Leads Biolabs’ Opamtistomig (PD-L1/4-1BB Bispecific Antibody) Completes Patient Enrollment in Phase II Study for Biliary Tract Cancer, Further Demonstrating Breakthrough Potential in Immune-Cold Tumors

On July 30, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that the Phase II clinical study of its core product Opamtistomig (LBL-024, a PD-L1/4-1BB bispecific antibody) for the treatment of first-line advanced biliary tract cancer (BTC) has completed enrollment of all 70 patients. In April 2026, the study successfully entered the expansion phase based on a favorable safety profile and robust efficacy that exceeded expectations, and rapidly completed full patient enrollment, fully demonstrating the efficient clinical advancement and continuously validated significant efficacy of Opamtistomig.

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Despite the recent adoption of PD-(L)1 immunotherapy combined with chemotherapy as a first-line standard of care for advanced BTC, clinical benefits remain limited. Current standard regimens, including pembrolizumab plus chemotherapy and durvalumab plus chemotherapy, have demonstrated objective response rates (ORR) below 30% and median overall survival (OS) of only approximately 12–13 months, leaving a substantial unmet medical need in this aggressive malignancy.

The potential of Opamtistomig as an IO 2.0 pan-tumor cornerstone therapy has been continuously validated across three dimensions: broad-spectrum anti-tumor activity, long-term survival benefit trends, and a safety profile comparable to PD-(L)1 monoclonal antibodies. Existing data show that, following extrapulmonary neuroendocrine carcinoma (EP-NEC) and small cell lung cancer (SCLC), Opamtistomig has once again demonstrated highly competitive efficacy in BTC, a typical immune-cold tumor, with the potential to elevate the efficacy of immunotherapy in BTC to new heights. Given that the predominant pathological type of BTC is adenocarcinoma, combined with the positive data previously observed in squamous cell carcinoma subtypes of major cancer types such as non-small cell lung cancer (NSCLC), Opamtistomig has shown clear efficacy in both adenocarcinoma and squamous cell carcinoma types, with its broad-spectrum anti-cancer potential being continuously validated.

The multicenter study is led by Academician Zhou Jian of Zhongshan Hospital, Fudan University and is being conducted across multiple hospitals in China. Results from safety run-in data showed that Opamtistomig in combination with chemotherapy demonstrated a favorable overall safety profile and good tolerability, with no new safety signals identified. Preliminary efficacy assessments showed an encouraging tumor shrinkage. Detailed clinical data will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting to be held in Madrid, Spain from October 23 to 27, 2026.

Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said: "The rapid progress of our Phase II BTC study reflects the strong confidence investigators and patients have placed in the encouraging efficacy signals generated by Opamtistomig to date. Immune-cold tumors remain among the greatest challenges in oncology and represent one of the most important frontiers for next generation immunotherapy. Across multiple immune-cold tumor types, Opamtistomig has consistently demonstrated promising clinical activity, further validating its potential as an IO 2.0 pan-tumor cornerstone therapy. We are committed to accelerating the clinical development of Opamtistomig in BTC and look forward to bringing a more effective and durable treatment option to patients with this devastating disease as early as possible."

About Biliary Tract Cancer
Biliary tract malignancies primarily include gallbladder cancer and intrahepatic/extrahepatic cholangiocarcinoma, with approximately 419,100 new cases globally in 2024. These malignancies are predominantly ‌adenocarcinomas‌ with high invasiveness, and most cases are diagnosed at advanced stages, leading to ‌poor prognosis‌ (5-year survival rate <5%)‌. Currently, global incidence of biliary tract malignancies is rising, with the highest prevalence observed in Asian countries.

Although ‌PD-1/L1 inhibitors combined with chemotherapy‌ have been approved as first-line treatment for advanced biliary tract malignancies, clinical benefits remain limited: ‌Modest improvement in median overall survival (OS)‌ (from ~11.5 to 12.8 months)‌ and ‌Low objective response rate (ORR)‌ (<30%)‌. These gaps highlight ‌unmet medical needs‌ for more effective therapies‌.

