Cellectar Biosciences (NASDAQ: CLRB) is a late-stage clinical biopharmaceutical company, focused on the development and discovery of drugs that can be used for the treatment of cancer. The company intends to use its proprietary Phospholipid Drug Conjugate (PDC) platform to develop PDCs that can specifically target cancer cells.
The company’s drug pipeline includes CLR 131, one preclinical PDC chemotherapeutic program called CLR 1900, and several partnered PDC assets.
Cellectar Biosciences had cash and cash equivalents of $53.6 million on its balance sheet as of March 31. While the company did not earn any revenues in Q1, the net loss was $0.13 per share versus a loss of $0.42 per share in the same quarter last year.
James Caruso, President, and CEO of Cellectar Biosciences stated, “We also continue to make progress in our pediatric study of CLR 131 in children with relapsed or refractory solid tumors or malignant brain tumors [in the first quarter] and remain well positioned financially with a cash runway supporting our current strategic plan into the third quarter of 2023.”
However, the company admitted in its company filings that the COVID-19 pandemic has created uncertainty about expected timelines for its drugs. Furthermore, the situation may impact its ability to recruit patients for clinical studies in the future, get additional financing, and obtain an adequate supply of CLR 131, the company added.
The company’s lead PDC therapeutic is CLR 131, a small-molecule PDC that targets the delivery of iodine-131 directly to cancer cells, thus limiting the exposure to healthy cells. This PDC is currently being examined in the CLOVER-WaM (Waldenstrom’s macroglobulinemia) Phase 2 pivotal study.
Last month, CLRB presented a poster at the American Society of Clinical Oncology (ASCO) Annual meeting and later hosted a Key Opinion Leader (KOL) call with the lead investigator for its Phase 2 CLOVER-1 study of CLR 131, Dr. Sikander Ailawadhi, M.D. of the Mayo Clinic.
The poster gave an update regarding six patients from CLRB’s Phase 2a study of CLR 131. It indicated that the progression-free survival for patients with MYD88 wild type, and high-risk patients, did not exceed 18 months.
Following the call, Oppenheimer analyst Kevin DeGeeter reiterated a Buy rating with a price target of $5.50 (370% upside) on the stock.
In a research note to investors, DeGeeter said, “KOL noted WM [Waldenstrom’s macroglobulinemia] patients prefer treatments of limited duration vs. chronic therapy.”
“We view these observations combined with poster demonstrating CLR-131 activity across genotypes as supportive of use in 2nd line prior to BTK [Bruton’s tyrosine kinase] therapy, particularly in MYD88 [a type of gene] WT patients,” the analyst added.
DeGeeter noted that the poster presentation offered additional insights beyond abstract data and attributed the weakness in CLRB shares “as likely related to investor expectations for a more in-depth update.”
In Q1, the European Commission granted CLR 131 an orphan drug designation in the treatment of WM, resulting in CLRB getting European market exclusivity for 10 years, in addition to other benefits, including a reduction in associated fees and fewer regulatory filings in the European Union (EU), along with protocol assistance. (See Cellectar Biosciences stock chart on TipRanks)
Analyst DeGeeter’s investment thesis regarding CLRB assumes “1) CLR-131 advances to a registration study in BTK-refractory lymphoplasmacytic lymphoma (LPL), 2) registration study of 50 patients supports approval in 1H23, and 3) CLR-131 generates 2028 sales of $290M.”
“Our outlook assumes approval for LPL will support off-label sales for multiple myeloma in the US based on data from Phase II program in treatment of triple refractory patients. We do not include sales for treatment of rare pediatric cancers in our outlook,” the analyst added.
Consensus among analysts on Wall Street is a Strong Buy based on 3 unanimous Buys. The average Cellectar Biosciences price target of $6.17 implies approximately 427.4% upside potential to current levels.
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