On November 7, 2025 Indapta Therapeutics, Inc., a privately held clinical stage biotechnology company developing next-generation differentiated immunotherapies for the treatment of cancer and autoimmune diseases, reported the presentation of data highlighting the clinical activity of IDP-023, the Company’s allogeneic g-NK cell therapy, in patients with relapsed/refractory multiple myeloma. IDP-023 treatment was given as a standalone therapy and in combination with isatuximab, an anti-CD38 monoclonal antibody approved for the treatment of multiple myeloma.

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"We are encouraged to observe this degree of clinical activity of IDP-023 alone and in combination with isatuximab," said Dr. Mark Frohlich, CEO of Indapta. "This is particularly noteworthy given the extent of prior therapies and adverse prognostic features of the patients treated. We look forward to treating additional patients to better characterize the response proportion and durability of treatment effect."

The data will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting, taking place November 7-9, 2025, in Washington, DC. The presentation (Abstract #1322), entitled "IDP-023 Allogeneic g-NK-cells +/- Anti-CD38 Monoclonal Antibody for the Treatment of Relapsed/Refractory Multiple Myeloma: Safety, Efficacy and Determination of Recommended Phase 2 Dose," summarizes the data from the safety run-in of the Phase 1 trial as well as the initial cohort of patients treated with IDP-023 in combination with an anti-CD38 monoclonal antibody. Patients received one to three doses of IDP-023, with or without interleukin-2 (IL-2).

Key highlights from the data presentation include:

Marked tumor reduction was observed in patients treated with IDP-023 alone and in combination with isatuximab.
In patients treated with IDP-023 at the second dose level of 10 billion cells/dose in combination with isatuximab, confirmed responses were observed in 4 of 5 response evaluable patients. These patients were heavily pre-treated with high-risk and ultra high-risk cytogenetics.
Responses included a stringent complete response in a patient with extramedullary disease who experienced prior progression following treatment with both CAR-T and T-cell engager therapy.
A second cycle of IDP-023 in combination with isatuximab in select patients appeared to improve the depth and duration of response.
Treatment was generally well-tolerated with no dose limiting toxicities. The most common adverse events were cytopenias related to the conditioning chemotherapy.
Indapta’s Proprietary g-NK Cell Therapy

Indapta’s universal, allogeneic NK cellular immunotherapy platform consists of a potent subset of naturally occurring NK cells, known as "g minus" NK cells, or "g-NK" cells. g‑NK cells arise from epigenetic changes resulting from exposure to cytomegalovirus (CMV). To generate IDP-023, Indapta preferentially expands g-NK cells from healthy donors, with low donor to donor variability. IDP-023 has several differentiated mechanisms of killing target cells without the need for genetic engineering, including highly robust antibody-dependent cell mediated cytotoxicity (ADCC), the targeting of HLA-E expressing cells via the NKG2C receptor, and the inherent anti-viral activity of g-NK cells.

Indapta’s g-NK can release dramatically more immune activating cytokines and cell-killing compounds than conventional NK cells. In preclinical studies, IDP-023 has demonstrated more potent and durable antitumor activity when combined with cancer targeting monoclonal antibodies as compared to conventional NK cells. (Bigley et al., Blood Advances 2021, View Source). g-NK cells in combination with a B cell targeting antibody can also deplete normal B cells from healthy donors or patients with autoimmune disease.

(Press release, Indapta Therapeutics, NOV 7, 2025, View Source [SID1234659659])

On November 7, 2025 Gilead Sciences, Inc. (Nasdaq: GILD) reported the Phase 3 ASCENT-07 study investigating Trodelvy (sacituzumab govitecan-hziy) versus chemotherapy as a first-line treatment post-endocrine therapy in HR+/HER2-negative metastatic breast cancer patients did not meet the primary endpoint of progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1 criteria.

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Overall survival is a key secondary endpoint and was not mature at the time of the primary analysis; however, an early trend was observed favoring patients treated with Trodelvy compared to chemotherapy. The ASCENT-07 study will continue to further assess overall survival.

"HR+/HER2-negative metastatic breast cancer is a highly heterogeneous disease, and this complexity makes it particularly challenging to manage, especially in patients whose disease has already progressed on multiple lines of endocrine therapy," said Hope S. Rugo, MD, ASCENT-07 Principal Investigator, Chief, Division of Breast Oncology, Director of Women’s Cancer Program, City of Hope Comprehensive Cancer Center. "It will be critical that we continue to follow patients for overall survival to better understand the potential impact of sacituzumab govitecan long-term in this treatment setting."

