On August 5, 2026 Coherus Oncology, Inc. (Nasdaq: CHRS), reported financial results for the second quarter 2026, and provided an overview of recent business highlights.

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"During the second quarter we continued to pursue our science-driven clinical development strategy, creating multiple avenues for long-term value creation, and look forward to further maturation of data with both tagmokitug and casdozokitug," said Denny Lanfear, Chairman and Chief Executive Officer.

"We continue to advance our pipeline studies, including completion of enrollment with casdozokitug in HCC, as well as with tagmokitug in HNSCC and CRC, with emerging evidence of clinical activity in combination with toripalimab in HNSCC. While preliminary, the activity observed to date reinforces our confidence in the Treg depletion mechanism," said Rosh Dias, MD, Chief Medical Officer.

RECENT BUSINESS HIGHLIGHTS

LOQTORZI (toripalimab-tpzi) Commercial Updates

● LOQTORZI revenue for Q2 2026 was $13.6 million, a 37% increase over $10.0 million in Q2 2025, and a 15% increase versus the $11.8 million in Q1 2026 which was impacted by severe weather events as well as normal seasonality.
● Demand trends remained strong in the second quarter, with the highest number of new patient starts since launch, normalized patient discontinuation rates following seasonal Q1 trends, and continued improvement in therapy duration, supporting further growth opportunities.
● LOQTORZI remains the only FDA-approved and available treatment in the U.S. for recurrent, locally advanced or metastatic nasopharyngeal carcinoma (NPC.) It is the only preferred Category 1 first-line treatment option recommended in combination with cisplatin and gemcitabine; and the only preferred subsequent-line treatment recommended by the National Comprehensive Cancer Network (NCCN).
We will continue to appropriately communicate the six-year overall survival (OS) follow-up results from the Phase 3 JUPITER-02 trial evaluating LOQTORZI plus chemotherapy versus chemotherapy alone.

ADVANCEMENT OF INNOVATIVE, NEXT-GENERATION ONCOLOGY PIPELINE

Tagmokitug is a highly selective cytolytic CCR8 antibody that specifically binds and preferentially depletes CCR8+ tumor regulatory T cells (Tregs) with no off-target binding.

● The Phase 1b dose-optimization studies evaluating tagmokitug in combination with toripalimab in second-line head and neck squamous cell carcinoma (HNSCC) and upper gastrointestinal adenocarcinomas remain ongoing, with initial data readouts expected in 2H 2026.
● The Phase 1b study evaluating tagmokitug in combination with toripalimab, with and without chemotherapy, in first- and second-line esophageal squamous cell carcinoma (ESCC), continues to enroll patients, with initial data expected in 2H 2026.
● The Phase 1b/2a study evaluating the tagmokitug and toripalimab combination in fourth-line and beyond colorectal cancer with no liver metastasis, is fully enrolled, with initial data expected in 2H 2026.
● A Phase 1b clinical study evaluating tagmokitug in combination with pasritamig, a T-cell engaging bispecific antibody, in patients with metastatic castration-resistant prostate cancer (mCRPC) is expected to initiate in the fall of 2026.
Casdozokitug is a first-in-class IL-27 antagonistic antibody currently being evaluated in a Phase 2 study in patients with first-line unresectable hepatocellular carcinoma (uHCC) to assess treatment benefit, safety and response biomarkers.

● Enrollment is complete in the randomized Phase 2 trial of casdozokitug/toripalimab/bevacizumab in 1L uHCC and the first data readout is expected 2H 2026.
SECOND QUARTER 2026 FINANCIAL RESULTS

Net revenue from continuing operations was $14.3 million and $10.3 million during the three months ended June 30, 2026 and 2025, respectively, and $26.6 million and $17.9 million during the six months ended June 30, 2026 and 2025, respectively. The increases were driven primarily by volume growth of LOQTORZI.

Cost of goods sold (COGS) from continuing operations was $4.2 million and $3.4 million during the three months ended June 30, 2026 and 2025, respectively, and $8.1 million and $6.0 million during the six months ended June 30, 2026 and 2025, respectively. The increases were primarily due to volume growth of LOQTORZI.

