On November 4, 2026 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the third quarter ended September 26, 2026.

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Key Highlights

•Reports third-quarter revenue of $982.7 million, GAAP earnings per share of $6.86, and non-GAAP earnings per share of $3.09.
•Organic revenue growth of 4.7%, outperforming the Company’s prior outlook and representing a return to organic revenue growth for the second consecutive quarter.
•Operating margin increased year-over-year, with non-GAAP operating margin increasing 330 basis points to 23.0% and GAAP operating margin increasing 730 basis points to 20.6%.
•Non-GAAP earnings per share increased 27.2% year-over-year.
•Increases 2026 guidance for revenue and non-GAAP earnings per share.
•Organic revenue guidance increasing by 100 basis points and non-GAAP earnings per share guidance increasing by $0.15 at midpoint.

•Guidance increases primarily driven by third-quarter outperformance, led by a better-than-expected performance in the DSA segment and a lower tax rate.

•Charles River unveiled its Pathway to Purpose strategic vision and Create the FutureTM initiative at its 2026 Investor Day, outlining initiatives designed to enhance operational excellence, strengthen scientific leadership, and drive long-term value creation.

•The Company advanced modernization efforts through the implementation of its Endosafe Cartridge Technology Automated Manufacturing Suite, which utilizes a fully automated production suite to increase production capacity and strengthen manufacturing controls and digital traceability. In addition, the Company partnered with Autolomous to launch Apollo OrchestrateTM, a new capability within Charles River’s Apollo platform to digitize and transform
laboratory workflows, increase efficiency, and provide greater transparency and connectivity with clients.

•Charles River has also taken steps to continue to strengthen its scientific capabilities. It recently announced an industry collaboration with the U.S. Food and Drug Administration (FDA) to validate preclinical screening tools to quantify and rank the abuse potential of new drugs.

•To further advance its Alternative Methods Advancement ProjectTM (AMAPTM) initiative, the Company introduced a new, rapid cell banking program designed to significantly accelerate product release timelines in its Biologics Testing Solutions business by incorporating in vitro next-generation sequencing capabilities into the cell bank production process. In addition, its Virtual Control Group (VCG) database and methodology will be used in an upcoming Good Laboratory Practice (GLP)-compliant safety assessment study for Ipsen.

Third-Quarter Results
Revenue was $982.7 million, a decrease of 2.2% from $1,004.9 million in the third quarter of 2025, primarily driven by the impact of the May 2026 divestitures. On an organic basis, revenue increased 4.7%, driven by revenue growth in the Manufacturing Solutions (Manufacturing) and Discovery and Safety Assessment (DSA) segments. Organic revenue growth excludes the effect of acquisitions, divestitures, and foreign currency translation.

In the third quarter of 2026, the GAAP operating margin was 20.6%, compared to 13.3% in the third quarter of 2025, driven primarily by a benefit of $44.6 million in the DSA segment from the reversal of acquired non-income tax reserves following newly enacted tax legislation and completion of certain tax requirements in a foreign jurisdiction. The GAAP net income available to common shareholders for the third quarter of 2026 was $333.1 million, or $6.86 per diluted share, compared to GAAP net income of $54.4 million, or $1.10 per diluted share for the same period in 2025. The GAAP net income and earnings per share increases included a benefit totaling $245.6 million, or $5.06 per share, associated with the reversal of acquired tax reserves following newly enacted tax legislation and completion of certain tax requirements in a foreign jurisdiction.

On a non-GAAP basis, the third-quarter operating margin increased to 23.0% from 19.7% in the third quarter of 2025, primarily as a result of the benefit of the CDMO divestiture and operating leverage from higher sales volume for safety assessment services. Non-GAAP net income was $150.1 million for the third quarter of 2026, an increase of 24.8% from $120.3 million for the same period in 2025. Third-quarter diluted earnings per share on a non-GAAP basis were $3.09, an increase of 27.2% from $2.43 per share in the third quarter of 2025. The non-GAAP net income and earnings per share increases were driven primarily by the higher operating margin and a lower tax rate.

