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Cullinan Therapeutics Provides Corporate Update and Reports First Quarter 2026 Financial Results

On May 7, 2026 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, reported an update on recent and anticipated business highlights and announced its financial results for the first quarter ended March 31, 2026.

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"T cell engagers have the potential to transform outcomes for people living with autoimmune diseases and cancer, and emerging clinical data underscore their promise as a compelling therapeutic modality. We look forward to sharing initial clinical data for CLN-978 and velinotamig throughout 2026. CD19 and BCMA are now well-validated autoimmune targets, and by addressing both, we aim to comprehensively treat more diseases and redefine standards of care for more patients with these two clinical-stage programs. Similarly, the early success of CLN-049 in AML further reinforces the remarkable promise of T cell engagers in many high unmet need disease settings across immunology and oncology" said Nadim Ahmed, President and CEO of Cullinan Therapeutics.

"Further, with our partner Taiho, we announced FDA acceptance of our first NDA submission, representing a significant milestone for Cullinan Therapeutics and bringing zipalertinib meaningfully closer to being available for patients, with a PDUFA date of February 27, 2027. With multiple upcoming catalysts and milestones across the pipeline through 2026 and beyond, the company is well-positioned for continued momentum and value creation."

Portfolio Highlights and 2026 Milestones

Immunology

•
CLN-978 (CD19xCD3 T cell engager): treatment-refractory moderate to severe systemic lupus erythematosus (SLE), difficult-to-treat rheumatoid arthritis (RA), and treatment-refractory moderate to severe Sjögren’s disease (SjD)
•
OUTRACE SLE
o
In June, the Company will share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood, as well as other biomarker data and preliminary clinical activity data. The initial data will be presented in a poster session at the EULAR 2026 Congress on June 6, 2026.
•
OUTRACE RA
o
In June, the Company will share initial data from the single target dose escalation portion of the study with a focus on safety and B cell depletion in peripheral blood and tissue, as well as other biomarker data and preliminary clinical activity data. The initial data will be presented in a poster session at the EULAR 2026 Congress on June 6, 2026.
o
In Q3 2026, the Company plans to share initial multi-dose regimen data, including B cell depletion in peripheral blood and tissue, as well as other biomarker data and preliminary clinical activity data.
•
OUTRACE SjD
o
In Q4 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood and tissue, as well as other biomarker data and preliminary clinical activity data.

•
Velinotamig (BCMAxCD3 T cell engager): treatment-refractory autoimmune diseases
o
Genrix Bio is enrolling a Phase 1 study in China in patients with autoimmune diseases, starting with moderate to severe SLE and to be followed by planned expansion into other indications. Initial multi-dose regimen data from the dose escalation phase in patients with SLE are expected to be shared in Q4 2026. Cullinan intends to use the data generated to accelerate global clinical development.
Oncology

•
CLN-049 (FLT3xCD3 T cell engager): acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
o
The Company plans to share an update from the dose escalation portion of the Phase 1 study in patients with relapsed/refractory AML or MDS in H2 2026. Dose level expansion continues in order to determine the recommended Phase 2 dose (RP2D) by Q4 2026 for a potential single-arm pivotal registrational trial.
o
In Q4 2026, the Company plans to initiate a Phase 1/2 combination study in patients with previously untreated AML.
o
Enrollment continues in a parallel Phase 1 study in patients with AML and measurable residual disease (MRD) immediately following induction therapy.

•
Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
o
In April, the U.S. FDA accepted an NDA for zipalertinib for the treatment of patients with locally advanced or metastatic EGFR ex20ins NSCLC whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab. The Prescription Drug User Fee Act (PDUFA) target action date is February 27, 2027.
o
In February, Taiho completed enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC. Taiho expects to obtain top-line results by the end of 2026.
o
Cullinan is eligible to receive $30 million and up to $100 million upon 2L and 1L U.S. regulatory approvals, respectively, and a 50/50 profit share in the U.S.
First Quarter 2026 Financial Results

•
Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $393.3 million as of March 31, 2026. Cullinan expects its cash resources to provide runway into 2029 under its current operating plan.

•
R&D Expenses: Research and development expenses were $42.1 million for the first quarter of 2026, compared to $41.5 million for the same period in 2025.
•
G&A Expenses: General and administrative expenses were $11.6 million for the first quarter of 2026, compared to $13.5 million for the same period in 2025.
•
Net Loss: Net loss was $49.7 million for the first quarter of 2026, compared to $48.5 million for the same period in 2025.

