Cellectar Biosciences, Inc.
For the period ended Sep 30, 2025. Filed Nov 13, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 13, 2025
CLRB$1.25+8.7%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-14.
0001410578-25-001778
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-13.
0001104659-25-110827
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 82 previous paragraphs and 83 current paragraphs.
58 unchanged; 18 reworded; 6 added; 4 removed; 2 previous and 1 current paragraphs rearranged.
Tables are not compared: 7 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (6)
Current report
October 2025 Warrant Inducement
Current report
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. 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. 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
Current report
4(a)(2) of the Securities Act. In connection with the exercise of the October Existing Warrants, the Company issued new warrants (the October 2025 Inducement Warrants) in two different series: the Series I Inducement Warrants and the Series II Inducement Warrants. Each October 2025 Inducement Warrant is immediately exercisable at an exercise price of $6.00 per share. The Series I Inducement Warrants will expire on October 8, 2030, and the Series II Inducement Warrants will expire on April 8, 2027. The investors paid $0.125 per October 2025 Inducement Warrant. 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. 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. 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.
Current report
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. 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.
Current report
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. 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. It is not within the remit of the SAWP to determine whether the data shows the sufficiency of safety and efficacy for a CMA; however, the SAWP advised that iopofosine I 131 met the eligibility requirements for a CMA submission for the proposed patient population. 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.
Current report
Nine Months EndedSeptember 30, 2025 and 2024
Removed paragraphs (4)
Previous report
This meeting followed a November 2024 meeting where the FDA informed the Company that while the data from the CLOVER WaM study was meaningful, the FDA’s preferred route to accelerated approval of iopofosine in WM was via a one trial design approach in alignment with the recently issued accelerated approval guidance.
Previous report
We received a response from the EMA regarding scientific advice on the Company’s submission for Conditional Market Authorization (CMA). The submission to EMA included data from our Phase 2b CLOVER WaM clinical trial where we observed a statistically significant major response rate and meaningful duration of response, and an integrated summary of safety for all patients treated with iopofosine I 131 for hematologic malignancies. A meeting has been scheduled with the EMA regarding their final decision on whether they support our plan to submit for a CMA. The response is expected by late third quarter or early fourth quarter 2025.
Previous report
expense of approximately $2,710,000, or 43%, was driven by costs associated with a decrease in pre-commercialization activities and personnel costs.
Previous report
Six Months EndedJune 30, 2025 and 2024
Reworded paragraphs (18)
Previous wording
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. We believe this profile differentiates our PRCs from many traditional on-market treatments and radiotherapeutics. Our three lead programs are: CLR 121125 (CLR 125), an iodine-125 Auger-emitting program, prepared to enter a clinical trial in 2025; CLR 121225 (CLR 225), an actinium-225 based program; 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. 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).
Current wording
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. We believe this profile differentiates our PRCs from many traditional on-market treatments and radiotherapeutics. Our three lead programs are: CLR 121125 (CLR 125), an iodine-125 Auger-emitting program, prepared to enter a clinical trial in 2025; CLR 121225 (CLR 225), an actinium-225 based program; 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. 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.
Previous wording
In preclinical,in vivoevaluations 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. Additionally, no signs of end-organ toxicity were observed, including hematological toxicity.
Current wording
In preclinicalin vivoevaluations 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. Additionally, no signs of end-organ toxicity were observed including hematological toxicity.
Previous wording
The company plans to initiate a Phase 1b clinical study in TNBC with CLR 125. We expect the study to be a Phase 1b, 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. Three dose levels will be assessed in parallel, with enrollment of patients in a 1:1:1 manner. We expect that each arm will have a minimum of 15 evaluable patients. 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. Depending on arm assignments, patients will receive between two and four cycles. An expansion arm may consist of at least 15 patients following evaluation of the three dose levels by the data monitoring committee (DMC).
Current wording
The Company initiated a Phase 1b clinical study in TNBC with CLR 125. 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. Three dose levels will be assessed in parallel, with enrollment of patients in a 1:1:1 manner. We expect that each arm will have a minimum of 15 evaluable patients. 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. Depending on arm assignments, patients will receive between two and four cycles. An expansion arm may consist of at least 15 patients following evaluation of the three dose levels by the data monitoring committee (DMC).
Previous wording
The CLOVER WaM study was designed as a pivotal registration study evaluating iopofosine in WM patients that were r/r to at least two prior lines of therapy including having failed or had a suboptimal response to a Bruton tyrosine kinase inhibitor (BTKi). The study completed enrollment in the fourth quarter of 2023, and initial top line data from the study was reported in January 2024. CLOVER-WaM was a single-arm study with a target enrollment of 50 patients. Based upon the data from September 2024, the CLOVER WaM study enrolled a total of 55 patients in the modified Intent to Treat (mITT) population and met its primary endpoint with a major response rate (MRR) of 58.2% (95% confidence interval [44.50%, 75.80%, two-sided p value < 0.0001]) exceeding the FDA agreed-upon statistical hurdle of 20%. The overall response rate (ORR) in evaluable patients was 83.6%, and 98.2% of patients experienced disease control. Responses were durable, with median duration of response not reached at 11.4 months of follow-up and 76% of patients remaining progression free at a median follow-up of eight months. These outcomes exceed historic real world data which demonstrate a 4-12% MRR and a duration of response of approximately six months or less despite continuous treatment in a patient population that is less pretreated and not refractory to multiple classes of drugs. Notably, iopofosine I 131 monotherapy achieved a 7.3% complete remission (CR) rate in this highly refractory WM population. Overall, 45 (69.2%) patients had prior exposure to at least 3 drug classes and 19 (29.2%) patients had prior exposure to at least 4 drug classes of anti-cancer therapies. Forty-eight (73.8%) patients had prior exposure to a BTKi of which 37 (77.1%) were deemed to be refractory to BTKis. Forty-three (66.2%) patients were exposed to BTKi and anti-CD20 antibody with 25 (58.1%) being refractory to both BTKi and anti-CD-20 antibodies. Thirty-seven (56.9%) patients had prior exposure to BTKi, anti-CD20 antibody, and chemotherapy and 18 (48.6%) patients were refractory to all three classes of drugs, BTKi, anti-CD20 antibody, and chemotherapy. Iopofosine I 131 was well tolerated and its toxicity profile was consistent with the Company’s previously reported safety data. The safety population was 65 patients which was composed of patients that received at least a single dose of iopofosine I 131 but did not receive enough drug to be assessed for efficacy. There were 3 (4.6%) patients that experienced treatment-related adverse events (TRAEs) leading to discontinuation. The rates of greater TRAEs observed in more than 10% of patients included thrombocytopenia (56 [86.2%] patients), neutropenia (52 [80.0%] patients), anemia (42 [64.6%] patients) and decreased white blood cell count (21 [32.3%] patients) among hematologic toxicities and fatigue (22 [33.8%] patients), nausea (19 [29.2%] patients and diarrhea (13 [20.0%] patients) among non-hematologic toxicities. The rates of Grade 3 or greater T…
Excerpt shortened here; the source contains the full paragraph.
Current wording
The CLOVER WaM study was designed as a pivotal registration study evaluating iopofosine in WM patients that were r/r to at least two prior lines of therapy including having failed or had a suboptimal response to a BTKi. The study completed enrollment in the fourth quarter of 2023, and initial top line data from the study was reported in January 2024. CLOVER-WaM was a single-arm study with a target enrollment of 50 patients. Based upon the data from September 2024, the CLOVER WaM study enrolled a total of 55 patients in the modified Intent to Treat (mITT) population and met its primary endpoint with a major response rate (MRR) of 58.2% (95% confidence interval [44.50%, 75.80%, two-sided p value < 0.0001]) exceeding the FDA agreed-upon statistical hurdle of 20%. The overall response rate (ORR) in evaluable patients was 83.6%, and 98.2% of patients experienced disease control. Responses were durable, with median duration of response not reached at 11.4 months of follow-up and 76% of patients remaining progression free at a median follow-up of eight months. These outcomes exceed historic real world data which demonstrate a 4-12% MRR and a duration of response of approximately six months or less despite continuous treatment in a patient population that is less pretreated and not refractory to multiple classes of drugs. Notably, iopofosine I 131 monotherapy achieved a 7.3% complete remission (CR) rate in this highly refractory WM population. Overall, 45 (69.2%) patients had prior exposure to at least 3 drug classes and 19 (29.2%) patients had prior exposure to at least 4 drug classes of anti-cancer therapies. Forty-eight (73.8%) patients had prior exposure to a BTKi of which 37 (77.1%) were deemed to be refractory to BTKis. Forty-three (66.2%) patients were exposed to BTKi and anti-CD20 antibody with 25 (58.1%) being refractory to both BTKi and anti-CD-20 antibodies. Thirty-seven (56.9%) patients had prior exposure to BTKi, anti-CD20 antibody, and chemotherapy and 18 (48.6%) patients were refractory to all three classes of drugs, BTKi, anti-CD20 antibody, and chemotherapy. Iopofosine I 131 was well tolerated and its toxicity profile was consistent with the Company’s previously reported safety data. The safety population was 65 patients which was composed of patients that received at least a single dose of iopofosine I 131 but did not receive enough drug to be assessed for efficacy. There were 3 (4.6%) patients that experienced treatment-related adverse events (TRAEs) leading to discontinuation. The rates of greater TRAEs observed in more than 10% of patients included thrombocytopenia (56 [86.2%] patients), neutropenia (52 [80.0%] patients), anemia (42 [64.6%] patients) and decreased white blood cell count (21 [32.3%] patients) among hematologic toxicities and fatigue (22 [33.8%] patients), nausea (19 [29.2%] patients and diarrhea (13 [20.0%] patients) among non-hematologic toxicities. The rates of Grade 3 or greater TRAEs observed in more than 10% of p…
Excerpt shortened here; the source contains the full paragraph.
Previous wording
On March 6, 2025 the Company conducted its End-of-Phase-2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA). As a result of the meeting, the Company believes that it understands a path forward for a one trial design for potential accelerated and full approval based upon a randomized Phase 3 trial assessing major response rate and progression free survival, respectively, as the primary endpoints in WM patients previously treated with a BTKi. The FDA and Cellectar agreed to utilize an Investigator Choice comparator approach where investigators can select between one of two fixed duration treatments currently recommended by the NCCN guidelines. The initiation of this study is dependent on funding.
Current wording
On March 6, 2025, the Company conducted its End-of-Phase-2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA). 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. 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. The confirmatory study will be executed in an earlier line of therapy than was tested in the CLOVER WaM patients. The initiation of this study is dependent on funding.
Previous wording
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. 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.
Current wording
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. As a result, we believe that we can create PDCs to treat a broad range of cancers with the potential to improve the
Previous wording
On June 4, 2025, we announced that the FDA has granted Breakthrough Therapy Designation for iopofosine I 131, as a radioconjugate monotherapy for the treatment of relapsed/refractory Waldenstrom macroglobulinemia (r/r WM).
Current wording
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).
Previous wording
funding and once a confirmatory trial is underway. 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 meaningful duration of response. 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 Bruton Tyrosine Kinase inhibitor (BTKi) treatment failures regardless of line of therapy.
Current wording
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. 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. 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.
Previous wording
Research and Development. Research and development expenses for the three months ended June 30, 2025, were approximately $2,390,000, compared to approximately $7,345,000 for the three months ended June 30, 2024.
Current wording
Research and Development. 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.
Previous wording
The overall decrease in research and development expense was approximately $4,955,000, or 67%. The reduction is spending was composed primarily of decreased clinical project costs and manufacturing and related costs resulting from the conclusion of patient enrollment in our CLOVER WaM Phase 2b clinical trial.
Current wording
The overall decrease in research and development expense was approximately $2,970,000, or 54%. 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.