Birgit Girshick, Chief Executive Officer, said, "In the third quarter, we were encouraged by the continued strength of the biopharmaceutical demand environment and that was reflected in our financial results. Revenue and earnings per share outperformed our prior expectations, DSA net bookings and proposals continued to show robust, year-over-year increases, and we continued to make meaningful progress towards our strategy and long-term financial targets. We see significant opportunities to continue to strengthen Charles River’s position as a leading scientific partner for regulated testing across the drug development continuum. Through our Pathway to Purpose strategy, we are building a more agile, client-centric organization that will deepen client relationships, expand engagement across our portfolio, and increase our share of R&D spend as demand trends continue to improve."
Third-Quarter Segment Results
Discovery and Safety Assessment (DSA)
Revenue for the DSA segment was $596.3 million in the third quarter of 2026, a decrease of 0.7% from $600.7 million in the third quarter of 2025, primarily driven by the divestiture of certain European Discovery Services sites. Organic revenue increased by 5.9%, driven primarily by higher study volume for regulated safety assessment services.

In the third quarter of 2026, the DSA segment’s GAAP operating margin increased to 28.9% from 20.5% in the third quarter of 2025. The increase was primarily driven by the reversal of acquired non-income tax reserves. On a non-GAAP basis, the operating margin increased to 26.8% from 25.4% in the third quarter of 2025. The non-GAAP operating margin increase was primarily driven by operating leverage from higher study volume for regulated safety assessment services, as well as lower sourcing costs for large research models.

Manufacturing Solutions (Manufacturing)

Revenue for the Manufacturing segment was $178.9 million in the third quarter of 2026, a decrease of 6.2% from $190.7 million in the third quarter of 2025, primarily driven by the CDMO divestiture. Organic revenue increased 7.4%, driven by strong demand in both the Biologics Testing Solutions and Microbial Solutions businesses.
The Manufacturing segment’s GAAP operating margin was 35.7%, compared to 20.9% in the third quarter of 2025. On a non-GAAP basis, the operating margin increased to 38.6% from 26.7% in the third quarter of 2025. The GAAP and non-GAAP increases were driven primarily by the benefit of the CDMO divestiture.
Research Models and Services (RMS)
Revenue for the RMS segment was $207.5 million in the third quarter of 2026, a decrease of 2.8% from $213.5 million in the third quarter of 2025, primarily driven by the Cell Solutions divestiture. Organic revenue decreased by 0.6%, due primarily to lower revenue for small research models in North America and for large research models. The decline was partially offset by higher revenue for small research models in China and for research model services, particularly the Insourcing Solutions business.

In the third quarter of 2026, the RMS segment’s GAAP operating margin increased to 19.9% from 16.2% in the third quarter of 2025, primarily due to lower costs related to the Cell Solutions divestiture and restructuring initiatives. On a non-GAAP basis, the operating margin decreased to 24.4% from 25.0%. The non-GAAP operating margin decrease was primarily driven by the impact of an unfavorable revenue mix, both geographically and related to large research models.

2026 Guidance Update
The Company is increasing its 2026 revenue and earnings per share guidance, which was last updated on August 5, 2026. This increase primarily reflects the third-quarter outperformance, which was principally driven by the better-than-expected performance in the DSA segment and a lower tax rate. On a GAAP basis, the Company is also increasing its earnings per share guidance, due primarily to the third-quarter benefit associated with the reversal of acquired tax reserves.

(Press release, Charles River Laboratories, NOV 4, 2026, View Source [SID1234674161])

On November 4, 2026 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of cancer therapies, reported that three posters highlighting compelling data and clinical progress for its lead radiopharmaceutical candidate, iopofosine I 131 in Waldenström macroglobulinemia (WM), will be presented at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place December 12 – 15 in New Orleans, Louisiana.

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The presentations will summarize updated 12-month follow-up data from the Phase 2b CLOVER WaM clinical trial, including new analyses exhibiting a significantly longer duration of response in patients who received iopofosine I 131 after only two prior lines of therapy compared with more heavily pretreated patients. These findings strengthen the clinical rationale for iopofosine I 131 in relapsed or refractory WM and support its potential evaluation in earlier treatment settings, where substantial unmet need remains. The company will also present, for the first time, the detailed design of its Phase 3 confirmatory study in WM patients previously treated with a Bruton tyrosine kinase inhibitor (BTKi). Site activation and other start-up activities are underway for the company’s global Phase 3 confirmatory study, with first patient dosing anticipated in the first quarter of 2027.

"The new data being presented at ASH (Free ASH Whitepaper) further strengthen the clinical profile of iopofosine I 131, underscoring its potential to deliver durable responses and address a significant unmet need in relapsed or refractory Waldenström macroglobulinemia," said Jarrod Longcor, chief operating officer of Cellectar Biosciences. "These updated CLOVER WaM results demonstrate durable responses in heavily pretreated patients, while new analyses suggest the potential for even greater durability of benefit when iopofosine I 131 is used in earlier lines of therapy. These findings reinforce our confidence in its clinical potential as we advance our registrational strategy. In parallel, we are targeting the first half of 2027 for an FDA submission seeking accelerated approval. These planned milestones define a clear path forward as we work to bring iopofosine I 131 to patients with limited treatment options."