About Opamtistomig
Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Developed using Leads Biolabs’ proprietary X-Body bispecific platform, Opamtistomig is designed to simultaneously block PD-1/L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential. To date, Opamtistomig has demonstrated first- or best-in-class potential in Phase II or registrational clinical trials across four indications: non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), and extrapulmonary neuroendocrine carcinoma (EP-NEC).

As the first 4-1BB–targeting bispecific antibody globally to advance to a single-arm pivotal trial as monotherapy, Opamtistomig has been evaluated in 13 solid tumor indications in China, including 1 pivotal registration trial and 8 proof-of-concept studies. These cover EP-NEC, NSCLC, SCLC, BTC, ovarian cancer (OC), esophageal squamous cell carcinoma (ESCC), hepatocellular carcinoma (HCC), gastric cancer (GC), triple-negative breast cancer (TNBC), malignant melanoma, and other areas with high unmet medical needs.

Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically "cold" tumors. Recognizing its clinical potential, Opamtistomig received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of neuroendocrine carcinoma in November 2024. Additionally, in January 2026, Opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission for the treatment of EP-NEC, further underscoring its potential to address unmet medical needs in this patient population.

(Press release, Nanjing Leads Biolabs, JUL 30, 2026, View Source [SID1234669563])

Castle Biosciences Reports Second Quarter 2026 Results

On July 30, 2026 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the second quarter ended June 30, 2026.

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"The Castle Biosciences team delivered another outstanding quarter," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We believe our strong growth through the first half of 2026 demonstrates the clinical value our tests bring to patient care and the dedication of our talented team to deliver results so that our clinician customers and patients can act with confidence.

"Given this momentum, we are raising our 2026 total revenue guidance to $365-375 million, up from our previous range of $345-355 million. We also now expect to achieve positive Adjusted EBITDA for the third quarter, the fourth quarter and the full year 2026.

"We are also encouraged by an independent study supporting the clinical impact of AdvanceAD-Tx in guiding systemic treatment selection. At the Revolutionizing Atopic Dermatitis meeting in June, data from a multi-center study showed only 54.3% of patients receiving baseline systemic therapy were initially on pathway-concordant treatment; however, following testing with our AdvanceAD-Tx test, 97.8% of patients were initiated on molecularly concordant systemic therapy.

I want to thank the entire Castle team for their focus, commitment and disciplined execution, which continue to advance our mission of improving health through innovative tests that guide patient care."

Second Quarter Ended Jun. 30, 2026, Financial and Operational Highlights
•Revenues were $103.5 million, compared to $86.2 million in the second quarter of 2025. Affecting second quarter 2026 revenue was the change in DecisionDx-SCC Medicare coverage effective April 24, 2025, the re-focus of our commercial efforts, as well as the discontinuation of IDgenetix in May 2025.

Core revenue drivers:
•Second quarter 2026 total test reports for our core revenue drivers (DecisionDx-Melanoma, TissueCypher) increased 32% over the second quarter of 2025:
◦DecisionDx-Melanoma test reports delivered in the quarter were 10,280, compared to 9,981 in the second quarter of 2025.
◦TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 14,988, compared to 9,170 in the second quarter of 2025.

Additional tests:
◦DecisionDx-SCC test reports delivered in the quarter were 4,011, compared to 4,762 in the second quarter of 2025.
◦MyPath Melanoma test reports delivered in the quarter were 1,061, compared to 1,166 in the second quarter of 2025.
◦DecisionDx-UM test reports delivered in the quarter were 482, compared to 468 in the second quarter of 2025.

•Gross margin was 75%, and Adjusted Gross Margin was 76%, compared to 77% and 80%, respectively, for the same periods in 2025.
•Net loss, which includes non-cash stock-based compensation expense of $11.6 million, was $2.1 million, compared to net income of $4.5 million for the same period in 2025.
•Net loss per share and Adjusted Net Loss per Share, Basic and Diluted, was $0.07, compared to net income per share and Adjusted Net Income per Share, Basic and Diluted, of $0.16 and $0.15, respectively, for the same period in 2025.
•Adjusted EBITDA was $12.4 million, compared to $10.4 million for the same period in 2025.
•Net cash provided by operations was $15.2 million, compared to net cash provided by operations of $20.8 million for the same period in 2025.

