On August 14, 2026 Evotec SE (NASDAQ: EVO; Frankfurt Prime Standard: EVT) reported financial results for the second quarter and first half of 2026 and confirmed its updated full-year 2026 outlook.

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Dr. Christian Wojczewski, Chief Executive Officer of Evotec, said:

"While the first half of 2026 results reflect the challenging start to the year previously anticipated, we are seeing clear and encouraging signs that our actions are gaining traction. Commercial activity is improving across both segments, with strong growth in D&PD base net sales, increasing customer engagement and continued momentum at Just – Evotec Biologics. At the same time, Horizon is progressing according to plan, supporting greater focus, accountability and efficiency across the organization. While the financial benefits of these developments will take time to fully materialize, they represent important building blocks for recovery and the next phase of growth. We continue to see attractive opportunities across both segments and remain confident in the strength of our strategic partnership pipeline, with a significant portion of opportunities progressing through advanced discussions. Our continued investment in next-generation discovery capabilities, including our proteomics and transcriptomics platforms, strengthens our scientific differentiation, enhances the quality of our partner offerings and expands future opportunities for strategic collaborations."

Selected Business Highlights

Strategic Partnership Pipeline

Evotec maintains an active strategic partnership opportunity pipeline, supported by ongoing discussions across a broad range of therapeutic areas and modalities. The Company is actively advancing opportunities at various stages of evaluation, including a significant number in advanced due diligence and term sheet discussions. While Evotec remains confident in its ability to enter new strategic partnerships in 2026, the timing, complexity and revenue ramp-up associated with individual agreements remain inherently variable and are reflected in the Company’s updated full-year 2026 outlook.

As communicated in the outlook update on July 14, 2026, Evotec expects lower contributions from both existing and potential new strategic partnerships in 2026 than previously anticipated. Approximately 40% of the reduction in expected full-year 2026 revenue relative to the previous outlook reflects revised project phasing and milestone schedules for existing partnerships, with the associated revenues now expected to be recognized in 2027. Approximately 45% reflects lower-than-anticipated contributions from potential new strategic partnerships due to the timing of agreement execution and development activities. Approximately 15% is attributable to lower-than-expected revenue conversion against the Company’s internal ambition for accelerated sales-to-revenue conversion, with the associated revenues now also expected to shift into 2027.

Commercial Execution

Commercial execution remains a key focus area of the Horizon transformation and an important driver of Evotec’s path to recovery. Within the Horizon transformation, the Company has strengthened its commercial organization, sharpened customer focus and enhanced business development processes across both segments. These efforts are increasingly reflected in commercial indicators, including higher customer engagement, growing new business activity and improved sales effectiveness.

Commercial momentum across Evotec’s base CRO and CDMO businesses strengthened during the first half of 2026. In Drug Discovery & Preclinical Development (D&PD), net sales increased by more than 28% year-on-year, reflecting improved customer engagement and commercial execution. Just – Evotec Biologics continues to demonstrate positive operating momentum as well, supported by high-capacity utilization and expansion of its customer base.

Based on the typical conversion cycle between sales generation and revenue recognition, increased commercial activity in D&PD is expected to contribute increasingly to revenues from the fourth quarter of 2026 onwards.

Governance Update: Supervisory Board Transition

Camilla Macapili Languille has decided to step down from Evotec’s Supervisory Board effective August 7, 2026. Since her appointment in June 2022, she has served as an independent Supervisory Board member and as a member of the Audit & Compliance Committee. Following her departure, Supervisory Board member Wes Wheeler has been appointed by the Supervisory Board to the Audit & Compliance Committee. Evotec would like to thank Ms. Macapili Languille for her commitment and service.

The Supervisory Board has initiated the process to identify a successor and will focus on candidates with strong financial expertise to maintain the Supervisory Board’s balanced competency profile and committee composition.

Strategic Evaluation

The strategic evaluation announced in connection with the Company’s first quarter 2026 results on May 6, 2026, remains ongoing and continues alongside the implementation of the Horizon transformation program. Additional details regarding the review are available in the Company’s Q1 2026 results announcement.

Horizon Transformation

Horizon remains Evotec’s framework for the next phase of its transformation, focused on operational excellence, scientific leadership and commercial execution.

