What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-15 compared with 2025-10-30 · 143 added, 193 removed, 200 unchanged (63% of the section changed)

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Plus Therapeutics is a U.S.

pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (“CNS”) cancers.

Our novel radioactive drug formulations and medical device and therapeutic candidates are designed to deliver safe and effective doses of radiation to tumors.

healthcare company developing and commercializing precision diagnostics and targeted radiopharmaceuticals for central nervous system (“CNS”) cancers.

CNSide Diagnostics, LLC (“CNSide Diagnostics”) is our wholly owned subsidiary that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas.

In radiopharmaceuticals, our lead candidate, rhenium ( 186 Re) 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.

Our acquired radiotherapeutic candidate, Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere (“ 188 RNL-BAM”) is designed to treat many solid organ cancers including primary and secondary liver cancers by intra-arterial injection.

Traditional approaches to radiation therapy for cancer, such as external beam radiation, have many disadvantages including continuous treatment for four to six weeks (which is onerous for patients), that the radiation damages healthy cells and tissue, and that the amount of radiation delivered is very limited and, therefore, is frequently inadequate to fully destroy the cancer.

Our novel radioactive drug formulations, medical devices and therapeutic candidates have the potential to overcome these disadvantages as they are designed to deliver safe and effective doses of radiation at the tumors—potentially in a single treatment.

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.

Our targeted radiotherapeutic platform and unique investigational drugs have the potential to overcome these disadvantages by directing higher, more powerful radiation doses at the tumor—and only the tumor—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, and radiation oncology, affords us the opportunity to target a broad variety of cancer types.

Our lead radiotherapeutic candidate, REYOBIQ (rhenium ( 186 Re) 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.

Our acquired radiotherapeutic candidate, Rhenium-188 NanoLiposome Biodegradable Alginate Microsphere (“ 188 RNL-BAM”), is designed to treat many solid organ cancers including primary and secondary liver cancers by intra-arterial injection.

Our cerebrospinal fluid cancer diagnostic portfolio known as the CNSide Platform is currently being utilized in the ReSPECT-LM clinical trial funded by the Cancer Prevention and Research Institute of Texas (“CPRIT”).

In connection with our business plan for developing the CNSide Platform, we formed CNSide Diagnostics, LLC (“CNSide Diagnostics”), a wholly owned subsidiary of the Company, and our board of directors appointed a board of managers for CNSide Diagnostics.

We are planning for the CNSide Cerebrospinal Fluid Tumor Cell Enumeration test (the “CNSide Test”), which is a laboratory developed test (“LDT”), to be re-introduced to the U.S.

market starting in the fourth quarter of 2025.

Our radiotherapeutic platform, combined with advances in neurosurgery, nuclear medicine, interventional radiology, neuro-oncology, and radiation oncology, affords us the opportunity to target a broad variety of cancer types.

The CNSide Cerebrospinal Fluid Assay is currently being utilized in the ReSPECT-LM clinical trial funded by the Cancer Prevention and Research Institute of Texas (“CPRIT”).

In connection with our business plan for developing the CNSide Platform, we formed CNSide Diagnostics and our board of directors appointed a board of managers for CNSide Diagnostics.

We re-introduced the CNSide Cerebrospinal Fluid Tumor Cell Enumeration test (the “CNSide Test”), which is a laboratory developed test (“LDT”) in August 2025.

The laboratory for the CNSide Test in Houston, Texas has received a certificate of accreditation from the Centers for Medicare & Medicaid Services (CMS) which deems the lab compliant with Clinical Laboratory Improvement Amendments (“CLIA”) regulations.

Furthermore, CNSide Diagnostics has signed a national agreement with UnitedHealthcare Insurance Company, effective September 15, 2025, covering over 51 million people throughout the United States, to provide the CNSide Test.

Furthermore, CNSide Diagnostics has signed national agreements to provide the CNSide Test with four payers, including United Healthcare, Humana, Highmark, and Blue Shield of California, expanding patient access nationwide.

Our headquarters is located in Houston, Texas, in proximity to world-class cancer institutions and researchers.

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 the U.S.

Food and Drug Administration (“FDA”) conditionally accepted the proprietary name REYOBIQ to be used by us for our proprietary rhenium ( 186 Re) 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.

The REYOBIQ technology was part of a licensed radiotherapeutic portfolio that we acquired from NanoTx, Corp.

Our most advanced investigational drug, rhenium ( 186 Re) obisbemeda, is a patented radiotherapy potentially useful for patients with CNS and other cancers.

Preclinical study data describing the use of rhenium ( 186 Re) obisbemeda 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, rhenium ( 186 Re) obisbemeda has been reported to have potential applications for head and neck cancer, ovarian cancer, breast cancer and peritoneal metastases.

The rhenium ( 186 Re) obisbemeda 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.

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 potentially more effectively treats 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.

National Institutes of Health/National Cancer Institute which is expected to provide financial support for the continued clinical development of rhenium ( 186 Re) obisbemeda for recurrent GBM through the completion of a Phase 2 clinical trial, including enrollment of up to 55 patients.

Rhenium ( 186 Re) obisbemeda versus External Beam Radiation Therapy for Recurrent GBM

Rhenium ( 186 Re) obisbemeda 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.

Rhenium ( 186 Re) obisbemeda 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 rhenium ( 186 Re) obisbemeda compared to standard external beam radiotherapy or external beam radiation therapy (“EBRT”) include:

• The rhenium ( 186 Re) obisbemeda 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.

