11/13/2026 | Press release | Distributed by Public on 11/13/2026 16:07
Management's Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis should be read in conjunction with the unaudited financial information and the notes thereto included herein, as well as the "Management's Discussion and Analysis of Financial Condition and Results of Operations" and our audited consolidated financial statements and notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2025, as filed on March 12, 2026. This discussion contains forward-looking statements that involve risks and uncertainties. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under the caption "Cautionary Statement Regarding Forward-Looking Statements" in this Quarterly Report, as well as under "Part I - Item 1A - Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2025, in other subsequent filings with the Securities and Exchange Commission, and elsewhere in this Quarterly Report. These statements, like all statements in this Quarterly Report, speak only as of the date of this Quarterly Report (unless another date is indicated), and the Company undertakes no obligation to update or revise these statements in light of future developments.
Our Management's Discussion and Analysis of Financial Condition and Results of Operations includes the following sections:
Overview
Cerenome is a U.S. pharmaceutical and diagnostics company developing targeted radiotherapeutics and advanced diagnostic platform technologies for central nervous system ("CNS") cancers. Our therapeutic and diagnostic programs are designed to improve the detection, characterization, and treatment of aggressive CNS malignancies, including primary brain tumors and metastatic disease involving the CNS. There are over 1.3 million U.S. patients living with or at risk of a primary brain or metastatic brain tumor today and it is estimated that up to 30% of adult cancer patients will develop CNS metastases.
Our therapeutic platform focuses on novel radioactive drug formulations and medical devices designed to deliver safe and effective doses of radiation directly to tumors. To achieve this, we have developed innovative approaches to drug formulation, including encapsulating radionuclides such as rhenium isotopes with nanoliposomes and microspheres. Our formulations are intended to achieve elevated patient-absorbed radiation doses and extend retention times such that the clearance of the isotope occurs after significant and essentially complete radiation decay, which will contribute and provide less normal tissue/organ exposure and improved safety margins.
Traditional approaches to radiation therapy for cancer, such as external beam radiation, have many disadvantages including prolonged treatment regimens lasting four to six weeks, collateral damage to healthy and developing cells and tissue, and limitations on the total radiation dose that can be safely delivered, which may be insufficient to fully eradicate tumors.
Our targeted radiotherapeutic platform and unique investigational drugs have the potential to overcome these limitations by directing higher, more potent radiation doses to tumors while minimizing exposure to surrounding healthy tissues, potentially in a single treatment. By minimizing radiation exposure to healthy tissues while simultaneously maximizing locoregional delivery and, thereby, efficacy, we hope to reduce the radiation toxicity for patients, improving their quality of life and life expectancy. Our radiotherapeutic platform, combined with advances in surgery, nuclear medicine, interventional radiology, radiation oncology, and existing oncolytic therapies provides opportunities to target a broad variety of cancer types.
Our lead radiotherapeutic candidate, REYOBIQ (rhenium (186Re) obisbemeda), is designed specifically for CNS cancers, including recurrent glioblastoma ("GBM"), leptomeningeal metastases ("LM"), and pediatric brain cancers ("PBC") by direct localized delivery utilizing approved standard-of-care tissue access such as with convection-enhanced delivery ("CED") and intraventricular brain (Ommaya reservoir) catheters. The goal of REYOBIQ is to treat both tumor and infiltrative margin with at least 100 Gy radiation. Our acquired radiotherapeutic candidate, Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere ("188RNL-BAM") is designed to treat many solid organ cancers including primary and secondary liver cancers by intra-arterial injection.
On April 26, 2024, we acquired all of the right, title and interest in a cerebrospinal fluid cancer diagnostic portfolio known as the "CNSide® Platform" from Biocept, Inc. ("Biocept"). In connection with this acquisition, we formed CNSide Diagnostics, LLC ("CNSide Diagnostics"), a wholly owned subsidiary of the Company, to develop and commercialize diagnostic solutions for CNS cancers. Biocept invested approximately $300 million in the core tech for the CNSide Platform prior to our acquisition.
The CNSide Platform is a proprietary CSF-based assay platform designed to detect, enumerate, and characterize tumor cells present in the CSF of patients with suspected or confirmed CNS malignancies, including leptomeningeal metastases. The platform integrates standardized CSF sample collection, specialized preservation and processing methods, and advanced cellular and molecular analysis techniques to identify rare tumor cells that may not be detectable using conventional diagnostic approaches such as CSF cytology or imaging studies.
The CNSide Cerebrospinal Fluid Tumor Cell Enumeration test (the "CNSide®Test") is a laboratory developed test ("LDT") intended to provide clinicians with quantitative and clinically actionable information regarding the presence and burden of tumor cells in the CSF. The CNSide Test is intended to support disease detection, treatment monitoring, and inform clinical decision-making in patients with suspected or confirmed leptomeningeal metastases, and continues to be utilized in the ReSPECT-LM clinical trial funded by the Cancer
Prevention and Research Institute of Texas ("CPRIT"). In April 2026, the American Medical Association ("AMA") issued a dedicated Proprietary Laboratory Analyses ("PLA") code, 0640U, for the CNSide Test, effective July 1, 2026.
We re-introduced the CNSide Test to a select number of major cancer centers in the U.S. market beginning in August 2025, following receipt of laboratory certifications, state licenses, and payer coverage. Since re-introduction, we have obtained CAP accreditation for our Houston laboratory, expanded contracted payer coverage, and, in October 2026, expanded the CNSide Platform with the launch of the CNSide CSF Molecular Profile tests. Since 2020, more than 11,000 CNSide tests have been performed at more than 120 U.S. cancer institutions, and the clinical utility of CNSide CSF tumor-cell analysis in LM has been evaluated in 12 peer-reviewed publications. We intend to further develop the CNSide Platform to support additional clinical applications.
Segments
As of July 1, 2026, our operations are organized and managed through two reportable segments: Therapeutics and Diagnostics, consistent with the financial information regularly provided to our Chief Executive Officer, who is our chief operating decision maker. For additional information on our segments, refer to Note 15, "Segment Information".
Pipeline
Our most advanced investigational drug, REYOBIQ, is a patented radiotherapy potentially useful for patients with CNS and other cancers. We announced in March 2025 that U.S. Food and Drug Administration ("FDA") conditionally accepted the proprietary name, REYOBIQ, to be used by us for rhenium (186Re) obisbemeda. Preclinical study data describing the use of REYOBIQ for several cancer targets have been published in peer-reviewed journals and reported at a variety of medical society peer-reviewed meetings. Besides GBM, LM and PBC, REYOBIQ has been reported to have potential applications for head and neck cancer, ovarian cancer, breast cancer and peritoneal metastases. In addition to REYOBIQ's radiotherapeutic mechanism of action, there is emerging evidence of the drug's ability to shift the tumor immune microenvironment toward an active, effector-dominant state. This may open the possibility of new combined therapies with REYOBIQ.
The REYOBIQ technology was part of a licensed radiotherapeutic portfolio that we acquired from NanoTx, Corp. ("NanoTx") on May 7, 2020. The licensed radiotherapeutic has been evaluated in preclinical studies for several cancer targets and we have an active $3.0 million award from U.S. National Institutes of Health/National Cancer Institute which is expected to provide financial support for the continued clinical development of REYOBIQ for recurrent GBM through the completion of a Phase 2 clinical trial, including enrollment of up to 55 patients.
On August 29, 2022, we announced feedback from a Type C meeting with the FDA regarding Chemistry, Manufacturing and Controls practices. The FDA indicated agreement with our proposed application of cGMP guidance for radiotherapeutics, small molecule drug products and liposome drug products for REYOBIQ in support of ongoing and future GBM clinical trials, manufacturing scale up, and commercialization. Alignment with the FDA includes support of our proposed controls and release strategy for new drug substance and new drug product. Because this product is identical for recurrent GBM, LM, and PBC, we believe alignment will be consistent for REYOBIQ used in other clinical development programs, including LM and PBC.
REYOBIQ versus External Beam Radiation Therapy for Recurrent GBM
REYOBIQ is a novel injectable radiotherapy designed to deliver targeted, high dose radiation directly into GBM tumors in a safe, effective, and convenient manner that may ultimately prolong patient survival. REYOBIQ is composed of the radionuclide Rhenium-186 and a nanoliposomal carrier, and is infused in a highly targeted, controlled fashion, directly into the tumor via precision brain mapping and CED catheters. Potential benefits of REYOBIQ compared to standard external beam radiotherapy or external beam radiation therapy ("EBRT") include:
|
|
The REYOBIQ radiation dose delivered to patients may be up to 20 times greater than what is possible with commonly used EBRT, which, unlike EBRT and proton beam devices, spares normal tissue and the brain from radiation exposure. |
|
|
REYOBIQ can be visualized in real-time during administration, possibly giving clinicians better control of radiation dosing, distribution and retention. |
|
|
REYOBIQ is potentially more effective in treating a bulk tumor and microscopic disease that has already invaded healthy tissue. |
|
|
REYOBIQ is infused directly into the targeted tumor by CED catheter insertion using MRI guided software to avoid critical patient neurological structures and neural pathways and also bypasses the blood brain barrier, which delivers the therapeutic product where it is needed. Importantly, it reduces radiation exposure to healthy and/or developing cells, in contrast to EBRT, which passes through normal tissue to reach the tumor, continuing its path through the tumor, hence being less targeted and selective. |
|
|
REYOBIQ is given during a single, short, in-patient hospital visit, and is available in all hospitals with nuclear medicine and neurosurgery, while EBRT requires out-patient visits five days a week for approximately four to six weeks. |
ReSPECT-GBM Trial for Recurrent GBM
GBM affects approximately 15,000 patients annually in the U.S. and is the most common and lethal form of brain cancer. The average life expectancy with GBM is less than 24 months, with a one-year survival rate of 40% and a five-year survival rate of around 5%. There is no clear standard of care for recurrent GBM and the few currently approved treatments provide only marginal survival benefit and are associated with significant side effects, which limit dosing and prolonged use. Approximately 90% of patients experience GBM tumor recurrence at or near the original tumor location, yet there are no FDA-approved treatments in the recurrent or progressive setting that can significantly extend a patient's life. GBM routinely presents with headaches, seizures, vision changes and other significant neurological complications, with a significant compromise in quality of life. Despite the best available medical treatments, the disease remains incurable. Even after efforts to manage the presenting signs and symptoms and completely resect the initial brain tumor, some microscopic disease almost always remains and tumor regrowth occurs within months. Complete surgical removal of GBM is usually not possible and GBM is often resistant or quickly develops resistance to most available current and investigational therapies. Today, the treatment of GBM remains a significant challenge and it has been nearly a decade since the FDA approved a new therapy for this disease, and these more recent approvals have not improved the overall survival ("OS") for GBM patients over past decades, and a significant unmet medical need persists.
