earlier treatment and better outcomes for patients. We are building a successful commercial business, while advancing our high value development programs to address significant unmet medical needs in patients with solid tumor cancers."

Third Quarter Financial Highlights
Topline Growth, Significant Margin Improvement, and Initial Benefits of Cost Optimization

Total product revenue grew 13% over the prior quarter to ~$68 million, including U.S. Amtagvi revenue of ~$58 million and global Proleukin revenue of ~$10 million.
Gross margin of 43% from cost of sales of ~$39 million reflected improved execution and the initial benefits of cost optimization. Additional operational excellence initiatives are underway to drive further near- and long-term improvements.
Cash and cash equivalents, investments, and restricted cash totaled ~$307 million as of September 30, 2025. The current cash position, bolstered by expense reductions, is expected to fund operations into the second quarter of 2027.
Full-year 2025 revenue guidance is reaffirmed within the range of $250 to $300 million in the first full calendar year of Amtagvi sales.
Centralizing manufacturing at the Iovance Cell Therapy Center (iCTC) in early 2026 will reduce external manufacturing expenses and continue to improve gross margins.
Amtagvi U.S. Launch
Strong Commercial Execution Across Growing Academic and Community Treatment Networks

More than 80 U.S. authorized treatment centers (ATCs) have been activated across nearly 40 states, providing a broad network within a two-hour drive for ~95% of Amtagvi patients.
Community ATCs have treated their first Amtagvi patients, with growth acceleration expected in future quarters.
More community ATCs are being opened, which is expected to further drive demand.
Increased awareness of treatment benefits from real-world evidence data is driving earlier Amtagvi adoption and improved referral trends among medical oncologists.
A number of initiatives are underway to broaden patient access to Amtagvi, including a specialty pharmacy agreement with InspiroGene by McKesson.
Manufacturing turnaround time continues to improve with a current average of 32 days from inbound to return shipment to ATCs.
Amtagvi Global Expansion
Opportunity to Address up to 30,000 Patients Globally with Previously Treated Advanced Melanoma1

In August 2025, Health Canada granted the first Amtagvi approval outside the U.S. for patients with previously treated advanced melanoma.
Potential approvals of Amtagvi are anticipated in the United Kingdom and Australia in the first half of 2026 and Switzerland in 2027.
Iovance is finalizing a strategy with the European Medicines Agency (EMA) to support EU marketing authorization for Amtagvi.
Pipeline Progress and Anticipated Milestones by Program

Lifileucel in Solid Tumors

Positive interim data from the IOV-LUN-202 clinical trial demonstrated a potentially best-in-class clinical profile for lifileucel in previously treated advanced nonsquamous NSCLC patients.
The objective response rate (ORR) was 26% and the median duration of response (mDOR) was not reached at more than 25 months of follow up. Updated data will be presented at a medical meeting in 2026.
The U.S. Food and Drug Administration (FDA) previously provided positive regulatory feedback on the IOV-LUN-202 trial design and the proposed potency assay matrix to support registration.
Iovance expects the IOV-LUN-202 trial to complete enrollment in 2026 and support a supplemental Biologics License Application for lifileucel in nonsquamous NSCLC, with a potential launch in 2027.
Initial results from the IOV-END-201 clinical trial of lifileucel in previously treated advanced endometrial cancer are on track for early 2026.
The TILVANCE-301 clinical trial is active at more than 75 clinical sites and continues to accrue patients to investigate lifileucel in combination with pembrolizumab in frontline advanced melanoma. The trial is designed with FDA and EMA input to show contribution of components compared to pembrolizumab alone.
A new potentially registrational clinical trial, designated IOV-MEL 202, will investigate lifileucel in advanced melanoma patients previously treated with anti-PD-1 therapy, primarily outside the U.S. The trial includes outpatient use of Amtagvi in the community setting and will enroll a subgroup of true second-line BRAF mutation positive patients without prior BRAF inhibitor therapy.
Next Generation Programs

Clinical results for IOV-4001, a PD-1 inactivated TIL cell therapy, in previously treated advanced melanoma patients are anticipated in the first quarter of 2026. Other potential indications for IOV-4001 are also in development.
Dose escalation is continuing for 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. Advancement into Phase 2 development is expected in 2026.
An Investigational New Drug (IND) submission is planned in early 2026 for IOV-5001, a genetically engineered, inducible, and tethered interleukin-12 TIL therapy, in solid tumor cancers with large patient populations and urgent unmet medical.
Webcast and Conference Call

Management will host a conference call and live audio webcast to discuss these results and provide a corporate update today at 8:30 a.m. ET. To listen to the live or archived audio webcast, please register at View Source The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.Iovance.com, for one year.

(Press release, Iovance Biotherapeutics, NOV 6, 2025, View Source [SID1234659576])

On November 6, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported robust preliminary results from its ongoing Phase 3 UTOPIA trial, demonstrating a 77.8% three-month complete response (CR) rate (95% CI, 68.3%, 85.5%) with UGN-103 (mitomycin) for intravesical solution in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). This result is consistent with the 79.6% three-month CR rate (95% CI, 73.9%, 84.5%) observed following treatment with ZUSDURI in the pivotal ENVISION trial. In addition, the U.S. Food and Drug Administration (FDA) agreed that CR and durability results from the UTOPIA trial can support the submission of a New Drug Application (NDA) for UGN-103 for recurrent LG-IR-NMIBC.

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"The robust 77.8% three-month CR rate observed in the UTOPIA trial is highly encouraging and reinforces the potential of UGN-103 to deliver meaningful benefits to patients," said Liz Barrett, President and Chief Executive Officer of UroGen. "In addition, the FDA’s agreement that the UTOPIA trial can support the submission of an NDA for UGN-103 represents a significant regulatory milestone and a strong validation of our clinical strategy. Together, these achievements give us significant momentum and a clear path toward potential approval, positioning UGN-103 as a key growth driver and marking an important advancement in expanding our leadership in uro-oncology. We look forward to working closely with the FDA as we complete the UTOPIA trial and prepare for an NDA submission in 2026."

UGN-103 is designed to offer key improvements over ZUSDURI (mitomycin) for intravesical solution, the first and only FDA-approved treatment for adults with recurrent LG-IR-NMIBC. These include a shorter manufacturing process and a simplified reconstitution procedure, while maintaining UroGen’s established approach that enables prolonged drug exposure within the bladder. UroGen has two U.S. patents with claims relating to the combination of the Company’s RTGel technology combined with medac’s licensed proprietary lyophilized mitomycin formulation. These patents cover UGN-103 as well as the use of UGN-103 for the treatment of LG-IR-NMIBC and expire in December 2041.

About UTOPIA

The UTOPIA trial is a single-arm, multicenter study evaluating the efficacy and safety of UGN-103 in 99 patients across global sites. Enrolled patients received 75 mg of UGN-103 via intravesical instillation once weekly for six weeks. The primary endpoint is complete response rate at three months, with responders entering a follow-up phase of up to 12 months to assess durability of response. For more information on the UTOPIA study, please visit View Source

About UGN-103
In January 2024, UroGen entered into a licensing and supply agreement with medac to develop UGN-103 for LG-IR-NMIBC. UGN-103 is an innovative mitomycin formulation that aims to streamline manufacturing and reconstitution processes while providing intellectual property coverage until December 2041. It utilizes UroGen’s RTGel technology for prolonged mitomycin exposure.

About ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.

About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the U.S. every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include transurethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.

(Press release, UroGen Pharma, NOV 6, 2025, View Source [SID1234659592])