Details of the upcoming presentations are as follows:

Title: "An Open-Label, Multicenter, Randomized, Phase 3 Trial of Iopofosine I 131 versus Rituximab-Cyclophosphamide-Dexamethasone (R-CD) in Waldenstrom Macroglobulinemia Patients Previously Treated with a Bruton Tyrosine Kinase Inhibitor: A Trial-in-Progress"
Session #: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I
Date/Time: December 12, 2026, 5:30:00 PM – 7:30:00 PM
Location: MCCNO – Hall F
Publication Number: 1799
Presenter: Jarrod Longcor, Chief Operating Officer of Cellectar Biosciences

Title: "Duration of Response to Iopofosine I 131 in Patients with Relapsed/Refractory Waldenström Macroglobulinemia by Prior Lines of Therapy: Results from the Pivotal Phase 2b CLOVER WaM Study"
Session #: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I
Date/Time: December 12, 2026, 5:30:00 PM – 7:30:00 PM
Location: MCCNO – Hall F
Publication Number: 1790
Presenter: Jarrod Longcor, Chief Operating Officer of Cellectar Biosciences

Title: "Iopofosine I 131 in Waldenström macroglobulinemia: 12-month follow up data from the CLOVER-WaM trial"
Session #: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III I
Date/Time: December 14, 2026, 6:00:00 PM – 8:00:00 PM
Location: MCCNO – Hall F
Publication Number: 5325
Presenter: Sikander Ailawadhi, MD, Professor of Medicine, Mayo Clinic

(Press release, Cellectar Biosciences, NOV 4, 2026, View Source [SID1234674160])

On November 4, 2026 Cartherics Pty Ltd ("Cartherics" or "Company"), a biotechnology company developing off-the-shelf immune cell therapies reported that it will present an update on CTH-401 for the treatment of ovarian cancer at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2026 Annual Meeting in Phoenix, Arizona. The Company is focused on high-impact women’s diseases such as ovarian cancer and endometriosis, and CTH-401 is its lead product candidate.

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Ovarian cancer causes more than 200,000 deaths worldwide each year. Most patients are diagnosed at an advanced stage, and fewer than 30% survive five years. New treatments are urgently needed.

Deputy Chief Scientific Officer, Dr Keefe Chan will present the findings in an oral presentation and a poster:

Oral presentation: Oral Abstract Session 2, Friday 6 November, 3:58–4:13pm (US Mountain Time)
Poster: # 161
Presentation title: CTH-401: Allogeneic iPSC-derived CAR-NK cells for the treatment of ovarian cancer

CTH-401 is an off-the-shelf immune cell therapy made from induced pluripotent stem cells (iPSCs). It is engineered to target TAG-72, a protein found on ovarian and other adenocarcinomas but with negligible expression on normal adult tissues. The cells also carry two gene deletions, DGKα and DGKζ, which remove an internal "brake" that normally dampens natural killer (NK) cell function following their activation.

Cartherics is manufacturing CTH-401 in its own clinical manufacturing facility. The product is made in advance from a master cell bank. Unlike autologous cell therapies, it is designed to be manufactured at scale and made available off the shelf, rather than custom-made for each patient.

Key findings to be presented include:

Consistent manufacturing: CTH-401 is produced with high consistency from a fully characterised, GMP-compliant master cell bank.
Targeted tumour killing: In laboratory studies, CTH-401 killed TAG-72-positive cancer cells, and the gene deletions significantly improved the cells’ resistance to tumour immunosuppression.
Anti-tumour activity: CTH-401 produced significant tumour control in a preclinical ovarian cancer model.
Safety: GLP toxicology studies showed an acceptable safety profile at dose equivalents well above the intended clinical range.
With IND-enabling studies complete, CTH-401 is positioned for a first-in-human trial in ovarian cancer, planned for early 2027, subject to regulatory approval.

TAG-72 is also expressed in colorectal, gastric and other adenocarcinomas, giving CTH-401 the potential to expand into further solid tumours. Cartherics’ iPSC platform is also designed to support additional products, including programs in endometriosis.