While EBRT has been shown to be safe and has temporary efficacy in many malignancies including GBM, typically at absorbed, fractionated radiation dose of ~30 Gray in GBM, this maximum possible administered dose is always limited by toxicity to the normal tissues surrounding the malignancy and because EBRT requires fractionation to manage toxicity and maximum EBRT limits are typically reached before long-term efficacy reached. Because of this limitation, EBRT cannot provide a cure or long-term control of GBM and GBM always recurs within months after EBRT. In contrast, locally delivered and targeted radiopharmaceuticals that precisely deliver radiation in the form of beta particles such as Iodine-131 for thyroid cancer, are known to be safe and effective and minimize exposure to normal cells and tissues especially with optimal administered dose and minimizing exposure to normal tissue. The locally delivered REYOBIQ is designed for and provides patient tolerability and safety. Though no REYOBIQ head-to-head trial with chemo, immune, EBRT or systemic radiopharmaceutical products have been conducted, patient tolerability and safety considerations have been reported as expected.
In September 2020, the FDA granted both Orphan Drug and Fast Track designations to REYOBIQ for the treatment of patients with GBM.
REYOBIQ is under clinical investigation in a Phase 1/2 multicenter, sequential cohort, open-label, volume and dose escalation study ("ReSPECT-GBM") of the safety, tolerability, and distribution of REYOBIQ given by CED catheters to patients with recurrent or progressive malignant glioma after standard surgical, radiation, and/or chemotherapy treatment (NCT01906385). The Phase 1 portion of the clinical study is complete. The Phase 2 portion of the clinical study in progress and is a multicenter, single arm, prospective study utilizing a non-DLT dose obtained from the dose escalation portion of the Phase 1 clinical study. The trial is funded through Phase 2 in large part by a National Institute of Health/National Cancer Institute grant.
On January 18, 2023, we announced that the first patient was dosed in Phase 2 of the ReSPECT-GBM Phase 1/2 trial evaluating REYOBIQ for the treatment of recurrent GBM. Phase 2 of the trial was expected to enroll up to 34 total patients with small- to medium-sized tumors but was terminated in October 2026 with a total of 32 patients. We currently expect a data read-out in the first half of 2027.
On September 30, 2024, we showcased new interim ReSPECT-GBM Phase 2 Trial Data at the 2024 Congress of Neurological Surgeons Annual Meeting that included the following findings as of that date:
|
|
42 total patients enrolled in ReSPECT-GBM trial at 3 sites, with 19 out of 42 patients having been treated at the recommended Phase 2 dose (22.3 mCi in 8.8 mL) in tumors of approximately 20 cm3 or less. |
|
|
All Phase 2 patients have recurrent, histologically confirmed glioblastoma; 1 recurrence, bevacizumab naïve, single tumor of approximately 20 cm3 or less (small-to-medium sized tumors). |
|
|
Average tumor size in Phase 2 was 7.5 mL (range 0.9-22.8 mL). |
|
|
Increases in absorbed dose correlated with specific drug delivery parameters such as infused dose and volume, maximal convection flow rate, and number of catheters. |
|
|
REYOBIQ continues to show a favorable safety profile in the 42 enrolled patients; one dose-limiting toxicity (hemiplegia) has been reported, which was observed in Cohort 8 (41.5 mCi and 16.3 mL). |
|
|
In Phase 2, most adverse events were mild (73.5%) or moderate (18.8%), and largely unrelated (37.7%), or unlikely related (27.1%) to the drug. Of the 9 severe adverse events, only 2 were related to the study drug. |
|
|
Average absorbed radiation dose to the tumor in Phase 2 was 300 Gy (n=18, 1 patient still under analysis). |
|
|
88.9% of Phase 2 patients met key CED drug delivery parameters shown to correlate with overall survival, achieving a tumor absorbed dose >100 Gy and radiation coverage of >70%. |
|
|
29 out of 42 patients treated thus far participated in the Phase 1 dose escalation phase of the trial (as per protocol, 6 out of 42 patients were included in both the Phase 1 and Phase 2 trial arms and related analyses). |
|
|
Phase 1 dose-escalation increased administered doses from 1.0 mCi to 41.5 mCi and volumes from 0.66 mL to 16.3 mL. |
|
|
In terms of objective tumor response based on quantitative image analysis, a statistically significant reduction in tumor volume rate change was seen in tumors receiving > 100 Gy absorbed dose (n=11 patients analyzed to date, p<0.005). Sufficient tumor coverage correlated with tumor control, while regrowth occurred outside treated areas. |
We have completed both Phase 1 and Phase 2 of our ReSPECT-GBM Trial.
In December 2025, we reported results from our Phase 1 ReSPECT-GBM Trials and provided updates on Phase 2, which included:
|
|
Phase 1 dose-escalation study completed, with patients dosed from 1.0 mCi to 41.5 mCi, achieving a maximum absorbed tumor dose of 739.5 Gy. Dose 22.3 mCi was selected as the recommended Phase 2 dose due to its favorable safety profile. |
|
|
Ongoing Phase 2 study has enrolled 32 of planned 34 patients as of the data cutoff; study continues to evaluate safety and efficacy at the Phase 2 recommended dose. |
Safety:
|
|
Across all patients treated in both Phase 1 and 2, most treatment-related adverse events were Grade 1 or 2, including lymphopenia (7.9%), cognitive disorder (7.0%), and headache (7.0%), with no treatment-related deaths or study discontinuations due to serious adverse reactions (SARs). |
Response:
|
|
Efficacy data from Phase 1 cohorts 1 to 6 showed a median overall survival of 17 months for patients receiving ≥100 Gy, compared to 6 months for those receiving <100 Gy, surpassing historical bevacizumab monotherapy outcomes. |
|
|
SPECT/CT imaging continues to confirm high tumor-specific radiation retention, with minimal systemic exposure. |
With respect to assessment of REYOBIQ efficacy for recurrent GBM using MRI and SPECT imaging biomarkers, the Company reported that Phase 1 showed promising improvements in overall survival. REYOBIQ dose positively correlates with treatment coverage ratio, time to peak, and progression free survival; negatively correlates with mean transit time and tumor volume. Based on a Wilcoxon Signed Rank test on 23 patients receiving REYOBIQ, untreated tumor volume was significantly increased relative to treated tumor volume. Overall survival negatively associated with tumor volume. As of the date of this document, 32 patients have been enrolled in the Phase 2 ReSPECT-GBM Trial.
ReSPECT-LM Clinical Trials for LM
LM is a rare complication of cancer in which the disease spreads to the membranes (meninges) surrounding the brain and spinal cord. The incidence of LM is growing and occurs in approximately 5%, or more, of people with late-stage cancer, or 110,000 people in the U.S. each year. It is highly lethal with an average one-year survival of just 7%. All solid cancers, particularly breast, lung, GI, and melanoma, have the potential to spread to the leptomeninges.
The ReSPECT-LM Phase 1 clinical trial was preceded with preclinical studies in which tolerance to doses of REYOBIQ as high as 1,075 Gy were shown in animal models with LM without significant observed toxicity. Furthermore, treatment led to a marked reduction in tumor burden in both C6 and MDA-231 LM models.
Upon receiving acceptance of our Investigational New Drug application and Fast Track designation by the FDA for REYOBIQ for the treatment of LM in November 2021, we initiated the trial and began screening patients for the ReSPECT-LM Phase 1 clinical trial in the fourth quarter of 2021.
ReSPECT-LM is a multi-center, sequential cohort, open-label, dose escalation study evaluating the safety, tolerability, and efficacy of a single-dose application of REYOBIQ administered through intrathecal infusion to the ventricle of patients with LM after standard surgical, radiation, and/or chemotherapy treatment. The primary endpoint of the study is the incidence and severity of adverse events and dose limiting toxicities, together with determining the maximum tolerated and recommended Phase 2 dose. Full enrollment in the Phase 1 trial was achieved at the end of 2024, and we announced the trial completion on February 26, 2025. It has shown that the use of REYOBIQ can increase overall survival by 50%. Trial closeout procedures are now taking place including final data review and monitoring, and a clinical study report and manuscript will be prepared.
On September 19, 2022, we entered into a Cancer Research Grant Contract (the "CPRIT Contract"), effective as of August 31, 2022, with CPRIT, pursuant to which CPRIT provides us a grant of up to $17.6 million (the "CPRIT Grant") over a three-year period to fund the continued development of REYOBIQ for the treatment of patients with LM through Phase 2 of the ReSPECT LM clinical trial. The CPRIT Grant is subject to customary CPRIT funding conditions, including, but not limited to, a matching fund requirement (one dollar from us for every two dollars awarded by CPRIT), revenue sharing obligations upon commercialization of REYOBIQ based on specific dollar thresholds until CPRIT receives the aggregate amount of 400% of the proceeds awarded under the CPRIT Grant, and
certain reporting requirements. As of September 30, 2026, we had received approximately $15.9 million in milestone payments under the CPRIT Contract.
Interim results showed that a single treatment with REYOBIQ resulted in a consistent decreased cerebrospinal fluid ("CSF") tumor cell count/ml and was tolerated by all LM patients. REYOBIQ is an outpatient administration and treatment and is easily and safely administered through a standard intraventricular catheter (Ommaya Reservoir), distributed promptly throughout the CSF, and with durable retention in the leptomeninges at least through day seven. All patients have shown well tolerated prompt and durable REYOBIQ distribution throughout the subarachnoid space.
In November 2023, the FDA granted Orphan Drug designation to REYOBIQ for the treatment of patients with breast cancer with LM.
On February 26, 2025, we announced the completion of the ReSPECT-LM Phase 1 single-dose escalation trial, having determined a recommended Phase 2 dose. Enrollment in Cohort 6 was completed (75.0 mCi). The Cohort 4 dose (44.1 mCi) was determined to be the recommended Phase 2 dose with no dose-limiting toxicities observed at that dose level. One patient at the Cohort 4 dose was observed to have achieved a complete response, as evidenced by the eradication of tumor cells in the cerebrospinal fluid-a key therapeutic endpoint.
In March 2025, the FDA granted Orphan Drug designation to REYOBIQ for the treatment of LM in patients with lung cancer.