Since the launch of Horizon in March 2026, Evotec has continued to advance measures to streamline operations, increase agility and focus resources on areas with the clearest path to value. The updated full-year 2026 outlook does not change the strategic direction of Horizon or the timeline for its implementation.

Evotec remains on track to deliver approximately 20-30% of cost savings in 2026 as part of its previously announced objective of €75 million in annual run-rate savings by the end of 2027. Horizon measures implemented to date are delivering as planned, with first-half savings providing a foundation for achieving the expected 2026 savings contribution.

Financial Results

Claire Hinshelwood, Chief Financial Officer of Evotec, said:

"As previously announced, we confirm that our updated full-year outlook primarily reflects a revised view surrounding strategic partnership activities and milestone contributions in the second half of the year. The reduced contribution from these activities is expected to affect profitability disproportionately relative to revenues, reflecting their typically attractive economics and impact on overall capacity utilization. The current year continues to require disciplined execution and careful cash flow management. We remain focused on driving efficiency across the organization, increasing transparency around our business performance and strategic priorities and delivering on our Horizon objectives. Alongside ongoing cost and footprint optimization, we continue to invest in key strategic areas to support future growth opportunities while preserving financial flexibility."

Group Financials

For the second quarter of 2026, Group revenues amounted to €143.5 million (€146.3 million CER) compared to €171.2 million in the same period in 2025, representing a 16.2% decrease. Adjusted Group EBITDA was -€20.8 million (-€18.6 million CER), reflecting a decrease of 320.3% versus -€5.0 million in the same prior-year period, mainly driven by lower revenues.

For the six months ended June 30, 2026, Evotec generated Group revenues of €300.1 million (€313.2 million CER), a 19.2% decline versus €371.2 million in the first half of 2025. R&D expenses were managed in line with the Company’s focus on cost discipline, decreasing to €20.3 million (6.8% of total Group revenues) compared to €29.4 million in the prior year (7.9% of total Group revenues). Adjusted Group EBITDA decreased to -€42.7 million (-€37.4 million CER), down from -€1.9 million for H1 2025. The decrease was partially offset by lower cost of revenue as well as reduced R&D and SG&A expenses.

Evotec closed the second quarter of 2026 with a liquidity position of €465.6 million, reflecting a net cash position.

Segment Financials

Discovery and Preclinical Development (D&PD)

For the second quarter of 2026, revenues for Discovery & Preclinical Development amounted to €108.1 million (€109.5 million CER), representing a year-on-year decrease of 15.8%. Adjusted EBITDA for the quarter amounted to -€14.6 million (-€13.0 million CER), down from -€2.5 million in the second quarter of 2025.

For the first half of 2026, revenues totaled €228.1 million (€235.9 million CER), representing a year-on-year decrease of 15.3% compared with €269.0 million in the prior-year period, primarily driven by weak sales to revenue conversion across all business areas and softer-than-expected customer demand, reflecting the continued challenging market environment. Adjusted EBITDA for the segment was -€24.4 million (-€18.4 million CER), compared with -€9.3 million in the prior year, reflecting the reduced topline performance.

(Press release, Evotec, AUG 14, 2026, View Source [SID1234670125])

On August 14, 2026 Cerenome, Inc. (Nasdaq: CNSY) ("Cerenome" or the "Company"), a CNS oncology company advancing an integrated platform that combines precision diagnostics, targeted therapeutics, and artificial intelligence, reported financial results for the second quarter ended June 30, 2026, and provided an overview of recent and upcoming business highlights.

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"Our team made substantial progress this quarter in advancing our integrated CNS oncology platform including a full repositioning and rebranding of the Company," said Marc H. Hedrick, M.D., M.B.A., Cerenome President and Chief Executive Officer. "For the remainder of the year, I expect the progress to accelerate across all verticals, highlighted by our buildout of the diagnostic commercial organization."