Previous wording
*General and administrative.*General and administrative expense for the three months ended June 30, 2025, was approximately $3,648,000, compared to approximately $6,358,000 for the same period in 2024. The overall decrease in general and administrative
Current wording
*General and administrative.*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. 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.
Previous wording
Other income (expense), net. Other income (expense), net, for the three months ended June 30, 2025, was approximately $590,000, as compared to approximately $12,784,000 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 fluctuation s in the Company’s common stock price. Interest income decreased year-over-year to approximately $88,000 in 2025 as compared to approximately $329,000 in 2024. The Company’s lower amounts of invested funds drove the reduction.
Current wording
Other income (expense), net. 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. Interest income decreased year-over-year to approximately $113,000 in 2025 as compared to approximately $318,000 in 2024. Declining rates and lower amounts of invested funds drove the reduction.
Previous wording
Research and Development. Research and development expenses for the six months ended June 30, 2025, were approximately $5,817,000, compared to approximately $14,434,000 for the six months ended June 30, 2024.
Current wording
Research and Development. 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.
Previous wording
The following table is a summary comparison of approximate research and development costs for the three months ended June 30, 2025 and 2024:
Current wording
The following table is a summary comparison of approximate research and development costs for the nine months ended September 30, 2025 and 2024:
Previous wording
The overall decrease in research and development expense of approximately $8,617,000, or 60%, was primarily a result of decreased clinical project costs of approximately $4,540,000 and a decrease in manufacturing and related costs of approximately $4,361,000, driven by the conclusion of patient enrollment in our WM, partially offset by increased activity in our pre-clinical project costs.
Current wording
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.
Previous wording
*General and administrative.*General and administrative expense for the six months ended June 30, 2025, was approximately $6,622,000, compared to approximately $11,272,000 for the same period in 2024. The overall decrease in general and administrative expense of approximately $4,650,000, or 41%, was driven by costs associated with a decrease in pre-commercialization and personnel costs.
Current wording
*General and administrative.*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. 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.
Previous wording
Other income (expense), net. Other income (expense), net, for the six months ended June 30, 2025, was approximately $387,000, as compared to approximately $1,856,000 of expense in the same period of 2024, resulting almost exclusively from changes in warrant valuation. These impacts are non-cash in nature and are largely driven by fluctuations in the Company’s common stock price. Interest income decreased to approximately $225,000 in the six months ended June 30, 2025, as compared to approximately $649,000 for the same period in 2024. Reduced amounts of invested funds in the current year were the primary driver of the reduction.
Current wording
Other income (expense), net. 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. These impacts are non-cash in nature and are largely driven by fluctuations in the Company’s common stock price. 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. Declining interest rates and reduced amounts of invested funds in the current year were the primary driver of the reduction.
Previous wording
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. During the six months ended June 30, 2025, we generated a net loss of approximately $12.1 million and used approximately $14.5 million in cash for operations. We expect that we will continue to generate operating losses for the foreseeable future. As of June 30, 2025, our consolidated cash balance was approximately $11 million. 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 million of unrestricted cash and cash equivalents. 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 2026. 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. Management also plans to preserve liquidity, as needed, by implementing 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. In the event management’s plans are not effectively implemented, the Company will be required to seek other
Current wording
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. 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. We expect that we will continue to generate operating losses for the foreseeable future. As of September 30, 2025, our consolidated cash balance was approximately $12.6 million. 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. 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. 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. Management also plans to preserve liquidity, as needed, by implementing 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. In the event management’s plans are not effectively implemented, the Company will be required to seek other alternatives which may include, among others, strategic alternatives such as mergers, acquisitions, partnerships, joint ventures, licensing arrangements or other strategic transactions, the sale of assets, discontinuance of certain operations, and/or filing for bankruptcy protection.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
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.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
We plan to submit an NDA to the FDA for accelerated approval of iopofosine I 131 as a treatment for WM subject to sufficient
Previous report — wording carried elsewhere
alternatives which may include, among others, strategic alternatives such as mergers, acquisitions, partnerships, joint ventures, licensing arrangements or other strategic transactions, the sale of assets, discontinuance of certain operations, and/or filing for bankruptcy protection.