On November 6, 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 third quarter 2025 financial results and provides a corporate update.

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Corporate Update

INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the 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 October 2024, in collaboration with the Swiss Cancer Group, formerly the Swiss Cancer Group for Clinical Cancer Research (SAKK), the Company initiated and dosed our first patient in the INVINCIBLE-4 Study. In September 2025, the Company paused new patient enrollment to revise the dosing regimen for patients receiving INT230-6 in cohort A due to some patients in Cohort A experiencing localized skin irritation near the tumor site. The Company plans to file a protocol amendment for this revision in dosing in the first quarter of 2026, and expects to reinitiate enrollment for the 54-patient study in the first quarter of 2026. The Company is targeting to complete enrollment by the end of 2026 and will likely add resources to help sites enroll.

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, the Company paused new site activations and patient enrollments due to funding constraints. Prior to this pause, the trial had enrolled 21 patients. The Company continues to treat patients enrolled in this study, maintain the database, conduct pharmacovigilance and other study related activities in cooperation with its third-party contract research organizations to reduce ongoing costs during this pause. Once sufficient funding is obtained, the Company plans to restart site activations and patient enrollment in the INVINCIBLE-3 Study.

IT-01 Study Manuscript Publication: On October 29, 2025, eBioMedicine, a Lancet Discovery Science journal, published the Company’s phase 1/2 IT-01 clinical study manuscript, "Safety and Efficacy of Intratumourally Administered INT230-6 in Adult Patients with Advanced Solid Tumours: Results from an Open-Label Phase 1/2 Dose Escalation Study," for the treatment of metastatic or refractory cancers. The manuscript included the following data results:
•In heavily pretreated patients with advanced disease having over 20 different types of cancer who had progressed following multiple prior lines of therapy, intratumoral INT230-6 achieved:
◦A disease control rate of 75% (48/64 patients) and median overall survival (mOS) of 11.9 months; these results compare favorably in phase 1/2 studies that historically reported an mOS of 4 to 7 months
◦In a metastatic sarcoma subset population receiving only INT230-6, the median overall survival was 21.3 months
•In an exploratory analysis comparing patients receiving INT230-6 at a total dose (in mL) that treated greater than 40% of the patient’s total tumor burden ("TTB") compared to those treated with less than 40% of their TTB, the:
◦Disease control rate was 83.3% (40/48) compared to 50% (8/16)
◦Median overall survival was 18.7 months (95% CI: 11.5–23.5) compared to 3.1 months (95% CI: 1.6–5.9) with a hazard ratio (HR) of 0.17 (95% CI: 0.081–0.342); P<0.0001
◦Improved survival was consistent across a range of low to high tumor burden and tumor sizes
•Approximately 20% of patients in the >40% group had uninjected tumors shrink, abscopal effects
•Fifteen of 64 patients survived for more than 21 months
•INT230-6 induced a qualitative decrease in proliferating cancer cells in injected tumors and a qualitative increase in activated T-cells infiltrating the tumor microenvironment
•No dose-limiting toxicities were reported among 64 monotherapy patients; seven patients had a grade 3 (10.9%) with no grade 4 or 5 treatment-related adverse events
•Pharmacokinetic results showed that greater than 95% of the active cytotoxic agents remained in the injected tumors

Capital Raises and Cash Runway: the Company has raised $13.6 million in gross proceeds since the beginning of the third quarter of 2025.
•$7.5 million raised in the third quarter of 2025 via the Company’s ATM (net proceeds of $7.2 million).
•$2.1 million raised in October 2025 via the Company’s ATM (net proceeds of $2.0 million).
•$4.0 million raised in October 2025 in a registered direct offering with an institutional investor, before deducting the placement agent’s fees and related offering expenses (net proceeds of $3.7 million).
With the capital raised to date, the Company has extended its cash runway until the end of the first quarter of 2027.

"In the past four months, we were able to substantially improve our balance sheet with multiple fundraising transactions. In particular, the October 2025 registered direct offering was significant, as this brought in a new long-term fundamental, healthcare-savvy investor. The new capital raised in 2025 enables us to execute on our business strategy until the end of the first quarter of 2027 without any additional funds. In addition, our peer-reviewed paper published in the Lancet Discovery Group’s journal, eBioMedicine, provides another level of validation of the potential of our lead drug INT230-6, injected directly into tumors, to treat multiple types of cancer in both the metastatic and local disease settings. We believe this is the first peer-review publication of a local therapy alone to report disease control rate, the potential for an overall survival benefit and a 20% patient abscopal rate in metastatic disease," stated Lewis H. Bender, Intensity Founder, President and CEO. "Lastly, working with our collaboration partners at the Swiss Cancer Institute, we analyzed the data from the patients in the Phase 2 randomized controlled INVINCIBLE-4 study, and have identified a path forward to restarting the study, which is expected to be in the first quarter of 2026. The endpoint will remain pathological complete response, which is accepted by FDA for accelerated approval."