Q2 2026 AND RECENT HIGHLIGHTS

Corporate

•
Rebranded from Plus Therapeutics, Inc. to Cerenome, Inc., effective August 3, 2026, with the Company’s common stock trading on the Nasdaq Capital Market under the ticker symbol "CNSY"

REYOBIQ Development

•
Continued enrollment in the ReSPECT-LM multiple-dose clinical trial. As of June 30, 2026, approximately one-third of patients had been enrolled, with no dose-limiting toxicities observed to date, supporting the development of a recommended Phase 2 dose/dosing regimen by year-end
•
Continued enrollment in the ReSPECT-GBM Phase 2 trial. Current enrollment rates indicate full enrollment in 2026 followed by a data readout and a subsequent End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA)
•
Initial site activation of the ReSPECT-PBC pediatric brain cancer Phase 1 trial at Lurie Children’s Hospital. First dosing expected in the third quarter of 2026.
•
Continued commercial-level manufacturing scale-up and supply chain enhancement for REYOBIQ drug supply

CNSide CSF Assay Platform

•
Performed 232 CNSide cerebrospinal fluid tests during the first half of 2026 and continued to grow the number of ordering providers and institutions
•
Achieved the 2026 corporate objective for contracted commercial payer coverage of 150 million covered lives by mid-year
•
Received Medicare Provider Transaction Access Number and dedicated American Medical Association billing identifier for CNSide
•
Partnered with Genomic Testing Cooperative to integrate next-generation sequencing into the CNSide platform
•
Achieved College of American Pathology or CAP accreditation, the gold standard in laboratory quality assurance, for Cerenome’s CLIA laboratory in Houston, TX
•
Partnered with Xifin, Inc., the market leader in artificial intelligence enabled revenue cycle management for diagnostic providers, to serve as our billing and clearinghouse partner

Data & Artificial Intelligence

•
Partnered with Ephemeral Technologies to develop native artificial intelligence, a corporate operating system and data infrastructure designed to integrate therapeutic, diagnostic and bioinformatic data sets and to facilitate advanced data analytics and machine learning across Cerenome’s CNS oncology platform

SECOND QUARTER 2026 FINANCIAL RESULTS

•
Cash, cash equivalents and investments were $8.6 million as of June 30, 2026 and December 31, 2025.

•
Recognized $0.4 million in grant revenue from CPRIT for the advancement of REYOBIQ in LM in the second quarter of 2026, compared with $1.4 million in grant revenue from CPRIT for the same program in the second quarter of 2025
•
Operating loss for the second quarter of 2026 was $9.1 million, compared with an operating loss of $1.5 million for the second quarter of 2025. The change primarily reflects expansion of CNSide commercial operations and continued funding of the REYOBIQ Phase 2 trial
•
Net loss for the second quarter of 2026 was $9.0 million, or $1.31 per basic share, compared with net income of $5.2 million, or $0.62 per basic share, for the second quarter of 2025, which included a $6.5 million change in fair value of derivative instruments

AFFIRMED ANTICIPATED MILESTONES AND OUTLOOK FOR 2026

The Company is affirming the milestone framework and outlook it provided when reporting full-year 2026 financial results, as follows:

REYOBIQ Clinical Program

•
Define the optimal dose/dosing interval for REYOBIQ in Leptomeningeal Metastases
•
Complete enrollment in the ReSPECT-GBM Phase 2 trial for glioblastoma; data is expected in Q1 2027, followed by an End-of-Phase 2 meeting with the FDA
•
Begin enrollment in the ReSPECT-PBC pediatric brain cancer Phase 1 trial
•
Complete commercial manufacturing scale-up for REYOBIQ

CNSide Commercial Rollout

•
Expand U.S. commercial payer coverage beyond 150 million covered lives
•
Secure Medicare coverage and reimbursement
•
Achieve an annualized run-rate of test orders exceeding 1,250
•
Expand the CNSide assay platform to include a comprehensive portfolio of clinically relevant test for patients at risk for CNS cancers

About Leptomeningeal metastases (LM)

Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ (rhenium Re186 obisbemeda)

REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high-dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off-target risks and improve outcomes for CNS cancer patients versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials, respectively. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

(Press release, Cerenome, AUG 14, 2026, View Source [SID1234670124])

On August 14, 2026 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical stage biopharmaceutical company targeting transformative therapies for immune-mediated diseases, reported second quarter 2026 financial results as well as recent business highlights.