• Rhenium ( 186 Re) obisbemeda can be visualized in real-time during administration, possibly giving clinicians better control of radiation dosing, distribution and retention.

• Rhenium ( 186 Re) obisbemeda potentially more effectively treats a bulk tumor and microscopic disease that has already invaded healthy tissue.

• Rhenium ( 186 Re) obisbemeda 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 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.

• Rhenium ( 186 Re) obisbemeda 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

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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 designation 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.

The locally delivered rhenium ( 186 Re) obisbemeda is designed for and provides patient tolerability and safety.

Though no rhenium ( 186 Re) obisbemeda 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 designation and Fast Track designations to rhenium ( 186 Re) obisbemeda for the treatment of patients with GBM.

Rhenium ( 186 Re) obisbemeda 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 rhenium ( 186 Re) obisbemeda given by CED catheters to patients with recurrent or progressive malignant glioma after standard surgical, radiation, and/or chemotherapy treatment.

The trial is funded through Phase 2 in large part by a National Institute of Health/National Cancer Institute grant.

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All solid cancers, particularly breast, lung, GI, and melanoma, have the potential to spread to the leptomeninges.

The ReSPECT-LM Phase 1 clinical trial (ClinicalTrials.gov NCT05034497) 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.

The ReSPECT-LM Phase 1 clinical trial (ClinicalTrials.gov NCT05034497) was preceded with preclinical studies in which tolerance to doses of rhenium ( 186 Re) obisbemeda 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.

Upon receiving acceptance of our Investigational New Drug application and Fast Track designation by the FDA for rhenium ( 186 Re) obisbemeda 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 rhenium ( 186 Re) obisbemeda 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.

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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, 2025, we had received approximately $14.3 million in milestone payments under the CPRIT Contract.

Interim results show that a single treatment with REYOBIQ resulted in a consistent decreased cerebrospinal fluid (“CSF”) tumor cell count/ml and is 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.

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 rhenium ( 186 Re) obisbemeda 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 rhenium ( 186 Re) obisbemeda 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 March 31, 2026, we had received approximately $15.9 million in milestone payments under the CPRIT Contract.

Interim results showed that a single treatment with rhenium ( 186 Re) obisbemeda resulted in a consistent decreased cerebrospinal fluid (“CSF”) tumor cell count/ml and was tolerated by all LM patients.

Rhenium ( 186 Re) obisbemeda 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 rhenium ( 186 Re) obisbemeda distribution throughout the subarachnoid space.

In November 2023, the FDA granted orphan drug designation to rhenium ( 186 Re) obisbemeda for the treatment of patients with breast cancer with LM.

On December 12, 2023, we announced our partnership with K2bio to implement the CNSide Test.

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 rhenium ( 186 Re) obisbemeda 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, 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 that additional steps would be necessary to validate CTCs as a surrogate endpoint to potentially support other future applications.

The FDA recommended that the study evaluate an endpoint with established clinical benefit, such as overall survival, while encouraging further study of reported outcomes and neurologic function as endpoints that could potentially support a marketing application.

We were aligned that CTCs could be considered for use as a secondary endpoint.

We discussed with the FDA a randomized controlled trial design approach and that the study may include an itrathecal chemotherapeutic as a comparator, as well as approaches to standardize the comparator and any additional interventions available under the trial protocol.

The FDA conveyed it may be reasonable to incorporate multiple histologies (i.e., multiple underlying disease etiologies) in a single trial.

We plan to consider the Agency’s feedback and propose an updated protocol for our next study for FDA’s feedback.

In December 2025, we reported completion of the ReSPECT-LM single dose trial showed rhenium ( 186 Re) obisbemeda 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 at optimal dose selected by assessing response

using the CNSide Test.

Enrollment in Cohort 1 has begun with delivery of 13.2 mCi at 3 intervals with one patient receiving all doses without dose limiting toxicity.

Our ReSPECT LM Multi-dose Phase 2 Study is currently enrolling patients.

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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 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.

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.

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.

While cases occur across the pediatric age spectrum and the overall median age at diagnosis is approximately nine years, the highest incidence of supratentorial high-grade gliomas is observed in older adolescents aged 15 to 19 years.

Overall, pediatric high-grade glioma confers a three-year progression free survival (“PFS”) of 11 ± 3% and three-year OS of 22 ±5%.

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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

The DoD Award will be used to support the planned expansion of our clinical trial for pediatric brain cancer.

We anticipate beginning enrollment for our Phase 1 ReSPECT-PBC clinical trial in 2025.

On June 25, 2025, we announced that the FDA cleared its Investigational New Drug ("IND") application (No.

168178) for REYOBIQ for the treatment of pediatric patients with supratentorial recurrent, refractory, or progressive high-grade glioma ("HGG") and ependymoma.

The Phase 1/2a trial is a two-part, single-arm, prospective study aimed at determining the maximum tolerated dose ("MTD"), safety, and tolerability of REYOBIQ in pediatric patients aged 6 to 21 years (with consideration for patients up to 25 years on a case-by-case basis).

We anticipate enrolling for our first patient for our Phase 1 ReSPECT-PBC clinical trial in 2026.

Key elements of the trial design include:

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This phase will enroll approximately 32 patients (12 with ependymoma and 20 with HGG) at the RP2D to assess efficacy.

• We anticipate to begin enrollment in our ReSPECT-PBC clinical trial before the end of 2025.

• We anticipate beginning enrollment in our ReSPECT-PBC clinical trial, with our first patient enrolled, in 2026.