Cartherics brings discovery, process development and clinical manufacturing together in its own facility in Melbourne, giving it direct control over quality, cost and timelines as CTH-401 moves into the clinic.

"It’s a privilege to present our work on CTH-401 at the SITC (Free SITC Whitepaper) 2026 Annual Meeting. These data reflect years of work by an outstanding team, from gene editing iPSCs through to establishing a scalable manufacturing process of an off-the-shelf iPSC-derived natural killer cell product. We look forward to bringing CTH-401 to patients in need of new treatments," said Dr Keefe Chan, Deputy Chief Scientific Officer, Cartherics.

Read the abstract published in the Journal for ImmunoTherapy of Cancer here: View Source

(Press release, Cartherics, NOV 4, 2026, View Source [SID1234674159])

On November 4, 2026 Asgard Therapeutics, a privately held biotech company pioneering in vivo direct cell reprogramming for cancer immunotherapy, reported the publication of a landmark study in the journal Immunity demonstrating that its proprietary cell reprogramming platform can reliably induce the formation of mature immunogenic tertiary lymphoid structures (imgTLSs) directly within tumors and across multiple tumor types.

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imgTLSs are strongly associated with improved responses to immunotherapy and better survival across many cancers. However, previous approaches have struggled to reliably induce the formation of imgTLS across diverse tumor microenvironments (TMEs).

Filipe Pereira, Co-founder and Head of Innovation at Asgard, and lead author of the paper, said: "These findings provide strong evidence that, using Asgard’s in vivo cell reprogramming technology alone, we can reliably induce mature immunogenic TLSs across multiple tumor types. Recent work has implicated natural cDC1s in the formation and maintenance of TLS, and our study shows that the cDC1-like cells generated by in vivo reprogramming recapitulate these functions, supporting the fidelity of our mechanism of action."

Cristiana Pires, Co-founder and Chief Executive Officer of Asgard Therapeutics, said: "Demonstrating reliable induction of mature, immunogenic TLSs is something many companies and institutions have been trying to achieve. Thus, these new results are an important validation of the potential of our platform to turn tumors into sites of productive anti-tumor immunity. Together with the data we are presenting at SITC (Free SITC Whitepaper), the findings further support our efforts to advance our lead asset AT-108 toward the clinic next year, where we believe it could have a transformative impact on cancer patients."

The study, titled "Inducing immunogenic lymphoid niches across cancers by tumor-to-dendritic cell reprogramming", demonstrated that reprogramming tumor cells into cDC1-like cells using Asgard’s proprietary in vivo technology induced imgTLS formation across murine models of seven tumor types – melanoma, colon, bladder, breast, lung, pancreatic and glioblastoma, including both subcutaneous and orthotopic models. This breadth of activity across multiple cancer types, all with different mutational burdens and TMEs, strongly supports a tumor-agnostic effect.

Induced immunogenic niches contained CD4+ and CD8+ T cells and B cells, with BCL6+ germinal centers driving class-switching and tumor-reactive antibodies. Moreover, B cells were required for both imgTLS formation and tumor control, linking the induced TME remodeling to anti-tumor function. Importantly, the same DC-LAMP+ cDC1-nucleated architecture was detected in human tumors, suggesting that cDC1 reprogramming engages a TLS program conserved in human tumors and supporting the clinical translation of in situ reprogramming to induce functional TLS in patients.

Furthermore, inducing imgTLSs by cell reprogramming led to dramatic increases in complete response rates, compared to anti-PD1 immune checkpoint blockade monotherapy, across all models tested, including 100% tumor regressions in colorectal and breast cancer models.

Researchers also found a statistically significant positive correlation between the presence of larger imgTLSs and better long-term tumor control, supporting the potential use of imgTLSs as a clinical response biomarker in oncology.

The study, a collaboration between Asgard Therapeutics, Lund University, Shanghai Cancer Centre and the University of Coimbra, can be found here: View Source

The mechanistic findings reported in Immunity are complemented by preclinical studies with Asgard’s lead candidate, AT-108. Following intratumoral administration, AT-108 induces dose-dependent immune remodeling, characterized by increased cytotoxic and activated T-cell populations, reduced immunosuppressive macrophages, and transcriptional signatures of B-cell and immunoglobulin-associated programs. Importantly, TME remodeling was reflected systemically in the blood, with measurable dose-dependent changes in circulating immune cells and transcriptional signatures, providing accessible pharmacodynamic biomarkers of AT-108 activity.

These AT-108 biomarker data will be presented in a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 41st Annual Meeting, taking place 4-8 November 2026 in Phoenix, Arizona.