Third Quarter 2025 Financial Results

Research and development expenses were $1.6 million for the three months ended September 30, 2025, compared to $2.2 million for the same period in 2024. Clinical trial expenses decreased $0.4 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 21 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 September 30, 2025, compared to $1.4 million for the same period in 2024. Consulting expense decreased due to less business development activity compared to the prior year period.

Overall, net loss was $2.7 million for the three months ended September 30, 2025, compared to a net loss of $3.5 million for the three months ended September 30, 2024.

As of September 30, 2025, cash and cash equivalents totaled $7.1 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.

(Press release, Intensity Therapeutics, NOV 6, 2025, View Source [SID1234659575])

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 financial results for the third quarter ended September 30, 2025, and provided an overview of recent developments.

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"Our launch of ZUSDURI, the first and only FDA-approved medicine for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, continues to gain momentum," said Liz Barrett, President and Chief Executive Officer of UroGen. "Despite slower than anticipated new patient starts, we are encouraged by the patient demand reflected in our patient enrollment forms. Strong enthusiasm and engagement from urologists, growing physician awareness, and broad reimbursement coverage are expanding patient access. Early launch indicators reflect robust interest and confidence in ZUSDURI’s clinical value, reinforcing our belief in the significant commercial opportunity ahead and our ability to fully capitalize on it. The strong complete-response rate for UGN-103 and the FDA’s agreement with our NDA submission plan supports our strategy for the next-generation medicines that are expected to enhance supply, improve manufacturing and preparation efficiencies and provide opportunity for lifecycle extensions. With a strong financial position, we are committed to driving a successful launch of ZUSDURI and advancing our pipeline in ways that deliver lasting impact for patients and long-term value for shareholders."

Q3 2025 and Recent Business Highlights:

ZUSDURI (mitomycin) for intravesical solution:

Following U.S. Food and Drug Administration (FDA) approval on June 12, 2025, UroGen launched ZUSDURI (formerly UGN-102), the first and only FDA-approved medicine for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), marking a major milestone in bladder cancer care.
ZUSDURI was assigned a unique, permanent Healthcare Common Procedure Coding System J-code (J9282) by the Centers for Medicare & Medicaid Services. The J-code is expected to be effective January 1, 2026.
ZUSDURI is now broadly accessible to patients through Commercial, Medicare, and Medicaid insurance programs, with open access for more than 95% of covered lives and approximately 296 million eligible patients.
ZUSDURI achieved net product revenue of $1.8 million in Q3 2025; October 2025 preliminary demand revenue estimate of $4.5 million demonstrates accelerating commercial uptake and growing physician adoption.
From launch on July 1, 2025 through October 31, 2025, UroGen reports:
592 activated sites of care
54 unique ZUSDURI prescribers
16 repeat ZUSDURI prescribers
The article "Review of UGN-102: A Reverse Thermal Gel Containing Mitomycin for the Treatment of Recurrent, Low-Grade, Intermediate-Risk Non-Muscle Invasive Bladder Cancer" was published in Reviews in Urology and highlights durable efficacy and manageable safety profile of ZUSDURI in patients with recurrent LG-IR-NMIBC.

JELMYTO (mitomycin) for pyelocalyceal solution in low-grade upper tract urothelial cancer (LG-UTUC)

Generated net product revenue of $25.7 million in the quarter ended September 30, 2025, compared to $25.2 million (which included CREATES Act sales of $2.6 million) reported for same quarter in 2024. Underlying demand revenue grew by approximately 13% year-over-year.

Next-generation novel mitomycin-based formulation for urothelial cancers

Enrollment is complete in the ongoing Phase 3 UTOPIA clinical trial of investigational drug UGN-103 (mitomycin) for intravesical solution in patients with LG-IR-NMIBC. UroGen reported a three-month complete response rate (CRR) of 77.8% (95% CI, 68.3% to 85.5%), consistent with results from the ENVISION clinical trial.
The FDA agreed with the regulatory plan to submit an NDA based on the data from the single-arm Phase 3 UTOPIA trial to support potential approval of UGN-103. UroGen anticipates submitting an NDA for UGN-103 in the second half of 2026 with potential approval anticipated in 2027.
UGN-103 is a next generation product designed to offer certain improvements over ZUSDURI (mitomycin) for intravesical solution, including a shorter manufacturing process and simplified reconstitution procedure. UGN-103 combines UroGen’s RTGel technology with a novel mitomycin formulation licensed from medac GmbH. For more information on the UTOPIA trial, refer to clinicaltrials.gov/NCT06331299.
The Phase 3 clinical trial to explore the safety and efficacy of UGN-104 is ongoing. UGN-104 is an investigational next-generation mitomycin product for LG-UTUC. Like UGN-103, UGN-104 combines UroGen’s RTGel technology with a novel mitomycin formulation licensed from medac GmbH.