In November 2025, we had our end of phase 1 meeting with the FDA. During this meeting, there was FDA alignment with our dose optimization design for multiple doses of REYOBIQ administration. The FDA conveyed that while accelerated approval may be appropriate for this indication, there are insufficient data to support the use of CTCs as an intermediate clinical endpoint, and there was discussion of the potential to submit a comprehensive plan to pursue validation of CTCs as a potential endpoint in LM. FDA stated that a randomized trial is necessary to support a marketing application, and encouraged the study of patient reported outcomes and neurologic function as endpoints that could potentially support a marketing application, alongside an established primary endpoint like overall survival. There was alignment that CTCs could be considered for use as a key secondary endpoint. There was also discussion of a randomized controlled design approach, for a registration study, that may include an intrathecal chemotherapeutic as a comparator, and approaches to standardize other therapeutic interventions in both active and control arms. FDA also indicated that it may be reasonable to incorporate multiple histologies in a single trial. These feedback have been incorporated into an ongoing protocol amendment while the trial is actively enrolling patients for dose optimization.
In December 2025, we reported completion of the ReSPECT-LM single dose trial showed REYOBIQ was well-tolerated up to a maximum tolerated dose of 66mCi, with a recommended phase 2 dose of 44.1 mCi, and absorbed doses delivered of >300 Gy observed. We also reported the ReSPECT-LM open label, multidose Phase 1/2 trial initiation to identify maximum tolerated dose across varying dosing intervals and to characterize efficacy of multiple doses of REYOBIQ. As noted above, enrollment in the dose optimization phase of the trial is ongoing and no dose limiting toxicities have been reported.
ReSPECT-PBC Clinical Trial for Pediatric Brain Cancer
The average annual age adjusted mortality rate for children aged 0-14 for malignant brain (and other CNS) tumors is 0.71/100,000, making it the most common cause of death and cancer death in this age group. The 2021 World Health Organization Classification of CNS Tumors classifies gliomas, glioneuronal tumors, and neuronal tumors into six different families: (1) adult-type diffuse gliomas; (2) pediatric-type diffuse low-grade gliomas; (3) pediatric-type diffuse high-grade gliomas ("HGG"); (4) circumscribed astrocytic gliomas; (5) glioneuronal and neuronal tumors; and (6) ependymomas.
In August 2021, we announced plans for treating pediatric brain cancer at the 2021 American Association of Neurological Surgeons Annual Scientific Meeting. In July 2021, we reported that we had received FDA feedback pertaining to a pre-Investigational New Drug Application ("IND") meeting briefing package in which the FDA stated that we are not required to perform any additional preclinical or toxicology studies.
Given the initial FDA feedback, receipt of adult GBM data and experience with REYOBIQ and follow-up communications with the FDA, we submitted a pediatric brain tumor IND for our ReSPECT-PBC clinical trial to investigate the use of REYOBIQ in two pediatric brain cancers, high-grade glioma and ependymoma, in the fourth quarter of 2024.
Pediatric high-grade gliomas can be found almost anywhere within the CNS; however, they are most commonly found within the supratentorium. The highest incidence of supratentorial, high-grade gliomas in pediatrics appears to occur in children aged 15 to 19 years, with a median age of approximately nine years. Overall, pediatric high-grade glioma confers a three-year progression free survival ("PFS") of 11 ± 3% and three-year OS of 22 ±5%. One-year PFS is as low as 40% in recent trials. Ependymomas are slow-growing central nervous system tumors that involve the ventricular system. Diagnosis is based on MRI and biopsy and survival rate depends on tumor grade and how much of the tumor can be removed. Grade II pathology was associated with significantly improved OS compared to Grade III (anaplastic) pathology (five-year OS = 71 ± 5% vs. 57 ± 10%; p = 0.026). Gross total resection compared to subtotal resection was associated with significantly improved OS (five-year OS = 75 ± 5% vs. 54 ± 8%; p = 0.002).
Overall, pediatric HGG and ependymoma are extremely difficult-to-treat pediatric brain tumors, frequently aggressive, and in recurrent settings, carry an extremely poor prognosis.
Effective September 1, 2024, we entered into an agreement with the Department of Defense office of the Congressionally Directed Medical Research Programs to receive a $3.0 million fund for research and development purposes ("DoD Award") over a three-year period. The DoD Award is being used to support the expansion of our clinical trial for pediatric brain cancer. We have activated a single site within the United States and enrollment is ongoing.
Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere Technology
In January 2022, we announced that we licensed Biodegradable Alginate Microsphere ("BAM") patents and technology from The University of Texas Health Science Center at San Antonio ("UTHSCSA") to expand our tumor targeting capabilities and precision radiotherapeutics pipeline. We intend to combine our Rhenium NanoLiposome technology with the BAM technology to create a novel radioembolization technology. Initially, we intend to utilize the Rhenium-188 isotope, 188RNL-BAM for the intra-arterial embolization and local delivery of a high dose of targeted radiation for a variety of solid organ cancers such as hepatocellular cancer, hepatic metastases, pancreatic cancer and many others.
Preclinical data from an ex vivo embolization experiment in which Technetium99m-BAM was intra-arterially delivered to a bovine kidney perfusion model was presented at the Society of Interventional Radiology Annual Scientific Meeting. The study concluded that the technology required for radiolabeling BAM could successfully deliver, embolize and retain radiation in the target organ. 188RNL-BAM is a preclinical investigational device we intend to further develop and move into clinical trials. Specifically, in 2022 we transferred the 188RNL-BAM technology from UTHSCSA, and began planning to develop the product and complete early preclinical studies to support a future FDA IND submission. Our intended initial clinical target is liver cancer, which is the sixth most common and third deadliest cancer worldwide. It is a rare disease with increasing U.S. annual incidence (42,000) and deaths (30,000).
The FDA has informed us that 188RNL-BAM will be regulated as a medical device under the Federal Food, Drug, and Cosmetic Act (the "FDCA").
The CNSide Platform and the FORESEE Trial
The CNSide Platform is a menu of CSF-based LDTs intended to support the diagnosis, molecular characterization, treatment selection, and longitudinal monitoring of patients with CNS cancers, including LM. Multiple CNSide tests can be performed from a single CSF collection. The CNSide Platform includes the following tests:
CNSide CSF Tumor Cell Enumeration (the CNSide Test). Detects and quantitatively enumerates tumor cells in CSF from patients with suspected or confirmed LM. The CNSide Test is performed by CNSide Diagnostics in its CLIA-certified, CAP-accredited laboratory in Houston, Texas, and is billed under PLA code 0640U.
CNSide CSF Molecular Profile - Solid Tumor (DNA & RNA) and CNSide CSF Molecular Profile - Hematologic Malignancies (DNA & RNA). Launched on October 6, 2026 and available to order beginning October 12, 2026. These tests analyze more than 300 cancer-related genes in cell-free DNA and more than 1,600 transcripts by RNA sequencing to characterize sequence variants, copy-number alterations, and gene fusions; the Hematologic Malignancies test also supports molecular assessment of clonality. The Molecular Profile tests extend the CNSide Platform beyond LM to primary CNS tumors, solid tumors metastatic to the CNS, and hematologic malignancies involving the CNS, and may be ordered independently or alongside the CNSide Test. The Molecular Profile tests are currently performed for CNSide Diagnostics by Genomic Testing Cooperative, LCA ("GTC"), a CLIA-certified and CAP-accredited reference laboratory, under a collaboration entered into in July 2026. GTC performs the DNA and RNA sequencing and bioinformatics analysis, and CNSide Diagnostics manages test ordering, results delivery, physician support, and billing.
CNSide CSF Cellular Biomarkers (planned). We expect to launch our first CNSide CSF Cellular Biomarkers, a group of breast cancer protein expression assays for estrogen receptor (ER), progesterone receptor (PR), and HER2, in the fourth quarter of 2026. These assays are intended to characterize biomarker expression on tumor cells captured and detected by a positive CNSide Test on the same CSF specimen. They are not yet commercially available, and there can be no assurance that they will launch on the expected timeline or at all.
The CNSide tests are LDTs and have not been cleared or approved by the FDA. Coverage and reimbursement vary by test, payer, and patient benefit design. Unless otherwise noted, the payer agreements, PLA code, and Medicare pricing relate to the CNSide Test and do not establish coverage or payment for the Molecular Profile tests or other CNSide tests. The CNSide Test is also used to assess response as an exploratory endpoint in the ReSPECT-LM trial.
In August 2024, data from the CNSide FORESEE clinical trial in patients with LM was presented at the Society for Neuro-Oncology ("SNO") / American Society for Clinical Oncology ("ASCO") CNS Metastases Conference. The trial met its key primary and secondary endpoints and the data showed that the CNSide Test more than doubled the diagnostic sensitivity versus gold standard cerebrospinal fluid cytology and influenced clinical management decisions in over 90% of LM cases.
On November 24, 2024, CNSide Diagnostics presented data at the 2024 SNO Annual Meeting from the FORESEE trial showcasing the CNSide Platform's utility in diagnosing and guiding clinical decision making for breast cancer and non-small cell lung cancer patients with LM.
The FORESEE study (NCT05414123) was a multicenter, prospective clinical utility study that enrolled 39 patients with breast cancer (21 patients) or non-small cell lung cancer (18 patients) with suspected or confirmed LM. The primary endpoint assessed the impact of CNSide results on physician treatment decisions; secondary endpoints compared CNSide with CSF cytology and assessed its use to personalize treatment selection based on tumor molecular phenotype. FORESEE results have also been presented at the 2025 SNO/ASCO CNS Metastases Conference and published in abstract form in Neuro-Oncology Advances.
FORESEE results have been published to date in abstract form. The Company and the FORESEE investigators intend to seek publication of the full trial methods and results in a peer-reviewed journal in early 2027.
Key highlights included:
|
|
The FORESEE trial achieved its primary endpoint, demonstrating that the CNSide Test influenced treatment decisions in over 90% of clinical decisions evaluated (50 of 55), surpassing the predetermined 20% primary endpoint target. |
|
|
The CNSide Test demonstrated enhanced sensitivity in detecting tumor cells (80%) vs. CSF cytology (29%) in matched samples from patients with LM. |
|
|
The CNSide Test identified actionable mutations in the CSF, such as HER2 amplification, helping to inform therapy selection in 24% of provider decisions (13 of 55). |
|
|
The CNSide Test exhibited high specificity, with no tumor cells detected in patients without LM. |
Additional Evidence and Guidelines. At the 2026 SNO/ASCO CNS Metastases Conference, held August 13-15, 2026, we presented an updated health economic analysis of a CNSide-enabled LM care pathway incorporating earlier definitive LM diagnosis, targeted treatment, and quantitative disease monitoring. The model estimated average LM-related treatment costs of approximately $119,550 per month and, under modeled scenarios, estimated that a CNSide-enabled pathway could reduce monthly LM-related costs by approximately 33% to 47%. These estimates are based on modeling assumptions, have not been validated in a prospective study, and may not reflect actual cost savings.