Six Months Ended Jun. 30, 2026, Financial and Operational Highlights
•Revenues were $187.2 million, compared to $174.2 million for the six months ended June 30, 2025. Affecting comparison to 2025 includes the change in DecisionDx-SCC Medicare coverage effective April 24, 2025, the re-focus of our commercial efforts, as well as the discontinuation of IDgenetix in May 2025.

Core revenue drivers:
•First half 2026 total test reports for our core revenue drivers (DecisionDx-Melanoma, TissueCypher) increased 34% over the six months ended June 30, 2025.
◦DecisionDx-Melanoma test reports delivered in the six months ended June 30, 2026, were 20,301, compared to 18,602 for the same period in 2025.
◦TissueCypher Barrett’s Esophagus test reports delivered in the six months ended June 30, 2026, were 26,733, compared to 16,602 for the same period in 2025.
Additional tests:
◦DecisionDx-SCC test reports delivered in the six months ended June 30, 2026, were 7,713, compared to 9,137 for the same period in 2025.
◦MyPath Melanoma test reports delivered in the six months ended June 30, 2026, were 2,034, compared to 2,092 for the same period in 2025.
◦DecisionDx-UM test reports delivered in the six months ended June 30, 2026, were 974, compared to 938 for the same period in 2025.

•Gross margin for the six months ended June 30, 2026, was 74%, and Adjusted Gross Margin was 77%, compared to 63% and 81%, respectively, for the same period in 2025.
•Net loss, which includes non-cash stock-based compensation expense of $21.4 million, was $16.6 million, compared to net loss of $21.3 million for the same period in 2025.
•Net loss per share and Adjusted Net Loss per Share, Basic and Diluted, was $0.55, compared to net loss per share and Adjusted Net Loss per Share, Basic and Diluted, of $0.74 and $0.04, respectively, for the same period in 2025.
•Adjusted EBITDA was $7.3 million, compared to $23.4 million for the same period in 2025.

•Net cash used in operations was $6.9 million, compared to $14.8 million net cash provided by operations for the same period in 2025.
Cash, Cash Equivalents and Marketable Investment Securities
As of Jun. 30, 2026, the Company’s cash, cash equivalents and marketable investment securities totaled $266.8 million.
2026 Outlook
Castle Biosciences is raising its guidance for anticipated total revenue in 2026. The Company now anticipates generating between $365-375 million in total revenue in 2026, compared to the previously provided guidance of between $345-355 million. Further, the Company expects to achieve positive Adjusted EBITDA for the third quarter, the fourth quarter and the full year 2026.

Second Quarter and Recent Accomplishments and Highlights

Dermatology – Skin Cancer
•The Company announced the publication of a prospective, multicenter study in Dermatology and Therapy demonstrating that DecisionDx-Melanoma’s integrated sentinel lymph node biopsy test result (i31-SLNB) outperforms the Melanoma Institute Australia (MIA) nomogram in identifying patients at low and high risk of SLN positivity, supporting more informed SLNB decision-making for patients with cutaneous melanoma (CM). This is the second multicenter study showing that the i31-SLNB result outperforms the MIA nomogram in assessing SLN positivity risk. See the Company’s news release from June 25, 2026, for more information.