Research and development (R&D) expenses from continuing operations were $21.4 million and $26.3 million for the three months ended June 30, 2026 and 2025, respectively, and $43.0 million and $50.7 million during the six months ended June 30, 2026 and 2025, respectively. The decreases were primarily due to savings from reduced headcount, lower infrastructure costs, and lower clinical trial and R&D manufacturing costs.

Selling, general and administrative (SG&A) expenses from continuing operations were $21.0 million and $26.0 million during the three months ended June 30, 2026 and 2025, respectively, and $44.1 million and $52.1 million during the six months ended June 30, 2026 and 2025, respectively. The decreases were driven primarily by lower headcount and decreased operating costs resulting from Coherus completing the exit from the biosimilar business in 2025.

Net (loss) from continuing operations for the second quarter of 2026 was $33.3 million, or $(0.22) per share on a diluted basis, compared to a net loss of $44.9 million, or $(0.39) per share on a diluted basis, for the same period in 2025. Net loss for the first half of 2026 was $70.3 million, or $(0.48) per share on a diluted basis, compared to a net loss of $92.3 million, or $(0.80) per share on a diluted basis for the first half of 2025.

Non-GAAP net loss from continuing operations for the second quarter of 2026 was $30.1 million, or $(0.19) per share on a diluted basis, compared to $39.0 million, or $(0.34) per share for the same period in 2025. Non-GAAP net loss for the first half of 2026 was $64.1 million, or $(0.44) per share on a diluted basis, compared to $79.9 million, or $(0.69) per share for the first half of 2025. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss from continuing operations and a reconciliation to the most directly comparable GAAP measures.

Cash, cash equivalents and marketable securities totaled $105.3 million as of June 30, 2026, compared to $172.1 million as of December 31, 2025. These balances were inclusive of Transition Service Agreement (TSA)-related collections that will be applied to associated TSA payables and accrued liabilities which totaled $22.7 million and $65.1 million as of June 30, 2026 and December 31, 2025, respectively.

Conference Call Information

When: Wednesday, August 5, 2026, starting at 5:00 p.m. Eastern Standard Time

To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: View Source

Webcast: View Source

A live and archived webcast will be available on the "Investors" section of the Coherus website at

View Source

Please dial in 15 minutes early to ensure a timely connection to the call.

(Press release, Coherus Oncology, AUG 5, 2026, View Source [SID1234669723])

On August 5, 2026 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported a number of updates on the SECuRE trial.

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Preliminary assessment of the 8 GBq 67Cu-SAR-bisPSMA dose cohorts
Patient population
The SECuRE trial is currently recruiting in the Cohort Expansion phase at the 8 GBq 67Cu-SAR-bisPSMA dose level (up to 6 doses). This preliminary efficacy and safety assessment includes all trial participants who received 8 GBq treatment cycles, comprising 16 participants from the ongoing Cohort Expansion phase and 3 participants from cohort 2 of the Dose Escalation phase (19 participants in total), by the data cut-off of 20 July 2026.

Most participants had bone metastases (63%) and had received multiple lines of therapy prior to being enrolled in the trial (79% received 5 or more previous anti-cancer regimens). Previous standard treatments included androgen deprivation therapy (ADT), radiation, first- and/or second-generation androgen receptor pathway inhibitor (ARPI), with some participants having received taxane-based therapy for metastatic hormone-sensitive disease. Some participants were exposed to an experimental prostate-specific membrane antigen (PSMA) T-Cell Engager prior to their enrolment into the SECuRE study. The median number of treatment cycles of 67Cu-SAR-bisPSMA across participants was two (range: 1-4, mean 2.1±1.0 [SD]). Three of these participants from the Cohort Expansion phase were treated with concomitant enzalutamide.

PSA and radiographic assessments
A substantial reduction in PSA was observed, with 74% (n=14) of participants achieving a PSA25 response (i.e. reductions of ≥25% in PSA), 63% (n=12) PSA50, 53% (n=10) PSA75, and 26% (n=5) PSA90 (Figure 1).