In July 2026, the National Comprehensive Cancer Network ("NCCN") updated its Clinical Practice Guidelines in Oncology for Central Nervous System Cancers. The updated guidelines continue to recognize CSF analysis as a standard component of LM diagnosis and disease assessment, including CSF cytology re-evaluation typically every four to eight weeks in patients receiving intrathecal therapy, and reflect an expanded role for CSF-based molecular testing in certain CNS cancer settings. The NCCN guidelines do not specifically reference the CNSide Platform, and references to the NCCN guidelines do not imply endorsement by NCCN of any commercial product.
The approach underlying the CNSide CSF Molecular Profile tests was evaluated in a peer-reviewed, real-world study by GTC investigators that analyzed 1,391 evaluable CSF specimens from patients being evaluated for primary CNS tumors, metastatic CNS disease, and hematologic malignancies involving the CNS, and identified cancer-related molecular findings in 78.4% of evaluable specimens (Albitar M, et al., The Journal of Liquid Biopsy, 2026;14:100500).
CNSide Business and Operational Highlights
Since the commercial re-introduction of the CNSide Test in August 2025, the Company, through its wholly owned subsidiary CNSide Diagnostics, LLC, has focused on laboratory and regulatory readiness, commercial availability, market access and reimbursement, test menu expansion, and generating clinical evidence and awareness for the CNSide Platform. Key developments during 2025 and 2026 to date include the following.
Clinical and Scientific Progress
The CNSide Platform continues to be utilized in clinical research settings, including the CPRIT-funded ReSPECT-LM clinical trial. During 2025, the Company presented data supporting the platform's ability to detect and enumerate tumor cells in CSF and to support longitudinal disease monitoring at major neuro-oncology and oncology scientific conferences, including the 2025 SNO/ASCO CNS Metastases Conference. During 2026, the Company presented health economic analyses of CNSide-enabled LM management, including at the 2026 SNO/ASCO CNS Metastases Conference, and launched the CNSide CSF Molecular Profile tests, whose underlying approach is supported by a peer-reviewed study of 1,391 evaluable CSF specimens, as described above.
Laboratory Readiness and Regulatory Milestones
CNSide Diagnostics completed key laboratory and operational milestones required to support commercial testing services. In 2025, CNSide Diagnostics obtained a certificate under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA") for its Houston, Texas laboratory, together with related state clinical laboratory licenses, enabling performance of the CNSide Test as an LDT. In June 2026, the laboratory received accreditation from the College of American Pathologists ("CAP") following an on-site inspection. In September 2026, the laboratory relocated to the Company's facility at the Levit Green life sciences campus in Houston. The Company has filed the related CLIA address change, and its CAP accreditation continues to apply at the new site. The laboratory includes in-house manufacturing of key test components, including the CEE-Sure® CSF collection tube preservative, antibody mix, and microfluidic chip.
Commercial Launch and Geographic Expansion
The Company initiated the commercial launch of the CNSide Test in Texas in August 2025 and subsequently expanded state licensure, enabling the CNSide Test to be offered in 49 of 50 U.S. states as of January 2026. The Company is awaiting a clinical laboratory permit from the New York State Department of Health; until it is obtained, testing for patients in New York requires a test-specific exemption, and the Company currently expects to obtain the permit in 2027. The initial commercialization strategy focused on NCI-designated cancer centers, large academic medical centers, and health systems with specialized neuro-oncology practices. As of June 30, 2026, 18 institutions were onboarded and ordering, with 17 additional institutions in process. As of September 30, 2026, 43 healthcare providers, including 39 physicians, at 24 institutions had ordered the CNSide Test.
Market Access and Reimbursement Progress
In April 2026, the AMA issued PLA code 0640U for the CNSide Test, effective July 1, 2026. On May 7, 2026, CNSide Diagnostics enrolled in the Medicare program and received its Provider Transaction Access Number, enabling it to submit claims to Medicare. In September 2026, CMS issued a favorable preliminary payment determination for PLA code 0640U under the Medicare Clinical Laboratory Fee Schedule ("CLFS") proposing to crosswalk 0640U to PLA code 0338U, an existing code for a circulating tumor cell assay, based on similar methods and resources. The proposed calendar year 2027 CLFS rate for 0338U is $2,313.25 per test. CMS anticipates finalizing calendar year 2027 CLFS payment rates in November 2026, with final rates effective January 1, 2027. A CLFS payment rate does not by itself establish Medicare coverage, and payment requires a favorable coverage determination. The Company is pursuing a coverage determination from Novitas Solutions, the Medicare Administrative Contractor with jurisdiction over our Texas laboratory, and continues to pursue Medicaid coverage.
In August 2026, the Company selected XiFin, Inc. to provide revenue cycle management and clearinghouse services for the CNSide Platform. CNSide Diagnostics began billing for diagnostic testing in the first quarter of 2026, and in the third quarter of 2026 billed 222 tests to payers. In October 2026, CNSide Diagnostics received an initial commercial payer payment for the CNSide Test. Payer yield, the proportion of claims paid, and time to payment have not yet been established.
Commercial Infrastructure and Organizational Development
To support the CNSide Platform's transition from development to commercialization, the Company expanded its diagnostics operations during 2025 and 2026. This included investments in laboratory infrastructure, testing capacity, and operational systems; expansion of field-based commercial, medical science liaison, customer service, and laboratory operations teams; and the addition of leadership in market access and health economics and outcomes research. In July 2026, CNSide Diagnostics entered into a collaboration with GTC to integrate next-generation sequencing into the CNSide Platform, which supports the Molecular Profile tests described above. These efforts are intended to position CNSide Diagnostics for increased test volumes, an expanded test menu, and broader clinical adoption in future periods.
Strategic Importance to the Company
The CNSide diagnostic platform represents a strategic expansion of the Company's business beyond therapeutics into CNS-focused diagnostics. The Company believes that the CNSide Platform has the potential to complement its radiotherapeutic development programs by improving disease detection, molecular characterization, patient stratification, and treatment monitoring in CNS cancers, and that longitudinal CSF data generated through CNSide testing may support the Company's data and analytics initiatives. The Company expects to continue evaluating opportunities to integrate diagnostic insights from the CNSide Platform with its therapeutic development and data activities over time.
Licensing
On December 31, 2021, we entered into a Patent and Technology License Agreement (the "UTHSCSA License Agreement") with UTHSCSA, pursuant to which UTHSCSA granted us an irrevocable, perpetual, exclusive, fully paid-up license, with the right to sublicense and to make, develop, commercialize and otherwise exploit certain patents, know-how and technology related to the development of BAM containing nanoliposomes loaded with imaging and/or therapeutic payloads. Therapeutic payloads may include radiotherapeutics, chemotherapeutics, or thermotherapeutics. The BAM development project remains preclinical at the time of this document.
The financial terms of the UTHSCSA License Agreement are primarily success-based with development and sales milestones and single-digit royalty payments contingent on achieving key clinical, regulatory and sales milestones. In addition, we pay an annual maintenance fee to UTHSCSA.
On March 29, 2020, we entered into a Patent and Know-How License Agreement (the "NanoTx License Agreement") with NanoTx, pursuant to which NanoTx granted us an irrevocable, perpetual, exclusive, fully paid-up license, with the right to sublicense and to make, develop, commercialize and otherwise exploit certain patents, know-how and technology related to the development of radiolabeled nanoliposomes.
The transaction terms included an upfront payment of $0.4 million in cash and $0.3 million in our voting stock. The transaction terms also included success-based milestone and royalty payments contingent on key clinical, regulatory and sales milestones, as well as the requirement to pay 15% of any non-dilutive monetary awards or grants received from external agencies to support product development of the nanoliposome encapsulated BMEDA-chelated radioisotope, which includes grants from CPRIT.
The licensed NanoTx portfolio benefits from proprietary nanoliposome-encapsulated technology to encapsulate radionuclides allowing direct local delivery for several cancer targets.
The licensed radiolabeled nanoliposome platform was developed by a multi-institutional consortium based in Texas at the Mays Cancer Center / UTHSCSA MD Anderson Cancer Center led by Dr. Andrew Brenner, MD, PhD, who is the Kolitz Chair in Neuro-Oncology Research and Co-Leader of the Experimental and Developmental Therapeutics Program. The technology was previously owned by NanoTx and funded by both the NIH/NCI and CPRIT. There is an active $3 million award from NIH/NCI that is expected to financially support the continued clinical development of REYOBIQ for recurrent GBM.
Manufacturing
We have entered into master services agreements with third parties, including Piramal Pharma Solutions, Inc., ABX Advanced Biochemical Compounds GmbH, Telix Pharmaceuticals, LLC, Radiomedix, Inc., Alamo Nuclear Pharmacy Services, Inc., and Nuke Med, Inc. (aka SpectronRx) in connection with the development, manufacture, and supply of our REYOBIQ drug product. Upon completion of the research and development phase of a drug candidate, certain parts of the manufacturing processes for such candidate may be transferred to contract manufacturers to support clinical trials and commercial release. Upon approval of our drug candidates, we expect our manufacturing capabilities to include validated manufacturing processes for the drug product as well as a quality assurance product release process with the ability to ultimately scale-up the process to meet increasing market demands. We believe our strategic investments in our analytical, development and manufacturing capabilities, including personnel with expertise from drug discovery through drug development, will allow us to advance our product candidates more quickly. Expertise gained in manufacturing our drug products may be applied to other formulations in the future, further leveraging our capabilities.
Competition
Our business is conducted in intensely competitive and highly regulated markets. The life science industry is characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary therapeutics. We face competition from a number of sources, some of which may target the same indications as our products, product candidates and laboratory tests, including small and large, domestic and multinational, medical device, biotechnology and pharmaceutical companies, academic institutions, government agencies, private and public research institutions and clinical laboratories. Competitors may have greater experience in, and resources to devote to, developing drugs and clinical laboratory tests, conducting clinical trials, obtaining regulatory clearances or approvals, manufacturing and commercialization.
We expect that product candidates in our pipeline, if approved, would compete on the basis of, among other things, product efficacy and safety; time to market; price, coverage, and reimbursement by third-party payers; extent of adverse side effects; and convenience of treatment procedures.
Competition for our LDT offering and therapeutic product candidate REYOBIQ may come in the future.
Currently, there are many other entities pursuing drug development programs for the indications we are currently pursuing with our product candidates.