Dermatology – Atopic Dermatitis
•The Company announced that its AdvanceAD-Tx test has received assay approval from the New York State Department of Health (NYSDOH). With this approval, Castle has New York State approval for all tests within its dermatology and ophthalmology portfolios, its TissueCypher test within gastroenterology and its clinical laboratories in Phoenix and Pittsburgh. See the Company’s news release from July 14, 2026, for more information.
•The Company announced that its AdvanceAD-Tx test was selected as the winner of the "Genomics Innovation Award" in the 10th annual MedTech Breakthrough Awards program, which recognizes companies driving meaningful progress and improving patient care across the global health and medical technology industry. AdvanceAD-Tx is Castle’s clinically validated gene expression profile (GEP) test designed to guide systemic treatment decision making in patients 12 and older with moderate-to-severe atopic dermatitis (AD). This marks the fifth MedTech Breakthrough Award that Castle has earned for its innovative testing solutions. See the Company’s news release from May 12, 2026, for more information.

Pipeline Initiatives
•In June 2026, the first patient was enrolled in DETECT-AD, a multicenter prospective clinical study being conducted through Castle’s collaboration with SciBase, a global medical technology company, specializing in early detection and prevention in dermatology. The study will investigate the ability of Electrical Impedance Spectroscopy (EIS) to predict the onset of flares in patients with AD, with the goal of enabling proactive interventions and improving patient quality of life.

Corporate
•The Company announced that Frank Stokes, its chief financial officer, has been named a 2026 CFO Awards honoree by the Houston Business Journal. Stokes is among 22 chief financial officers from across the Greater Houston area recognized for their financial leadership and contributions to their organizations’ success. See the Company’s news release from June 23, 2026, for more information.

Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Thursday, July 30, 2026, at 4:30 p.m. Eastern time to discuss its second quarter 2026 results and provide a corporate update.

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website, View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until August 20, 2026.
There will be a brief Question & Answer session following management commentary.

(Press release, Castle Biosciences, JUL 30, 2026, View Source [SID1234669528])

Pulse Biosciences to Present at Canaccord Genuity’s 46th Annual Growth Conference

On July 30, 2026 Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation (nano-PFA or nsPFA) technology, reported plans to participate in the upcoming Canaccord Genuity 46th Annual Growth Conference in Boston, MA.

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Pulse Biosciences’ Management is scheduled to present on Tuesday, August 11, at 2:30 pm ET. A live and recorded webcast of the fireside chat will be available on the "Events Calendar and Presentations" page of the company’s investor website at View Source

(Press release, Pulse Biosciences, JUL 30, 2026, View Source [SID1234669548])

IMUNON Reports Strong Enrollment Momentum in Phase 3 OVATION 3 Trial of IMNN-001 in Advanced Ovarian Cancer

On July 30, 2026 IMUNON, Inc. (Nasdaq: IMNN) ("IMUNON" or "the Company"), a clinical-stage biotechnology company developing its novel DNA-mediated immunotherapies, reported a progress update on its pivotal Phase 3 OVATION 3 trial of IMNN-001 in patients with newly diagnosed advanced ovarian cancer. Since initiating the trial, the Company has observed rapid site activation and an enrollment rate that is exceeding its forecast. The trial advanced from protocol submission to site activation in approximately 6 months and from protocol approval to first patient randomized in approximately 2 months, a third of the time of the external industry benchmark.

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The currently observed study-level enrollment rate of approximately 0.5 patients per site per month meaningfully exceeds the assumed rate of 0.3 patients per site per month used in the trial plan. That planning assumption was already set at a premium relative to the Company’s OVATION 2 experience and to historical industry ovarian cancer trials, which have generally enrolled at approximately 0.2 patients per site per month. The strong OVATION 3 enrollment is supported by highly promising clinical and biomarker data, most notably the overall survival (OS) evidence from the large, randomized Phase 2 OVATION 2 study and a high rate of conversion from pre-screening to randomization underscores strong interest in the trial by investigators and patients. More than 70% of sites are currently meeting or exceeding the assumed average enrollment rate of 0.3 patients per month. The Company now projects enrollment to be completed in the second quarter of 2029. Two pre-planned interim analyses are expected with the goal of early BLA filing for full regulatory approval if they achieve the pre-specified threshold.