A total of 81% (n=13) of the participants who were evaluable for radiographic assessment (n=16) achieved disease control. This includes 50% (n=8) with stable disease and 31% (n=5) with complete response/undetectable disease (as assessed by RECIST and/or bone scan.

Figure 1. PSA responses of participants from cohort 2 (N=3) and Cohort Expansion (N=16) who received 1-4 doses of 8 GBq of 67Cu-SAR-bisPSMA as of 20 July 2026.

Safety profile
Participants who received 8 GBq cycles, including those in the Cohort Expansion Phase, generally developed a lower prevalence and severity of related AEs compared to the overall trial population. The most frequently reported related AEs were dry mouth and nausea, each occurring in 9 (47%) and 8 (42%) participants, respectively. Anaemia and decreased neutrophil count were each reported in 4 (21%) participants, while fatigue was reported in 5 (26%) participants. Most events were low grade (mild/moderate) and transient, with two Grade 3 events (lymphocyte and white blood cell count decreases) in 1 (5%) participant. No Grade ≥4 related events were reported.

Complete response/undetectable disease observed in seven participants in the 67Cu-SAR-bisPSMA program
Two new participants in the Cohort Expansion phase of the SECuRE trial who were evaluable at data cut-off achieved complete response as assessed by RECIST. Combined with the five previously announced cases2,3,4,5, this brings the total number of participants who achieved complete response or undetectable disease (assessed by RECIST, bone scan and/or PSA) across the 67Cu-SAR-bisPSMA program to seven. Five out of these seven participants received treatment at the 8 GBq 67Cu-SAR-bisPSMA dose level. This represents almost a third (31%) of all participants evaluable for radiographic assessment treated at the 8 GBq 67Cu-SAR-bisPSMA dose level.

The median baseline PSA among these seven participants was 90.3 ng/mL (range 3.3 – 490.3). They had received a median of 5 prior anti-cancer regimens (range 4-7). Bone metastases were present in four of seven participants (57%). Among the participants who had received 8 GBq doses, the median number of cycles was 3 (range 1-4, mean 2.8±0.8 [SD]). All seven participants had received prior second-generation ARPI.

These observations demonstrate considerable anti-tumour activity of 67Cu-SAR-bisPSMA following a small number of 8 GBq treatment cycles in metastatic castration-resistant prostate cancer (mCRPC) patients who have failed multiple lines of therapy.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "The SAR-bisPSMA product continues to generate an impressive body of evidence in clinical trials and case studies, highlighting the strength of the evidence in both diagnostic and theranostic applications.

"Most impressively, despite the relatively small numbers of patients enrolled in the SECuRE trial to date, and most having received up to 2 treatment cycles at 8 GBq, we see a trend that is impossible to ignore. We continue seeing patients with mCRPC, who have gone through numerous lines of therapy prior to the SECuRE study enrolment, achieve undetectable disease and/or complete response following 67Cu-SAR-bisPSMA treatment. Seven participants have now achieved undetectable disease and/or complete response across all cohorts (assessed by RECIST, bone scan and/or PSA), and five of these are from the 8 GBq cohorts. This means that almost a third of all evaluable patients treated at this dose level have achieved a complete response and/or undetectable disease.

"The evidence of the depth and consistency of responses achievable with 67Cu-SAR-bisPSMA is further substantiated by the PSA responses across the SECuRE study in patients who received their 67Cu-SAR-bisPSMA treatments at the 8 GBq dose level. PSA reductions of ≥50% are currently at 63%, with over a quarter of patients reaching PSA90. Importantly, 67Cu-SAR-bisPSMA at the 8 GBq dose level shows a favourable safety profile, with AEs being mostly mild to moderate and transient. This highlights the potential of this therapy in earlier stages of disease, aiming to help improve treatment outcomes of a broader prostate cancer patient population.