Significant competitors that have reported drug development programs or clinical laboratory tests at various clinical stages for the various indications listed include, but are not limited to:
Recurrent Glioblastoma
Companies developing or commercializing therapies for glioblastoma, including recurrent glioblastoma, include Telix Pharmaceuticals, Novocure, CarThera, SonALAsense, AstraZeneca, Merck, Karyopharm Therapeutics, Kazia Therapeutics, and others.
These companies are pursuing a range of treatment approaches, including targeted radiopharmaceutical therapies, tumor treating fields, chemotherapy, targeted therapies, immunotherapies, sonodynamic therapy, and blood-brain barrier modulation. Telix Pharmaceuticals is developing TLX101-Tx, an investigational iodine-131-based targeted radiopharmaceutical therapy undergoing Phase 3 clinical evaluation for recurrent glioblastoma.
Leptomeningeal Metastases
Companies developing or commercializing therapies with potential applications in leptomeningeal metastases include Telix Pharmaceuticals, AstraZeneca, Daiichi Sankyo, Roche/Genentech, Pfizer, Bristol Myers Squibb, Merck, ArriVent BioPharma, Amgen, Summit Therapeutics, Nuvalent, and others.
These companies are developing or evaluating a variety of treatment approaches, including targeted radiopharmaceutical therapies, CNS-penetrant small-molecule targeted therapies, antibody-drug conjugates, monoclonal antibodies, bispecific antibodies, immunotherapies, and intrathecal treatments. Telix Pharmaceuticals is developing TLX102-Tx, an investigational astatine-211-based alpha-emitting radiopharmaceutical, with leptomeningeal disease identified as its planned initial development indication.
Academic medical centers and research institutions, including Memorial Sloan Kettering Cancer Center, Dana-Farber Cancer Institute, City of Hope, and other institutions conducting investigator-sponsored studies, are also evaluating investigational treatments for leptomeningeal disease, including intrathecal immunotherapies, cellular therapies, and radiation-based approaches.
We also face competition from existing intrathecal chemotherapy regimens, proton craniospinal irradiation, external beam radiation therapy, and other CNS-directed treatment approaches.
Pediatric Brain Cancer
Companies developing or commercializing therapies for pediatric brain cancers include Jazz Pharmaceuticals, Servier, AstraZeneca, Novartis, Novocure, SonALAsense, SERB Pharmaceuticals, and others.
These companies market or are developing products for various pediatric brain tumors and related CNS malignancies, including high-grade and low-grade gliomas, diffuse midline gliomas, and other pediatric CNS cancers. Jazz Pharmaceuticals markets Modeyso (dordaviprone) for certain patients with H3 K27M-mutant diffuse midline glioma, while Servier, which acquired Day One Biopharmaceuticals in April 2026, markets Ojemda (tovorafenib) for certain patients with pediatric low-grade glioma. Competitive treatment approaches include targeted therapies, chemotherapy, immunotherapies, radiotherapy, and investigational medical device and radiopharmaceutical technologies.
Liver Cancer
Companies developing or commercializing radioembolization therapies for liver cancer include Boston Scientific, Sirtex Medical, ABK Biomedical, and others.
These companies market or are developing radioactive microsphere technologies and other liver-directed therapies for primary and metastatic liver cancers. Competing therapies include commercially available yttrium-90 radioembolization products and investigational radioembolization technologies.
CNSide Platform
Companies offering or developing cerebrospinal fluid-based or blood-based tumor cell detection, molecular profiling, or other oncology diagnostic technologies for patients with primary or metastatic CNS cancers include Belay Diagnostics, Lucence, Menarini Silicon Biosystems, Caris Life Sciences, Genomic Testing Cooperative, NeoGenomics, Quest Diagnostics, Labcorp, BillionToOne, Predicine, FYR Diagnostics, and others.
Belay Diagnostics, Lucence, and Genomic Testing Cooperative offer CSF-based molecular profiling tests that compete with our CNSide CSF Molecular Profile offerings. Menarini Silicon Biosystems offers circulating tumor cell detection technologies that may compete with our CSF tumor cell detection and enumeration capabilities. Other diagnostic companies offer broader oncology molecular testing and liquid biopsy technologies that may compete with certain aspects of our CNSide Platform or become more direct competitors in the future.
Academic medical centers, hospital laboratories, and commercial reference laboratories performing conventional CSF cytology, flow cytometry, molecular testing, and other CSF-based diagnostic analyses also compete with our offerings.
Genomic Testing Cooperative, which performs molecular testing for our CNSide CSF Molecular Profile offerings, independently offers CSF-based molecular testing services and may compete with us in the market.
We expect competition to intensify as existing competitors expand their clinical development programs, diagnostic testing capabilities, and commercialization activities, and as new therapeutic and diagnostic technologies are developed and introduced into the market. Our competitors may develop treatments or diagnostic tests that are more effective, safer, less expensive, more convenient, or more widely accepted than our products and product candidates, which could adversely affect our ability to successfully develop and commercialize our offerings.
Recent Developments
CNSide CSF Molecular Profile Tests
On October 6, 2026, we announced the commercial launch of two cerebrospinal fluid-based molecular profiling tests: CNSide CSF Molecular Profile - Solid Tumor and CNSide CSF Molecular Profile - Hematologic Malignancies. The tests are laboratory developed tests performed for CNSide by Genomic Testing Cooperative, LCA ("GTC"), a third-party reference laboratory, under a collaboration announced in July 2026. GTC performs the sequencing and bioinformatics analysis. CNSide manages test ordering, results delivery, physician support and billing. The tests have not been cleared or approved by the U.S. Food and Drug Administration. We recognized no revenue from these tests during the three and nine months ended September 30, 2026.
Corporate Rebrand
Effective August 3, 2026, we changed our name from Plus Therapeutics, Inc. to Cerenome, Inc. In addition, on August 3, 2026, shares of our Common Stock began trading on The Nasdaq Capital Market under the symbol "CNSY".
The new name reflects our evolution from a therapeutics-focused organization toward an integrated CNS oncology company. We have expanded beyond targeted radiotherapeutics as it believes effective approaches to CNS cancer may require a multimodal approach. Cerenome's strategy is to integrate precision diagnostics, targeted therapeutics, and proprietary data within a single organization to support the detection, treatment, and understanding of CNS cancers.
Houston Lease
On August 10, 2026, we entered into an amendment (the "Amendment") to our lease (the "Lease") with LG 1 Property Owner LP, pursuant to which we agreed to lease approximately 25,103 rentable square feet of additional space located at 6420 Levit Green Boulevard, Houston, Texas 77021 (the "Building") such that, pursuant to the Lease as amended by the Amendment, the Company will rent a total of approximately 36,473 rentable square feet in the Building (the "Premises").
The Amendment also provides for an increased monthly base rent of $188,444, which increases annually by approximately 3.0%, plus our share of the Building's direct expenses. Furthermore, the Amendment provides for a rent abatement (the "Rent Abatement") for the first seven (7) months of the term of the Lease and a right of first offer, which gives us the one-time right to rent additional space on the same floor as the original Lease, subject to certain conditions, and an increase to the tenant improvement allowance for the design, permitting and construction of the Premises.
The Amendment changed the deemed commencement of the Lease from November 1, 2026, to on or about November 1, 2027. With the Rent Abatement, the first month's rent will be due on or around June 1, 2028. The Lease, as amended, has an initial term of 127 calendar months.
Results of Operations
Beginning with the three months ended September 30, 2026, we manage our business and report our results through two reportable segments, Diagnostics and Therapeutics. Our Diagnostics segment develops and commercializes the CNSide cerebrospinal fluid ("CSF") assay platform through our subsidiary, CNSide Diagnostics, LLC. Our Therapeutics segment consists of the development of our radiotherapeutic product candidates, including rhenium (186Re) obisbemeda (REYOBIQ).
Our Chief Executive Officer, who is our chief operating decision maker ("CODM"), evaluates segment performance and allocates resources based on segment operating income (loss) before the intercompany shared services allocation, which consists of segment revenue less the significant segment expenses and other segment items regularly provided to the CODM in the monthly business-unit income statements. Costs of our corporate functions are not allocated to the segments and are presented below as unallocated corporate operating expenses. Prior period segment information has been recast to conform to the current presentation. For additional information, including a reconciliation of segment operating loss to consolidated net loss, refer to Note 15, "Segment Information," to our condensed consolidated financial statements.
Revenue
The following table summarizes the components of our revenue for the three and nine months ended September 30, 2026 and 2025 (in thousands):
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||||||||||
|
(in thousands) |
2026 |
2025 |
Change |
2026 |
2025 |
Change |
||||||||||||||||||
|
Grant revenue |
$ |
- |
$ |
1,397 |
$ |
(1,397 |
) |
$ |
1,439 |
$ |
3,846 |
$ |
(2,407 |
) |
||||||||||
|
Diagnostic revenue, net |
722 |
- |
722 |
722 |
- |
722 |
||||||||||||||||||
|
Total revenue |
$ |
722 |
$ |
1,397 |
$ |
(675 |
) |
$ |
2,161 |
$ |
3,846 |
$ |
(1,685 |
) |
||||||||||
Grant revenue represents CPRIT's share of the costs incurred for our rhenium (186Re) obisbemeda development for the treatment of patients with LM. The decline during the three and nine months ended September 30, 2026 compared with the same periods in 2025 relate to the timing of eligible expenses under the CPRIT-funded ReSPECT-LM program.
During the three months ended September 30, 2026, we began commercial billing for CNSide diagnostic testing services and recorded our first period of CNSide revenue and accounts receivable. CNSide diagnostic revenue for the period reflects our estimates of net reimbursement after contractual adjustments and implicit price concessions, which are applied at the time of revenue recognition and reduce gross charges to the amount we expect to collect.
As CNSide reimbursement pathways mature and payer mix evolves, net revenue will be driven by a combination of test volume, coverage status, contracted rates, and denial trends. Our accounts receivable balance is expected to increase as billed volumes grow. Management monitors collection experience by payer portfolio and aging category and updates its estimates of implicit price concessions and credit losses at least quarterly.
Cost of Revenue
Cost of revenue relates to our Diagnostics segment and was $0.9 million for the three and nine months ended September 30, 2026. Cost of revenue includes material, labor, and overhead costs, including personnel costs (salaries, bonuses, stock-based compensation, payroll taxes, and benefits), laboratory supplies and consumables, depreciation and maintenance on equipment, clinical diagnostic test costs, and certain allocated overhead expenses. Costs associated with performing the diagnostic tests are recorded as the tests are processed.