"The early momentum we are seeing in OVATION 3 reflects the strength of our clinical data, the quality of our sites and the commitment of the investigators and patients participating in the trial," said Stacy Lindborg, Ph.D., President and Chief Executive Officer of IMUNON. "We’ve seen enrollment build quarter after quarter, including through the early summer months when trials typically slow down, a trend we view as a strong signal of investigator and patient engagement. The consistent safety profile we’ve now observed across multiple studies further re-enforces our confidence in IMNN-001, uniquely designed to safely exploit the pluripotent capability of IL-12 to recruit the entirety of the patient’s own immune system to fight cancer, as we continue to advance our pivotal Phase 3 OVATION 3 trial."

IMNN-001 has continued to demonstrate a highly favorable safety and tolerability profile, with no observed episodes of cytokine release syndrome, systemic toxicities or serious immune-related adverse events that have historically foiled the use of IL-12 to effectively treat cancer patients. Safety profiles have been comparable between the two arms of the study (IMNN-001 plus neoadjuvant and adjuvant chemotherapy {N/ACT} versus N/ACT alone), consistent with observations from the Company’s ongoing Phase 2 Minimal Residual Disease (MRD) study. No safety issues have been raised in recent Independent Data Monitoring Committee (IDMC) reviews of either ongoing study.

About the Phase 3 OVATION 3 Trial

The pivotal Phase 3 OVATION 3 trial is evaluating intraperitoneal IMNN-001 at 100 mg/m² in combination with standard-of-care neoadjuvant and adjuvant chemotherapy versus chemotherapy alone in patients with newly diagnosed advanced epithelial ovarian cancer. The trial is enrolling an all-comers population that includes both homologous recombination-deficient and homologous recombination-proficient patients; eligible patients who respond to first-line platinum-based chemotherapy will proceed to PARP inhibitor maintenance according to applicable guidelines and prescribing information. The primary endpoint is overall survival, with secondary endpoints including chemotherapy response score, surgical response score at interval debulking surgery, time to second-line treatment or death, and objective response rate.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local production of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel neoadjuvantly in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

(Press release, IMUNON, JUL 30, 2026, View Source [SID1234669564])

Cerus Corporation Announces Second Quarter 2026 Financial Results

On July 30, 2026 Cerus Corporation (Nasdaq: CERS) reported financial results for the second quarter ended June 30, 2026, and provided a business update.

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"This quarter we made significant progress in expanding patient access to safer blood components around the globe," said Vivek Jayaraman, Cerus’ president and chief executive officer. "I’m particularly pleased with the performance of our INTERCEPT Fibrinogen Complex (IFC) franchise in the U.S. The value proposition for blood centers, hospitals and clinicians is resonating and leading to earlier patient access to fibrinogen across the country. We view IFC as a compelling growth driver for Cerus."

Additional highlights include:

Second-quarter 2026 total revenue comprised of (in millions, except percentages):
Three Months Ended

Six Months Ended

June 30,

Change

June 30,

Change

2026

2025

$

%

2026

2025

$

%

Product Revenue

$

57.4

$

52.4

$

5.0

10

%

$

111.1

$

95.7

$

15.4

16

%

Government Contract Revenue

5.9

7.7

(1.8

)

-24

%

12.1

13.3

(1.2

)

-9

%

Total Revenue

$

63.3

$

60.1

$

3.2

5

%

$

123.2

$

109.0

$

14.2

13

%

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

Demand for IFC continued to increase, with second quarter volumes – including kits and finished therapeutic doses (measured in FC15* equivalent units) – up approximately 20% compared to the prior year period. Second quarter U.S. IFC sales totaled $6.7 million, up from $5.6 million in the prior year period.
Submitted PMA for the INTERCEPT Blood System for Platelets with INT200 Illuminator, the Company’s next generation LED-based illumination device, to the FDA as planned. Given review timelines, a regulatory decision is anticipated in early 2027.
Completed debt refinancing, including a $30 million reduction in the outstanding term loan funded with $20 million of cash on hand and $10 million drawn under the new, lower-cost revolving credit facility.
Expanded the Company’s ongoing collaboration with the Biomedical Advanced Research and Development Authority, or BARDA, to further advance the development of the INTERCEPT Red Blood Cell system, increasing the total potential value of the 2024 contract by $21.9 million from $248.6 million to $270.5 million. The BARDA contract is funded in whole or in part with federal funds from the Department of Health and Human Services’ Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority under Contract No. 75A50124C00046.
Cash, cash equivalents, and short-term investments were $56.3 million at June 30, 2026.
Revenue