On April 8, 2026, we announced that the FDA granted Orphan Drug Designation to rhenium ( 186 Re) obisbemeda for the treatment of pediatric malignant gliomas.

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 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.

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The FDA has informed us that 188 RNL-BAM will be regulated as a medical device under the FDCA.

The CNSide FORESEE Trial

The CNSide Platform consists of four LDTs used for treatment selection and treatment monitoring of patients with LM.

The CNSide Platform facilitates tumor cell detection/enumeration and biomarker identification using cellular assays (immunocytochemistry (ICC) and fluorescence in situ hybridization (FISH)) and molecular assays (next-generation sequencing (NGS)).

The CNSide CSF Assay Platform

The CNSide CSF Assay Platform consists of four LDTs used for detection, quantification, and characterization of tumor cells in patients with LM.

The CNSide Platform facilitates tumor cell detection/enumeration and biomarker identification using cellular assays (tumor cell enumeration (“TCE”), immunocytochemistry (“ICC”), and fluorescence in situ hybridization (“FISH”)) and molecular assays (next-generation sequencing (“NGS”)).

The CNSide Test is currently being used in the ReSPECT-LM trial as an exploratory endpoint.

Since acquiring the CNSide Platform in 2024, we have established infrastructure to support a scalable and centralized testing laboratory in Houston, TX that will service the U.S.

We have been executing on our commercial market access strategy, which includes prioritized state licensure, proprietary reimbursement codes, commercial and government payor coverage, and value-based pricing to optimize revenue.

We anticipate introducing the CNSide Platform first in Texas in the second half of 2025, followed rapidly by expansion into additional states in 2026.

In parallel, additional expanded CNS testing capabilities are also expected to roll out over the next year.

Since acquiring the CNSide Platform in 2024, we have established infrastructure to support a scalable and centralized testing laboratory in Houston, TX that services the U.S.

We have been executing on our commercial market access strategy, which includes state licensure, receipt of proprietary reimbursement codes, commercial and government payor coverage, and value-based pricing to optimize revenue.

We re-introduced the CNSide Platform first in Texas in August of 2025, signed a national agreement to provide the CNSide Test with UnitedHealthcare Insurance Company, Humana, Inc., Highmark and Blue Shield of California, and obtained state licensure for 49 of 50 US states, with the remaining license for the state of New York on track for 2027.

In parallel, we expect to launch a portfolio of additional CSF tumor characterization tests that expand our CNSide testing platform later in 2026.

When the CNSide CSF Assay Platform was previously commercially available, market acceptance and adoption were widespread, with several national and regional commercial payor agreements in place and the test in regular use at major cancer centers across the U.S.

We are now in contact with the legacy payors and healthcare providers in anticipation of the planned 2025 launch, and later this year will be expanding those contacts to support a 50-state strategy.

Finally, we have hired experienced leadership with expertise in the development and commercialization of clinical diagnostic technologies on a large scale.

During the three months ended March 31, 2026, we started commercial billing for our diagnostic CNSide business.

Net diagnostic revenue was immaterial to be presented in the condensed consolidated statement of operations for the three months ended March 31, 2026 (refer to Note 2 Summary of Significant Accounting Policies of the footnotes).

In April 2026, management obtained approval of proprietary laboratory analyses codes from significant medical payors, and will continue to seek additional authorizations.

We expect diagnostic revenue to increase during the remainder of 2026 and beyond.

Recent Developments

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Refer to the “Liquidity and Capital Resources” section below for information on our recent financings.

Financing Related Transactions

As of September 30, 2025, we recorded a $6.4 million liability in accounts payable and accrued expenses due to the March 2025 Private Placement Purchasers.

Such liability declined by $1.3 million from September 30, 2025 to October 27, 2025 due to 1) a $0.9 million reduction as a result of the reselling of securities acquired in the March 2025 Private Placement by certain March 2025 Private Placement Purchasers, which was recorded as a reduction of liability that would have been settled in cash, with a corresponding increase to

stockholders’ equity, and 2) a payment of $0.4 million to the March 2025 Private Placement Purchasers subsequent to September 30, 2025, with 0.6 million shares of the Company’s common stock returned and cancelled under the terms of the Letter Agreement.

On October 28, 2025, we entered into an amendment to the Letter Agreement and the Support Letters with certain March 2025 Private Placement Purchasers (the “Amendment Agreement”), pursuant to which (a) the Support Letters were terminated other than with respect to the participation rights granted therein, and (b) the repayment mechanism under the Letter Agreement was modified.

As modified, we are no longer required to use 90% of the proceeds from any subsequent financing to repay the March 2025 Private Placement Purchasers.

Instead, we are only required to retain sufficient funds in an interest bearing account to cover such repayment obligations and make such repayments upon request by any March 2025 Private Placement Purchaser who executed the Amendment Agreement until each such purchaser has received cash either from us or from reselling securities acquired in the March 2025 Private Placement in an amount equal to 115% of the purchase price such purchaser paid in the March 2025 Private Placement.

If such requests are made, the requesting purchaser must return shares acquired in the March 2025 Private Placement at a value of $0.66 per share.

In addition, we issued approximately 3.3 million shares on the Lincoln Park Purchase Credit Agreement, raising an additional $1.9 million of capital through October 29, 2025.

Houston Lease

On October 16, 2025, we entered into a lease (the “Houston Lease”) with LG 1 Property Owner LP, pursuant to which we agreed to lease approximately 11,370 rentable square feet of space located at 6420 Levit Green Boulevard, Houston, Texas 77021.

The Houston Lease is expected to commence on or about November 1, 2026.