"The SECuRE trial will continue enrolment into the Cohort Expansion Phase with Phase III registrational trial planning ongoing based on data that continues to be generated.

"The benefits we are seeing in the clinic, based on the treatment responses and favorable safety profile achieved with so few doses, are due to our unique combination of the optimised bivalent "bis" structure with the advantages offered by the beta emitter, copper-67, enabled by the proprietary sarcophagine (SAR) chelating technology. Time and time again we are seeing the benefits of this approach across both the diagnostic and therapeutic areas with this one molecule, from early detection in pre-prostatectomy patients to visualisation of biochemically recurrent prostate cancer and then to the treatment of mCRPC patients. Armed with the growing body of high-quality data, our team and collaborators continue to advance SAR-bisPSMA towards the paradigm shift it could bring to the prostate cancer space, aiming to improve the outcomes of so many patients with prostate cancer across multiple stages of their disease."

About the SECuRE trial
The SECuRE trial (NCT04868604)1 is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm study, planning to enroll approximately 54 participants in the US. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.

The SECuRE trial consists of the Dose Escalation (Phase I) and Cohort Expansion (Phase II) Phases. Based on the data from the Dose Escalation Phase, which demonstrated a favourable safety profile and efficacy of 67Cu-SAR-bisPSMA, the SECuRE trial progressed to the Cohort Expansion at an 8 GBq dose level as per the Safety Review Committee (SRC) recommendation (up to 6 cycles per patient in total)3. Recruitment is currently ongoing for the Cohort Expansion Phase which will include 24 participants (Figure 2). A subset of participants will be treated with the combination of 8 GBq of 67Cu-SAR-bisPSMA with enzalutamide (ARPI), in line with the positive results from the Enza-p trial6 and previous discussions with and advice from key global medical experts in the field of prostate cancer.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary SAR technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

(Press release, Clarity Pharmaceuticals, AUG 5, 2026, View Source [SID1234669722])

On August 5, 2026 Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology-focused biopharmaceutical company and majority-owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), reported an update on the expanding base of institutions ordering LYMPHIR (denileukin diftitox-cxdl) through wholesalers, continued formulary progress at priority U.S. treatment centers, and other key indicators supporting the product’s commercial launch.

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"Our commercial progress is reflected in two closely connected measures: growth in the number of institutions ordering LYMPHIR and continued expansion of the formulary approvals that enable additional institutions to begin ordering the product and treating patients," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology. "I am pleased to report that the number of new institutions ordering LYMPHIR rose, total institutional vial orders increased, formulary reviews and approvals grew, and wholesalers are reordering LYMPHIR to reflect this growth. Formulary inclusion is a key gateway to institutional ordering and patient access. The success of our targeted launch, so far, was accomplished by a small yet focused internal launch team. Together with our recently expanded commercial and medical affairs teams, we believe Citius Oncology is well positioned to broaden engagement with over 250 priority treatment centers, support continued adoption, and accelerate topline growth through the balance of the year."

LYMPHIR is now available in 42 institutions including academic oncology centers, leading National Comprehensive Cancer Network (NCCN) institutions and community infusion centers. During the quarter ended June 30, 2026, the number of new institutions increased 78% compared with the prior quarter. Vials ordered by institutions from wholesalers rose 31% during the quarter. Subsequent to the quarter ended June 30, 2026, following an increase in both the number of ordering institutions and vial demand, orders from wholesalers have begun to reflect this incremental demand. Citius revenue is recognized when wholesale orders for LYMPHIR are placed and filled.

LYMPHIR’s growing institutional footprint consists of leading academic and cancer treatment centers with recognized CTCL expertise. Formulary inclusion is an important step in the commercial adoption process. Once approved, an institution can order the product through a nationwide wholesaler network and make the therapy available for prescribing to eligible adult patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL). Review times vary by institution and may range from several weeks to several months. Based on Company experience to date, institutions that add LYMPHIR to formulary have generally placed their first patient order within approximately two to six weeks. Citius Oncology anticipates more than 20 additional institutions during the current quarter, and is targeting formulary inclusion with 100 priority institutions by year-end.

