6 unchanged sentences
We believe that our PDC platform possesses the potential for the discovery and development of the next generation of cancer-targeting treatments, and we plan to develop PDCs both independently and through research and development collaborations.
−Removed: On April 30, 2025, we announced that we will explore a full range of strategic alternatives to advance our platform and radiopharmaceutical drug development pipeline.
−Removed: Strategic alternatives under consideration may include, but are not limited to mergers, acquisitions, partnerships, joint ventures, licensing arrangements or other strategic transactions.
The Company is primarily focused on the development of its radioconjugate PDC programs, also known as phospholipid radioconjugates or PRCs, designed to provide targeted delivery of a radioisotope directly to cancer cells, while limiting exposure to healthy cells.
1 unchanged sentence
Our three lead programs are:
−Removed: CLR 121125 (CLR 125), an iodine-125 Auger-emitting program, prepared to enter a clinical trial in 2025;
−Removed: CLR 121225 (CLR 225), an actinium-225 based program;
−Removed: and iopofosine I 131 (iopofosine I 131, or simply iopofosine), a beta-emitting iodine-131 based program which has been studied extensively, as described below.
+Added: iopofosine I 131 (iopofosine I 131, or simply iopofosine), a beta-emitting iodine-131 based program which has been studied extensively, as described below, CLR 121125 (CLR 125), an iodine-125 Auger-emitting program, currently being studied in a Phase 1b dose finding study in triple-negative breast cancer (TNBC);
+Added: and CLR 121225 (CLR 225), an actinium-225 based program.
On June 4, 2025, the Company announced that the U.S Food and Drug Administration (the “FDA”) granted Breakthrough Therapy Designation for iopofosine I 131, as a radioconjugate monotherapy for the treatment of relapsed/refractory Waldenstrom macroglobulinemia (r/r WM).
On October 6, 2025, the Company announced that after a scientific advice procedure, the Scientific Advice Working Party (SAWP) of the European Medicines Agency (EMA) advised that filing for a Conditional Marketing Authorization (CMA) for iopofosine I 131 as a treatment for post - Bruton Tyrosine Kinase inhibitor (BTKi) refractory patients with Waldenstrom macroglobulinemia (WM) could be acceptable for a CMA.
−Removed: ● CLR 125, an Auger-emitting PRC, utilizes iodine-125 and has been observed to show tolerability with minimal toxicities in animal models.
−Removed: Additionally, the Company observed CLR 125 to have good activity in multiple solid tumor models, especially in triple negative breast cancer.
+Added: ● Iopofosine, a beta-emitting iodine-131 PRC, was studied in our CLOVER WaM Phase 2 study of iopofosine in patients with r/r WM where it was observed to result in statistically significant outcomes on both primary and secondary endpoints, and our Phase 2b studies in r/r multiple myeloma (MM) patients and r/r central nervous system lymphoma (CNSL).
+Added: The CLOVER-2 Phase 1a study for a variety of pediatric cancers has concluded and a Phase 1b study in pediatric patients with high grade glioma is in follow-up.
+Added: Additionally, a Phase 1 investigator-initiated study conducted by the University of Wisconsin-Madison of iopofosine in combination with external beam radiation in patients with recurrent head and neck cancer has also been completed.
+Added: ● CLR 125, an Auger-emitting PRC, utilizes iodine-125 as its radiation source and has been observed to show tolerability with minimal toxicities in animal models.
+Added: Additionally, the Company observed CLR 125 to have good activity in multiple solid tumor models, especially in TNBC.
Auger emitters provide the greatest precision in targeted radiotherapy as the emission can only travel a few nanometers.
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CLR 125 is the subject of a Phase 1b dose finding study as described below.
−Removed: ● CLR 225, an alpha-emitting, actinium-225 based PRC has shown activity in multiple solid tumor animal models, including pancreatic, colorectal, and breast cancer.
+Added: ● CLR 225, an alpha-emitting, actinium-225 based PRC has shown activity in multiple solid tumor animal models including pancreatic, colorectal and breast cancers.
CLR 121225 was well tolerated in these models with the animals showing no adverse events at the highest doses tested.
−Removed: The compound demonstrated excellent biodistribution and uptake by the tumor.
+Added: The compound demonstrated excellent biodistribution and uptake by tumors.
Furthermore, in multiple models of pancreatic adenocarcinoma, including highly refractory pancreatic cancer, we have observed proportional dose response with a single dose of CLR 225 providing either tumor stasis at the lowest dose tested or tumor volume reduction at the higher doses.
−Removed: The Company is currently prepared to initiate a Phase 1 imaging and dose escalation safety study subject to our ability to obtain additional financing.