The Houston Lease provides for a monthly base rent of $58,745, which increases annually by approximately 3%, plus our share of the building’s direct expenses.

The Houston Lease has an initial term of 120 calendar months.

Results of Operations

Grant Revenue

We recognized $1.4 million and $3.8 million, and $1.5 million and $4.4 million of grant revenue during the three and nine months ended September 30, 2025 and 2024, respectively, which represents CPRIT’s share of the costs incurred for our rhenium ( 186 Re) obisbemeda development for the treatment of patients with LM.

CPRIT Grant Revenue

We recognized $1.0 million and $1.1 million of grant revenue during the three months ended March 31, 2026 and 2025, respectively, which represents CPRIT’s share of the costs incurred for our rhenium ( 186 Re) obisbemeda development for the treatment of patients with LM.

Research and development expenses

Research and development expenses 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.

The following table summarizes the components of our research and development expenses for the three and nine months ended September 30, 2025 and 2024 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

The following table summarizes the components of our research and development expenses for the three months ended March 31, 2026 and 2025 (in thousands):

Three Months Ended March 31,

Research and development

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Total research and development expenses

Research and development expenses decreased by approximately $0.4 million during the three months ended September 30, 2025 as compared to the same period in 2024.

The decrease was due primarily to a decrease of $0.4 million in development expenses, a decrease of $0.4 million in compensation expense, a decrease of $0.4 million in professional research and development services, and a decrease of $0.1 million in depreciation expense.

These decreases were partially offset by an increase of $0.5 million in licensing expenses and an increase of $0.4 million in diagnostics.

Research and development expenses decreased by approximately $3.0 million during the nine months ended September 30, 2025 as compared to the same period in 2024.

The decrease was due primarily to a decrease of $1.3 million in clinical expenses, a decrease of $1.1 million in compensation expense, a decrease of $0.7 million in professional services, a decrease of $0.3 million in development expenses, a decrease of $0.2 million in depreciation expense and a decrease of $0.1 million in travel costs.

These decreases were partially offset by an increase of $0.4 million in diagnostics, and $0.3 million in licensing expenses.

We expect aggregate research and development expenses to increase during the remainder of 2025 as compared to the corresponding comparable period in 2024 as we commence the ReSPECT-LM dose optimization trial for REYOBIQ and prepare for the launch of the CNSide Test.

Research and development expenses increased by approximately $1.1 million during the three months ended March 31, 2026 as compared to the same period in 2025.

The increase was due primarily to an increase of $0.4 million in clinical expenses, $0.3 million in diagnostics, $0.3 million in professional research and development services, and $0.1 million in other research and development expenses.

We expect aggregate research and development expenditures to increase during the remainder of 2026 as compared to the corresponding comparable period in 2025, due to increased costs for the ReSPECT-LM clinical trial (for which CPRIT grant funding is expected to be available), manufacturing scale up for rhenium ( 186 Re) obisbemeda commercial and approval trial drug availability and initial patient enrollments in the ReSPECT-PBC clinical trial together with expansion of CNSide research and development teams.

General and administrative expenses

General and administrative expenses include costs for administrative personnel, legal and other professional expenses, and general corporate expenses.

The following table summarizes the general and administrative expenses for the three and nine months ended September 30, 2025 and 2024 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

The following table summarizes the general and administrative expenses for the three months ended March 31, 2026 and 2025 (in thousands):

Three Months Ended March 31,

General and administrative

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Total general and administrative expenses

General and administrative expenses increased by $1.0 million during the three months ended September 30, 2025, as compared to the same period in 2024, primarily due to an increase of $0.6 million in compensation expense, an increase of $0.3 million in legal and professional fees, and an increase of $0.1 million in accounting expenses.

General and administrative expenses increased $1.2 million during the nine months ended September 30, 2025, as compared to the same period in 2024, primarily due to an increase of $1.3 million in compensation expense, partially offset by a decrease of $0.1 million in legal and professional services.

We expect general and administrative expenditures to increase during the remainder of 2025 as compared to the corresponding comparable period in 2024 as we work towards the commercial launch of the CNSide Test, which will require an increase in administrative and sales headcount.

Stock-based compensation expense

Stock-based compensation expense includes charges related to equity awards issued to employees, directors and non-employees.

We measure stock-based compensation expense based on the grant-date fair value of any awards granted to our employees.

General and administrative expenses increased by $2.4 million during the three months ended March 31, 2026, as compared to the same period in 2025, primarily due to an increase of $1.4 million in compensation expense which included an increase of $0.9 million in stock based compensation, $0.5 million in legal and professional fees, $0.3 million in rent expense, and $0.2 million in other general and administrative expenses.

We expect general and administrative expenditures to increase during the remainder of 2026 as compared to the corresponding comparable period in 2025 as we expand the CNSide commercial operations team (including sales, customer service and laboratory operations).

Stock-based compensation expenses

Stock-based compensation expenses include charges related to options and restricted stock awards issued to employees, directors and non-employees.

We measure stock-based compensation expenses based on the grant-date fair value of any awards granted to our employees.

Such expense is recognized over the requisite service period.

The following table summarizes the components of our stock-based compensation expenses for the three and nine months ended September 30, 2025 and 2024 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

The following table summarizes the components of our stock-based compensation expenses for the three months ended March 31, 2026 and 2025 (in thousands):

Three Months Ended March 31,

Research and development

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Our stock-based compensation expense is impacted by grants of equity awards, the vesting schedule of such grants, as well as the grant date fair value of equity awards.