The Company continues to engage leading CTCL experts through scientific exchange and educational initiatives designed to increase understanding of LYMPHIR’s clinical profile and support institutional evaluation of the therapy. At the Sixth World Congress of Cutaneous Lymphomas in Montreal, the Company met with many U.S. and international CTCL key opinion leaders. The expanded medical affairs team is expected to increase the frequency and breadth of the Company’s scientific engagement with the CTCL community.

According to Company tracking, LYMPHIR has secured near-universal payer coverage. Formulary inclusion and payer coverage address complementary requirements for market access. Together, these indicators reflect continued progress in building LYMPHIR’s commercial foundation.

About LYMPHIR (denileukin diftitox-cxdl)

LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.

In 2021, reformulated denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize reformulated denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025.

(Press release, Citius Pharmaceuticals, AUG 5, 2026, View Source [SID1234669721])

On August 5, 2026 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the second quarter ended June 27, 2026.

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Key Highlights
•Reports second-quarter revenue of $1.00 billion, GAAP loss per share of $(0.03), and non-GAAP earnings per share of $3.02.
•Organic revenue growth of 0.1% reached the highest level since the third quarter of 2023.
•Non-GAAP operating margin increased 420 basis points on a sequential basis to 20.5%, while the GAAP operating margin was essentially flat on a sequential basis at 11.9%.
•Increases 2026 guidance for revenue and non-GAAP earnings per share.
•Organic revenue guidance increasing by 150 basis points and non-GAAP earnings per share guidance increasing by $0.25 at midpoint.
•Guidance increases primarily driven by improving demand trends in the DSA segment and better-than-expected performance in the Manufacturing segment.
•Repurchased $100 million of common stock in the second quarter at an average price of $174 per share to enhance shareholder value.
•To refine and further strengthen its portfolio, the Company completed the divestitures of certain European Discovery Services sites as well as the CDMO and Cell Solutions businesses in May 2026.
•To further deepen its client relationships, the Company has joined Eli Lilly’s TuneLab AI/ML platform by providing non-clinical testing expertise to optimize drug discovery and advance R&D modernization efforts. Additionally, it has collaborated with Arovella Therapeutics to provide in vitro Next Generation Sequencing (NGS) services, which was added through the PathoQuest acquisition. This collaboration will accelerate progress towards Arovella’s alternative cancer treatment approaches.
•To advance its modernization efforts, Charles River introduced an enhanced digital pathology solution to drive efforts to further digitize and automate the Company. This AI-enabled, end-to-end workflow will deliver improved study turnaround times and increased pathologist efficiency.

Second-Quarter Results
Revenue was $1.00 billion, a decrease of 2.7% from $1.03 billion in the second quarter of 2025. On an organic basis, revenue increased 0.1%, driven by revenue growth in the Manufacturing Solutions (Manufacturing) and Discovery and Safety Assessment (DSA) segments, offset by a decline in the Research Models and Services (RMS) segment. Organic revenue growth excludes the effect of acquisitions, divestitures, and foreign currency translation.
In the second quarter of 2026, the GAAP operating margin was 11.9%, compared to 9.7% in the second quarter of 2025. The increase in the GAAP operating margin was primarily driven by the CDMO business, including lower accelerated amortization expense related to certain client relationships. The GAAP net loss available to common shareholders for the second quarter of 2026 was $(1.5) million, or $(0.03) per diluted share, compared to GAAP net income of $52.3 million, or $1.06 per diluted share for the same period in 2025. The decrease was principally due to a loss related to the CDMO and Cell Solutions divestiture totaling $63.7 million, or $1.40 per share.
On a non-GAAP basis, the second-quarter operating margin decreased to 20.5% from 22.1% in the second quarter of 2025, primarily as a result of higher study-related direct costs in the DSA segment and higher unallocated corporate costs. Non-GAAP net income was $146.2 million for the second quarter of 2026, a decrease of 5.0% from $154.0 million for the same period in 2025. Second-quarter diluted earnings per share on a non-GAAP basis were $3.02, a decrease of 3.2% from $3.12 per share in the second quarter of 2025. The non-GAAP net income and earnings per share decreases were driven primarily by the lower operating margin. The earnings per share decrease was partially offset by investment gains associated with the Company’s deferred compensation plan, which totaled a net benefit of $0.19 per share in the second quarter.