(Press release, Cullinan Oncology, MAY 7, 2026, View Source [SID1234665318])

Crinetics Pharmaceuticals Reports First Quarter 2026 Financial Results
and Provides Business Update

On May 7, 2026 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a global pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported financial results for the first quarter ended March 31, 2026.

"We are extremely pleased with the significant impact that Palsonify is making across the community. This is illustrated by the strong adoption of Palsonify by healthcare providers and the positive patient response to treatment," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "The significant growth in our unique prescriber base reflects a growing confidence among endocrinologists in the compelling clinical data and proven efficacy of Palsonify. Expanding clinical adoption is fueling sustained demand, evidenced by the steady growth trend in new patient start forms. We are seeing an increasingly efficient path to treatment for patients as the reimbursement environment matures. These results reinforce our confidence in the long-term commercial trajectory of Palsonify and our ability to deliver transformative therapies at scale."

First Quarter 2026 and Recent Highlights:
•Reported $10.3 million in net product revenue, reflecting the rapid adoption of PALSONIFY as the preferred choice for the acromegaly community.
•Received 232 enrollment forms1 during the first quarter of 2026. Breadth and depth of PALSONIFY prescribers continued to grow, with 263 unique healthcare providers (HCPs) having prescribed PALSONIFY within the first two quarters of launch. Approximately 70% of patients treated with PALSONIFY at the end of the first quarter of 2026 were on reimbursed therapy, as payers have increasingly provided coverage.
•In January 2026, we initiated the BALANCE-CAH Phase 2/3 trial addressing the critical unmet need in pediatric CAH patients.
•In February 2026, the CHMP of the EMA adopted a positive opinion, recommending the marketing authorization of PALSONIFY for the medical treatment of adult patients with acromegaly. In April 2026, the European Commission approved PALSONIFY, the first once-daily oral, selectively targeted somatostatin receptor type 2 nonpeptide agonist, for the medical treatment of adults with acromegaly.
•In March 2026, Crinetics submitted a Marketing Authorization Application (MAA) to Brazil’s National Health Surveillance Agency (ANVISA) for PALSONIFY for the treatment of acromegaly in adults. In April 2026, SKK submitted a New Drug Application (NDA) in Japan for paltusotine for the treatment of acromegaly.
•In May 2026, Crinetics entered into an exclusive license agreement with Ohio University to develop an early preclinical growth hormone receptor antagonist for the treatment of acromegaly.
•We remain on schedule to initiate, in the second quarter of 2026, the pivotal, seamless Phase 2/3 trial evaluating atumelnant for the treatment of ACTH-dependent Cushing’s syndrome. The study will assess the efficacy and safety of our once-daily, oral ACTH antagonist, atumelnant, in a broad population including patients with both Cushing’s disease and ectopic ACTH syndrome.

First Quarter 2026 Financial Results:
•Revenue was $10.7 million for the quarter ended March 31, 2026, compared to $0.4 million for the same period in 2025. Revenue for the quarter ended March 31, 2026 includes $10.3 million in net product revenue from the U.S. commercial launch of PALSONIFY, up from $5.4 million in net product revenue reported in the fourth quarter of 2025.
•Cost of product revenue was $0.2 million for the quarter ended March 31, 2026, primarily related to distribution, packaging, and fulfillment of PALSONIFY.
•Research and development expenses were $100.1 million for the quarter ended March 31, 2026, compared to $76.2 million for the same period in 2025, and compared to $85.1 million in the quarter ended December 31, 2025. The increase compared to the prior year period reflects the advancement of our clinical and preclinical programs. The sequential increase compared to the prior quarter was primarily due to the ramp-up of ongoing Phase 3 trials, as well as the initiation of the Phase 2/3 pediatric study of atumelnant in CAH.
•Selling, general and administrative expenses were $50.8 million for the quarter ended March 31, 2026, compared to $35.5 million for the same period in 2025, and compared to $53.7 million in the quarter ended December 31, 2025. The increase compared to the prior year period is related to investments in our corporate infrastructure as we transition into a commercial-stage company. The fluctuation compared to the prior quarter reflects timing of commercial investment.
•Net loss was $127.8 million for the quarter ended March 31, 2026, compared to net loss of $96.8 million for the same period in 2025.
•Cash, cash equivalents, and investment securities totaled $1.3 billion as of March 31, 2026, compared to $1.0 billion as of December 31, 2025. The March 31, 2026 total includes net proceeds of $380 million from our January 2026 public equity offering.