Stock-based compensation expense increased during the three and nine months ended September 30, 2025 as compared to the same periods in 2024 primarily due to an increase in the number of awards granted, which was partially offset by a decrease in the grant date fair value of equity awards granted.

Financing items

The following table summarizes non-operating income and expenses for the three and nine months ended September 30, 2025 and 2024 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

Stock-based compensation expense increased during the three months ended March 31, 2026 as compared to the same period in 2025 primarily due to an increase in the number of awards granted, which was partially offset by a decrease in the grant date fair value of equity awards granted.

Other Income (Expense)

The following table summarizes non-operating income and expenses for the three months ended March 31, 2026 and 2025 (in thousands):

Three Months Ended March 31,

Interest income

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Warrant issuance costs

Interest income decreased for the three and nine months ended September 30, 2025 compared with the same period in 2024 primarily due to reduced accreted income on our available-for-sale securities in 2024 and a lower interest rate environment in 2025.

The decrease in interest expense for the three months ended September 30, 2025 as compared to the same period in 2024 was due to the January 2025 payoff of the Pershing Credit Facility.

The increase in interest expense for the nine months ended September 30, 2025 as compared to the same period in 2024 was due to interest expense incurred in connection with the Funding Notes and Exchange Notes issued in February 2025, partially offset by the January 2025 payoff of the Pershing Credit Facility.

The decrease in financing expenses for the nine months ended September 30, 2025 as compared to the same period in 2024 was primarily due to the March 2025 PIPE and May 2024 PIPE transactions.

The change in the fair value of the derivative instruments for the three months ended September 30, 2025 as compared to the same period in 2024 was due to the March 2025 Private Placement and May 2024 Private Placement and accompanying warrants issued in both financings.

The change in the fair value of the derivative instruments for the nine months ended September 30, 2025 as compared

to the same period in 2024 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), offset by the May 2024 Private Placement (specifically the May 2024 Series A Warrants and May 2024 Series B Warrants, which were initially classified as liabilities before being reclassified as equity).

The decrease in warrant issuance costs for the three months ended September 30, 2025 as compared to the same period in 2024, was due to warrant issuance costs related to the May 2024 Private Placement.

The increase in the warrant issuance costs for the nine months ended September 30, 2025 as compared to the same period in 2024 was due to the warrant issuance costs from the March 2025 Private Placement and May 2024 Private Placement.

Interest income increased for the three months ended March 31, 2026 compared with the same period in 2025 was primarily due to a higher investment balance in 2026 as compared to the same period in 2025.

The decrease in interest expense for the three months ended March 31, 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 months ended March 31, 2025 related to the March 2025 PIPE and February 2025 transactions.

The change in the fair value of the derivative instruments for the three months ended March 31, 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 three months ended March 31, 2025 related to the March 2025 Private Placement.

Liquidity and Capital Resources

Short-term and long-term liquidity

The following is a summary of our key liquidity measures at September 30, 2025 and December 31, 2024 (in thousands):

September 30, 2025

The following is a summary of our key liquidity measures at March 31, 2026 and December 31, 2025 (in thousands):

March 31, 2026

December 31, 2025

Cash and cash equivalents

Cash, cash equivalents and restricted cash

Current assets

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Working capital

We incurred net losses of $16.7 million for the nine months ended September 30, 2025.

We have an accumulated deficit of $510.2 million as of September 30, 2025.

Additionally, we used net cash of $14.5 million to fund our operating activities for the nine months ended September 30, 2025.

We incurred net losses of $6.9 million for the three months ended March 31, 2026.

We have an accumulated deficit of $522.8 million as of March 31, 2026.

Additionally, we used net cash of $6.2 million to fund our operating activities for the three months ended March 31, 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, proceeds from our now-repaid in full term loan with Oxford Finance, LLC (“Oxford”), our line of credit facility with Pershing LLC 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, and commercialize the CNSide Test.

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, warrants, 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.

January 2026 Public Offering

On January 13, 2026, the Company completed an underwritten public offering pursuant to which the Company (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 the Company.

February 2025 SPEA

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March 2025 Private Placement

On March 4, 2025, we entered into a securities purchase agreement (the “March 2025 Purchase Agreement”) with accredited investors, including certain of our existing stockholders, identified on the signature page thereto (collectively, the “March 2025 Private Placement Purchasers”) for a private placement of securities (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 4,069,738 shares (the “March 2025 Private Placement Shares”) of our common stock and 23,972,400 Pre-Funded Warrants, with each March 2025 Private Placement Share or Pre-Funded Warrant accompanied by (i) a Series A common warrant (the “March 2025 Series A Warrants”) to purchase one share of common stock and (ii) one Series B common warrant (the “March 2025 Series B Warrants”) to purchase one share of common stock.

The combined purchase price of $0.66 for each March 2025 Private Placement Share or $0.659 for each Pre-Funded Warrant in the March 2025 Private Placement, together with one accompanying March 2025 Series A Warrant and one accompanying March 2025 Series B Warrant, represented the applicable “Minimum Price” in accordance with Listing Rule 5635(d) of Nasdaq.

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 Pre-Funded Warrants, with each March 2025 Private Placement Share or 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 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.

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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.

The liability classified March 2025 Series B Warrants were remeasured immediately prior to exercise, which resulted in a $3.8 million gain on the change in fair value for the nine months ended September 30, 2025, and a $0.8 million credit to additional paid-in-capital.

Letter Agreement

On June 17, 2025, the Company and the Purchasers entered into a letter agreement (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.