Significant Segment Expenses
The following table summarizes the components of our significant segment expenses for the three and nine months ended September 30, 2026 and 2025 (in thousands):
|
Three Months Ended September 30, |
Diagnostics |
Therapeutics |
Total |
|||||||||||||||||||||||||||||||||
|
(in thousands) |
2026 |
2025 |
Change |
2026 |
2025 |
Change |
2026 |
2025 |
Change |
|||||||||||||||||||||||||||
|
Research and development, professional services and consulting |
$ |
101 |
$ |
700 |
$ |
(599 |
) |
$ |
1,203 |
$ |
1,141 |
$ |
62 |
$ |
1,304 |
$ |
1,841 |
$ |
(537 |
) |
||||||||||||||||
|
Personnel costs (including stock-based compensation) |
798 |
488 |
310 |
655 |
342 |
313 |
1,453 |
830 |
623 |
|||||||||||||||||||||||||||
|
Other segment items |
673 |
191 |
482 |
212 |
113 |
99 |
885 |
304 |
581 |
|||||||||||||||||||||||||||
|
Significant segment expenses |
$ |
1,572 |
$ |
1,379 |
$ |
193 |
$ |
2,070 |
$ |
1,596 |
$ |
474 |
$ |
3,642 |
$ |
2,975 |
$ |
667 |
||||||||||||||||||
|
Nine Months Ended September 30, |
Diagnostics |
Therapeutics |
Total |
|||||||||||||||||||||||||||||||||
|
(in thousands) |
2026 |
2025 |
Change |
2026 |
2025 |
Change |
2026 |
2025 |
Change |
|||||||||||||||||||||||||||
|
Research and development, professional services and consulting |
$ |
1,926 |
$ |
1,314 |
$ |
612 |
$ |
4,282 |
$ |
2,208 |
$ |
2,074 |
$ |
6,208 |
$ |
3,522 |
$ |
2,686 |
||||||||||||||||||
|
Personnel costs (including stock-based compensation) |
3,231 |
1,223 |
2,008 |
1,527 |
1,112 |
415 |
4,758 |
2,335 |
2,423 |
|||||||||||||||||||||||||||
|
Other segment items |
2,154 |
299 |
1,855 |
657 |
437 |
220 |
2,811 |
736 |
2,075 |
|||||||||||||||||||||||||||
|
Significant segment expenses |
$ |
7,311 |
$ |
2,836 |
$ |
4,475 |
$ |
6,466 |
$ |
3,757 |
$ |
2,709 |
$ |
13,777 |
$ |
6,593 |
$ |
7,184 |
||||||||||||||||||
Research and development expenses, professional services, and consulting include costs associated with the design, development, testing, and enhancement of our product candidates, payment of regulatory fees, laboratory supplies, preclinical studies, and clinical studies.
Research and development expenses, professional services, and consulting decreased by approximately $0.5 million during the three months ended September 30, 2026 as compared to the same period in 2025. The decrease primarily reflected a $0.6 million decrease in Diagnostics research and development costs as CNSide moved from development to commercial operations. The 2025 period included $0.4 million of development and validation study costs that did not recur. The decrease was partially offset by a $0.1 million increase in Therapeutics professional services and consulting.
Research and development expenses, professional services, and consulting increased by approximately $2.7 million during the nine months ended September 30, 2026 as compared to the same period in 2025. The increase primarily reflected a $1.4 million increase in Therapeutics research and development costs which represented higher drug supply and clinical study costs for REYOBIQ; a $1.0 million increase in Diagnostics professional services and consulting supporting CNSide commercial readiness; and a $0.6 million increase in Therapeutics professional services and consulting. These increases were partially offset by a $0.4 million decrease in Diagnostics research and development costs, as the 2025 period included $0.9 million of development and validation study costs that did not recur.
Personnel costs (including stock-based compensation) increased by approximately $0.6 million during the three months ended September 30, 2026 as compared to the same period in 2025. The increase primarily reflected higher salaries, wages and bonuses of $0.5 million, including $0.2 million in Diagnostics from additional personnel supporting CNSide commercial operations and $0.2 million in Therapeutics from additional research and development personnel supporting REYOBIQ clinical programs, and $0.1 million of higher related payroll taxes and benefits.
Personnel costs (including stock-based compensation) increased by approximately $2.4 million during the nine months ended September 30, 2026 as compared to the same period in 2025. The increase primarily reflected a $2.0 million increase in Diagnostics, reflecting additional personnel supporting CNSide laboratory and commercial operations, and a $0.4 million increase in Therapeutics, reflecting additional research and development personnel supporting REYOBIQ clinical programs and higher stock-based compensation.
Other segment costs increased by approximately $0.6 million during the three months ended September 30, 2026 as compared to the same period in 2025. The increase primarily reflected a $0.3 million increase in Diagnostics rent, facilities and IT costs associated with CNSide laboratory space and systems, and a $0.2 million increase in Diagnostics recruiting and temporary labor costs to staff CNSide commercial operations. Therapeutics other segment costs increased by $0.1 million, mainly from higher travel and depreciation.
Other segment costs increased by approximately $2.1 million during the nine months ended September 30, 2026 as compared to the same period in 2025. The increase primarily reflected a $1.1 million increase in Diagnostics rent, facilities and IT costs associated with CNSide laboratory space and systems, a $0.3 million increase in Diagnostics recruiting and temporary labor costs, and a $0.5 million increase in other Diagnostics general and administrative, travel and insurance costs as CNSide built out its commercial operations. Therapeutics other segment costs increased by $0.2 million, mainly from higher travel.
Unallocated Corporate Operating Expenses
Unallocated corporate operating expenses consist of the costs of our corporate functions, including executive, finance and accounting, legal, human resources, investor relations and IT, and public-company costs such as audit, legal and SEC reporting fees, directors' and officers' insurance, and stock-based compensation for corporate employees and directors. These costs are not included in segment operating loss, the measure of segment profit or loss reviewed by the CODM.
The following table summarizes the components of our unallocated corporate operating expenses for the three and nine months ended September 30, 2026 and 2025 (in thousands):
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||||||||||
|
(in thousands) |
2026 |
2025 |
Change |
2026 |
2025 |
Change |
||||||||||||||||||
|
Unallocated corporate operating expenses |
$ |
(3,623 |
) |
$ |
(2,904 |
) |
$ |
(719 |
) |
$ |
(11,103 |
) |
$ |
(6,809 |
) |
$ |
(4,294 |
) |
||||||
Unallocated corporate operating expenses increased by approximately $0.7 million during the three months ended September 30, 2026 as compared to the same period in 2025. The increase primarily reflected a $0.6 million increase in corporate salaries, payroll taxes and benefits, a $0.1 million increase in stock-based compensation, and increases of $0.1 million in rent, facilities and IT costs and $0.1 million in recruiting costs, partially offset by a $0.4 million decrease in professional services and consulting fees.
Unallocated corporate operating expenses increased by approximately $4.3 million during the nine months ended September 30, 2026 as compared to the same period in 2025. The increase primarily reflected a $1.5 million increase in stock-based compensation, a $1.1 million increase in corporate salaries, payroll taxes and benefits, a $0.8 million increase in professional services and consulting fees, primarily because the 2025 period included $1.0 million of credits from the settlement and adjustment of legal and advisory fees in June 2025, and a $0.9 million increase in other corporate costs, including general and administrative, rent, facilities and IT, recruiting and travel costs.
Other Income (Expense)
The following table summarizes non-operating income and expenses for the three and nine months ended September 30, 2026 and 2025 (in thousands):
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
|
2026 |
2025 |
2026 |
2025 |
|||||||||||||
|
Interest income |
$ |
119 |
$ |
59 |
$ |
365 |
$ |
87 |
||||||||
|
Interest expense |
(14 |
) |
- |
(36 |
) |
(548 |
) |
|||||||||
|
Financing expenses |
(1,618 |
) |
- |
(1,618 |
) |
(3,061 |
) |
|||||||||
|
Warrant issuance costs |
- |
- |
- |
(964 |
) |
|||||||||||
|
Change in fair value of financial instruments |
490 |
- |
490 |
- |
||||||||||||
|
Change in fair value of derivative instruments |
- |
- |
- |
(2,631 |
) |
|||||||||||
|
Other expense |
(179 |
) |
- |
(179 |
) |
- |
||||||||||
|
Total |
$ |
(1,202 |
) |
$ |
59 |
$ |
(978 |
) |
$ |
(7,117 |
) |
|||||
Interest income increased for the three and nine months ended September 30, 2026 compared with the same periods in 2025 primarily due to a higher investment balance in 2026 as compared to the same periods in 2025.
The decrease in interest expense for the nine months ended September 30, 2026 as compared to the same period in 2025 was due to interest related to the Funding Notes issued and redeemed during the three months ended March 31, 2025.
Financing expenses for the three and nine months ended September 30, 2026 related to the excess of fair value over the purchase price of the Initial Note and the royalty obligation of $1.4 million and the transaction costs related to the same agreement of $0.2 million. Financing expenses for the nine months ended September 30, 2025 related to the March 2025 PIPE and February 2025 transactions.
The change in the fair value of the financial instruments for the three and nine months ended September 30, 2026 was primarily due to the fair value change of the Initial Note from the date of issuance to September 30, 2026.
The change in the fair value of the derivative instruments for the three and nine months ended September 30, 2025 was primarily due to the March 2025 Private Placement (specifically the liability classified March 2025 Series B Warrants, which were remeasured immediately prior to exercise, before being reclassified as equity).
Warrant issuance costs for the nine months ended September 30, 2025 were related to the March 2025 Private Placement.
Other expense of $0.2 million for the three and nine months ended September 30, 2026 related to a loss on investments.
Liquidity and Capital Resources
Short-term and long-term liquidity
The following is a summary of our key liquidity measures at September 30, 2026 and December 31, 2025 (in thousands):
|
September 30, 2026 |
December 31, 2025 |
|||||||
|
Cash, cash equivalents and restricted cash |
$ |
879 |
$ |
8,758 |
||||
|
Current assets |
$ |
8,067 |
$ |
14,848 |
||||
|
Current liabilities |
13,123 |
12,314 |
||||||
|
Working capital |
$ |
(5,056 |
) |
$ |
2,534 |
|||
We incurred net losses of $24.6 million for the nine months ended September 30, 2026. We have an accumulated deficit of $540.5 million as of September 30, 2026. Additionally, we used net cash of $21.0 million to fund our operating activities for the nine months ended September 30, 2026. These factors raise substantial doubt about our ability to continue as a going concern.
To date, our operating losses have been funded primarily from outside sources of invested capital from issuance of our common and preferred equity, warrants, convertible loan, term loan, our line of credit facility with Pershing and grant funding. We have had, and will continue to have, an ongoing need to raise additional cash from outside sources to fund our future clinical development programs and other operations. There can be no assurance that we will be able to continue to raise additional capital in the future. Our inability to raise additional cash would have a material and adverse impact on our operations and ability to satisfy our obligations.
