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Day One Reports Second Quarter 2025 Financial Results and Corporate Progress

On August 5, 2025 Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported its second quarter 2025 financial results and highlighted recent corporate achievements (Press release, Day One, AUG 5, 2025, View Source [SID1234654784]).

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"We have strong momentum going into the second half of 2025. We continue to focus on our three core priorities: accelerating revenue growth with OJEMDA, advancing our pipeline, and pursuing value-driving portfolio expansion anchored in financial discipline," said Jeremy Bender, Ph.D., chief executive officer of Day One. "With strong execution across the organization and a solid financial foundation, we’re building a company that aims to deliver meaningful value to patients and to shareholders."

OJEMDA Commercial Performance

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OJEMDA net product revenue was $33.6 million in the second quarter of 2025, an increase of 310% from the second quarter of 2024.

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U.S. OJEMDA net product revenue increased 10% from the first quarter of 2025.

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OJEMDA prescriptions exceeded 1,000 in the second quarter of 2025, representing a 15% increase compared to the first quarter of 2025 and a 346% increase compared to the second quarter of 2024.

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Achieved $113.1 million in OJEMDA net product revenue for the most recent 12-month period ended June 30, 2025.

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The Company is providing 2025 net product revenue guidance of $140 to $150 million.

Program Highlights

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DAY301, the Company’s PTK7-targeted ADC, is actively enrolling patients in the Phase 1a portion of the Phase 1a/b clinical trial; the trial is progressing as planned.

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Day One expects to present 3-year follow-up data from the FIREFLY-1 clinical trial in the fourth quarter of 2025.

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Day One published additional data characterizing growth velocity recovery and effective rash management at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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Abstract 10029: Growth recovery in patients with BRAF-altered pediatric low-grade gliomas (pLGGs) after discontinuation of tovorafenib
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Abstract 10037: Post hoc analysis of rashes reported in patients with BRAF-altered relapsed/refractory pediatric low-grade glioma treated with the type II RAF inhibitor tovorafenib in FIREFLY-1

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Patient enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial is on track to achieve completion of trial enrollment in the first half of 2026.

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Day One terminated its research collaboration and license agreement with Sprint Bioscience AB following careful consideration of the current development status for the VRK1 program and the Company’s overall strategic objectives.

Corporate Highlights

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Industry leader Michael Vasconcelles, M.D., joined Day One in June 2025 as Head of Research and Development. Dr. Vasconcelles brings more than 25 years of extensive oncology research and development experience to the Company, most recently as Executive Vice President and Head of Research, Development and Medical Affairs at ImmunoGen.

Second Quarter 2025 Financial Highlights

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Product Revenue, Net: OJEMDA net product revenue was $33.6 million for the second quarter of 2025 compared to $8.2 million for the second quarter of 2024.

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License Revenue: License revenue from the sale of ex-U.S. commercial rights for tovorafenib was $0.3 million for the second quarter of 2025.

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R&D Expenses: Research and development expenses were $36.1 million for the second quarter of 2025 compared to $92.1 million for the second quarter of 2024. The decrease was primarily due to the MabCare Therapeutics license agreement upfront payment of $55.0 million in the second quarter of 2024.

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SG&A Expenses: Selling, general and administrative expenses were $29.0 million for the second quarter of 2025 compared to $30.2 million for the second quarter of 2024. The decrease was primarily due to lower employee compensation costs.

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Net Loss: Net loss totaled $30.3 million for the second quarter of 2025 with non-cash stock-based compensation expense of $10.9 million, compared to a net loss of $4.4 million for the second quarter of 2024, with non-cash stock-based compensation expense of $13.0 million and gain from sale of priority voucher of $108.0 million.

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Cash Position: The Company’s cash, cash equivalents and short-term investments totaled $453.1 million as of June 30, 2025.