The safety profile was consistent with prior Trodelvy breast cancer studies and no new safety signals were identified in this patient population.

"Trodelvy remains a standard of care for pre-treated HR+/HER2-negative metastatic breast cancer based on the demonstrated overall survival results seen in the TROPiCS-02 study," said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. "We are deeply grateful to the patients, their families, advocates, and investigators who continue to contribute to this important research. We look forward to sharing the full data of ASCENT-07 at an upcoming medical conference."

Trodelvy is the only globally approved Trop-2-directed antibody-drug conjugate (ADC) to show meaningful overall survival advantages in two distinct types of metastatic breast cancer: pre-treated HR+/HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) metastatic breast cancer and second-line and later metastatic triple-negative breast cancer (TNBC). Trodelvy is recognized as a Category 1 preferred treatment for both approved indications per the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelinesi) and is the only ADC with a European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) rating of 5 for metastatic TNBC and a rating of 4 for HR+/HER2-negative mBC.

Trodelvy also stands as the only ADC to demonstrate a statistically significant and clinically meaningful PFS improvement in the first-line metastatic TNBC setting regardless of PD-L1 status across two positive Phase 3 studies (ASCENT-04 and ASCENT-03) presented earlier this year.

Gilead continues to build on this foundation with a robust development program exploring Trodelvy across multiple disease stages and tumor types, including the ongoing Phase 3 ASCENT-05 study in high-risk early-stage TNBC (eTNBC) and additional Phase 3 studies evaluating its potential in lung and gynecologic cancers.

The use of Trodelvy in patients as a first treatment post-endocrine therapy in HR+/HER2-negative metastatic breast cancer is investigational, and its safety and efficacy have not been established in this population. The use of Trodelvy in first-line metastatic TNBC is also investigational and the safety and efficacy have not been established for that use.

About HR+/HER2-negative Metastatic Breast Cancer (First Treatment Post-Endocrine Therapy)
HR+/HER2-negative is the most common breast cancer subtype, representing ~70% of cases (~400,000 diagnoses globally each year). While endocrine therapies have extended survival, nearly all patients with metastatic disease eventually progress and become resistant. Once patients are no longer candidates for endocrine therapy, chemotherapy becomes the primary treatment option but is often linked to higher rates of disease resistance and limited clinical outcomes. Attrition between treatment lines is substantial, underscoring the need for more effective and better-tolerated options earlier in care, regardless of IHC status (IHC 0, 1+, 2+/ISH-).

About the ASCENT-07 Study
The ASCENT-07 study is a global, open-label, randomized Phase 3 trial evaluating the efficacy and safety of Trodelvy (sacituzumab govitecan-hziy) compared with treatment of physician’s choice chemotherapy in patients with locally advanced, inoperable, or HR+/HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) metastatic breast cancer who have received prior endocrine therapy and are candidates for cytotoxic chemotherapy. The study enrolled 654 patients across nearly 30 countries.

Patients were randomized 2:1 to receive either sacituzumab govitecan-hziy (10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle) or treatment of physician’s choice, which included a choice of single-agent chemotherapy including capecitabine, paclitaxel and nab-paclitaxel. Treatment continued until BICR-verified disease progression or unacceptable toxicity.

The primary endpoint of the study is PFS as assessed by BICR according to RECIST v1.1 criteria. Key secondary endpoints include overall survival, objective response rate, quality of life, and safety.

More information about ASCENT-07 is available at ClinicalTrials.gov: NCT05840211.

About Trodelvy
Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.

Trodelvy is currently approved in more than 50 countries for second-line or later metastatic triple-negative breast cancer (TNBC) patients and in more than 40 countries for certain patients with pre-treated HR+/HER2-negative metastatic breast cancer. With more than 60,000 cancer patients treated globally over the past five years, healthcare professionals have extensive real-world experience with Trodelvy, which has shown generally consistent outcomes across clinical and real-world settings.

Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2-negative breast cancer—including in curative settings—as well as in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.

INDICATIONS

TRODELVY (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
IMPORTANT SAFETY INFORMATION
BOXED WARNING: NEUTROPENIA AND DIARRHEA

TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS

Severe hypersensitivity reaction to TRODELVY.
WARNINGS AND PRECAUTIONS

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.

Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.

Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.

ADVERSE REACTIONS

In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).

In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.

UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.

Please see full Prescribing Information, including BOXED WARNING.

(Press release, Gilead Sciences, NOV 7, 2025, View Source [SID1234659644])

On November 7, 2025 Synthekine Inc., an engineered cytokine therapeutics company, reported positive initial results from a Phase 1a/1b clinical trial of STK-012 in first-line, PD-L1 negative nonsquamous (NSQ) non-small cell lung cancer (NSCLC) in combination with standard of care (SoC) pembrolizumab and chemotherapy (PCT). The data will be presented by Adam J. Schoenfeld, M.D., Memorial Sloan Kettering Cancer Center, New York, as a late-breaking oral presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2025 in National Harbor, MD, on Saturday, November 8.

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STK-012 is a first-in-class α/β-IL-2 receptor biased partial agonist engineered to selectively stimulate antigen-activated T cells, which are associated with potent anti-tumor activity, and avoid broad stimulation of other lymphocytes, such as natural killer (NK) cells, which are associated with IL-2 toxicity.

STK-012 combined with SoC PCT demonstrated favorable safety and efficacy. The efficacy evaluable dataset (N = 21) included a highly immune resistant population with 17 subjects that were PD-L1<1% and 4 that were PD-L1 1% or greater; 15/21 subjects also had loss-of-function (LoF) tumor suppressor gene (TSG) mutations (STK11, KEAP1, and/or SMARCA4) or mucinous histology, features known to further limit response to SoC PCT.

"We set a high bar by enrolling first-line PD-L1 negative non-squamous NSCLC—a population marked by intrinsic immune resistance where standard-of-care therapies have consistently underperformed," said Naiyer Rizvi, M.D., Chief Medical Officer of Synthekine. "The high response rate observed with STK-012 in this setting is particularly encouraging and supports its potential to convert immune desert tumors into responders when added to SoC. STK-012’s unique selectivity for antigen-activated T cells, while sparing bystander lymphocytes, enables delivery of the critical IL-2 signal without the associated toxicity. These compelling data position STK-012 for advancement into a randomized Phase 2 trial."

The late-breaking oral presentation (Abstract Number: 1345), titled "Initial Phase 1a/1b Results of STK-012, an α/β IL-2 Receptor Biased Partial Agonist, with Pembrolizumab, Pemetrexed, and Carboplatin in 1L PD-L1 Negative Non-Squamous NSCLC" will be presented on November 8 at SITC (Free SITC Whitepaper) at 2:00 pm ET. The presentation will take place in the Potomac Ballroom at the Gaylord National Resort and Convention Center during the Clinical Oral Abstract session.

"Despite advances that have improved outcomes for newly diagnosed lung cancer patients, a significant unmet need persists — most notably among PD-L1 negative nonsquamous NSCLC and tumors with immune resistance mutations," said Dr. Schoenfeld. "Early STK-012 + SoC PCT data in these hard to treat populations are encouraging; if replicated in larger cohorts, they could reshape the treatment landscape."

Following the meeting, the presentation will be available on Synthekine’s website. For additional information about the trial, please visit www.clinicaltrials.gov using the identifier NCT05098132.

STK-012 Initial Phase 1a/1b Data in Combination with Pembrolizumab + Chemotherapy

25 subjects were treated with STK-012 2.25 mg SC Q3W in combination with SoC pembrolizumab, pemetrexed, and carboplatin.

In 21 efficacy evaluable subjects (N=17 PD-L1<1%, N=3 PD-L1 1%, and N=1 PD-L1 5%), the ORR was 57% with STK-012 + SoC PCT.

In 17 PD-L1<1% subjects, the ORR was 53%, comparing favorably to 23 – 32% ORR expected with SoC PCT
In 10 subjects with at least 1 immune resistance mutation (STK11, KEAP1, SMARCA4), the ORR was 60%, comparing favorably to historical ORR of 7 – 33% with SoC PCT
In 5 subjects with mucinous histology, the ORR was 80%, comparing favorably to historical ORR of 21% with SoC PCT
In 25 safety evaluable subjects, the most frequent TRAEs were manageable and reversible nausea, fatigue, and rash/dermatitis. No subjects discontinued treatment with STK-012 due to TRAEs. No treatment-related hypotension, capillary leak syndrome, or cytokine release syndrome was observed.

(Press release, Synthekine, NOV 7, 2025, View Source [SID1234659660])

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])