Senior Secured Convertible Note and Royalty Obligation
On September 4, 2026, we entered into a Securities Purchase Agreement (the "Purchase Agreement") with 3i, LP (the "Investor"), providing for the issuance of senior secured convertible notes (the "Notes") in an aggregate original principal amount of up to $21.3 million for aggregate cash purchase prices of up to $20.0 million. The Notes are issuable in three stages: (i) a note in the original principal amount of $3.2 million for a purchase price of $3.0 million (the "Initial Note"), which was issued on September 10, 2026 (the "Initial Closing"); (ii) notes in the original principal amount of $2.1 million for a purchase price of $2.0 million, issuable after a resale registration statement covering the underlying shares is declared effective and other closing conditions are satisfied; and (iii) additional
notes in an aggregate original principal amount of up to $16.0 million for aggregate purchase prices of up to $15.0 million, issuable at optional or mandatory additional closings during the 18 months following the Initial Closing, subject to closing conditions. The second and additional notes are conditional commitments and are not recognized until issued. As of September 30, 2026, only the Initial Note had been issued.
As partial consideration for the Investor's purchase of the Notes, our subsidiary, CNSide Diagnostics, LLC ("CNSide"), entered into a royalty agreement with the Investor (the "Royalty Agreement"). The Purchase Agreement prohibits us from using the proceeds of the Initial Note or the second notes to repay indebtedness, redeem or repurchase securities, or settle litigation. The Purchase Agreement also prohibits us from entering into variable rate transactions, other than sales under our existing at-the-market offering program, until the later of the expiration of the additional closing period and the date no Notes remain outstanding, and grants the Investor a right to participate in our subsequent financings through the first anniversary of the Initial Closing.
To date, we have received $2.8 million of net proceeds for the Initial Note, and any additional funding under the Purchase Agreement remains subject to the satisfaction of applicable closing conditions.
Equity Distribution Agreement
On June 1, 2026, we entered into an Equity Distribution Agreement (the "Distribution Agreement") with Canaccord Genuity LLC ("Canaccord"), pursuant to which we could issue and sell, from time to time, shares of our common stock in "at-the-market" offerings, having an aggregate offering price of up to $17,350,000, depending on market demand, with Canaccord acting as an agent for sales. During the nine months ended September 30, 2026, we issued 977,675 shares under the Distribution Agreement for net proceeds of approximately $3.1 million, after deducting the commissions and other issuance costs payable by us.
January 2026 Public Offering
On January 13, 2026, we completed an underwritten public offering pursuant to which we (a) sold an aggregate of (i) 1,578,947 shares of common stock, par value $0.001 per share, of the Company and (ii) warrants to purchase 1,578,947 shares of common stock (the "January 2026 Warrants"), at a combined public offering price of $9.50 per share and January 2026 Warrant, and (b) granted the underwriter a 30-day option to purchase up to an additional 236,837 shares of common stock, additional January 2026 Warrants to purchase up to 236,837 shares of common stock or any combination thereof, at the public offering price, in each case less underwriting discounts and commissions. Each January 2026 Warrant is immediately exercisable, entitles the holder to purchase one share of common stock at an exercise price of $9.50 per share and expires five (5) years from the date of issuance. On January 14, 2026, the underwriter exercised its over-allotment option with respect to additional January 2026 Warrants to purchase 236,837 shares of common stock. Net proceeds from the underwritten public offering were approximately $13.9 million after deducting the underwriting discounts and commissions and other offering expenses payable by us.
February 2025 SPEA
On February 13, 2025 (the "February 2025 SPEA Closing Date"), we entered into a securities purchase and exchange agreement (the "February 2025 SPEA") with certain existing accredited investors. Pursuant to the February 2025 SPEA, on the February 2025 SPEA Closing Date we issued secured convertible promissory notes (the "Funding Notes") in the aggregate principal amount of $3.3 million together with common stock purchase warrants (the "February 2025 Warrants") to purchase 120,080 shares of our common stock at an exercise price of $28.00 per share. The aggregate purchase price for the Funding Note and February 2025 Warrants was approximately $3.7 million and included payment of $3.13 per February 2025 Warrant in accordance with the listing rules of Nasdaq.
Exchange Notes
The May 2024 Purchase Agreement included certain limitations and restrictions on our ability to issue securities and provided the May 2024 Private Placement Purchasers other than our directors and executive officers (the "Outside Investors") participation rights in future equity and equity-linked offerings of securities, subject to certain limited exceptions (the "Financing Restrictions"). On the February 2025 SPEA Closing Date, pursuant to the February 2025 SPEA, we issued to the Outside Investors secured convertible promissory notes in the aggregate amount of $3.2 million (the "Exchange Notes") in exchange for cancellation of the 141,731 May 2024 Series A Warrants held by them, and the Outside Investors entered into a second amendment to the May 2024 Purchase Agreement to eliminate the Financing Restrictions.
As described below, we repurchased the Funding Notes and issued common stock and warrants for cancellation of the Exchange Notes in connection with the March 2025 Private Placement.
March 2025 Private Placement
On March 4, 2025, we entered into the March 2025 SPA with the March 2025 Private Placement Purchasers for the March 2025 Private Placement for gross proceeds of approximately $15.0 million. Pursuant to the March 2025 Purchase Agreement, we issued an aggregate of 162,789 shares (the "March 2025 Private Placement Shares") of our common stock and 958,896 March 2025 Pre-Funded Warrants, with each March 2025 Private Placement Share or March 2025 Pre-Funded Warrant accompanied by (i) the March 2025 Series A Warrants to purchase one share of common stock and (ii) one March 2025 Series B Warrant to purchase one share of common stock.
The initial exercise price of each March 2025 Series A Warrant is $33.00 per share of common stock. The March 2025 Series A Warrants are exercisable only following stockholder approval and expire five (5) years thereafter. The March 2025 Series A Warrants are subject to certain price reset, share combination event and anti-dilution provisions which, if triggered, provide that the number of shares issuable
upon exercise of the March 2025 Series A Warrants will downward adjust, subject to the Floor Price, and the number of shares issuable upon exercise therefor will increase such that the aggregate exercise price remains unchanged.
The initial exercise price of each March 2025 Series B Warrant is $49.50 per share of common stock. The March 2025 Series B Warrants are exercisable only following stockholder approval and expire two and one-half (2.5) years thereafter. The March 2025 Series B Warrants are subject to certain price reset and share combination event provisions which, if triggered, provide that the number of shares issuable upon exercise of the March 2025 Series B Warrants will downward adjust, subject to the Floor Price, and the number of shares issuable upon exercise therefor will increase such that the aggregate exercise price remains unchanged. In addition, the March 2025 Series B Warrant alternative cashless exercise provision provides that the March 2025 Series B Warrant can be exercised without further payment to us and for three times the number of shares of common stock then subject to the March 2025 Series B Warrant.
Of the securities issued in the March 2025 Private Placement, 123,090 shares of Common Stock, 786,000 shares of March 2025 Pre-Funded Warrants in lieu thereof, and the accompanying 909,090 March 2025 Series A Warrants and 909,090 March 2025 Series B Warrants, were issued in consideration of new capital subscriptions, and 39,699 shares of Common Stock, 172,896 March 2025 Pre-Funded Warrants in lieu thereof, and the accompanying 212,595 March 2025 Series A Warrants and 212,595 March 2025 Series B Warrants, were issued in exchange for the cancelation of the Exchange Notes.
The March 2025 Private Placement closed on March 7, 2025. The aggregate gross proceeds at the closing were approximately $15.0 million, before deducting $1.4 million of expenses payable by us.
On May 2, 2025, our stockholders approved, among other things, the March 2025 Series A Warrants and March 2025 Series B Warrants and an amendment of our Certificate of Incorporation, as amended, to increase the authorized share capital to an amount sufficient to cover the shares of common stock issuable upon the exercise of the March 2025 Series A Warrants and March 2025 Series B Warrants. As part of the March 2025 Series A Warrants and March 2025 Series B Warrants agreement, the exercise price of the March 2025 Series A Warrants and March 2025 Series B Warrants were reset on May 19, 2025 to $10.9325 per share. Prior to modification of the March 2025 Series B Warrants as part of the Letter Agreement (as further described below), certain March 2025 Series B Warrants were cashless exercised for the issuance of 859,299 shares of common stock.
Letter Agreement
On June 17, 2025, the Company and the Purchasers entered into the Letter Agreement with each of the Purchasers in an effort to, among other items, minimize the dilutive impact of the March 2025 Private Placement. The Letter Agreement extinguished the March 2025 Series A Warrants, modified the March 2025 Series B Warrants, and provided for the return of Private Placement Shares and March 2025 Pre-Funded Warrants, as further discussed in the following paragraphs.
As part of the same transaction, the March 2025 Series B Warrants were amended ("Amended March 2025 Series B Warrants"), to (a) reduce the overall number of March 2025 Series B Warrant Shares issuable upon exercise of the Series B Warrants to an aggregate of up to 1,421,455 Series B Warrant Shares, (b) reduce the alternative cashless exercise ratio in such March 2025 Series B Warrants from 3:1 to 1:1, and (c) remove provisions contained in the March 2025 Series B Warrants that would otherwise reduce the Company's stockholders' equity. As a result of the Letter Agreement, the Amended March 2025 Series B Warrants no longer fail the indexation guidance under ASC 815, Derivatives and Hedging, and the fair value of the warrant liability was reclassified to equity. After the June 17, 2025 modification, 1,391,781 Amended March 2025 Series B Warrants were cashless exercised.
Lastly, in conjunction with the Letter Agreement, each of the March 2025 Private Placement Purchasers agreed to the Letter Agreement Repurchase Option, to return an aggregate of 489,679 Private Placement Shares and March 2025 Pre-Funded Warrants issuable for an aggregate of 425,346 March 2025 Pre-Funded Warrant Shares, held by them as of the date of the Letter Agreement, upon request of the Company, which were issued pursuant to the March 2025 Private Placement Purchase Agreement for a value of $16.50 per Private Placement Share and $16.475 per March 2025 Pre-Funded Warrant. In exchange therefor, the Company agreed to repay the March 2025 Private Placement Purchasers holding such securities 115% of such value, using 90% of the proceeds from any capital raised by the Company subsequent to July 1, 2025. The Company and each of the March 2025 Private Placement Purchasers also agreed to waive any restrictions on subsequent equity sales and variable rate transactions contained in March 2025 Private Placement Purchase Agreement to allow for such repayment. During the nine months ended September 30, 2026, we paid the March 2025 Private Placement Purchasers $4.5 million and 272,821 shares were returned and cancelled under the terms of the Letter Agreement.
