Cellectar Biosciences Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
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Item 2.02 Results of Operations and Financial Condition.
On July 23, 2024, Cellectar Biosciences, Inc. (the “Company”) disclosed that the Company had approximately $25.9 million of cash and cash equivalents as of June 30, 2024.
Because the Company’s consolidated financial statements for the quarter ended June 30, 2024 have not been finalized or reviewed, the preliminary statement of the Company’s cash and cash equivalents as of June 30, 2024 in this Item 2.02 is subject to change, and the Company’s actual cash and cash equivalents as of June 30, 2024 may differ materially from this preliminary estimate. Accordingly, you should not place undue reliance on this preliminary estimate.
Item 7.01 Regulation FD Disclosure.
On July 23, 2024, the Company issued a press release announcing positive results from its ongoing CLOVER WaM pivotal study. A copy of the Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information contained in Item 2.02 and Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing with the Securities and Exchange Commission made by the Company, regardless of any general incorporation language in such filings.
Item 8.01 Other Events.
On July 23, 2024, the Company announced positive results data from its ongoing CLOVER WaM pivotal study evaluating iopofosine I 131 for the treatment of relapsed/refractory Waldenstrom’s macroglobulinemia (“WM”) patients that have received at least two prior lines of therapy, including Bruton tyrosine kinase inhibitors (“BTKi”). The data presented was as of an May 31, 2024 data cut.
As of May 31, 2024, results in the CLOVER WaM study had an overall response rate (“ORR”) of 80% and a major response rate (“MRR”) of 56.4% (95% CI, 0.42 to 0.67), which exceeded the agreed-upon primary endpoint of a 20% MRR. Median age was 70 years (range, 50-88) in the modified intent to treat (“mITT”) population (n=55). The median number of prior lines of therapy was 4 (range, 2-14), with approximately 27% of patients refractory to all available therapies (BTKi, anti-CD20 antibody, chemotherapy), and 40% of patients dual-class refractory (BTKi and rituximab). Notably, comparable ORRs were observed across all clinically challenging disease subgroups, including: MYD88-wt (81%; n=16), P53-mutated (80%; n=5), and clinical patient cohorts including post-BTKi (72%; n=39), as well as dual-class (59%; n=22), and triple-class (53%; n=15) refractory patients.
Secondary endpoints of disease control rate (98.2%) and duration of response (“DoR”) presented evidence that iopofosine provided durable clinical benefit across all response categories. The median DoR in patients achieving major response and overall response were not reached as of the data cutoff, with 78% and 72% of patients remaining free from disease progression at 18 months, respectively.
Item 9.01 Financial Statements and Exhibits.
| Exhibit Number |
Description | |
| 99.1 | Press Release, dated July 23, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CELLECTAR BIOSCIENCES, INC. | ||
| Date: July 23, 2024 | By: | /s/ Chad J. Kolean |
| Chad J. Kolean | ||
| Chief Financial Officer | ||