Birgit Girshick, Chief Executive Officer, said, "We made excellent progress in the second quarter on the execution of our Pathway to Purpose strategy. We are actively evaluating opportunities to modernize the Company and drive greater efficiency, to strengthen our leading drug development portfolio centered on regulated testing, and to further enhance our growth profile. We are focused on continuing to move forward on achieving our strategic initiatives and financial goals, which will strengthen our foundation and underpin our future success."

"We were encouraged that the demand environment continued to strengthen in the second quarter, particularly for our DSA segment, as evidenced by the fact that we recorded the highest net book-to-bill in nearly four years. This improvement was broad based across our global biopharmaceutical and small and mid-sized biotechnology clients, and it is our goal to continue to capture additional share of our clients’ R&D spending by providing client-centric solutions and by leveraging our global scale and deep scientific expertise. As a result of our collective efforts, we delivered on our second-quarter financial targets – exceeding our prior outlook – and are raising our revenue and non-GAAP earnings per share guidance for the year," Ms. Girshick concluded.

Second-Quarter Segment Results
Research Models and Services (RMS)
Revenue for the RMS segment was $209.5 million in the second quarter of 2026, a decrease of 1.8% from $213.3 million in the second quarter of 2025. Organic revenue decreased by 1.4%, due primarily to lower revenue for small research models in North America, as well as for research model services. The decline was partially offset by higher revenue for small research models in China.
In the second quarter of 2026, the RMS segment’s GAAP operating margin increased to 17.3% from 16.8% in the second quarter of 2025, primarily due to lower amortization of intangible assets related to the sale of the Cell Solutions business. On a non-GAAP basis, the operating margin decreased to 24.5% from 25.3%. The non-GAAP operating margin decrease was primarily driven by the impact of lower sales volume and an unfavorable geographic revenue mix.

Discovery and Safety Assessment (DSA)
Revenue for the DSA segment was $606.5 million in the second quarter of 2026, a decrease of 1.9% from $618.0 million in the second quarter of 2025. Organic revenue increased by 0.2%, driven primarily by higher study volume for regulated safety assessment services.
In the second quarter of 2026, the DSA segment’s GAAP operating margin increased to 20.5% from 19.9% in the second quarter of 2025. The increase was primarily driven by lower amortization of intangible assets related to the divestiture of certain European Discovery Services sites and lower third-party legal costs related to a non-human primate (NHP) supply matter. On a non-GAAP basis, the operating margin decreased to 25.6% from 27.4% in the second quarter of 2025. The non-GAAP operating margin decrease was primarily driven by higher study-related direct costs.

Manufacturing Solutions (Manufacturing)