Guidance and Outlook:
•Crinetics continues to expect 2026 operating expenses presented in accordance with U.S. generally accepted accounting principles ("GAAP") to be between $600 million to $650 million and non-GAAP operating expenses – which exclude cost of product revenue, stock-based compensation, depreciation and amortization – to be between $480 million to $520 million.
•Crinetics is unable to reconcile forward-looking non-GAAP operating expenses to the most directly comparable GAAP measure without unreasonable effort because the items that are being excluded are difficult to predict or a range of results could lead to disclosure that would be imprecise or potentially misleading. Material changes to any one of the exclusions could have a significant effect on our forward-looking estimates and GAAP results. Such items include cost of product revenue, stock-based compensation, depreciation and amortization. See "Use of Non-GAAP Financial Measures".

Conference Call and Webcast Details
Management will hold a live conference call and webcast today, Thursday, May 7, 2026 at 4:30 p.m. ET. To participate, please dial 1-833-461-5787 (domestic) or 1-585-542-9983 (international) and refer to Meeting ID 173777518. To access the webcast, the direct link (here) or visit the Events page of the Crinetics website. Following the live event, the webcast will be archived on the Investor Relations section of www.crinetics.com.

(Press release, Crinetics Pharmaceuticals, MAY 7, 2026, View Source [SID1234665317])

Corvus Pharmaceuticals Provides Business Update and Reports First Quarter 2026 Financial Results

On May 7, 2026 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported a business update and announced financial results for the first quarter ended March 31, 2026.

"We started the year with strong momentum for soquelitinib, our selective ITK inhibitor that we believe is well positioned to improve therapy for a broad range of patients with atopic dermatitis, other immune diseases and cancers," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "The data generated from our clinical and preclinical work support soquelitinib’s potential to provide a new treatment paradigm for these diseases based on a rebalancing of the immune system. We will share additional data supporting this mechanism at the upcoming annual meeting of the Society for Investigative Dermatology, where we are reviewing data from our Phase 1 atopic dermatitis trial in two oral presentations. Looking forward, we are focused on our ongoing and planned soquelitinib clinical trials, including the initiation of new Phase 2 studies in hidradenitis suppurativa and asthma anticipated later this year."

Business Update and Strategy

Soquelitinib for Immune Diseases

In January 2026, Corvus reported data from cohort 4 of the randomized, blinded, placebo-controlled Phase 1 trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis (data as of January 15, 2026). Cohort 4 data demonstrated positive safety and efficacy results, including additional clinical benefit observed following longer 8-week treatment.
Final data from the randomized, blinded, placebo-controlled Phase 1 trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis will be presented in two oral sessions at the Society for Investigative Dermatology (SID) Annual Meeting, which is taking place May 13-16, 2026 in Chicago. The Company will host an in-person and virtual investor and analyst meeting on May 14, 2026 to review soquelitinib data being presented at SID, including new immunologic and biomarker data that focus on the drug’s mechanism of action and potential for drug-free remissions.
Corvus initiated its Phase 2 randomized placebo-controlled atopic dermatitis clinical trial during the first quarter 2026. The trial is anticipated to enroll approximately 200 patients with moderate-to-severe atopic dermatitis that have failed at least one prior topical or systemic therapy. This includes four cohorts of 50 patients each, with soquelitinib doses of 200 mg once per day, 200 mg twice per day and 400 mg once per day, along with a placebo group. The treatment period is 12 weeks with a 90-day follow-up period with no treatment.
Angel Pharmaceuticals, Corvus’ partner in China, is enrolling a Phase 1b/2 clinical trial evaluating soquelitinib in patients with moderate-to-severe atopic dermatitis. This is a blinded, placebo-controlled trial that is planned to evaluate a 12-week treatment regimen in 48 patients utilizing soquelitinib doses of 100 mg twice per day, 200 mg once per day, 200 mg twice per day and 400 mg once per day. The patient eligibility and endpoints are similar to those used previously by Corvus. Depending on the results from the Phase 1b portion of the study, an additional 60-90 patients will be enrolled in the Phase 2 portion of the study. The trial is open at several leading dermatology centers in China who have been involved in global registration trials. The study is conducted in close collaboration with Corvus. Results from the initial cohorts are anticipated late this year.
Corvus plans to initiate two additional Phase 2 clinical trials evaluating soquelitinib in patients with hidradenitis suppurativa and asthma.
Corvus also continues to advance its next-generation ITK inhibitor preclinical product candidates, which are designed to deliver precise T-cell modulation for specific immunology and oncology indications.

Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)

The Autoimmune Lymphoproliferative Syndrome (ALPS) Phase 2 clinical trial continues to advance. This trial is being conducted under a clinical research and development agreement with NIAID. The Phase 2 clinical trial (NCT06730126) is anticipated to enroll up to 30 patients aged 16 or older with confirmed ALPS based on genetic testing.

Soquelitinib for T Cell Lymphoma

Corvus continues to enroll patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL at multiple clinical sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed/refractory PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate chemotherapies. The primary endpoint of the trial is progression free survival. There are no FDA fully approved agents for the treatment of relapsed/refractory PTCL, and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory PTCL after at least two lines of systemic therapy.

Financial Results
As of March 31, 2026, Corvus had cash, cash equivalents and marketable securities of $236.7 million compared to $56.8 million as of December 31, 2025. Cash, cash equivalents and marketable securities as of March 31, 2026 included approximately $189.4 million in net proceeds received in a financing completed on January 23, 2026. Based on its current plans, Corvus expects its cash, cash equivalents and marketable securities to fund operations into the second quarter of 2028.

Research and development expenses for the three months ended March 31, 2026 totaled $11.2 million compared to $7.5 million for the same period in 2025. The increase in research and development expenses of $3.7 million was primarily due to higher clinical trial costs associated with the development of soquelitinib as well as an increase in personnel related costs.

Net loss for the three months ended March 31, 2026 was $13.7 million compared to net income of $15.2 million for the same period in 2025. Included in net loss for the three months ended March 31, 2026 and net income for the three months ended March 31, 2025 were non-cash losses of $0.6 million and $0.5 million, respectively, from Corvus’ investment in Angel Pharmaceuticals and non-cash income of $25.1 million in the three months ended March 31, 2025 associated with a change in fair value of the Company’s warrant liability. Total stock compensation expense for the three months ended March 31, 2026 was $2.7 million compared to $1.3 million for the same period in 2025.

(Press release, Corvus Pharmaceuticals, MAY 7, 2026, View Source [SID1234665316])

CHARLES RIVER LABORATORIES ANNOUNCES FIRST-QUARTER 2026 RESULTS

On May 7, 2026 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the first quarter of 2026. For the quarter, revenue was $995.8 million, an increase of 1.2% from $984.2 million in the first quarter of 2025.

The impact of foreign currency translation increased reported revenue by 2.8%, while a divestiture reduced reported revenue by 0.1%. Excluding the effect of these items, revenue declined 1.5% on an organic basis. By segment, organic revenue growth in the Manufacturing Solutions (Manufacturing) segment was more than offset by organic revenue declines in the Research Models and Services (RMS) and Discovery and Safety Assessment (DSA) segments.
In the first quarter of 2026, the GAAP operating margin was 12.0%, compared to 7.6% in the first quarter of 2025. The increase in the GAAP operating margin was primarily driven by lower accelerated amortization expense related to certain CDMO client relationships. The GAAP net loss available to common shareholders for the first quarter of 2026 was $(14.8) million, or $(0.30) per diluted share, compared to GAAP net income of $25.5 million, or $0.50 per diluted share for the same period in 2025. The decrease was principally due to a loss on assets held for sale related to the CDMO and Cell Solutions divestiture totaling $118.0 million, or $1.53 per share.

On a non-GAAP basis, the first-quarter operating margin decreased to 16.3% from 19.1% in the first quarter of 2025, primarily as a result of higher study-related direct costs in the DSA segment, unfavorable revenue mix in the RMS segment, and higher stock-based compensation expense related largely to executive transition. Non-GAAP net income was $101.7 million for the first quarter of 2026, a decrease of 14.6% from $119.1 million for the same period in 2025. First-quarter diluted earnings per share on a non-GAAP basis were $2.06, a decrease of 12.0% from $2.34 per share in the first quarter of 2025. The non-GAAP net income and earnings per share decreases were driven primarily by the lower operating margin.
Birgit Girshick, Chief Executive Officer, said, "We are pleased to deliver on our first-quarter financial targets, and remain well positioned to generate improving results over the course of the year. Our confidence is supported by a DSA demand environment that is tracking to our expectations, resulting in solid bookings in the first quarter, as well as the successful execution of our strategy."

"As we look to the future, our focus remains on enhancing our clients’ experience, strengthening our world-class scientific portfolio, achieving our financial and operational goals, and increasing long‑term shareholder value. We have already established a solid foundation and with a refreshed strategic focus aimed at modernizing the Company and the industry, we intend to continue to evolve and lead the way. By doing so, we will enable the Company to realize its full potential and ensure future success. I am energized to lead this great company into its next chapter of growth and am confident in the path we are taking to create the future for Charles River," Ms. Girshick concluded.

First-Quarter Segment Results

Research Models and Services (RMS)

Revenue for the RMS segment was $208.4 million in the first quarter of 2026, a decrease of 2.2% from $213.1 million in the first quarter of 2025. The impact of foreign currency translation increased revenue by 3.3%. Organic revenue decreased by 5.5%, due primarily to lower revenue for small research models in North America, as well as for large research models. The decline was partially offset by higher revenue for small research models in China.
In the first quarter of 2026, the RMS segment’s GAAP operating margin increased to 23.9% from 20.5% in the first quarter of 2025, primarily due to a gain on the sale of real estate in Massachusetts. On a non-GAAP basis, the operating margin decreased to 24.7% from 27.1%. The non-GAAP operating margin decrease was primarily driven by the unfavorable revenue mix, principally related to small research models in North America and large research models.
Discovery and Safety Assessment (DSA)
Revenue for the DSA segment was $596.9 million in the first quarter of 2026, an increase of 0.7% from $592.6 million in the first quarter of 2025. The impact of foreign currency translation increased DSA revenue by 2.2%, while a divestiture reduced reported revenue by 0.1%. Organic revenue decreased by 1.4%, driven primarily by lower revenue for discovery services due in part to the impact of prior site consolidation activities.
In the first quarter of 2026, the DSA segment’s GAAP operating margin increased to 17.4% from 15.9% in the first quarter of 2025. The increase was primarily driven by lower third-party legal costs related to a non-human primate (NHP) supply matter, as well as lower costs associated with the Company’s restructuring and efficiency initiatives. On a non-GAAP basis, the operating margin decreased to 21.0% from 23.9% in the first quarter of 2025. The non-GAAP operating margin decrease was primarily driven by higher study-related direct costs associated with large-model sourcing and study starts.
Manufacturing Solutions (Manufacturing)

Revenue for the Manufacturing segment was $190.5 million in the first quarter of 2026, an increase of 6.8% from $178.5 million in the first quarter of 2025. The impact of foreign currency translation increased Manufacturing revenue by 3.9%. Organic revenue increased 2.9%, driven by higher revenue in the Microbial Solutions business, partially offset by lower revenue in the CDMO business.

The Manufacturing segment’s GAAP operating margin was 24.6%, compared to (4.8)% in the first quarter of 2025. The increase was primarily the result of lower accelerated amortization expense related to certain CDMO client relationships. On a non-GAAP basis, the operating margin increased to 25.9% from 23.1% in the first quarter of 2025, driven primarily by the benefit of cost savings resulting from the Company’s restructuring initiatives.

Divestiture Update

On May 6, 2026, the Company completed the previously announced divestiture of the CDMO and Cell Solutions businesses to GI Partners. In addition, the Company expects to complete the sale of certain European Discovery Services sites in May 2026. These strategic transactions will enable Charles River to refine and refocus its comprehensive portfolio on core competencies and drive synergistic growth in areas in which it has differentiated scientific expertise, including regulated drug development testing.

Stock Repurchase Update

During the first quarter of 2026, the Company repurchased 1.1 million shares for a total of $200.0 million. As of March 28, 2026, the Company had $800.0 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 reaffirming its 2026 organic revenue and non-GAAP earnings per share guidance, which was last updated on February 25, 2026, and previously included the expected impact of the completed divestiture of the CDMO and Cell Solutions businesses, as well as the planned divestiture of certain European Discovery Services sites in May 2026.