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"I am pleased with our progress this quarter, advancing our pipeline and strengthening our position for long-term growth," said Shao-Lee Lin, M.D., Ph.D., president and chief executive officer of Cue Biopharma. "The CUE-221 license agreement augments our portfolio and opportunities and the higher expenditures this quarter reflect expected one-time non-cash items and payments related to the transaction. Combined with our recent CUE-221 IND submission, financing with high-quality investors, and strategic leadership additions, we believe we are well positioned for the next phase of execution. We look forward to anticipated CUE-221 Phase 2 data by the end of this quarter and remain on track to initiate a CUE-401 Phase 1 study by the end of the year."

Business, Financial and Leadership Highlights

Milestones
CUE-221

Recently submitted an IND to the FDA in food allergy applications
Phase 2 data readout in Chronic Spontaneous Urticaria anticipated by the end of the third quarter of 2026
CUE-401

Company anticipates submitting an IND to the FDA and initiating a Phase 1 clinical study by year-end 2026
Financial and Corporate

Completed a private placement for gross proceeds of $50 million primarily to support clinical development, pipeline advancement, and infrastructure growth
Leadership

Dr. Dominic Borie, Chief Medical Officer and Head of Research and Development, physician-scientist and immunology leader with deep expertise in immunology, joined Cue to help advance key clinical programs in allergic and autoimmune diseases
Mr. James M. Ahlers, Chief Financial Officer, a veteran biotechnology finance executive, joined Cue to help strengthen the Company’s financial leadership and the infrastructure needed to support execution of its corporate strategy
Second Quarter 2026 Financial Results
Second quarter revenue was $7.9 million, compared to $3.0 million in the second quarter of 2025. The increase in 2026 was due to revenue earned from the Boehringer Ingelheim collaboration and license agreement upon achievement of a preclinical milestone, triggered in the second quarter of 2026.

Research and development expenses were $49.0 million for the three months ended June 30, 2026, compared to $7.9 million in 2025. The increase primarily consisted of one-time cash payments of approximately $20.0 million, including the upfront payment to Ascendant and transaction-related costs. Additionally, approximately $20.0 million of expense was recognized as the fair value of warrants issued to Ascendant pursuant to the license agreement, with a corresponding credit to shareholders’ equity resulting in no net impact on stockholders’ equity.

General and administrative expenses were $46.6 million for the three months ended June 30, 2026, compared to $3.7 million in 2025. The increase was primarily attributable to one-time expenses incurred in connection with the Company’s strategic transformation, including approximately $23.0 million related to integration with a newly assembled, complementary management team and transaction-related costs, as well as approximately $19.7 million of non-cash stock-based compensation expense recognized during the quarter.

Other income and expense for the three months ended June 30, 2026, primarily comprised a net non-cash loss of $63.1 million related to the license agreement with Ascendant. As a result, a loss on issuance of liability-classified warrants was recognized, partially offset by a gain on the fair value measurement of warrants issued.

Net loss for the three months ended June 30, 2026 was $153.1 million, compared to $8.5 million in 2025. The increase was primarily due to one-time non-cash losses accounted for in other income, and one-time expenses related to the license agreement.

As of June 30, 2026, the Company had $17.4 million in cash and cash equivalents after incurring one-time cash outflows related to the license agreement. Subsequent to June 30, 2026, the Company completed a $50 million private placement financing.

(Press release, Cue Biopharma, AUG 14, 2026, View Source [SID1234670123])

On August 14, 2026 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has filed a regulatory application with the Ministry of Health, Labour and Welfare for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq Intravenous Infusion 840mg [generic name: atezolizumab (genetical recombination)] for an additional indication as adjuvant treatment for adults and pediatric patients with microsatellite instability-high (MSI-High) colon cancer.

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"Colorectal cancer is the most commonly diagnosed cancer in Japan, and recurrence after adjuvant chemotherapy remains a significant challenge in patients with pathological Stage III disease. In the ATOMIC trial, the addition of Tecentriq to standard adjuvant chemotherapy demonstrated a reduction in the risk of disease recurrence or death. We will continue our efforts toward obtaining approval so that Tecentriq can be delivered to patients with MSI-High colon cancer as a new standard of care," said Chugai’s President and CEO, Dr. Osamu Okuda.