Conference Call

Day One will host a conference call and webcast today, August 5 at 4:30 p.m. ET. To access the live conference call by phone, dial 877-704-4453 (domestic) or 201-389-0920 (international), and provide the access code 13745150. Live audio webcast will be accessible from the Day One Media & Investors page. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events section of the Day One Investors & Media page for 30 days following the event.

About OJEMDA

OJEMDA (tovorafenib) is a Type II RAF kinase inhibitor of mutant BRAF V600, wild-type BRAF, and wild-type CRAF kinases.

OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Tovorafenib was granted Breakthrough Therapy and Rare Pediatric Disease designations by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration, and it was evaluated by the FDA under priority review. Tovorafenib has also received Orphan Drug designation from the FDA for the treatment of malignant glioma and from the European Commission for the treatment of glioma.

For more information, please visit www.ojemda.com.

Curis Provides Second Quarter 2025 Business Update

On August 5, 2025 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported its financial and operating results for the second quarter ended June 30, 2025 (Press release, Curis, AUG 5, 2025, View Source [SID1234654783]).

"We are pleased with our progress in the TakeAim Lymphoma study and are continuing to enroll PCNSL patients in both Part B (BTKi-experienced patients) and Part C (BTKi-naïve patients) to enable accelerated approval filings in the US and EU. We look forward to providing updated data later this year," said James Dentzer, President and Chief Executive Officer. "We are also excited to add a clinical study of emavusertib in combination with a BTK inhibitor in Chronic Lymphocytic Leukemia, as part of our strategy to expand across CLL and NHL and bring this novel treatment option to broader patient populations with unmet needs. For CLL patients in particular, this could represent a fundamental change in the treatment paradigm, with the potential of an emavusertib-BTKi combination to enable time-limited treatment. We look forward to beginning enrollment later this year."

Operational Highlights

NHL/CLL

Presented at the 2025 Annual Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting the poster titled, Analysis of genetic mutation profile and CNS pharmacokinetics in relapsed/refractory primary CNS lymphoma patients responding to novel emavusertib (IRAK4i) and BTKi combination.
Continued to enroll relapsed/refractory Primary Central Nervous System Lymphoma (R/R PCNSL) patients in the Company’s TakeAim Lymphoma study which, as a result of discussions with the EMA and FDA, is now enrolling patients to support registration. Emavusertib has been granted orphan drug designation by both the FDA and EMA in PCNSL.
Adding a proof-of-concept clinical study of emavusertib in combination with a BTKi in 20-30 patients with R/R CLL with the goal of improving upon the current standard of care (BTKi) with its limitations of partial responses and life-long therapy. The combination of emavusertib with a BTKi has the potential to enable patients to achieve complete remission or minimal residual disease (MRD) negativity and time-limited treatment, which would be a paradigm shift in the management of CLL.
Leukemia

Completed enrollment in the TakeAim Leukemia Phase 1/2 study of emavusertib as a monotherapy in patients with R/R Acute Myeloid Leukemia (AML) or R/R Myelodysplastic Syndrome (MDS) and are following several patients still on study treatment.
Engaged clinical trial investigators and key opinion leaders at ASCO (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress on the design of a head-to-head registrational trial vs. gilteritinib in R/R AML based upon encouraging data, Preliminary Safety, Efficacy and Molecular Characterization of Emavusertib (CA-4948) in Relapsed/Refractory Acute Myeloid Leukemia Patients, presented by Dr. Eric Winer at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.
Engaged clinical trial investigators and key opinion leaders at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) on the design of a Phase 1/2 study in frontline high-risk MDS (hrMDS) in combination with azacitidine based upon encouraging R/R MDS clinical data at ASH (Free ASH Whitepaper) 2024 in the poster, Preliminary Safety, Efficacy and Molecular Characterization in Higher-Risk Myelodysplastic Syndrome Patients Treated with Single Agent Emavusertib (CA-4948).
Ongoing triplet study evaluating different dosing regimens of emavusertib, venetoclax, and azacitidine in frontline AML, with data expected at the 67th ASH (Free ASH Whitepaper) Annual Meeting in December.
Corporate