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 Pre-Funded Warrants, as further discussed in the following paragraphs.

As part of the Letter Agreement, all March 2025 Series A Warrants were cancelled, which resulted in a $2.7 million gain on change in fair value recorded as capital contribution to additional paid-in capital, as the extinguishment was deemed equivalent to a capital contribution by existing shareholders of the Company.

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, in the amount of $11.0 million was reclassified to equity.

Immediately prior to reclassification, the March 2025 Series B Warrant liability was remeasured, and $4.5 million was recorded as a capital contribution to additional paid-in capital, as the modification of the March 2025 Series B Warrants was deemed equivalent to a capital contribution by existing shareholders of the Company.

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 return an aggregate of 12,241,986 Private Placement Shares and Pre-Funded Warrants issuable for an aggregate of 10,633,650 Pre-Funded Warrant Shares, held by them as of the date of the Letter Agreement, upon request of the Company (the "Letter Agreement Repurchase Option"), which were issued pursuant to the March 2025 Private Placement Purchase Agreement for a value of $0.66 per Private Placement Share and $0.659 per Pre-Funded Warrant.

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 Pre-Funded Warrants issuable for an aggregate of 425,346 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 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 three and nine months ended September 30, 2025, we paid the March 2025 Private Placement Purchasers $2.3 million and 3,472,740 shares were returned and cancelled under the terms of the Letter Agreement .

During the three months ended March 31, 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

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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.

In accordance with the Support Letters, we made a cash payment of $0.5 million to each purchaser for a total cash payment of $2.3 million, which was recorded as a reduction to additional paid-in capital in the condensed consolidated balance sheet as of September 30, 2025.

Such payment counted as cash received by the purchaser towards its Maximum Amount.

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.

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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.

May 2024 Private Placement

In May 2024, we entered into a securities purchase agreement (the “May 2024 Purchase Agreement”), which was subsequently amended, with certain investors, including certain of the our directors and executive officers (the “May 2024 Private Placement Purchasers”), whereby we issued and sold in a private placement (the “May 2024 Private Placement”):

(i) 3,591,532 shares of common stock or, at the election of each investor, Pre-Funded warrants (“May 2024 Pre-Funded Warrants”) to purchase shares of common stock exercisable immediately at an exercise price of $0.001 per share.

Each share or May 2024 Pre-Funded Warrant was accompanied by (i) a Series A common warrant (“May 2024 Series A Warrants”) to purchase one share of common stock, for an aggregate of 3,591,532 Series A Warrants, and (ii) one Series B common warrant (“May 2024 Series B Warrants”) to purchase one share of common stock, for an aggregate of 3,591,532 May 2024 Series B Warrants.

At the closing of the May 2024 Private Placement, we received net proceeds of approximately $7.3 million.

Lincoln Park Purchase Agreement

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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.

In accordance with the Lincoln Park Purchase Agreement, we were required to pay Lincoln Park an initial commitment fee of $0.5 million, which was paid through the issuance of 1,612,903 shares of common stock on August 14, 2025.

The initial commitment fee was recorded as a reduction to additional paid-in capital in the condensed consolidated balance sheet as of September 30, 2025.

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.

As of the nine months ended September 30, 2025, we issued 44,575,496 shares under the Lincoln Park Purchase Agreement for gross proceeds of approximately $19.6 million.

The Company incurred approximately $50,000 for legal fees in connection with the Lincoln Park Purchase Agreement.

Subsequent to September 30, 2025, we issued 3.3 million shares under the Lincoln Park Purchase Agreement, raising an additional $1.9 million of capital through October 29, 2025.

On September 19, 2022, we entered into the CPRIT Contract, pursuant to which CPRIT will provide us with the CPRIT Grant of $17.6 million subject to the terms of the CPRIT Contract, to fund approximately two-thirds of the continued development of REYOBIQ for the treatment of patients with LM.

We recognized $3.8 million, $5.8 million, $4.9 million and $0.2 million of grant revenue during the nine months ended September 30, 2025, years ended December 31, 2024, 2023 and 2022, respectively, all of which has been received.

The amounts recognized represents CPRIT’s share of the costs incurred for our REYOBIQ development for the treatment of patients with LM.

As of September 30, 2025, we had $1.1 million of deferred grant liability related to the CPRIT Grant.

Nasdaq Listing Compliance

On March 8, 2024, we received notice from the Listing Qualifications staff of Nasdaq (the “Staff”), notifying us that we no longer complied with the requirement under Nasdaq Listing Rule 5550(b)(1) to maintain a minimum of $2.5 million in stockholders’ equity (the “Minimum Stockholders’ Equity Requirement”) for continued listing on The Nasdaq Capital Market or the alternative requirements of having a market value of listed securities of $35 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or two of the last three most recently completed fiscal years.

On September 5, 2024, Nasdaq notified us that we had not regained compliance with Nasdaq Listing Rule 5550(b)(1).

We requested a hearing before the Nasdaq hearing panel and on October 30, 2024, we received a decision from the panel, notifying us that we had until March 4, 2025 to demonstrate compliance with the Minimum Stockholders’ Equity Requirement.

On March 7, 2025, we received notification from Nasdaq that it had regained compliance with the Minimum Stockholders’ Equity Requirement due to the March 2025 Private Placement.

Pursuant to Nasdaq Listing Rule 5815(d)(4)(B), we will be subject to a Mandatory Panel Monitor until March 7, 2026.