Revenue for the Manufacturing segment was $188.1 million in the second quarter of 2026, a decrease of 6.3% from $200.8 million in the second quarter of 2025, primarily driven by the CDMO divestiture. Organic revenue increased 1.3%, driven primarily by higher revenue in the Microbial Solutions business.
The Manufacturing segment’s GAAP operating margin was 34.9%, compared to 6.0% in the second quarter of 2025. On a non-GAAP basis, the operating margin increased to 37.8% from 32.8% in the second quarter of 2025. The GAAP and non-GAAP increases were driven primarily by the CDMO business, including the benefit from the divestiture.
Stock Repurchase Update
The Company repurchased 1.7 million shares for a total of $300.0 million during the year-to-date period ended June 27, 2026, including 0.6 million shares for a total of $100.0 million in the second quarter of 2026. As of June 27, 2026, the Company had $700.0 million remaining under its $1.0 billion stock repurchase authorization that was approved by the Board of Directors on October 29, 2025.
2026 Guidance Update
The Company is increasing its 2026 revenue and non-GAAP earnings per share guidance, which was last updated on May 7, 2026. This increase primarily reflects the expected operational outperformance for the year, including in the second quarter, due primarily to improving demand trends in the DSA segment and better-than-expected performance in the Manufacturing segment. For the year, the Company expects the second-quarter investment gains associated with the deferred compensation plan will be largely offset by a higher tax rate, resulting in a negligible net impact to non-GAAP earnings per share.
On a GAAP basis, the Company is reducing its earnings per share guidance due primarily to the net loss related to the divestitures.
The Company’s 2026 guidance for revenue and earnings per share is as follows:
2026 GUIDANCE CURRENT PRIOR
Revenue growth/(decrease), reported (3.5)% – (2.5)%
(5.5)% – (4.0)%
Less: Contribution from acquisitions 0.0% – (0.5)%
0.0% – (0.5)%
Add: Impact from divestitures
~4.5%
~5.0%
Less: Favorable impact of foreign exchange (0.5)% – (1.0)%
(0.5)% – (1.0)%
Revenue growth/(decrease), organic (1)
0.0% – 1.0% (1.5)% – (0.5)%
GAAP EPS estimate $3.05 – $3.35
$5.35 – $5.85
Acquisition-related amortization (2) ~$2.30
~$2.30
Acquisition- and divestiture-related costs (3) ~$4.75
~$2.30
Costs associated with restructuring and efficiency initiatives (4) ~$1.20
~$0.85
Other, net (5) ($0.17)
NM
Non-GAAP EPS estimate $11.15 – $11.45 $10.80 – $11.30

Footnotes to Guidance Table:
(1) Organic revenue growth is defined as reported revenue growth adjusted for completed acquisitions, divestitures (including the CDMO and Cell Solutions businesses, as well as certain European Discovery Services sites), as well as foreign currency translation.
(2) These adjustments primarily include amortization related to intangible assets, as well as the purchase accounting step-up on inventory and certain long-term biological assets.
(3) These adjustments include costs related to the evaluation and integration of acquisitions and divestitures, as well as a net loss on divestitures and other transaction-related tax adjustments.
(4) These adjustments primarily include site consolidation (including site transition costs), severance, impairment, third-party consulting and professional services, and other costs related to the Company’s restructuring actions and efficiency initiatives. These adjustments also include gains and/or losses on the sale of certain assets and real estate.
(5) These adjustments primarily include: (i) certain venture capital and other strategic investment losses/(gains), net. This item only includes recognized gains or losses on certain investments. The Company does not forecast the future performance of these investments; and (ii) reductions to a previous $27 million inventory charge associated with an NHP supply matter. As a result of the resolution of the U.S. government investigations during fiscal year 2025, certain NHPs were subsequently utilized.

Webcast
Charles River has scheduled a live webcast on Wednesday, August 5, 2026, at 9:00 a.m. ET to discuss matters relating to this press release. To participate, please go to ir.criver.com and select the webcast link. You can also find the associated slide presentation and reconciliations of GAAP financial measures to non-GAAP financial measures on the website.

(Press release, Charles River Laboratories, AUG 5, 2026, View Source [SID1234669720])

On August 5, 2026 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, including silevertinib, a potential best-in-class brain-penetrant epidermal growth factor receptor (EGFR) inhibitor, reported financial results for the second quarter ended June 30, 2026, and provided a corporate update.

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"Silevertinib continued to demonstrate robust clinical activity and durable responses in frontline patients with non-classical EGFR-mutant NSCLC, as presented at ASCO (Free ASCO Whitepaper) in May," said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We are particularly encouraged that no patients developed de novo brain metastases and that the CNS ORR was 86% in patients with baseline brain metastases. Approximately 80% of all patients with non-classical EGFR mutations progress in the brain, and approximately 40% of patients with non-classical EGFR-mutant NSCLC present with brain metastases at diagnosis, underscoring silevertinib’s potential to address this significant unmet medical need. We look forward to engaging with the FDA and providing an update on the pivotal development path for silevertinib in frontline NSCLC in the fourth quarter."