Completed a registered direct offering and concurrent private placement extending cash runway to the first quarter of 2026.
Upcoming Presentations and Conferences

Cantor Global Healthcare Conference 2025 – September 2-5, 2025
H.C. Wainwright 27th Annual Global Investment Conference – September 8-10, 2025
Upcoming Milestones

Additional data in R/R PCNSL patients from the TakeAim Lymphoma study is expected later this year.
Second Quarter 2025 Financial Results

For the second quarter of 2025, Curis reported a net loss of $8.6 million or $0.68 per share on both a basic and diluted basis as compared to $11.8 million or $2.03 per share on both a basic and diluted basis, for the same period in 2024. Curis reported a net loss of $19.2 million or $1.82 per share on both a basic and diluted basis, for the six months ended June 30, 2025, as compared to a net loss of $23.7 million or $4.08 per share on both a basic and diluted basis for the same period in 2024.

Revenues for the second quarter of 2025 were $2.7 million as compared to $2.5 million for the same period in 2024. Revenues were $5.1 million for the six months ended June 30, 2025, as compared to $4.6 million for the same period in 2024. Revenues consist of royalty revenues from Genentech/Roche’s sales of Erivedge.

Research and development expenses were $7.5 million for the second quarter of 2025, as compared to $10.3 million for the same period in 2024. The decrease was primarily attributable to lower employee related, research, consulting, and clinical costs. Research and development expenses were $16.0 million for the six months ended June 30, 2025, as compared to $19.9 million for the same period in 2024.

General and administrative expenses were $3.5 million for the second quarter of 2025, as compared to $4.8 million for the same period in 2024. The decrease was primarily attributable to lower employee-related and legal costs. General and administrative expenses were $7.5 million for the six months ended June 30, 2025, as compared to $9.7 million for the same period in 2024.

Other expense was $0.3 million for the second quarter of 2025, as compared to other income of $0.7 million for the same period in 2024. The decrease was primarily attributable to a decrease in interest income and an increase in the expense related to the sale of future royalties. Other expense was $0.8 million for the six months ended June 30, 2025, compared to other income of $1.3 million for the same period in 2024.

Curis’s cash and cash equivalents totaled $10.1 million as of June 30, 2025, and the Company had approximately 10.7 million shares of common stock outstanding. We believe that our existing cash and cash equivalents, together with the net proceeds of $6.0 million from the July 2025 Offerings, should enable us to fund our existing operations into the first quarter of 2026.

Conference Call and Webcast Information

Curis management will host a conference call today, August 5, 2025, at 8:30 a.m. ET, to discuss the business update and these financial results.

To access the live conference call, please dial 1-800-836-8184 from the United States or 1-646-357-8785 from other locations. To access the webcast login here shortly before 8:30 a.m. ET. The webcast can also be accessed on the Curis website at the Events and Presentations section of the Investors page.

Cumberland Pharmaceuticals Reports 23% Revenue Growth Year-to-Date

On August 5, 2025 Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, reported that its product portfolio of FDA-approved brands delivered combined net revenues of $10.8 million during the second quarter of 2025, a 10% increase over the prior year period (Press release, Cumberland Pharmaceuticals, AUG 5, 2025, View Source [SID1234654782]). Year-to-date revenues for the first six months of the year totaled $22.6 million, representing an increase of 23% over the first half of 2024.

Cumberland ended the quarter with approximately $68 million in total assets, $40 million in liabilities and $28 million of shareholders’ equity.

"We have had a strong first half of the year, especially following the progress of our clinical development programs," said Cumberland Pharmaceuticals CEO A.J. Kazimi. "We look forward to building on this success throughout the remainder of the year as we continue our mission of working together to provide unique products that improve the quality of patient care."