Details of the poster presentation are as follows:

Title: Preclinical characterization of local and systemic pharmacodynamic biomarkers of AT-108, a first-in-class in situ tumor-to-dendritic cell reprogramming agent

Abstract Number: 1055

Presenter: Emma Leire, Asgard Therapeutics

Date: Friday 6 November 2026

Location: Exhibition Halls 4-6

Times: 8:00 AM – 7:00 PM MT; Poster lunch session 12:15 PM – 1:45 PM MT; Poster reception: 5:30 PM – 7:00 PM MT

(Press release, Asgard Therapeutics, NOV 4, 2026, View Source [SID1234674158])

On November 4, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers, reported financial results for the third quarter ended September 30, 2026, and provided a business update.

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"We continue to make meaningful progress in advancing APR-1051 towards our goal of developing a differentiated, potentially best-in-class WEE1 inhibitor for patients with biomarker defined cancers," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "We have expanded our clinical site network from three to nine active sites and expect enrollment in ACESOT-1051 to reach six to ten patients per month during the fourth quarter of 2026, positioning us to accelerate clinical development. Our strategy is focused on biomarker defined endometrial cancers, including uterine serous carcinoma, building on the encouraging early clinical activity observed in these patients. The preliminary antitumor activity and manageable tolerability observed to date support our strategy to advance APR-1051 as a single agent in selected patient populations, while evaluating rational combination approaches to expand its therapeutic potential across multiple tumor types. We look forward to presenting updated Phase 1 clinical results at the upcoming EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics and remain on track to select the dose for Part 2 of the study, focused on dose optimization, in the first half of 2027. With $37.8 million in cash and cash equivalents as of September 30, 2026, and an expected cash runway into the first quarter of 2028, we believe we are well positioned to execute our clinical development strategy, achieve meaningful milestones, and create long-term value for patients and shareholders."

Key Business Updates and Upcoming Key Milestones

ACESOT-1051: A Biomarker-Focused, Phase 1 Trial of Oral WEE1 Inhibitor, APR-1051

· APR-1051 is a potent and selective oral small molecule WEE1 inhibitor designed to potentially address therapeutic window limitations observed with earlier WEE1 programs. It is currently being evaluated in ACESOT-1051, a multi-center, open-label Phase 1 study. The primary objectives of this study are safety, dose-limiting toxicity, maximum tolerated or maximum administered dose, and recommended Phase 2 dose (RP2D). Secondary objectives include pharmacokinetics and antitumor activity assessed by RECIST/PCWG3.

· Aprea is focused on developing APR-1051 in genetically defined cancers, with special emphasis on endometrial cancers, including uterine serous carcinoma. This focus includes tumors characterized by PPP2R1A, CCNE1, CCNE2 or FBXW7 mutations and Cyclin E overexpression. The Company remains on track to select the dose for Part 2 of the study in the first half of 2027. The Company also plans to evaluate APR-1051 in combination with pembrolizumab in HPV-positive head and neck squamous cell carcinoma. The Company is expanding ACESOT-1051 to enroll at least 50 patients with uterine serous carcinoma or Cyclin E-overexpressing, platinum-resistant ovarian cancer, with completion of dose escalation and backfill expansion enrollment expected in the second quarter of 2027. The Company expects this expansion and the activation of additional clinical sites to increase research and development expenses for APR-1051 relative to its prior plans.

· Updated interim results from ACESOT-1051 will be featured in an oral presentation at the 38th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (ENA 2026), to take place November 18-20, 2026, in Barcelona, Spain. The presentation, titled "Interim results from the first-in-human phase 1 study of WEE1 inhibitor APR-1051 in patients with advanced solid tumors (ACESOT-1051)," is scheduled for Friday, November 20, 2026, and will be delivered by Timothy A. Yap, MBBS, Ph.D., FRCP, of the Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. The associated abstract, expected to be available early November 2026, includes trial design and interim clinical data as of a May 6, 2026 data cutoff. The oral presentation on November 20 will include updated clinical results, including data on patients enrolled since the cutoff.

· On October 20, 2026, Aprea hosted a virtual expert panel, "The State of WEE1 Inhibition in Precision Oncology," ahead of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026. Moderated by Solomon Wilcots, the panel featured Alex Spira, M.D., of the Virginia Cancer Specialists Research Institute, NEXT Oncology, and Johns Hopkins University School of Medicine; Kevin DeGeeter of Ladenburg Thalmann & Co. Inc.; and Eugene Kennedy, M.D., Chief Medical Advisor of Aprea. The discussion addressed the underlying biology of WEE1, the selectivity challenges that have shaped the class, and scientific, clinical and market perspectives on the field. A replay of the expert panel can be accessed here. The views expressed by third-party panelists are their own and do not necessarily reflect the views of the Company.