Recent Developments & Upcoming Milestones:
•On May 30, 2026, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, data were presented from the Phase 2 trial of silevertinib dosed at 200 mg once daily (QD) in 43 frontline NSCLC patients harboring a broad spectrum of EGFR non-classical mutations, including compound and P-Loop and C-Helix Compressing (PACC) mutations. As of an April 11, 2026 data cutoff date, results were as follows:
◦Objective Response Rate (ORR by RECIST 1.1), CNS ORR (ORR by RANO-BM), and Disease Control Rate (DCR) were 60%, 86% and 91%, respectively
◦Variant allele frequency reduction observed in all evaluable patients across 25 unique EGFR non-classical mutations, including PACC
◦Median duration of response had not been reached (95% CI: 7.0, NE)
◦Preliminary median progression-free survival of 15.2 months (95% CI: 10.8, NE)
◦No patients developed de novo brain metastases
◦23 of 43 patients (53%) remained on therapy, with the longest at 23.5 months
◦No new safety signals were observed. The rate of treatment-related adverse events greater than or equal to Grade 3 was reduced to 28% following dose reduction, and patients maintained or deepened clinical responses after dose reduction.
◦Safety, pharmacokinetics, pharmacodynamics and efficacy data support a 150 mg QD dose for pivotal development

•The Company plans to provide an update on the Phase 2 trial of silevertinib in frontline patients with non-classical EGFR-mutant (EGFRm) NSCLC in the fourth quarter of 2026.
•The Company is seeking U.S. Food and Drug Administration (FDA) feedback on a pivotal development path for silevertinib in frontline patients with non-classical EGFRm NSCLC, and expects to provide an update in the fourth quarter of 2026.
•The Phase 2 trial of silevertinib in combination with temozolomide in newly diagnosed EGFRvIII+ glioblastoma (GBM) is enrolling patients in the safety lead-in portion of the study. The Company remains on track to initiate the randomized portion of the study in the fourth quarter of 2026.
Financial Highlights
•Cash Position: Black Diamond ended the second quarter of 2026 with approximately $110.5 million in cash, cash equivalents, and investments compared to $128.7 million as of December 31, 2025. Net cash used in operations was $8.0 million for the second quarter of 2026 compared to net cash used in operations of $9.2 million for the second quarter of 2025.
•Research and Development Expenses: Research and development (R&D) expenses were $7.4 million for the second quarter of 2026, compared to $9.3 million for the same period in 2025. The decrease in R&D expenses was primarily due to the progression of our Phase 2 trial for silevertinib in NSCLC, partially offset by increased spend related to the start-up activities for the Phase 2 trial for silevertinib in GBM.
•General and Administrative Expenses: General and administrative (G&A) expenses were $4.7 million for the second quarter of 2026, compared to $4.1 million for the same period in 2025. The increase in G&A expenses was primarily due to an increase in IP-related costs.
•Net Loss: Net loss for the second quarter of 2026 was $9.9 million, as compared to a net loss of $10.6 million for the same period in 2025.
Financial Guidance
•Black Diamond ended the second quarter of 2026 with approximately $110.5 million in cash, cash equivalents, and investments which the Company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the second half of 2028.
About Silevertinib
Silevertinib is an investigational oral, covalent, brain-penetrant fourth-generation tyrosine kinase inhibitor (TKI) that selectively targets classical and more than 50 non-classical EGFR mutations in NSCLC. It is also designed to potently inhibit key EGFR alterations seen in GBM, including EGFRvIII, while avoiding the paradoxical EGFR activation reported with reversible TKIs. To date, over 200 patients with EGFRm NSCLC or EGFR-altered GBM have been treated with silevertinib.
In addition to the ongoing Phase 2 trial of silevertinib in patients with non-classical EGFRm NSCLC, the Company also initiated a randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII-positive GBM (NCT07326566) in May 2026.

(Press release, Black Diamond Therapeutics, AUG 5, 2026, View Source [SID1234669719])