Product revenue for the second quarter of 2026 was $57.4 million, compared to $52.4 million for the prior year period, representing year-over-year growth of 10%. Second quarter growth was driven by increases across all product categories.

Government contract revenue for the second quarter of 2026 was $5.9 million, compared to $7.7 million during the prior year period. The decrease reflects the completion of the Company’s FDA contract in 2025, the wind-down of the BARDA 2016 contract, and timing of expenses related to the BARDA 2024 contract.

Product Gross Profit & Margin

Product gross profit for the second quarter of 2026 was $29.5 million, compared to $29.0 million, increasing by 2% over the prior year period. Product gross margin for the second quarter was 51.4% compared to 55.2% in the same period last year. The year-over-year decrease in gross margin was largely driven by a weaker U.S. dollar relative to the Euro and higher product costs driven by inflationary pressures.

Operating Expenses

Total operating expenses for the second quarter of 2026 were $37.3 million, compared to $40.1 million for the same period of the prior year, reflecting a year-over-year decrease of 7%.

R&D expenses for the second quarter of 2026 were $14.4 million, compared to $18.9 million in the second quarter of 2025. The primary contributors to lower R&D expenses were decreased development costs on the INT200, with the U.S. PMA submission completed, as well as lower development costs tied to government-funded projects, as reflected in the government contract revenue.

SG&A expenses totaled $22.9 million for the second quarter of 2026, compared to $21.2 million for the second quarter of 2025. The year-over-year increase in SG&A expenses was due to higher costs across various functions.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for the second quarter of 2026 was $2.9 million, or $0.01 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $5.7 million, of $0.03 per basic and diluted share, for the same period of the prior year. Net loss attributable to Cerus Corporation for the first half of 2026 was $4.6 million, compared to a net loss attributable to Cerus Corporation of $13.4 million for the first half of 2025.

Non-GAAP Adjusted EBITDA

Non-GAAP adjusted EBITDA for the second quarter of 2026 was positive $3.0 million, compared to non-GAAP adjusted EBITDA of positive $0.9 million for the same period of the prior year. Non-GAAP adjusted EBITDA for the first half of 2026 was a positive $7.0 million compared to non-GAAP adjusted EBITDA of positive $1.1 for the first half of 2025.

Balance Sheet and Cash Flows

At June 30, 2026, the Company had cash, cash equivalents, and short-term investments of $56.3 million, compared to $82.9 million at December 31, 2025.

As of June 30, 2026, the Company had $35.0 million outstanding on its term loan and $30.1 million drawn on its revolving credit facility. The Company’s revolving line of credit allows for an additional $14.9 million as of June 30, 2026, which is dependent on eligible assets supporting the borrowing base.

For the second quarter of 2026, cash used in operations totaled $2.7 million, compared to $2.4 million used during the same period of the prior year. Cash use in operations in the second quarter of 2026 was tied to an increase in working capital, namely inventory in support of the expected growth.

Narrowing And Raising Low End of 2026 Product Revenue Guidance

The Company now expects full-year 2026 product revenue to be in the range of $229 million to $231 million, reflecting growth of 11% to 12% from 2025. Included in this range is increased full-year 2026 IFC revenue guidance of $23 million to $25 million. Previously, the Company’s 2026 product revenue guidance range was $227 million to $231 million, including IFC revenue guidance between $22 million to $24 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 and will be available approximately three hours after the call through August 20, 2026.

*FC15 equivalent to a therapeutic dose of a cryoAHF pool.

(Press release, Cerus, JUL 30, 2026, View Source [SID1234669529])