If the Staff finds us again out of compliance with the Minimum Stockholders’ Equity Requirement before that date, we would not be permitted to provide the Staff with a plan of compliance with respect to that deficiency and the Staff would not be permitted to grant additional time for us to regain compliance with respect to that deficiency, nor would we be afforded an applicable cure or compliance period.

Instead, the Staff would issue a “Delist Determination Letter” and we would have an opportunity to request a hearing before the panel regarding our continued listing.

Furthermore, on May 16, 2025, we received notice from Nasdaq that, because the closing bid price for our common stock has fallen below $1.00 per share for 30 consecutive business days, we no longer comply with the minimum bid price requirement pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Requirement”).

Nasdaq’s Minimum Bid Requirement notice has no immediate effect on the listing or trading of our common stock.

Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), we are provided an initial compliance period of 180 calendar days, or until November 12, 2025, to regain compliance with the Minimum Bid Requirement.

To regain compliance, the closing bid price of our common stock must meet or exceed $1.00 per share for a minimum of 10 consecutive business days prior to November 12, 2025.

If we do not achieve compliance with the Minimum Bid Requirement by November 12, 2025, we may be eligible for an additional 180 calendar days to regain compliance.

To qualify, we would be required to meet the continued listing requirement for market value of publicly held shares and all other Nasdaq initial listing standards, with the exception of the Minimum Bid Requirement, and provide written notice of its intention to cure the minimum bid price deficiency during the second compliance period by effecting a reverse stock split if necessary.

If the Staff determines that we will not be able to cure the deficiency, or if we are otherwise not eligible for such additional compliance period, Nasdaq will provide notice that our common stock will be subject to delisting.

In the event we receive notice that its common stock is being delisted, Nasdaq rules permit us to appeal any delisting determination by the Staff.

We intend to monitor the closing bid price of our common stock and may, if appropriate, consider implementing available options to regain compliance with the Minimum Bid Requirement.

On May 2, 2025, our stockholders granted discretionary authority to our board of directors to (i) amend our Certificate of Incorporation to combine outstanding shares of our common stock into a lesser number of outstanding shares, or a “reverse stock split,” at a specific ratio within a range of one-for twenty five (1-for-25) to a maximum of one-for-two hundred fifty (1-for-250), with the exact ratio to be determined by the board of directors in its sole discretion;

and (ii) effect the reverse stock split, if at all, within twelve (12) months of the date the proposal is approved by stockholders.

In addition, on August 7, 2025, the stockholders granted discretionary authority to the Company’s board of directors to (i) amend the Company’s Certificate of Incorporation to combine outstanding shares of the Company’s common stock into a lesser number of outstanding shares, or a “reverse stock split,” at a specific ratio within a range of one-for two (1-for-2) to a maximum of one-for-two

hundred fifty (1-for-250), with the exact ratio to be determined by the board of directors in its sole discretion;

and (ii) effect the reverse stock split, if at all, within twelve (12) months of the date the proposal is approved by stockholders.

On June 3, 2025, the Staff notified the Company that it was not in compliance with the Minimum Stockholders’ Equity Requirement (the “June 3 Letter”).

The Company reported stockholders’ equity (deficit) of ($23,641,000) in its Quarterly Report on Form 10-Q for the period ended March 31, 2025, and, as a result, did not satisfy the Minimum Stockholders’ Equity Requirement pursuant to Listing Rule 5550(b)(1).

As a result, the Staff determined to delist the Company’s securities from Nasdaq, unless the Company timely requests an appeal of the Staff’s determination to a Hearings Panel (the “Panel”), pursuant to the procedures set forth in the Nasdaq Listing Rule 5800 Series.

The Company timely requested a hearing, which hearing took place as scheduled on July 15, 2025.

On July 22, 2025, the Panel issued a decision (the “July 2025 Decision”) granting the Company’s request for continued listing on Nasdaq, subject to the Company demonstrating compliance with (1) the Minimum Stockholders’ Equity Requirement pursuant to Listing Rule 5550 (b)(1) by August 14, 2025 by filing a timely public disclosure describing the transactions undertaken by the Company to achieve compliance and demonstrate long-term compliance of the Minimum Stockholders’ Equity Requirement, and by providing an indication of its equity following those transactions, with the option by including in the public filing a balance sheet not older than 60 days with pro forma adjustments for any significant transactions or events occurring on or before the report date;

and (2) the Minimum Bid Requirement by September 8, 2025.

On August 22, 2025, the Company received a letter (the “August 2025 Letter”) from Nasdaq confirming its compliance with Nasdaq Listing Rule 5550(b).

Specifically, the August 2025 Letter confirmed that the Company was in compliance with both (1) the Market Value of Listing Securities standard under 5550(b)(2), which requires certain companies to maintain a market value of listed securities of at least $35 million as well as compliance with (2) the alternative stockholders’ equity threshold under 5550(b)(1) or the Minimum Stockholders’ Equity Requirement.

Accordingly, the Company satisfied two alternative criteria under Nasdaq Listing Rule 5550.

As a result of such compliance, Nasdaq permitted the Company the remainder of the previously announced grace period to regain compliance with the $1.00 bid price rule under Nasdaq Listing Rule 5550(a)(2), through November 12, 2025.

Nasdaq previously required that the Company remedy the bid price deficiency by September 8, 2025, a deadline that no longer applies.

The August 2025 Letter also provided that, solely with respect to the Equity Standard, the Company remains subject to a one-year panel monitoring period, through August 22, 2026.