RECENT COMPANY DEVELOPMENTS INCLUDE:
Vibativ 4-Vial Starter Pak Now Available for Vizient Providers
Cumberland recently announced the availability of the Vibativ (telavancin) 4-Vial Starter Pak through a new supply arrangement with Vizient Inc., making it accessible to their health care providers nationwide.
As the country’s largest provider-driven health care performance improvement company, Vizient serves more than 65% of the nation’s acute care providers, including 97% of academic medical centers and 35% of the non-acute market. Through this agreement, Vizient members now have access to Vibativ’s new 4-vial configuration, which supports flexible treatment initiation in both inpatient and outpatient settings for this potentially life-saving therapy.

Pharmacokinetic Analysis Reinforces Vibativ Dosing Strategies

A comprehensive new pharmacokinetic analysis of Vibativ was published in Antimicrobial Agents and Chemotherapy in June 2025. The analysis utilizes data from over 1,200 patients across varied demographics and comorbidity profiles. The findings support optimized dosing strategies for patients with different infection severities and renal function levels, reinforcing Vibativ’s critical role in treating life-threatening gram-positive infections.

Ifetroban Clinical Studies
In June 2025, breakthrough findings from Cumberland’s Phase II FIGHT DMD trial, evaluating its ifetroban product candidate in patients with Duchenne muscular dystrophy ("DMD"), were presented at the Parent Project Muscular Dystrophy Annual Conference. The findings demonstrated that high-dose ifetroban delivered a 5.4% improvement in cardiac function in patients with DMD. The presentation also included additional biomarker data indicating reduced cardiac damage, which correlated with the clinical findings. These results position ifetroban as a potential treatment for DMD cardiomyopathy – the leading cause of death in these patients and a critical unmet medical need affecting 90% of DMD patients.

The top-line FIGHT DMD study findings were also selected for a late-breaking presentation at the Muscular Dystrophy Association’s Clinical & Scientific Conference in March 2025. In June 2025, Cumberland completed the comprehensive analysis of the study results, completed its clinical study report and submitted it to the FDA along with a request for an end-of-Phase II meeting.

Meanwhile, Cumberland has been evaluating its ifetroban product candidate in a Phase II clinical program in patients with Systemic Sclerosis. Enrollment in the study was completed this year, and Cumberland is monitoring the clinical sites in preparation to lock the database and begin evaluating the results.
In addition, Cumberland has a Phase II clinical study, the FIGHTING FIBROSIS trial, underway in patients with Idiopathic Pulmonary Fibrosis, the most common form of progressive fibrosing interstitial lung disease. Patient enrollment is now well underway in medical centers across the U.S. The study design includes both an interim safety analysis, as well as an interim efficacy analysis.

New Study Features Caldolor (ibuprofen injection) for Older Patients
In May 2025, Cumberland announced the publication of its study investigating Caldolor (intravenous ibuprofen) in Clinical Therapeutics, demonstrating the product’s safety and efficacy for managing post-operative pain in patients 60 years of age and older. The analysis, encompassing over 1,000 older patients from comprehensive post-surgical studies, represents the first such evaluation in this vulnerable population, where traditional pain management options such as opioids carry increased risk.

FINANCIAL RESULTS:
Net Revenue: For the second quarter of 2025, net revenues were $10.8 million and included $2.8 million for Kristalose, $3.1 million for Sancuso, $2.7 million for Vibativ and $1.6 million for Caldolor.
Year-to-date 2025 net revenues were $22.6 million. Year-to-date net revenues by product were $6.2 million for Kristalose, $5.4 million for Sancuso, $4.1 million for Vibativ and $2.9 million for Caldolor.
Operating Expenses: Total operating expenses were $11.6 million for the second quarter of 2025 and $22 million for the first half of the year.
Net Income (loss): Year-to-date net income was approximately $516,000 and the second quarter net loss was approximately $741,000.
Adjusted Earnings: Adjusted earnings for the six months ended 2025 were $2.8 million, or $0.18 per diluted share.
Balance Sheet: At June 30, 2025, Cumberland had approximately $68 million in total assets, including $16 million in cash and cash equivalents. Liabilities totaled $40 million, including $5 million on the company’s credit facility. Total shareholders’ equity was $28 million on June 30, 2025.
EARNINGS REPORT CALL:
A conference call will be held today, August 5, 2025, at 4:30 p.m. Eastern Time to provide a company update and discuss the financial results.
The link to register is View Source
Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference.
A replay of the call will be available for one year and can be accessed via Cumberland’s website or by visiting: View Source

