Cellectar Biosciences Inc (NASDAQ: CLRB) is creating an interesting opportunity. In the week or two ahead, there are a couple of events that are likely to take place that I believe will keep the stock on the uptrend. First, updated data from CLR 131 is expected by the end of the month. If this data is positive, it could send the stock soaring.
The stock has also been dealing with pressure as a result of an Import Alert placed on the Centre for Probe Development and Commercialization (CPDC). This was a big upset because CPDC is the sole supplier of the company’s CLR 131 product. The good news is that it’s likely that the FDA will put an exemption to the Import Alert for CLR 131. This also has the potential to lift the value of the stock.
A Clinical Catalyst Is Around The Corner
Cellectar Biosciences’ claim to faim is a candidate known as CLR 131. The treatment is a small-molecule, targeted Phospholipid Drug ConjugateTM (PDC) that was designed to deliver cytotoxic radiation on a selective basis, targeting cancer cells, rather than healthy, functional cells. The drug candidate is the center of four ongoing clinical Phase 1 and Phase 2 clinical trials. Although each one of these trials has the potential to result in a near-term catalystic event, the most important one for the time being is the Phase 2 clinical trial that is assessing CLR 131 as a treatment for multiple myeloma.
The trial was officially initiated in February of this year with the expectation that the trial will be completed in the current month, September. Previous data released by Cellectar Biosciences, suggests that CLR 131 has the potential to increase survival rates among patients with multiple myeloma. Believers in Cellectar Biosciences, including myself, are expecting that the Phase 2 data will confirm the improved survival rates among patients with this devastating illness.
I’m expecting that this trial will lead to a positive catalyst, and that the catalyst will likely take place next week. Cellectar Biosciences planned for the Phase 2 trial to be completed in September. Moreover, all eyes are going to be on the biotech space next week with the Cantor Fitzgerald Global Healthcare Conference starting on Monday, October 1, 2018 and running through Wednesday, October 3, 2018. With the healthcare sector being a primary area of focus and Cellectar Biosciences’ Phase 2 clinical trial coming to a head, and investor focus expected to be on the healthcare space, I believe that Cellectar Biosciences will take advantage of the opportunity to grab the attention of investors, especially if this data is positive. As a result, I’m expecting that some time between Monday and Wednesday of next week, new data will lead to gains.
A Regulatory Catalyst Is Also Likely
Another story coming to a climax has to do with a regulatory issue that concerned investors. On August 2, 2018, an import alert was placed on Centre for Probe Development and Commercialization (CPDC) by the United States FDA. Sadly for Cellectar Biosciences, CPDC is the sole supplier of its lead candidate, CLR 131. The good news is that the candidate is likely to be excluded from the import alert soon.
On September 24, 2018, Cellectar Biosciences announced that the FDA has initiated discussions with the company regarding the hold. Importantly, the following key statement was made in the press release:
As announced on August 10, 2018, Cellectar was informed by CPDC of the Import Alert on August 7, 2018, and further learned that the basis for the Import Alert was not related to CLR 131 or to CPDC’s production facility associated with CLR 131. Since notification of the Import Alert, Cellectar has been actively assisting CPDC to secure the timely removal of the Import Alert.
Considering that the import alert has nothing to do with CLR 131, or the facility in which it is manufactured, there is no reason for the FDA not to provide the exemption that Cellectar and the CPDC are actively working to achieve. If and when this exemption is announced, the stock has the potential to see climb.
Consider The Risks
Any time an investment is made, there is also an assumption of risk. When it comes to Cellectar Biosciences, the biggest risks to consider in my opinion include:
- Financial Risk – Cellectar Biosciences’ CLR 131 is impressive, but developing a candidate like this is an expensive process and the company is spending quite a bit of money to do so. With multiple positive catalysts likely to run the stock up in the near term, the company could take advantage of the ability to cash in on the news by announcing a dilutive transaction.
- Clinical Risks – Clinical-stage biotechnology companies are largely dependent on the clinical data that they produce. Should Cellectar Biosciences produce data that suggests a lack of efficacy or safety or tolerability concerns in any of its clinical development programs, the stock could see declines.
- Regulatory Risks – Cellectar Biosciences, like other clinical-stage biotechnology companies, is largely at the mercy of regulatory authorities. These authorities decide what is required for every step of the development process from clinical trials to approvals. If Cellectar Biosciences received upsetting news from a regulatory authority, it could lead to declines.
Cellectar Biosciences comes with risk, as all investments do. On the other hand, the near-term catalysts that are lining up for the company are hard to ignore. In my opinion CLR 131 is an incredibly promising asset that has the potential to become the goose that lays the golden eggs for the company and its investors. All in all, I’m expecting to see gains ahead.
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