This filing is based on the results from the investigator-initiated global Phase III ATOMIC trial (Alliance A021502) in patients with pathological Stage III deficient mismatch repair (dMMR) colon cancer following curative resection1,2. The trial evaluated the efficacy and safety of adding Tecentriq to standard adjuvant mFOLFOX6 chemotherapy. dMMR is known to lead to MSI-High status in tumor cells.
For the primary endpoint of disease-free survival (DFS), three-year DFS rates were 86.3% (95% CI: 81.8-89.8) in the Tecentriq combination arm and 76.2% (95% CI: 70.9-80.6) in the mFOLFOX6 arm.
The Tecentriq combination arm demonstrated a statistically significant improvement compared with mFOLFOX6 alone, reducing the risk of disease recurrence or death (stratified hazard ratio: 0.50, 95% CI: 0.35-0.73; p<0.001). The most common adverse events were hepatic dysfunction (43.9%), skin disorders (33.8%), and hypothyroidism (18.8%). The safety profile was consistent with the known safety profile of Tecentriq, and no new safety signals were identified.

Chugai Pharmaceutical, a leading company in the oncology field, remains committed to addressing unmet medical needs in cancer treatment with innovative medicines for patients and healthcare professionals.

About the ATOMIC (NCT02912559/Alliance A021502) trial
ATOMIC is an investigator-initiated overseas Phase III trial being conducted by the Alliance for Clinical Trials in Oncology, a research group supported by the U.S. National Cancer Institute (NCI), in patients with pathological Stage III deficient mismatch repair (dMMR) colon cancer following curative resection. The trial is being conducted as an open-label, randomized trial evaluating the efficacy and safety of a standard adjuvant mFOLFOX6 treatment arm (administered for six months) and a combination treatment arm in which mFOLFOX6 plus Tecentriq is administered for six months, followed by Tecentriq monotherapy for an additional six months (12 months in total). The FDA has granted Priority Review and is expected to make a decision on the approval by 9 October 2026.

About Colorectal Cancer with Deficient Mismatch Repair (dMMR) or Microsatellite Instability-High (MSI-High)
Colorectal cancer is the most commonly diagnosed cancer in Japan, with approximately 154,000 new cases reported in 2023 (approximately 102,000 cases of colon cancer and 52,000 cases of rectal cancer) and approximately 54,000 deaths reported in 2024 (approximately 38,000 cases of colon cancer and 16,000 cases of rectal cancer)3. Among colorectal cancer cases in Japan, approximately 6-7% are reported to have deficient mismatch repair (dMMR)4,5. dMMR refers to a condition in which the DNA mismatch repair system is impaired, resulting in the development of microsatellite instability-high (MSI-High) tumors. Most tumors with dMMR exhibit MSI-High status. Because these tumors accumulate large numbers of somatic mutations and are therefore highly immunogenic, they are considered likely to respond to treatment with immune checkpoint inhibitors6,7. However, clinical evidence supporting the use of immune checkpoint inhibitors in the adjuvant treatment of colorectal cancer has been limited to date.
Adjuvant chemotherapy is recommended for patients with pathological Stage III colorectal cancer; however, recurrence is still observed in approximately 30% of patients following treatment8,9. Furthermore, prognosis remains poor once recurrent colorectal cancer progresses to an unresectable stage. Therefore, there remains a need for new adjuvant treatment options that can help reduce the risk of recurrence following curative resection.

About Tecentriq
Tecentriq is an immune checkpoint inhibitor designed to target PD-L1 (programmed death-ligand 1) expressed on tumor cells or tumor-infiltrating immune cells. PD-L1 binds to PD-1 and B7.1 receptors on T cells and suppresses T-cell function. By inhibiting this interaction, Tecentriq is considered to restore T-cell activity and promote immune response against tumor cells. In Japan, Tecentriq was launched in April 2018 and has obtained approval for 7 tumor types (extensive-stage small cell lung cancer, non-small cell lung cancer, breast cancer, hepatocellular carcinoma, alveolar soft part sarcoma, extranodal natural killer/T-cell lymphoma nasal type, and thymic carcinoma).

(Press release, Chugai, AUG 14, 2026, View Source [SID1234670122])

On August 14, 2026 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported financial results for the second quarter of 2026 and provided a business update.

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"At Caribou, we are redefining what patients and physicians should expect from allogeneic CAR-T cell therapy," said Rachel Haurwitz, PhD, president and CEO of Caribou. "The data presented at EHA (Free EHA Whitepaper) 2026 continue to demonstrate that a single dose of vispa-cel can produce durable responses on par with autologous CAR-T cell therapies in patients with second-line large B cell lymphoma, and a single dose of CB-011 results in deep, durable responses in high-risk patients with relapsed or refractory multiple myeloma. With our off-the-shelf approach, these programs have the potential to dramatically expand CAR-T cell therapy access for patients."

Clinical highlights

Vispacabtagene regedleucel (vispa-cel; formerly CB-010), a clinical-stage allogeneic anti-CD19 CAR-T cell therapy for patients with relapsed or refractory B cell non-Hodgkin lymphoma
•In June, long-term follow-up clinical data from the ANTLER phase 1 clinical trial were presented at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting. Data presented reinforced vispa-cel is the only single-dose, off-the-shelf therapy to demonstrate deep and durable responses on par with autologous CAR-T cell therapies in second-line (2L) large B cell lymphoma (LBCL). Efficacy and safety data in 2L LBCL patients who had received a single dose of 80 million optimized vispa-cel CAR-T cells (N=27) included:
◦82% overall response rate (ORR)
◦67% complete response (CR) rate
◦17.1-month median progression-free survival (PFS)
◦Generally well-tolerated safety profile
•Optimized vispa-cel is defined as cells from a donor younger than 30 years old with at least two matched human leukocyte antigen (HLA) alleles between patient and donor. The 27-patient subgroup best represents the treatment regimen and patient population for Caribou’s planned ANTLER-3 pivotal phase 3 clinical trial.
•Caribou previously reached alignment with the U.S. Food and Drug Administration (FDA) regarding its planned ANTLER-3 pivotal phase 3 clinical trial design, which is expected to be a randomized, controlled clinical trial enrolling approximately 250 CD19-naïve 2L LBCL patients who are not eligible for transplant and not candidates or not eligible for autologous CAR-T cell therapy based on access challenges or medical criteria, including the urgent need for therapy.

CB-011, a clinical-stage allogeneic anti-BCMA CAR-T cell therapy for patients with relapsed or refractory multiple myeloma (r/r MM)
•In June, longer follow-up dose escalation clinical data from the CaMMouflage phase 1 clinical trial were presented at the 2026 EHA (Free EHA Whitepaper) Annual Meeting. Data continue to demonstrate that CB-011 drives deep, durable responses after a single dose. Twelve BCMA-naïve patients were treated with the recommended dose for expansion (RDE) of 450 million CB-011 CAR-T cells after lymphodepletion. Efficacy and safety data for this cohort included:
◦92% ORR
◦83% CR or stringent CR (≥CR) rate
◦91% minimal residual disease (MRD) negativity in 10/11 evaluable patients
◦50% of patients in ≥CR at 15 months
◦Manageable safety profile
•Caribou also reported a patient case study of a 71-year-old male with r/r MM who received eight prior lines of therapy, including ciltacabtagene autoleucel, an approved autologous CAR-T cell therapy. Before entering CaMMouflage, the patient never achieved a CR following any of his post-front-line therapies. After receiving a single dose of 450 million CB-011 CAR-T cells (the RDE), the patient achieved a CR at day 28 that was maintained at month 3 and remained ongoing as of the May 26, 2026, efficacy data cutoff date.
•Caribou is enrolling BCMA-naïve and prior BCMA therapy-exposed r/r MM patients in the dose expansion portion of the CaMMouflage trial. In the second half of 2026, Caribou expects to report initial safety and efficacy from dose expansion on more than 15 patients with a minimum of three months follow up, as well as longer follow-up data on the 12-patient, BCMA-naïve RDE cohort from dose escalation.
Second quarter 2026 financial results
Licensing and other third-party revenue: Revenue from licensing and other third-party agreements was $1.5 million for the three months ended June 30, 2026, compared to $2.7 million for the same period in 2025.

R&D expenses: Research and development expenses were $18.9 million for the three months ended June 30, 2026, compared to $27.7 million for the same period in 2025. The decrease was primarily related to decreased external contract manufacturing organization and contract research organization activities; expenses related to the reduction in workforce and strategic pipeline prioritization announced in April 2025; facilities and allocated expenses; and expenses related to licenses, sublicensing revenue, and milestones.

G&A expenses: General and administrative expenses were $7.9 million for the three months ended June 30, 2026, compared to $10.4 million for the same period in 2025. The decrease was primarily due to personnel-related expenses related to the reduction in workforce and strategic pipeline prioritization announced in April 2025; lower legal expenses; other service-related expenses; and other facilities and allocated expenses.

GAAP net loss and net loss per share, basic and diluted: Caribou reported a GAAP net loss of $24.3 million, or $0.24 per share, basic and diluted, for the three months ended June 30, 2026, compared to $54.1 million, or $0.58 per share, basic and diluted, for the same period in 2025, which included $21.3 million in non-cash impairment charges.

Cash, cash equivalents, and marketable securities: Caribou had $113.8 million in cash, cash equivalents, and marketable securities as of June 30, 2026, compared to $142.8 million as of December 31, 2025. Caribou now expects that its cash, cash equivalents, and marketable securities will be sufficient to fund its current operating plan, including dose expansion for CB-011 and certain start-up activities for its planned ANTLER-3 pivotal phase 3 clinical trial for vispa-cel, to the end of 2027. Caribou is exploring multiple options to fully fund its planned ANTLER-3 clinical trial.

About vispacabtagene regedleucel
Vispacabtagene regedleucel (vispa-cel; formerly known as CB-010) is an allogeneic anti-CD19 CAR-T cell therapy evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). To Caribou’s knowledge, vispa-cel is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. The FDA granted vispa-cel Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations for B-NHL.

About the ANTLER phase 1 clinical trial
The ANTLER phase 1 clinical trial evaluated vispa-cel in adult patients with r/r B-NHL in a multicenter, open-label trial. Eighty-five patients were treated in the trial. Using a 3+3 enrollment strategy, safety and efficacy were assessed in 16 patients in dose escalation who received a single dose of 40, 80, or 120 million CAR-T cells preceded by a lymphodepletion (LD) regimen of cyclophosphamide at 60 mg/kg/day for 2 days followed by fludarabine at 25 mg/m2/day for 5 days. Sixty-three second-line large B cell lymphoma (2L LBCL) patients received a single dose of vispa-cel during dose expansion. Eighty million CAR-T cells was selected as the recommended phase 2 dose (RP2D). Six patients were enrolled in a cohort of third-line or later LBCL patients with prior exposure to CD19-targeted therapy. Additional information on the ANTLER trial (NCT04637763) can be found at www.clinicaltrials.gov.

About CB-011
CB-011 is an allogeneic anti-BCMA CAR-T cell therapy being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM). To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to enable activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E-peptide fusion protein to blunt immune-mediated rejection. The FDA granted CB-011 RMAT, Fast Track, and Orphan Drug designations for r/r MM.

About the CaMMouflage phase 1 clinical trial
The CaMMouflage clinical trial is a multicenter, open-label phase 1 trial evaluating CB-011 in adults with r/r MM who have been treated with three or more prior lines of therapy. Using a 3+3 dose escalation design, safety and efficacy of CB-011 were evaluated in 48 patients at multiple dose levels and two different lymphodepletion (LD) regimens. Thirty-five patients were treated with a single dose of CB-011 (150 million [N=6], 300 million [N=13], 450 million [N=13], and 800 million [N=3] CAR-T cells) with an LD regimen of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. The dose expansion portion of the trial is evaluating safety and efficacy of 450 million CB-011 CAR-T cells with the selected LD of 500 mg/m2 cyclophosphamide and 30 mg/m2 fludarabine daily for three days. Additional information on the CaMMouflage trial (NCT05722418) can be found at www.clinicaltrials.gov.

(Press release, Caribou Biosciences, AUG 14, 2026, View Source [SID1234670121])