Cogent Biosciences Reports Recent Business Highlights and Second Quarter 2025 Financial Results

On August 5, 2025 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported financial results for the second quarter ended June 30, 2025 (Press release, Cogent Biosciences, AUG 5, 2025, View Source [SID1234654781]).

"We were thrilled to announce bezuclastinib’s impressive performance in the SUMMIT trial, demonstrating clinically meaningful and statistically significant results across all primary and key secondary endpoints," said Andrew Robbins, the Company’s President and Chief Executive Officer. "These positive data along with the favorable safety profile give us confidence that bezuclastinib has the potential to become the new standard-of-care for NonAdvSM patients. Supported by our recent upsized public offering, Cogent is advancing our mission from a position of strength as we prepare to report top-line results from two additional pivotal trials in GIST and AdvSM in the second half of this year, submit our first New Drug Application by the end of 2025 and make continued progress toward the anticipated commercial launch of bezuclastinib in 2026."

Recent Business Highlights

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Announced positive top-line results from the registration-directed Part 2 of the SUMMIT clinical trial in NonAdvanced Systemic Mastocytosis (NonAdvSM) patients.
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The SUMMIT trial, which was designed to assess the clinical benefit of bezuclastinib versus placebo, achieved its primary endpoint with a highly statistically significant difference in the mean change in Total Symptom Score (TSS) at 24 weeks (p=0.0002). TSS was assessed by the Mastocytosis Symptom Severity Daily Diary (MS2D2). The bezuclastinib arm had a mean reduction of 24.3 points in TSS at 24 weeks, versus the placebo arm which had a mean reduction of 15.4 points in TSS, resulting in a placebo-adjusted TSS improvement of 8.91 points. In addition, the SUMMIT trial demonstrated highly statistically significant benefit across all key secondary endpoints, including reduction of serum tryptase on which 87.4% of bezuclastinib-treated patients had ≥50% reduction, compared to no patients in the control arm (87.4% vs. 0%; p<0.0001).
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Bezuclastinib demonstrated a favorable safety and tolerability profile in SUMMIT.

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The majority of treatment emergent adverse events (TEAEs) (98.3% in bezuclastinib arm vs. 88.3% in placebo arm) were of low grade. The most frequent TEAEs reported on bezuclastinib treatment were hair color change (69.5% bezuclastinib vs. 5.0% placebo), altered taste (23.7% bezuclastinib vs. 0% placebo), nausea (22.0% bezuclastinib vs. 13.3% placebo) and ALT/AST elevations (22.0% bezuclastinib vs. 6.6% placebo; >Gr 3, 5.9% vs. 0%). Serious AEs occurred in 4.2% of patients treated with bezuclastinib, compared to 5.0% of patients treated with placebo. Discontinuations due to treatment-related AEs occurred in 5.9% of patients treated with bezuclastinib, all due to ALT/AST elevations and all patients fully resolved. There were no hepatic AEs reported in any patient other than transient and manageable lab abnormalities.
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Announced two financial transactions, positioning Cogent with access to over $800 million in capital.
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In June, secured a debt financing facility of up to $400 million with SLR Capital Partners. An initial tranche of $50 million was drawn at closing in June 2025, with additional tranches available upon achieving key clinical and commercial milestones.
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In July, successfully closed an upsized underwritten public offering of 25,555,556 shares of common stock at $9.00 per share, including the full exercise of the underwriters’ option to purchase an additional 3,333,333 shares. This offering generated net proceeds of $215.8 million.
Anticipated Upcoming Milestones

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Announce top-line results from PEAK in the second half of 2025. PEAK is a global, blinded, randomized Phase 3 clinical trial studying the combination of bezuclastinib and sunitinib versus sunitinib alone in patients with imatinib-resistant gastrointestinal stromal tumors (GIST).
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Announce top-line results from APEX in the second half of 2025. APEX is a registration-directed, global, open-label trial in patients with advanced systemic mastocytosis (AdvSM).
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Submit Cogent’s first NDA for bezuclastinib by the end of 2025.

Second Quarter 2025 Financial Results

Cash Position: As of June 30, 2025, Cogent had cash, cash equivalents and marketable securities of $237.8 million. The company expects its existing cash, cash equivalents and marketable securities, together with the net proceeds from the $230 million upsized public offering in July 2025, will be sufficient to fund its operating expenses and capital expenditure requirements into 2027, including through potential FDA approval of bezuclastinib for NonAdvSM and early commercial launch activities.

R&D Expenses: Research and development expenses were $62.2 million for the second quarter of 2025 as compared to $54.3 million for the second quarter of 2024. The increase was primarily due to costs incurred to support our on-going SUMMIT, PEAK and APEX clinical trials and to the continued progression of our early stage, preclinical and discovery programs. R&D expenses include non-cash stock compensation expense of $5.0 million for the second quarter of 2025 as compared to $4.7 million for the second quarter of 2024.

G&A Expenses: General and administrative expenses were $13.4 million for the second quarter of 2025 as compared to $10.1 million for the second quarter of 2024. The increase was primarily due to the growth of the organization. G&A expenses include non-cash stock compensation expense of $4.8 million for the second quarter of 2025 as compared to $5.3 million for the second quarter of 2024.

Net Loss: Net loss was $73.5 million for the second quarter of 2025 as compared to a net loss of $59.0 million for the same period of 2024.

Cerus Corporation Announces Second Quarter 2025 Financial Results

On August 5, 2025 Cerus Corporation (Nasdaq:CERS) reported financial results for the second quarter ended June 30, 2025, and provided a business update (Press release, Cerus, AUG 5, 2025, View Source [SID1234654780]).

"With our singular focus to advance blood safety and availability around the globe by establishing INTERCEPT as the standard of care, this quarter’s commercial results are evidence of the progress we are making in multiple geographies and across our INTERCEPT product portfolio. The early launch and adoption of our next generation, LED-based INT200 illumination device continues to surpass our expectations around performance and customer experience, and advancements in our product development pipeline are encouraging, including the early resubmission for RBC CE Mark and the recent DoD award for the CRYO-First study," said William "Obi" Greenman, Cerus’ president and chief executive officer.

"In addition, the continued strong commercial and financial execution in Q2 resulted in record product sales, a year-over-year narrowing of net loss attributable to Cerus, and another quarter of positive non-GAAP adjusted EBITDA," continued Greenman. "Given the anticipated sales trajectory, we are raising our full-year 2025 product revenue guidance today."

Additional highlights include:

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

Six Months Ended

June 30,

Change

June 30,

Change

2025

2024

2025

2024

Product Revenue

52.4

45.1

7.4

95.7

83.4

12.2

Government Contract Revenue

7.7

5.4

2.2

13.3

10.5

2.8

Total Revenue

60.1

50.5

9.6

109.0

93.9

15.1

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

Customer demand for Pathogen Reduced, Cryoprecipitated Fibrinogen Complex (commonly referred to as INTERCEPT Fibrinogen Complex, or IFC) continues to increase with second quarter IFC revenue of $5.6 million compared to $2.0 million in the prior year period.
The European regulatory review of our CE Mark application for the INTERCEPT Blood System for Red Blood Cells (RBCs) continues. TÜV-SÜD, the Notified Body, has completed their review of several modules of the submission, including the clinical module, and transferred the dossier to the State Institute for Drug Control (SÚKL), our Competent Authority, in the Czech Republic, for consultation.
Awarded an additional $7.2 million in funding from the U.S. Department of Defense Industrial Base Analysis and Sustainment (IBAS) program for the development of lyophilized IFC.
Second-quarter net loss attributable to Cerus Corporation was $5.7 million. Second-quarter non-GAAP adjusted EBITDA of $0.9 million, marking another quarter of positive non-GAAP adjusted EBITDA.
Cash, cash equivalents, and short-term investments were $78.0 million at June 30, 2025.
Revenue

Product revenue during the second quarter of 2025 was $52.4 million, compared to $45.1 million during the prior year period. This year-over-year increase of 16% was led by growth in IFC and global platelet sales. Second-quarter product revenue included U.S. sales of IFC, which were $5.6 million, up from $2.0 million during the prior year period.

Second-quarter 2025 government contract revenue was $7.7 million, compared to $5.4 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 second quarter of 2025 was $29.0 million, increasing by 17% over the prior year period. Product gross margin for the second quarter of 2025 was 55.2% compared to 54.7% for the second quarter of 2024. A number of offsetting factors resulted in relatively stable product gross margin in the second quarter of 2025.

Operating Expenses

Total operating expenses for the second quarter of 2025 were $40.1 million, compared to $33.9 million for the same period of the prior year, reflecting a year-over-year increase of 18%. Both R&D and selling, general, and administrative (SG&A) expenses increased year-over-year, reflecting investments in our business to drive future revenue growth.

R&D expenses for the second quarter of 2025 were $18.9 million, compared to $15.0 million for the second quarter of 2024. The primary drivers for the increase in R&D expenses were related to development costs on INT200, the new LED-based illumination device, higher government contract costs incurred to support the higher government contract revenue and higher employee compensation expenses tied to cost-of-living adjustments which became effective earlier in the year.

SG&A expenses totaled $21.2 million for the second quarter of 2025, compared to $19.0 million for the second quarter of 2024. The primary driver for the increase in SG&A expenses was higher employee compensation expenses tied to cost-of-living adjustments which became effective earlier in the year.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for the second quarter of 2025 was $5.7 million, or $0.03 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $5.8 million, or $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 2025 was $13.4 million compared to net loss attributable to Cerus Corporation of $15.5 million for the first half of 2024.

Non-GAAP Adjusted EBITDA

Non-GAAP adjusted EBITDA for the second quarter of 2025 was positive $0.9 million, compared to non-GAAP adjusted EBITDA of positive $0.8 million for the same period of the prior year. Non-GAAP adjusted EBITDA for the first half of 2025 was a positive $1.1 million compared to non-GAAP adjusted EBITDA of negative $1.9 million for the first half of 2024.

The Company remains committed to its goal of achieving 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 June 30, 2025, the Company had cash, cash equivalents, and short-term investments of $78.0 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 June 30, 2025, which is dependent on eligible assets supporting the borrowing base.

For the second quarter of 2025, cash used from operations totaled $2.4 million compared to $0.4 million generated during the same period of the prior year. Cash use from operations in the second quarter of 2025 was tied to an increase in working capital, namely inventory in support of the expected growth.

Increasing Full-Year 2025 Product Revenue Guidance

Given the strong performance during the first half of 2025, coupled with increasing conviction about expected second half growth, the Company now expects full-year 2025 product revenue will be in the range of $200 million to $203 million. These revisions include increased IFC guidance, which the Company now expects to be between $16 million to $18 million for 2025. Previously, the Company’s 2025 product revenue guidance range was $194 million to $200 million, including 2025 IFC revenue guidance between $12 million and $15 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 August 26, 2025.