−Removed: ● Iopofosine, a beta-emitting PRC, utilizes iodine-131 and was studied in our CLOVER WaM Phase 2 study of iopofosine in patients with r/r WM where it was observed to result in statistically significant outcomes on both primary and secondary endpoints, and our Phase 2b studies in r/r multiple myeloma (MM) patients and r/r central nervous system lymphoma (CNSL) are ongoing.
−Removed: The CLOVER-2 Phase 1a study for a variety of pediatric cancers has concluded and a Phase 1b study in pediatric patients with high grade glioma is enrolling.
−Removed: Additionally, a Phase 1 investigator-initiated study conducted by the University of Wisconsin Madison of iopofosine in combination with external beam radiation in patients with recurrent head and neck cancer has also been completed.
−Removed: The Company plans to submit a New Drug Application (NDA) to the U.S.
−Removed: Food and Drug Administration (FDA) for the accelerated approval of iopofosine I 131 as a treatment for WM once the confirmatory trial is underway, which is subject to sufficient funding.
−Removed: As part of our previous announcement to seek a full range of strategic alternatives, we have initiated a process that includes identifying a strategic partner with the resources to develop iopofosine I 131.
−Removed: Clinical and Preclinical Pipeline
−Removed: CLR 125 Proposed Study
−Removed: In preclinical in vivo evaluations of CLR 125 utilizing triple-negative breast cancer (TNBC) models, the compound was observed to have tumor uptake at a substantially higher rate than that of healthy tissue.
−Removed: Additionally, no signs of end-organ toxicity were observed including hematological toxicity.
−Removed: The Company initiated a Phase 1b clinical study in TNBC with CLR 125.
−Removed: We expect the study to be a randomized, open-label, multi-center study comparing the safety and efficacy of CLR 125 in patients with advanced TNBC who are relapsed/refractory (r/r) to at least one prior therapy.
−Removed: Three dose levels will be assessed in parallel, with enrollment of patients in a 1:1:1 manner.
−Removed: We expect that each arm will have a minimum of 15 evaluable patients.
−Removed: CLR 125 will be administered as a fractionated dose on Day 1 and Day 3 for cycle 1 and repeat approximately every 8-weeks for subsequent cycles.
−Removed: Depending on arm assignments, patients will receive between two and four cycles.
−Removed: An expansion arm may consist of at least 15 patients following evaluation of the three dose levels by the data monitoring committee (DMC).
−Removed: We anticipate a maximum of 75 patients to be enrolled in the trial.
−Removed: Safety and tolerability of CLR 125 will be assessed by physical examination, Eastern Cooperative Oncology Group (ECOG) performance status, vital signs, laboratory changes over time, ECGs and adverse events of special interest.
−Removed: Efficacy of CLR 125 will be assessed by CT (or MRI if needed) examinations obtained at six-week intervals following the initial dose of CLR 125.
−Removed: The study objective is to determine the Phase 2 dosing level with secondary endpoints including safety, tolerability, initial response assessment and distribution.
−Removed: Preclinical Evaluations of CLR 225
−Removed: In preclinical, in vivo evaluations of CLR 225, utilizing a pancreatic cancer model, the compound was observed to reduce tumor volume and improved survival benefit at four different dosing levels.
−Removed: Observed biodistribution exhibited substantial uptake in the tumor while remaining low in healthy tissue.
−Removed: Clinical Studies in Iopofosine
+Added: The Company is prepared to initiate a Phase 1 imaging and dose finding safety study with the timing subject to alignment with corporate strategy, progress with existing studies, ongoing company priorities and the availability of the necessary resources.
+Added: ● Further development of iopofosine I 131 will require sufficient additional funding to initiate and at least partially enroll a confirmatory study, which has been identified as a required predicate to the submission of a New Drug Application (NDA) to the U.S.
+Added: Food and Drug Administration (FDA) for the accelerated approval of iopofosine I 131 as a treatment for WM.
+Added: See Recent Developments below.
The CLOVER-1 Phase 2 study of iopofosine, conducted in r/r B-cell malignancies, met the primary efficacy endpoints from the Part A dose-finding portion.
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There were no treatment-related deaths in the study.
−Removed: The CLOVER-1 Phase 2 study met the primary efficacy endpoints from the Part A dose-finding portion, conducted in r/r B-cell malignancies and is now enrolling an MM and CNSL expansion cohort (Phase 2b).
−Removed: The Phase 2b study will evaluate highly refractory MM patients in triple class, quad- and penta-drug refractory patients, including post-BCMA immunotherapy patients and r/r CNSL patients.
+Added: The CLOVER-1 Phase 2 study met the primary efficacy endpoints from the Part A dose-finding portion, conducted in r/r B-cell malignancies.