However, the Company is reducing its 2026 reported revenue outlook by approximately 50 basis points to reflect recent changes in assumptions for foreign exchange rates. The Company’s GAAP earnings per share guidance has now been updated to primarily reflect the impact of the divestitures.
The Company’s 2026 guidance for revenue and earnings per share is as follows:

2026 GUIDANCE (1) CURRENT PRIOR
Revenue growth/(decrease), reported
(5.5)% – (4.0)%
(5.0)% – (3.5)%
Less: Contribution from acquisitions
0.0% – (0.5)%
0.0% – (0.5)%
Add: Impact from divestitures
~5.0%
~5.0%
Less: Favorable impact of foreign exchange
(0.5)% – (1.0)%
(1.0)% – (1.5)%
Revenue growth/(decrease), organic (2)
(1.5)% – (0.5)% (1.5)% – (0.5)%
GAAP EPS estimate
$5.35 – $5.85
—
Acquisition-related amortization (3)
~$2.30
—
Acquisition- and divestiture-related costs (4)
~$2.30
Costs associated with restructuring and efficiency initiatives (5)
~$0.85
—
Other, net (6)
NM
—
Non-GAAP EPS estimate $10.80 – $11.30 $10.80 – $11.30

Footnotes to Guidance Table:
(1) Revenue and earnings per share guidance assumes the planned divestiture of certain European Discovery Services sites will be completed in May 2026, and that the CDMO and Cell Solutions divestiture was completed on May 6, 2026.
(2) Organic revenue growth is defined as reported revenue growth adjusted for completed acquisitions and both completed and previously announced divestitures (including the CDMO and Cell Solutions businesses, as well as certain European Discovery Services sites), as well as foreign currency translation.
(3) 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.
(4) These adjustments include costs related to the evaluation and integration of acquisitions and divestitures, as well as a loss on assets held for sale related to divestitures and other transaction-related tax adjustments.
(5) 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.
(6) These adjustments primarily include immaterial items related to: (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 Thursday, May 7th, at 8:30 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, MAY 7, 2026, View Source [SID1234665315])

Altasciences and Certara Announce Strategic Partnership to Accelerate Early Drug Development

On May 7, 2026 Altasciences, a fully integrated drug development solution company, and Certara (Nasdaq: CERT), a global leader in model-informed drug development (MIDD), reported a strategic partnership to accelerate early-phase development programs.

Fewer than half of preclinical drug candidates successfully reach in-human trials. Failures are driven by toxicity, poor pharmacokinetics, lack of efficacy, and challenges translating results from animals to humans. Many of these risks can be mitigated through a fully integrated model-informed drug development approach.

Building on Altasciences’ Acceleration Platform, the integration of Certara’s strategic drug development services and biosimulation technology enables sponsors to establish proof of mechanism earlier, design more efficient studies, and make informed go/no-go decisions with greater confidence. By embedding modeling insights and digital workflows directly into development execution, study designs are optimized, dosing strategies are refined, and programs are more seamlessly integrated across nonclinical, clinical, bioanalytical, and manufacturing services.

"At Altasciences, we already help sponsors move from first safety assessment to proof of concept with speed and precision," said Marie-Hélène Raigneau, CEO of Altasciences. "By embedding Certara’s modeling capabilities into our platform, we can further inform critical decisions earlier and with greater confidence. This collaboration is about reducing uncertainty at the moments that matter most."

The partnership comes at an opportune time as the FDA continues to advance new guidance supporting more adaptive, data-driven, and real-time drug development approaches, capabilities that integrated MIDD execution models are well positioned to deliver.

"This partnership unlocks new opportunities to improve early development decisions for biotech sponsors and their investors," said Jon Resnick, CEO of Certara. "By embedding modeling and simulation directly into execution, we enable faster, more informed decision-making that ultimately benefits patients."

Together, Altasciences and Certara are advancing a model-first, fully integrated, and resource-efficient approach to early drug development that accelerates the path to proof of concept for biotech innovators, investors and pharmaceutical companies across the globe.

(Press release, Certara, MAY 7, 2026, View Source [SID1234665314])