UGN-301 (zalifrelimab), an anti-CTLA4 antibody for use in high-grade non-muscle invasive bladder cancer

UroGen has made the strategic decision to discontinue development of UGN-301 (zalifrelimab) following completion of its Phase 1 dose escalation study. While the study confirmed proof of concept for RTGel as a viable platform for local delivery of complex immunotherapies, UGN-301’s overall clinical profile did not meet UroGen’s internal benchmarks for advancement to Phase 2. The program achieved key proof of concept objectives, including sustained bladder exposure with minimal systemic absorption and was generally well tolerated, demonstrating the ability to mitigate CTLA-4–related toxicities, and encouraging efficacy signals. These findings further reinforce the versatility and potential of RTGel technology to enable localized delivery of immunotherapy candidates.
UroGen provided notice to Agenus Inc. of termination for convenience of the License Agreement between the parties. In accordance with the terms of the agreement, termination will become effective upon the later of (i) expiration of the 180-day notice period, or (ii) completion of all required wind-down activities, including the delivery of any Agenus Improvements as defined in the License Agreement.

UGN-501 (investigational next-gen oncolytic virus) for use in high-grade non-muscle invasive bladder cancer (

UGN-501 is a potent and fast-replicating investigational next generation oncolytic virus therapy being developed as a locally administered treatment for bladder cancer and other specialty cancers. Investigational New Drug (IND)-enabling studies are currently ongoing, with the goal of submitting an IND and initiating a Phase 1 trial in 2026.

Third quarter 2025 Financial Results

Revenue: Total revenues for the third quarter ended September 30, 2025 were $27.5 million. JELMYTO generated net product revenue of $25.7 million for the quarter ended September 30, 2025, compared to $25.2 million (which included $2.6 million of CREATES Act sales) in the same period of 2024, reflecting approximately 13% underlying year-over-year demand driven revenue growth. ZUSDURI achieved net product revenue of $1.8 million in its first quarter on the market, with October 2025 preliminary demand revenue estimate of $4.5 million demonstrating growing early commercial momentum.

R&D Expenses: Research and development (R&D) expenses for the third quarter of 2025 were $14.0 million, including non-cash share-based compensation expense of $0.7 million as compared to $11.4 million, including non-cash share-based compensation expense of $0.6 million, for the same period in 2024. The increase in R&D expenses of $2.6 million was primarily driven by costs associated with the Phase 3 UTOPIA trial for UGN-103, partially offset by lower clinical trial costs, manufacturing costs, and regulatory expenses in connection with ZUSDURI.

SG&A Expenses: Selling, general and administrative expenses (SG&A) for the third quarter of 2025 were $37.6 million, including non-cash share-based compensation expense of $2.3 million. This compares to $28.9 million, including non-cash share-based compensation expense of $2.9 million, for the same period in 2024. The increase in SG&A expenses of $8.7 million was primarily driven by ZUSDURI commercial launch activities as well as an increase in overall commercial operation costs.

Financing on Prepaid Forward Obligation: UroGen reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of $4.6 million in the third quarter of 2025, compared to $5.9 million in the same period in 2024. The decrease was primarily driven by changes in underlying assumptions for remeasuring the effective rate.

Interest Expense on Long-Term Debt: Interest expense related to the $125 million term loan facility with funds managed by Pharmakon Advisors was $3.4 million in the third quarter of 2025, compared to $2.7 million in the same period in 2024. The increase was primarily attributable to the interest expense on the third tranche of the loan that was funded in September 2024.

Net Loss: UroGen reported a net loss of $33.3 million or ($0.69) per basic and diluted share in the third quarter of 2025 compared with a net loss of $23.7 million or ($0.51) per basic and diluted share in the same period in 2024.

Cash and Equivalents: As of September 30, 2025, cash, cash equivalents and marketable securities totaled $127.4 million.

For further details on the Company’s financials, refer to Form 10-Q, filed with the SEC.

2025 JELMYTO Revenue and Company Operating Expense Guidance: Guidance for full-year 2025 net product revenues for JELMYTO remains unchanged and is expected to be in the range of $94 to $98 million. This implies a year-over-year growth rate of approximately 8% to 12% over the $87.4 million in demand driven JELMYTO sales in 2024, which excludes the $3.0 million in CREATES Act sales reported in 2024. Continue to expect full-year 2025 operating expenses to be in the range of $215 to $225 million, including non-cash share-based compensation expense of $11 million to $14 million.

Conference Call & Webcast Information: Members of UroGen’s management team will host a live conference call and webcast today at 10:00 AM Eastern Time to review UroGen’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at View Source Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast.

(Press release, UroGen Pharma, NOV 6, 2025, View Source [SID1234659591])

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])