Support Letters
On July 11, 2025, we and certain March 2025 Private Placement Purchasers party to the Letter Agreement entered into that certain letter of support (the "Support Letters") to modify certain portions of the Letter Agreement as between us and each of such March 2025 Private Placement Purchasers. In the event that we reasonably believe that, within the 30 days (the "Modification Period") prior to the end of any fiscal quarter, we will have stockholders' equity in an amount below $3.0 million as of the end of such fiscal quarter (the "Potential Equity Deficiency"), the Subsequent Financing Percentage (as defined in the Letter Agreement) shall be modified from 90% to 50% for any Subsequent Financing (as defined in the Letter Agreement) that occurs during the Modification Period pursuant to the Lincoln Park Purchase Agreement. Upon the end of the Modification Period, the Subsequent Financing Percentage shall be reverted to 90%, and such percentage shall apply to all Subsequent Financings, including all Subsequent Financings pursuant to the Lincoln Park Purchase Agreement. In the event we desire to trigger the modification of the Subsequent Financing Percentage, we agree to supply the purchaser who executed a Support Letter with a pro forma balance sheet to evidence its reasonable belief of the Potential Equity Deficiency approximately 30 days prior to each end of fiscal quarter once the books for prior months are closed. Each Support Letter also grants the purchaser party to the letter a participation right in certain future financings of ours for a period of 12 months.
First Amendment to the February 2025 SPEA
In connection with the March 2025 Purchase Agreement, we entered into that certain First Amendment to the February 2025 SPEA (the "First Amendment"). The February 2025 SPEA included certain limitations and restrictions on our ability to issue securities and provided the investors participation rights in future equity and equity-linked offerings of securities, subject to certain limited exceptions (the "New Financing Restrictions"). Pursuant to the First Amendment, subject to consummation of the March 2025 Private Placement, we agreed to repurchase from the Investors $3.4 million in principal amount of the Funding Notes and accrued interest, along with the February 2025 Warrants issued pursuant to the February 2025 SPEA for an aggregate purchase price of $4.2 million. In exchange for the repurchase by us of the Funding Notes and February 2025 SPEA Warrants, the February 2025 Purchasers agreed to consent to the March 2025 Private Placement and eliminate the New Financing Restrictions.
Lincoln Park Purchase Agreement
On June 17, 2025, we entered into a purchase agreement (the "Lincoln Park Purchase Agreement") and a registration rights agreement pursuant to which Lincoln Park Capital Fund ("Lincoln Park") committed to purchase up to $50.0 million of shares of our common stock. Under the terms and subject to the conditions of the Lincoln Park Purchase Agreement, we have the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $50.0 million of shares of our common stock. Sales of common stock by us are subject to certain limitations, and can occur from time to time, at our sole discretion, over the 36-month period commencing on June 23, 2025, subject to the satisfaction of certain conditions. Actual sales of shares of common stock to Lincoln Park under the Lincoln Park Purchase Agreement depend on a variety of factors to be determined by us from time to time, including, among others, market conditions, the trading price of the common stock and our determinations as to the appropriate sources of funding for the Company and its operations.
On June 23, 2025, a registration statement (the "Initial Registration Statement") was declared effective covering the resale of up to 680,000 shares of our common stock. On August 14, 2025, a registration statement (the "Second Registration Statement") was declared effective covering the resale of up to 1,320,000 shares of our common stock.
The initial commitment fee was recorded as a reduction to additional paid-in capital in the condensed consolidated balance sheet. An additional commitment fee of $0.5 million will be paid in cash or shares of common stock, or a combination of cash and shares of common stock, if and when we sell over $25.0 million of our common stock under the Lincoln Park Purchase Agreement.
There were no shares issued under the Lincoln Park Purchase Agreement during the nine months ended September 30, 2026. During the nine months ended September 30, 2025, we issued 1,783,019 shares for gross proceeds of approximately $19.6 million and incurred approximately $50,000 for legal fees in connection with the Lincoln Park Purchase Agreement.
Under the terms of the Purchase Agreement with 3i, LP, we are prohibited from effecting variable rate transactions, which include sales under the Lincoln Park Purchase Agreement, until the later of the expiration of the additional closing period and the date no Notes remain outstanding. In addition, Regular Purchases may not be made if the closing price of our common stock is below $2.50, and approximately 217,000 shares remain registered for resale. Accordingly, we do not currently expect to be able to access the Lincoln Park Purchase Agreement as a source of liquidity.
Nasdaq Listing Compliance
We were subject to monitoring with respect to Nasdaq Listing Rule 5550(b)(1) (the "Minimum Stockholders' Equity Requirement") through August 22, 2026, at which point the monitoring period concluded. Based on our stockholders' equity as of September 30, 2026 and the applicable Nasdaq continued listing requirements, we expect to receive a notice from Nasdaq indicating that as of September 30, 2026, we do not comply with the Minimum Stockholders' Equity Requirement.
For more information relating to our compliance with applicable Nasdaq continued listing requirements, see the risk factor under the heading "If we fail to comply with the applicable continued listing requirements of The Nasdaq Stock Market LLC, our common stock may be delisted, and the price of our common stock and our ability to access the capital markets could be negatively impacted." in Item 1A of this Quarterly Report.
Funding and Material Cash Requirements
To date, our operating losses have been funded primarily from outside sources of invested capital from issuance of shares of our common and preferred equity, warrants, convertible loan, term loan, the margin loan facility under a line of credit with Pershing and grant funding. However, we have had, and will continue to have, an ongoing need to raise additional cash from outside sources through a combination of equity offerings, debt financings and potential collaboration, license or development agreements to fund our future clinical development programs, commercialization of CNSide, and other operations in the next twelve months from the filing of this Quarterly Report. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. There can be no assurance that we will be able to continue to raise additional capital in the future. Our inability to raise additional cash would have a material adverse impact on our operations, implementation of our strategy and ability to maintain compliance with applicable requirements, including Nasdaq listing rules.
Our present and future funding and cash requirements will depend on many factors, including, among other things:
The accompanying condensed consolidated financial statements have been prepared assuming that we will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to our ability to continue as a going concern.
Cash (used in) provided by operating, investing, and financing activities for the nine months ended September 30, 2026 and 2025 is summarized as follows (in thousands):
|
Nine Months Ended September 30, |
||||||||
|
Net cash provided by (used in): |
2026 |
2025 |
||||||
|
Operating activities |
$ |
(21,044 |
) |
$ |
(14,518 |
) |
||
|
Investing activities |
(1,165 |
) |
223 |
|||||
|
Financing activities |
14,330 |
27,508 |
||||||
|
Net change in cash and cash equivalents |
$ |
(7,879 |
) |
$ |
13,213 |
|||
Material Cash Obligations
Under the CPRIT Contract, we receive matching funds for approximately two-thirds of the development costs for the development of REYOBIQ for the treatment of patients with LM, subject to various funding conditions. The CPRIT Contract is effective for three years, unless otherwise terminated pursuant to the terms of the contract. CPRIT may require us to repay some or all of the disbursed CPRIT Grant proceeds (with interest not to exceed 5% annually) in the event of the early termination of the CPRIT Contract.
Other than as described above, we have no purchase commitments or contractual obligations, except for lease obligations and the convertible note as of September 30, 2026. In addition, we have no off-balance sheet arrangements (as defined in the rules and regulations of the SEC) that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.
Operating activities
Net cash used in operating activities for the nine months ended September 30, 2026 of $21.0 million was primarily related to the net loss of $24.6 million, $0.7 million of changes to operating assets and liabilities and $0.4 million from the change in the fair value of financial instruments, partially offset by $2.6 million of stock-based compensation expense, $1.6 million of noncash financing expenses, and $0.4 million of depreciation and amortization.
Net cash used in operating activities for the nine months ended September 30, 2025 of $14.5 million was primarily related to the net loss of $16.7 million and $4.7 million of changes to operating assets and liabilities, partially offset by $3.1 million of noncash financing expenses, $0.8 million of stock-based compensation expense, and $2.6 million of changes to the fair value of derivative instruments.
Investing activities
Net cash used in investing activities for the nine months ended September 30, 2026 of $1.2 million was primarily related to the purchase of short-term investments of $15.1 million and purchase of property and equipment of $1.4 million, which was partially offset by the redemption of short-term investments of $4.6 million and sale of short-term investments of $10.7 million.
Net cash provided by investing activities for the nine months ended September 30, 2025 of $0.2 million was primarily related to the redemption of short-term investments of $11.3 million which was partially offset by the purchase of short-term investments of $11.1 million.
Financing Activities
Net cash provided by financing activities for the nine months ended September 30, 2026 of $14.3 million was related to $15.0 million in gross proceeds from the January 2026 underwritten public offering, $3.3 million in gross proceeds from the distribution agreement, $3.0 million of proceeds from the convertible note and royalty obligation, and $1.0 million of proceeds from the credit facility, partially offset by $1.8 million repayments of the credit facility, $1.4 million for offering costs for the sale of common stock, $4.5 million of payments to investors pursuant to the Letter Agreement and $0.4 million in payments for costs from the distribution agreement and the convertible note and royalty obligation.
Net cash provided by financing activities for the nine months ended September 30, 2025 of $27.5 million was related to $19.6 million in proceeds from the sale of common stock under the Lincoln Park Purchase Agreement, $15.9 million of proceeds from sale of common stock, Pre-Funded Warrants and warrants in connection with the March 2025 Private Placement, and $3.7 million of net proceeds from the issuance of notes payable and warrants, partially offset by $3.3 million repayment on the Pershing Credit Facility, $3.7 million repayment of Notes payable, $2.3 million of costs paid to investors pursuant to the Letter Agreement, $0.2 million of costs related to the sale of common stock, and $2.3 million of financing costs related to the return and cancellation of Private Placement Shares and Pre-Funded Warrants.
Critical Accounting Policies and Significant Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires us to make estimates and assumptions that affect the reported amounts of our assets, liabilities, revenues and expenses, and that affect our recognition and disclosure of contingent assets and liabilities.
While our estimates are based on assumptions we consider reasonable at the time they were made, our actual results may differ from our estimates, perhaps significantly. If results differ materially from our estimates, we will make adjustments to our consolidated financial statements prospectively as we become aware of the necessity for an adjustment.
We believe it is important for you to understand our most critical accounting policies. Our critical accounting policies and estimates are discussed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 and there have been no material changes during the nine months ended September 30, 2026, other than what was disclosed in Note 2 Summary of Significant Accounting Policies of the accompanying condensed consolidated financial statements.