+Added: The Phase 2b study evaluated highly refractory MM patients in triple class, quad- and penta-drug refractory patients, including post-BCMA immunotherapy patients and r/r CNSL patients.
The initial Investigational New Drug (IND) application was accepted by the FDA in March 2014 with multiple INDs submitted since that time.
−Removed: The Phase 1 study was designed to assess the compound’s safety and tolerability in patients with r/r MM and to determine maximum tolerated dose (MTD) and was initiated in April 2015.
+Added: The Phase 1 study was designed to assess the compound’s safety and tolerability in patients with r/r MM and to determine maximum tolerated dose (MTD) and was initiated in
The study completed enrollment, and the final clinical study report is expected in the first half of 2026.
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The maximum tolerated dose was determined to be greater than 60mCi/m2 administered as a fractionated dose.
−Removed: CLOVER-2 Phase 1b study is an open-label, international dose-finding study evaluating two different doses and dosing regiments of iopofosine in r/r pediatric patients with high grade gliomas.
+Added: CLOVER-2 Phase 1b study is an open-label, international dose-finding study evaluating two different doses and dosing regimens of iopofosine in r/r pediatric patients with high grade gliomas.
These cancer types were selected for clinical, regulatory and commercial rationales, including the radiosensitive nature and continued unmet medical need in the r/r setting, and the rare disease determinations made by the FDA based upon the current definition within the Orphan Drug Act.
This study is partially funded (~$2M) by a National Institutes of Health SBIR grant from the National Cancer Institute.
−Removed: Food and Drug Administration (FDA) granted iopofosine Fast Track Designation for lymphoplasmacytic lymphoma (LPL) and WM patients having received two or more prior treatment regimens, as well as r/r MM and r/r diffuse large B-cell lymphoma (DLBCL).
+Added: Food and Drug Administration (FDA) granted iopofosine Break-through Designation for r/r Waldenstrom’s macroglobulinemia (WM), Fast Track Designation for lymphoplasmacytic lymphoma (LPL) and WM patients having received two or more prior treatment regimens, as well as r/r MM and r/r diffuse large B-cell lymphoma (DLBCL).
Orphan Drug Designations (ODDs) have been granted for LPL/WM, MM, neuroblastoma, soft tissue sarcomas including rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma.
Iopofosine was also granted Rare Pediatric Disease Designation (RPDD) for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma.
−Removed: The European Commission granted ODD to iopofosine for treatment of r/r MM and WM, as well as PRIME designation for WM.
+Added: The European Commission granted PRIME designation and ODD to iopofosine for treatment of r/r MM and WM.
Additionally, in June 2020, the European Medicines Agency (EMA) granted us Small and Medium-Sized Enterprise (SME) status by the EMA’s Micro, Small and Medium-sized Enterprise office.
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Food and Drug Administration (FDA).
−Removed: As a result of the meeting, the Company believes that it understands a path forward for potential accelerated and full approval of iopofosine I 131 based upon the CLOVER WaM study and a randomized Phase 3 confirmatory trial assessing progression free survival as the primary endpoints in WM patients.
−Removed: The submission for accelerated approval utilizing the CLOVER WaM study data can occur at the time of the initiation of Phase 3 randomized controlled confirmatory study and patient enrollment must be ongoing at the time of decision on the accelerated NDA.
+Added: As a result of the meeting, and clarified by subsequent written correspondence, the Company believes that it understands a path forward for potential accelerated and full approval of iopofosine I 131 based upon the CLOVER WaM study and the initiation of a comparator controlled Phase 3 confirmatory trial assessing progression free survival as the primary endpoints in WM patients.
+Added: The submission for accelerated approval utilizing the CLOVER WaM study data can occur at the time of or after the initiation of Phase 3 randomized controlled confirmatory study and patient enrollment must be ongoing at the time of decision on the accelerated NDA.
The confirmatory study will be executed in an earlier line of therapy than was tested in the CLOVER WaM patients.
−Removed: The initiation of this study is dependent on funding.
−Removed: We have leveraged our PDC platform to establish three ongoing collaborations featuring four unique payloads and mechanisms of action.
−Removed: Through research and development collaborations, our strategy is to generate near-term capital, supplement internal resources, gain access to novel molecules or payloads, accelerate product candidate development and broaden our proprietary and partnered product pipelines.
−Removed: Our PDC platform is designed to provide selective delivery of a diverse range of oncologic payloads to cancerous cells, whether a hematologic cancer or solid tumor;
−Removed: a primary tumor, or a metastatic tumor;
−Removed: and cancer stem cells.
−Removed: The PDC platform’s mechanism of entry is designed not to rely upon a specific cell surface epitope or antigen as are required by other targeted delivery platforms but rather a unique change in the tumor cell membrane.
−Removed: Our PDC platform takes advantage of a metabolic pathway (beta oxidation) utilized by nearly all tumor cell types in all stages of the tumor cycle.
−Removed: Tumor cells modify the cell membrane to create specific, highly organized microdomains by which to transport lipids and long chain fatty acids into the cytoplasm, as a result of the utilization of this metabolic pathway.
−Removed: Our PDCs are designed to bind to these regions and directly enter the intracellular compartment.
−Removed: This mechanism allows the PDC molecules to accumulate in tumor cells over time, which we believe can enhance drug efficacy.
−Removed: The direct intracellular delivery allows our molecules to avoid the specialized, highly acidic cellular compartment known as lysosomes, which allows a PDC to deliver payloads that previously could not be delivered in this targeted manner.
−Removed: Additionally, molecules targeting specific cell surface epitopes face challenges in completely eliminating a tumor because the targeted antigens are limited in the total number presented on the cell surface, limiting total potential uptake and resulting in heterogenous uptake across the tumor, have longer cycling time from internalization to relocation on the cell surface, again diminishing their availability for binding, and are not present on all of the tumor cells because of the heterogenous nature of cancer cells, further increasing the unequal distribution of the drug across the tumor.
−Removed: This means a subpopulation of tumor cells always exists that cannot be addressed by therapies targeting specific surface epitopes.
−Removed: Additionally, epitopes utilized are often present on normal tissue, resulting in off-target toxicities.
−Removed: Beyond the benefits provided by the mechanism of entry, the PDC platform features include the capacity to link with almost any molecule, provide a significant increase in targeted oncologic payload delivery, a more uniform delivery and the ability to target all types of tumor cells.
−Removed: As a result, we believe that we can create PDCs to treat a broad range of cancers with the potential to improve the
−Removed: therapeutic index of oncologic drug payloads, enhance or maintain efficacy while also reducing adverse events by minimizing drug delivery to healthy cells, and increasing delivery to cancerous cells and cancer stem cells.
−Removed: We employ a drug discovery and development approach that allows us to efficiently design, research and advance drug candidates.
−Removed: Our iterative process allows us to rapidly and systematically produce multiple generations of incrementally improved targeted drug candidates without the expense of having to generate significant compound libraries.
Phase 2 Study in Select B-Cell Malignancies
4 unchanged sentences
The funds supported the Phase 2 study initiated in March 2017 to define the clinical benefits of iopofosine in r/r MM and other niche hematologic malignancies with unmet clinical need.
−Removed: These niche hematologic malignancies include CLL, SLL, MZL, LPL/WM and DLBCL.
+Added: These niche hematologic
+Added: malignancies include CLL, SLL, MZL, LPL/WM and DLBCL.
The study was conducted in approximately 10 U.S.
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An iDMC assessed the safety of iopofosine up to its planned maximum single, bolus dose of 31.25 mCi/m2 or a TBD of ~63 mCi.
−Removed: The four single dose cohorts examined were:
+Added: The four single dose cohorts
+Added: examined were:
12.5 mCi/m2 (~25mCi TBD), 18.75 mCi/m2 (~37.5mCi TBD), 25 mCi/m2(~50mCi TBD), and 31.25 mCi/m2(~62.5mCi TBD), all in combination with low dose dexamethasone (40 mg weekly).
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In November 2020, we announced clinical data providing that iopofosine had been measured in pediatric brain tumors, confirming that systemic administration of iopofosine crosses the blood brain barrier and is delivered into tumors and that the data show disease control in heavily pretreated patients with ependymomas.
−Removed: In November 2021, we announced favorable data on changes in various tumor parameters in a Phase 1 study in children and adolescents with relapsed and refractory high-grade gliomas (HGGs) and soft tissue sarcomas.
+Added: In November 2021, we announced favorable data on changes in various tumor
+Added: parameters in a Phase 1 study in children and adolescents with relapsed and refractory high-grade gliomas (HGGs) and soft tissue sarcomas.
Pediatric HGGs are a collection of aggressive brain and central nervous system tumor subtypes (i.e.
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We believe that these data support the notion of enhanced patient outcomes when combining the use of iopofosine I 131 in combination with external beam radiation for a treatment of solid tumors.
+Added: Recent Developments
+Added: CLOVER WaM Phase 2b 12 Month Follow-Up Data
+Added: On May 5, 2026, the Company reported positive 12-month follow-up data from its Phase 2b CLOVER WaM clinical trial evaluating iopofosine I 131 in patients with relapsed or refractory (r/r) WM.
+Added: The Company announced that 83.6% Overall Response Rate (“ORR”) and 61.8% Major Response Rate (“MRR”) were observed in the heavily pretreated population with median duration of response of 17.8 months.
+Added: A summary of the efficacy results in the per protocol study population (n=55) is below:
+Added: 61.8% (primary endpoint achieved)
+Added: ● Median Duration of Response (DoR):
+Added: 17.8 months (secondary endpoint achieved)
+Added: ● Median Progression-Free Survival (PFS):
+Added: ● Very Good Partial Response/Complete Response Rate (VGPR/CR):
+Added: ● Disease Control Rate (DCR):
+Added: Additionally, summaries of the efficacy results in BTKi-exposed and BTKi-refractory subsets of the trial population are below:
+Added: BTKi-Exposed Patients (n=39):
+Added: ● Median DoR:
+Added: ● Median PFS:
+Added: BTKi-Refractory Patients (n=33):
+Added: ● Median DoR:
+Added: ● Median PFS:
+Added: In the trial, observed adverse events were transient and there were no significant bleeding events and low rates of infection (<10%).
+Added: Cytopenias were the most common treatment-emergent adverse events.
+Added: Non-hematologic toxicities were primarily low grade (Grade <2).
+Added: On May 5, 2026, the Company announced that it had entered into a securities purchase agreement with certain institutional investors, and an additional securities purchase agreement with certain members of management, to issue and sell an aggregate of approximately $35 million upfront and up to $105 million in milestone-based securities in a registered direct offering of common stock and a concurrent private placement of common stock, pre-funded warrants, and milestone-based warrants.
+Added: The proceeds from this financing will be used for general corporate purposes, including to support the initiation of a Phase 3 confirmatory study of iopofosine I 131 for the treatment of WM patients.
+Added: CLR 125 Study
+Added: In preclinical in vivo evaluations of CLR 125 utilizing triple-negative breast cancer (TNBC) models, the compound was observed to have tumor uptake at a substantially higher rate than that of healthy tissue.
+Added: Additionally, no signs of end-organ toxicity were observed including hematological toxicity.
+Added: The Company initiated a Phase 1b clinical study in TNBC with CLR 125.
+Added: The study is a randomized, open-label, multi-center study designed to compare the safety and efficacy of CLR 125 in patients with advanced TNBC who are relapsed/refractory (r/r) to at least one prior therapy.
+Added: Three dose levels will be assessed in parallel, with enrollment of patients in a 1:1:1 manner.
+Added: We expect that each arm will have a minimum of 15 evaluable patients.
+Added: CLR 125 will be administered as a fractionated dose on Day 1 and Day 3 for cycle 1 and repeat approximately every 8-weeks for subsequent cycles.
+Added: Depending on arm assignments, patients will receive between two and four cycles.
+Added: An expansion arm may consist of at least 15 patients following evaluation of the three dose levels by the data monitoring committee (DMC).
+Added: We anticipate a maximum of 75 patients to be enrolled in the trial.
+Added: Safety and tolerability of CLR 125 will be assessed by physical examination, Eastern Cooperative Oncology Group (ECOG) performance status, vital signs, laboratory changes over time, ECGs and adverse events of special interest.
+Added: Efficacy of CLR 125 will be assessed by CT (or MRI if needed) examinations obtained at six-week intervals following the initial dose of CLR 125.
+Added: The study objective is to determine the Phase 2 dosing level with secondary endpoints including safety, tolerability, initial response assessment and distribution.
+Added: Preclinical Evaluations of CLR 225
+Added: In preclinical, in vivo evaluations of CLR 225, utilizing a pancreatic cancer model, the compound was observed to reduce tumor volume and improved survival benefit at four different dosing levels.
+Added: Observed biodistribution exhibited substantial uptake in the tumor while remaining low in healthy tissue.
Additional Pipeline Candidates
11 unchanged sentences
We are also evaluating other alpha-emitting isotopes such as astatine-211 and lead-212 in preclinical studies.
−Removed: Recent Developments
−Removed: October 2025 Warrant Inducement
−Removed: On October 7, 2025, the Company, entered into definitive agreements for investors to immediately exercise certain outstanding warrants to purchase an aggregate of 1,048,094 shares of common stock, issued by the company on October 25, 2022, July 21, 2024 and July 2, 2025 (the October Existing Warrants), at an exercise price of $5.25 per share.
−Removed: The shares of common stock issuable upon exercise of the October Existing Warrants are all registered, or their resale is registered, pursuant to effective registration statements.
−Removed: Other than the shares of common stock issued upon exercise of the Existing Warrants issued on July 2, 2025, the issuance of which was registered under an effective registration statement, the shares of common stock issued upon exercise of the October Existing Warrants were offered pursuant to the exemption from the registration requirements of the Securities Act available under Section
−Removed: 4(a)(2) of the Securities Act.
−Removed: In connection with the exercise of the October Existing Warrants, the Company issued new warrants (the October 2025 Inducement Warrants) in two different series:
−Removed: the Series I Inducement Warrants and the Series II Inducement Warrants.
−Removed: Each October 2025 Inducement Warrant is immediately exercisable at an exercise price of $6.00 per share.
−Removed: The Series I Inducement Warrants will expire on October 8, 2030, and the Series II Inducement Warrants will expire on April 8, 2027.
−Removed: The investors paid $0.125 per October 2025 Inducement Warrant.
−Removed: The Company issued the October 2025 Inducement Warrants pursuant to the exemption from the registration requirements of the Securities Act available under Section 4(a)(2) of the Securities Act and intends to issue the shares underlying the October 2025 Inducement Warrants pursuant to the same exemption or pursuant to the exemption provided by Section 3(a)(9) of the Securities Act.
−Removed: The Company agreed to file a registration statement on Form S-1 covering the resale of such shares within 15 calendar days of the date of closing of the transaction.
−Removed: The gross proceeds to the Company from the exercise of the October Existing Warrants and the issuance of the October 2025 Inducement Warrants was approximately $5.8 million, prior to deducting placement agent fees and offering expenses.
−Removed: Regulatory Pathway - EMA
−Removed: On October 6, 2025, the Company announced that after a scientific advice procedure, SAWP advised that filing for a CMA for iopofosine I 131 as a treatment for post- BTKi refractory patients with WM could be acceptable.
−Removed: While there is no guarantee of CMA approval, if iopofosine I 131 is granted CMA, it could potentially begin to be commercially available in the 30 countries represented by the EMA as early as 2027.
−Removed: The Company’s decision to file for CMA in Europe follows SAWP’s advice on the patient population for which iopofosine I 131 is acceptable for a CMA, particularly a discussion on a post BTKi patient population, consistent with the majority of the patients (>70%) enrolled in the CLOVER WaM Phase 2 study.
−Removed: The Company’s briefing document to the SAWP included iopofosine I 131’s safety database, CLOVER WaM clinical study results, subset analyses, and manufacturing information.
−Removed: It is not within the remit of the SAWP to determine whether the data shows the sufficiency of safety and efficacy for a CMA;
−Removed: however, the SAWP advised that iopofosine I 131 met the eligibility requirements for a CMA submission for the proposed patient population.
−Removed: As in the U.S., there remains a significant unmet medical need for the treatment of WM in Europe, where the condition affects a similar number of patients as in the U.S.
−Removed: Breakthrough Designation
−Removed: On June 4, 2025, we announced that the FDA granted Breakthrough Therapy Designation for iopofosine I 131, as a radioconjugate monotherapy for the treatment of relapsed/refractory Waldenstrom macroglobulinemia (r/r WM).
−Removed: Regulatory Pathway – FDA
−Removed: We plan to submit an NDA to the FDA for accelerated approval of iopofosine I 131 as a treatment for WM subject to sufficient funding and once a confirmatory trial is underway.
−Removed: The submission would be supported by data from the Phase 2b CLOVER WaM clinical trial demonstrating a statistically significant major response rate compared to a null hypothesis of 20% and a meaningful duration of response.
−Removed: The data set now includes the FDA-requested 12-month follow-up results on all patients from the trial and new subset analysis of data from patients immediately following BTKi treatment failures regardless of line of therapy.
+Added: We have leveraged our PDC platform to establish three ongoing collaborations featuring four unique payloads and mechanisms of action.
+Added: Through research and development collaborations, our strategy is to generate near-term capital, supplement internal resources, gain access to novel molecules or payloads, accelerate product candidate development and broaden our proprietary and partnered product pipelines.
+Added: Our PDC platform is designed to provide selective delivery of a diverse range of oncologic payloads to cancerous cells, whether a hematologic cancer or solid tumor;
+Added: a primary tumor, or a metastatic tumor;
+Added: and cancer stem cells.
+Added: The PDC platform’s mechanism of entry is not designed to rely upon a specific cell surface epitope or antigen as are required by other targeted delivery platforms but rather a unique change in the tumor cell membrane.
+Added: Our PDC platform takes advantage of a metabolic pathway (beta oxidation) utilized by nearly all tumor cell types in all stages of the tumor cycle.
+Added: Tumor cells modify the cell membrane to create specific, highly organized microdomains by which to transport lipids and long chain fatty acids into the cytoplasm, as a result of the utilization of this metabolic pathway.
+Added: Our PDCs are designed to bind to these regions and directly enter the intracellular compartment.
+Added: This mechanism allows the PDC molecules to accumulate in tumor cells over time, which we believe can enhance drug efficacy.
+Added: The direct intracellular delivery allows our molecules to avoid the specialized, highly acidic cellular compartment known as lysosomes, which allows a PDC to deliver payloads that previously could not be delivered in this targeted manner.
+Added: Additionally, molecules targeting specific cell surface epitopes face challenges in completely eliminating a tumor because the targeted antigens are limited in the total number presented on the cell surface, limiting total potential uptake and resulting in heterogenous uptake across the tumor, have longer cycling time from internalization to relocation on the cell surface, again diminishing their availability for binding, and are not present on all of the tumor cells because of the heterogenous nature of cancer cells, further increasing the unequal distribution of the drug across the tumor.
+Added: This means a subpopulation of tumor cells always exists that cannot be addressed by therapies targeting specific surface epitopes.
+Added: Additionally, epitopes utilized are often present on normal tissue, resulting in on-target toxicities.
+Added: Beyond the benefits provided by the mechanism of entry, the PDC platform features include the capacity to link with almost any molecule, provide a significant increase in targeted oncologic payload delivery, a more uniform delivery and the ability to target all types of tumor cells.
+Added: As a result, we believe that we can create PDCs to treat a broad range of cancers with the potential to improve the therapeutic index of oncologic drug payloads, enhance or maintain efficacy while also reducing adverse events by minimizing drug delivery to healthy cells, and increasing delivery to cancerous cells and cancer stem cells.
+Added: We employ a drug discovery and development approach that allows us to efficiently design, research and advance drug candidates.
+Added: Our iterative process allows us to rapidly and systematically produce multiple generations of incrementally improved targeted drug candidates without the expense of having to generate significant compound libraries.
Results of Operations
Research and development expenses.
−Removed: Research and development expenses consist of costs incurred in identifying, developing and testing, and manufacturing product candidates, which primarily include salaries and related expenses for personnel, cost of manufacturing materials and contract manufacturing fees paid to contract manufacturers and contract research organizations, fees paid to medical institutions for clinical studies.
+Added: Research and development expenses consist of costs incurred in identifying, developing and testing, and manufacturing product candidates, which primarily include salaries and related expenses for personnel, cost of manufacturing materials and contract manufacturing fees paid to contract manufacturers and contract research organizations, and fees paid to medical institutions for clinical studies.
The Company analyzes its research and development expenses based on four categories as follows:
5 unchanged sentences
Other income (expense), net, consists primarily of the impacts related to issuing and revaluing equity securities, and interest income.
−Removed: Three Months Ended September 30, 2025 and 2024
+Added: Three Months Ended March 31, 2026 and 2025
Research and Development .
−Removed: Research and development expenses for the three months ended September 30, 2025, were approximately $2,523,000, compared to approximately $5,493,000 for the three months ended September 30, 2024.
−Removed: The following table is a summary comparison of approximate research and development costs for the three months ended September 30, 2025 and 2024:
+Added: Research and development expenses for the three months ended March 31, 2026, were approximately $3,007,000, compared to approximately $3,427,000 for the three months ended March 31, 2025.
+Added: The following table is a summary comparison of approximate research and development costs for the three months ended March 31, 2026 and 2025:
Three Months Ended
−Removed: September 30,
Clinical project costs
2 unchanged sentences
General research and development costs
−Removed: The overall decrease in research and development expense was approximately $2,970,000, or 54%.
−Removed: The reduction in spending was composed primarily of decreased clinical project costs and manufacturing and related costs resulting from the conclusion of patient enrollment and declining patient follow-up in our CLOVER WaM Phase 2b clinical trial.
+Added: The overall decrease in research and development expense of approximately $420,000, or 12%, was primarily a result of decreased clinical project costs of approximately $348,000 driven by the conclusion of patient enrollment in our WM and pre-clinical project costs of approximately $446,000 offset by an increase in manufacturing and related costs of approximately $536,000 for further development of pre-clinical assets.
General and administrative.
−Removed: General and administrative expense for the three months ended September 30, 2025, was approximately $2,327,000, compared to approximately $7,834,000 for the same period in 2024.
−Removed: The overall decrease in general and administrative expense of approximately $5,507,000, or 70%, was driven by reduced pre-commercialization activities and personnel costs.
+Added: General and administrative expense for the three months ended March 31, 2026, was approximately $2,787,000, compared to approximately $2,974,000 for the same period in 2025.
+Added: The overall decrease in general and administrative expense of approximately $184,000, or 6%, was driven by costs associated with a decrease in personnel costs.
Other income (expense), net .
−Removed: Other income (expense), net, for the three months ended September 30, 2025, was approximately $407,000, as compared to approximately $1,337,000 of expense in the same period of 2024, resulting almost exclusively from changes in warrant valuation, which are non-cash in nature, and are primarily impacted by fluctuations in the Company’s common stock price.
+Added: Other income (expense), net, for the three months ended March 31, 2026, was income of approximately $140,000, as compared to approximately $203,000 of expense in the same period of 2025, resulting almost exclusively from changes in warrant valuation.
+Added: Fluctuations in the Company’s common stock price are the primary aspect of warrant valuation changes.
Interest income decreased year-over-year to approximately $63,000 in 2026 as compared to approximately $137,000 in 2025.
−Removed: Declining rates and lower amounts of invested funds drove the reduction.
−Removed: Nine Months Ended September 30, 2025 and 2024
−Removed: Research and Development .
−Removed: Research and development expenses for the nine months ended September 30, 2025, were approximately $8,340,000, compared to approximately $19,927,000 for the nine months ended September 30, 2024.
−Removed: The following table is a summary comparison of approximate research and development costs for the nine months ended September 30, 2025 and 2024:
−Removed: Nine Months Ended
−Removed: September 30,
−Removed: Clinical project costs
−Removed: Manufacturing and related costs
−Removed: Pre-clinical project costs
−Removed: General research and development costs
−Removed: The overall decrease in research and development expense of approximately $11,587,000, or 58%, was primarily a result of decreased clinical project costs of approximately $5,469,000 and a decrease in manufacturing and related costs of approximately $5,634,000, driven by the conclusion of patient enrollment and declining patient follow-up for our WM clinical study, partially offset by increased activity in our pre-clinical development project costs.
−Removed: General and administrative.
−Removed: General and administrative expense for the nine months ended September 30, 2025, was approximately $8,949,000, compared to approximately $19,106,000 for the same period in 2024.
−Removed: The overall decrease in general and administrative expense of approximately $10,157,000, or 53%, was driven by costs associated with reduced pre-commercialization and personnel costs.
−Removed: Other income (expense), net .
−Removed: Other income (expense), net, for the nine months ended September 30, 2025, was approximately $793,000, as compared to approximately $3,193,000 of expense in the same period of 2024, resulting almost exclusively from changes in warrant valuation.
−Removed: These impacts are non-cash in nature and are largely driven by fluctuations in the Company’s common stock price.
−Removed: Interest income decreased to approximately $338,000 in the nine months ended September 30, 2025, as compared to approximately $967,000 for the same period in 2024.
−Removed: Declining interest rates and reduced amounts of invested funds in the current year were the primary driver of the reduction.
+Added: The Company’s reduced cash on hand drove the reduction.
Liquidity and Capital Resources
We have incurred losses since inception in devoting substantially all of our efforts toward research and development of drug candidates for which we are seeking FDA approval.
−Removed: During the nine months ended September 30, 2025, we generated a net loss of approximately $16.5 million and used approximately $18.8 million in cash for operations.
+Added: During the three months ended March 31, 2026, we generated a net loss of approximately $5.7 million and used approximately $4.8 million in cash for operations.
We expect that we will continue to generate operating losses for the foreseeable future.
−Removed: As of September 30, 2025, our consolidated cash balance was approximately $12.6 million.
−Removed: As of the date the accompanying consolidated financial statements were issued (the issuance date), the Company’s available liquidity to fund the Company’s operations over the next twelve months beyond the issuance date was limited to approximately $15.6 million of unrestricted cash and cash equivalents.
−Removed: Absent further action taken by management to increase its liquidity, the Company may be unable to fund its operations under normal course beyond the third quarter of 2026.
+Added: As of March 31, 2026, our consolidated cash balance was approximately $8.3 million.
+Added: of the date the accompanying consolidated financial statements were issued (the “issuance date”), the Company’s available liquidity to fund the Company’s operations over the next twelve months beyond the issuance date was limited to approximately $37 million of unrestricted cash and cash equivalents.
+Added: Absent further action taken by management to increase its liquidity, the Company may be unable to fund its operations under normal course beyond the second quarter of 2027.
To improve the Company’s liquidity, management plans to secure additional outside capital via the sale of equity and/or debt securities or execute a strategic transaction.
−Removed: Management also plans to preserve liquidity, as needed, by implementing cost saving measures.
+Added: Management also plans to preserve liquidity, as needed, by implementing temporary cost saving measures.
While management believes their plans will be successful, no assurance can be provided such plans will be effectively implemented over the next twelve months beyond the issuance date.
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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.