If, within that one-year monitoring period, the Staff determines that the Company no longer satisfies the Equity Standard (and the Company is not then in compliance with one of the alternative standards under Rule 5550(b)), the Company will not be permitted to provide the Staff with a plan of compliance and the Staff is not permitted to grant additional time to regain compliance with the Equity Standard nor will the Company be afforded an applicable cure or compliance period.

Instead, the Staff will issue a delist determination letter, and the Company will have an opportunity to request a new hearing before the Nasdaq Hearings Panel, which request would stay any further action by the Staff pending the ultimate outcome of the hearing.

There can be no assurance that the Company will be able to regain compliance with the Minimum Bid Requirement or maintain compliance with the Equity Standard.

Minimum Stockholders’ Equity Requirement

We are currently in compliance with the Minimum Stockholders’ Equity Requirement.

We are subject to monitoring through August 22, 2026 with respect to the Minimum Stockholders’ Equity Requirement.

If, within such period, the Staff determines that we no longer satisfy the Minimum Stockholders’ Equity Requirement (and we are not then in compliance with one of the alternative standards under Nasdaq Listing Rule 5550(b)), we will not be permitted to provide the Staff with a plan of compliance and the Staff is not permitted to grant additional time to regain compliance with the Minimum Stockholders’ Equity Requirement nor will we be afforded an applicable cure or compliance period.

Instead, the Staff will issue a delist determination letter, and we will have an opportunity to request a new hearing before the Nasdaq Hearings Panel, which request would stay any further action by the Staff pending the ultimate outcome of the hearing.

Minimum Bid Requirement

On April 20, 2026, we received the Notification Letter from The Nasdaq Stock Market LLC notifying us that we had regained compliance with the Minimum Bid Requirement.

The Notification Letter was sent following the implementation of the Reverse Stock Split, which became effective on April 2, 2026.

Additional information regarding the Reverse Split can be found in our Current Report on Form 8-K filed on April 2, 2026.

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, proceeds from the now-repaid in full term loan with Oxford, the margin loan facility under a line of credit with Pershing and grant funding.

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, warrants, 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.

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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, 2025 and 2024 is summarized as follows (in thousands):

Nine Months Ended September 30,

Cash (used in) provided by operating, investing, and financing activities for the three months ended March 31, 2026 and 2025 is summarized as follows (in thousands):

Three Months Ended March 31,

Net cash provided by (used in):

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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 long-term contractual obligations, except for lease obligations as of September 30, 2025.

Other than as described above, we have no purchase commitments or long-term contractual obligations, except for lease obligations as of March 31, 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, 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.

Net cash used in operating activities for the nine months ended September 30, 2024 of $9.3 million was primarily related to the net loss of $9.1 million and a $5.7 million change to the fair value of derivative instruments, partially offset by $3.5 million of noncash financing expenses and $0.8 million of changes to operating assets and liabilities.

Net cash used in operating activities for the three months ended March 31, 2026 of $6.2 million was primarily related to the net loss of $6.9 million and $0.4 million of changes to operating assets and liabilities, partially offset by $1.0 million of stock-based compensation expense and $0.1 million of depreciation and amortization.

Net cash used in operating activities for the three months ended March 31, 2025 was $6.2 million, compared with $4.5 million in the same period of 2024, primarily due to an increase to net loss of $14.1 million, offset by non cash charges of $12.7 million during the three months ended March 31, 2025.

Investing activities

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.

Net cash used in investing activities for the nine months ended September 30, 2024 of $4.2 million was related to the purchase of Biocept assets of $0.5 million, short-term investments of $7.1 million and purchase of fixed assets of $0.1 million, partially offset by the redemption of short-term investments of $3.7 million.

Net cash used in investing activities for the three months ended March 31, 2026 of $8.5 million was primarily related to the purchase of short-term investments of $9.7 million and purchase of property and equipment of $0.8 million, which was partially offset by the redemption of short-term investments of $2.0 million.

Net cash provided by investing activities for the three months ended March 31, 2025 was related to maturities of short-term investments of $3.5 million.

Financing Activities

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.

Net cash provided by financing activities for the nine months ended September 30, 2024 of $6.2 million was related to net proceeds of $7.3 million from the exercise of Series B Warrants from the May 2024 Private Placement and the drawdown of $3.3 million from the Pershing Credit Facility, partially offset by the repurchase of treasury stock for approximately $0.4 million and repayment of the principle balance under the Oxford loan of $4.0 million.

Net cash provided by financing activities for the three months ended March 31, 2026 of $9.0 million was related to $15.0 million in proceeds from the January 2026 underwritten public offering and $1.0 million of proceeds from the credit facility, partially offset by $1.1 million repayments of the credit facility, $1.4 million for offering costs for the sale of common stock, and $4.5 million of payments to investors pursuant to the Letter Agreement.

Net cash provided by financing activities for the three months ended March 31, 2025 was related to $14.8 million of net proceeds from issuance of common stock, pre-funded warrants and warrants, $0.9 million related to cash received from exercise of warrants, and $3.7 million from issuance of Funding Notes payable and accompanying warrants, offset by repayment of $3.3 million of our line of credit facility, and repayment of Funding Notes payable and warrants for $3.7 million.

Critical Accounting Policies and Significant Estimates

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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, 2024 and there have been no material changes during the nine months ended September 30, 2025, other than what was disclosed in Note 2 of the accompanying condensed consolidated financial statements.

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 three months ended March 31, 2026, other than what was disclosed in Note 2 Summary of Significant Accounting Policies of the accompanying condensed consolidated financial statements.

Quantitative and Qualitat ive Disclosures about Market Risk

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis