Cellectar BioSciences Inc. (CLRB:NASDAQ; CLRB:OTCBB) recently announced two positive developments around its lead asset, iopofosine I-131. The first is a new licensing agreement and additional international patent allowances, wrote Roth MKM analyst Dr. Jonathan Aschoff in a December 19 research note. The company also awaits pivotal top-line data in Waldenström's macroglobulinemia next month.
New Licensing Agreement with WARF Cellectar signed an exclusive licensing deal with the Wisconsin Alumni Research Foundation (WARF) for intellectual property covering use of iopofosine I-131 in several pediatric cancers. This adds to the company's existing rights for the radiotherapeutics in adult cancer indications.
The pediatric cancers covered under the new WARF license include high-grade glioma, neuroblastoma, and sarcoma. Cellectar is already running a Phase 1 trial of iopofosine I-131 in pediatric brain tumors funded by a National Cancer Institute grant awarded last year.
"Given that grant funding, CLRB plans to initiate the Phase 1b portion in 3Q23 [in the] near term and identify the RP2D," wrote Aschoff.
Additional Patent Allowances Internationally Cellectar also recently received patent allowances from Japan, China, Eurasia, Brazil, and Mexico for a key composition of matter and use patent. This patent covers the company's phospholipid drug conjugate (PDC) platform that enables targeted delivery of plant cytotoxins known as flavaglines.
The PDC platform patent had already been allowed in the United States, Europe, Australia, and Canada. Aschoff described the additional international allowances as "patent actions that follow prior allowances for the same patent" regionally.
Awaiting Pivotal Top-Line Data in Early 2023 Cellectar is gearing up for pivotal Phase 2b results from its CLOVER-WaM study of iopofosine I-131 in Waldenström's macroglobulinemia in January 2023. Aschoff expects positive data based on strong earlier results.
"Most importantly, we await what we expect will be positive pivotal results with iopofosine I131 in Waldenstrom's macroglobulinemia early next month," the Aschoff wrote.
Valuation and Upside
Key risks, according to Aschoff, include clinical failure, regulatory issues, or development delays for the company's lead drug candidate. Cellectar also faces financing risk as a pre-revenue biopharma firm.
Still, Aschoff maintains a US$20 price target on Cellectar based on discounted cash flow projections of iopofosine I-131 in multiple myeloma and Waldenström's macroglobulinemia.
This target implies around 680% upside from current levels.
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Disclosures for Roth MKM, Cellectar Biosciences Inc., December 19, 2023
Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.
Disclosures: Within the last twelve months, ROTH Capital Partners, or an affiliate to ROTH Capital Partners, has received compensation for investment banking services from Cellectar Biosciences, Inc.. ROTH makes a market in shares of Cellectar Biosciences, Inc. and as such, buys and sells from customers on a principal basis. Shares of Cellectar Biosciences, Inc. may be subject to the Securities and Exchange Commission's Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.
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