· For more information on ACESOT-1051, refer to ClinicalTrials.gov NCT06260514.

ATR inhibitor, ATRN-119

· ATRN-119 is a potent and highly selective, potentially first-in-class macrocyclic ATR inhibitor designed for patients with tumors harboring mutations in DNA damage response (DDR)-related genes. We believe ATRN-119 was the first oral macrocyclic ATR inhibitor to enter clinical trials. Cancers with mutations in DDR-related genes represent a high unmet medical need, and these patients often have a poor prognosis and currently lack effective therapeutic options. Aprea is currently in discussions with leading academic centers to explore various combinations for ATRN-119. These include potential investigator-initiated studies evaluating ATRN-119 in combination with immuno-oncology (I/O) agents, chemotherapy, antibody-drug conjugates (ADCs) and/or radiation. Potential indications for these combinations include advanced solid tumors (e.g., HPV-positive head and neck cancers, sarcomas, and ovarian, colorectal and lung cancers) and hematologic malignancies (e.g., acute myeloid leukemia and myelodysplastic syndromes).

· In October 2025, Aprea determined the RP2D of 1,100 mg once daily for ATRN-119 in the ABOYA-119 Phase 1/2a dose-escalation study and subsequently closed this study to focus resources on the clinical development of APR-1051. Building on the completion of dose escalation, the Company is considering further ATRN-119 development in combination approaches that could expand its therapeutic potential, which may depend on its ability to collaborate successfully with third parties. Aprea believes ATRN-119’s mechanism of action, potentially favorable safety profile and pharmacologic characteristics could make it an ideal candidate for combination with other anti-cancer therapies, including radiation therapy, chemotherapy, ADCs and immune checkpoint inhibitors.

Pipeline

· Aprea also has an early-stage program focused on developing macrocyclic DYRK1A/B inhibitors, and is targeting lead identification in the second quarter of 2027, subject to the availability of resources.

Intellectual Property

· Aprea’s global intellectual property portfolio comprises 30 issued patents (US and ex-US) and 29 pending applications (US and ex-US) covering proprietary compounds, pharmaceutical compositions and methods of use across its WEE1 and ATR inhibitor programs. Pending applications, if granted, could provide patent protection through 2047 for the WEE1 program, including APR-1051, and extend protection for the ATR program, including ATRN-119, into 2045.

Financial Results for the Third Quarter Ended September 30, 2026

· As of September 30, 2026, the Company had cash and cash equivalents of $37.8 million, compared to $14.6 million as of December 31, 2025. Based on its current operating plan, the Company believes that its cash and cash equivalents as of September 30, 2026 will be sufficient to meet its currently projected operating expenses and capital expenditure requirements into the first quarter of 2028.

· For the third quarter ended September 30, 2026, the Company reported an operating loss of $5.2 million, compared to an operating loss of $3.1 million in the third quarter of 2025.

· Research and development (R&D) expenses were $3.3 million for the quarter ended September 30, 2026, compared to $1.6 million for the third quarter of 2025. The increase in R&D expenses was primarily related to an increase of $2.1 million in expenses for ACESOT-1051, the Company’s Phase 1 dose-escalation study for APR-1051, partially offset by a decrease of $0.5 million in expenses for the ABOYA-119 clinical trial of ATRN-119, which has been closed.

· General and administrative (G&A) expenses were $1.8 million for the quarter ended September 30, 2026, compared to $1.5 million for the third quarter of 2025. The increase was primarily related to higher professional fees and consulting expenses.

· The Company reported a net loss of $4.8 million, or $(0.09) per basic and diluted share, on approximately 53.7 million weighted-average common shares outstanding for the quarter ended September 30, 2026, compared to a net loss of $3.0 million, or $(0.47) per basic and diluted share, on approximately 6.4 million weighted-average common shares outstanding for the comparable period in 2025. Weighted-average common shares outstanding for the 2026 period include approximately 39.8 million shares issuable upon exercise of pre-funded warrants exercisable for nominal consideration. As of September 30, 2026, the Company had 14,191,136 shares of common stock outstanding.

(Press release, Aprea, NOV 4, 2026, View Source [SID1234674157])