Actinium; 2 Catalysts Before End Of 2022 Could Boost Value (NYSE:ATNM)

Actinium Pharmaceuticals, Inc. (NYSE:ATNM) is a great speculative biotech play to look into. That’s because it is gearing up to report topline results from the phase 3 SIERRA study, which is using Iomab-B as a preconditioning agent in patients over the age of 55 with active relapsed/refractory Acute Myeloid Leukemia (AML) prior to receiving a hematopoietic stem cell transplant (HSCT). The potential for this therapy is huge, because it could provide the capability for more patients to benefit from being able to receive HSCT.

Actinium is on track to report results from the phase 3 SIERRA study in Q4 of 2022. In addition to this catalyst, there is another opportunity for traders/investors to look forward to before the end of this year. Overall survival data, from the ongoing phase 1 study using Actimab-A in combination with CLAG-M for AML patients, are expected in Q4 of 2022. The reason why Actimab-A might be an important program to move forward is because it allows the treatment of AML patients to receive radiation at the cellular level, which is not possible with traditional external beam radiation. Positive results have been obtained with Actimab-A plus CLAG-M and the hope is that this ARC CD33 drug can be used with other agents to improve patient outcomes in hematological malignancies. With proof of concept established with Iomab-B as a conditioning agent for AML, plus a few catalysts expected before the end of 2022, these are the reasons why I believe it is a great speculative biotech play to look into.

Iomab-B Could Become A Great Preconditioning Agent For Acute Myeloid Leukemia Patients

The main drug in Actinium’s pipeline would be Iomab-B, which is being developed as a pre-transplant conditioning therapy. Specifically, it is being given before Hematopoietic stem cell transplant (HSCT) for relapsed/refractory acute myeloid leukemia (AML) patients. The pivotal phase 3 SIERRA trial is recruiting these r/r AML patients who are of the age 55 or older. Iomab-B is being provided as a preconditioning agent before bone marrow transplant (BMT) compared to patients who receive physician’s choice of salvage therapy instead.

This is a very crucial study, because there is no standard of care (SOC) option available for these patients. The primary endpoint for this SIERRA study is durable Complete Remission ((dCR)) of at least 180 days. The secondary endpoints for this late-stage study are Overall Survival (OS) and Event-Free Survival (EFS). It’s hard to say whether or not either of these endpoints will be met, but there is some prior proof of concept data which has been established, which shows that Iomab-B is crucial in allowing these r/r AML patients to receive the curative BMT therapy that they so desperately need. What do you mean Iomab-B helps? Well, to give you an idea how much potential Iomab-B has for this patient setting, consider this data below:

• 66 out of 66 patients (100%) who received Iomab-B were able to go on to receive BMT and engraftment without any type of delay in receiving this much-needed treatment
• 40 out of 40 patients who came over from the control arm and crossed over to receive Iomab-B were able to go through to receive BMT and engraftment without delay
• 14 out of 77 patients (18%) who were in the control arm were able to receive much-needed BMT

As you can see above, only 18% of patients in the control arm went on to receive the much needed bone marrow transplant (BMT) therapy to help with their AML, which is much lower than Iomab-B. What Iomab-B has done is amazing in allowing all those patients to be able to receive BMT. One item to note is that the 40 patients who came from the control arm to receive Iomab-B, did so because they failed to be able to go through BMT when given conventional salvage therapy (physician’s choice of therapy).

As long as the durable complete remission ((dCR)) endpoint is achieved with statistical significance in the phase 3 SIERRA trial, then Actinium will be able to file for regulatory approval for this patient population. Again, results from this late-stage study are expected before the end of 2022. If successful with AML in the SIERRA study, then such an approach with Iomab-B could be applied towards other hematological malignancies, where preconditioning is needed before BMT.

Actimab-A Plus Chemotherapy Combination Is Another Advancement

This next advancement for Actinium Pharmaceuticals can provide another avenue for shareholders. That’s because Actimab-A is being provided as a potential backbone therapy for patients with advanced acute myeloid leukemia (AML). There are two combinations being explored with respect to this drug and they are as follows:

• Actimab-A combination with CLAG-M
• Actimab-A combination with Venetoclax.

The Actimab-A combination with Venetoclax is focusing on targeting relapsed/refractory acute myeloid leukemia ((r/r AML)) patients who are not able to receive intensive therapy. On the flip side, the Actimab-A combination with CLAG-M is given to patients who are capable of receiving intensive therapy. Both of these avenues provide a pathway for Actimab-A to be moved forward in the clinic.

For purposes of a near-term catalyst, I want to focus on the Actimab-A combination with CLAG-M. That’s because this combination is expected to have updated results released any day now in Q4 of 2022. Specifically, the release of results will focus on overall survival for this phase 1 study combination. It’s a tossup on what this specific data will look like, but prior data showing different endpoints fared well. It was shown that there was a 72% MRD negativity rate, which is an important finding because CLAG-M alone without Actimab-A only achieves a 39% MRD negativity rate. Another very important finding is that 75% of patients were able to move on with a BMT, which excludes patients with prior transplant experience.

Financials

According to the 10-Q SEC Filing, Actinium Pharmaceuticals had cash and cash equivalents of approximately $116.3 million as of June 30, 2022. This includes the deal that this company made for Iomab-B with Immedica AB. The deal involves the license agreement that Immedica AB can obtain exclusive rights to sell Iomab-B in Europe, the Middle East and North Africa. There is potential for Actinium to receive up to $452 million in milestone payments, along with the typical royalties of net sales percentage in the mid-twenties.

The most important thing is that this deal provided upfront cash of $35 million to help fund its operations. With the current cash on hand, plus the deal made with Immedica AB, Actinium believes that it has enough cash to fund its operations through mid-2025. That means it has plenty of cash to get through both of these expected data readouts in Q4 of 2022. Should it need to raise cash again, I believe it might do so if the stock climbs on the back of positive results from the phase 3 SIERRA study. That’s only if management decides that it should go ahead and do so right away or wait some time.

Risks To Business

There are several risks that investors should be aware of before investing in Actinium Pharmaceuticals. The biggest risk would be with respect to the ongoing phase 3 SIERRA study, which is using Iomab-B as a pre-conditioning agent with bone marrow transplant (BMT) for the treatment of r/r AML patients ages 55 and older. That’s because topline results from this late-stage SIERRA study are expected to be released in Q4 of 2022. As long as the primary endpoint is met, then it is expected that this biotech should be able to file a Biologics Licensing Application (BLA) to the FDA for potential marketing authorization of Iomab-B for this patient population. Even if the primary endpoint is met, that doesn’t guarantee that the FDA will approve Iomab-B as a preconditioning drug.

Another risk to consider would be with respect to the other expected data release from the phase 1 study. This involves the early-stage study using Actimab-A in combination with CLAG-M for relapsed/refractory AML patients unfit for intensive therapy. Results from this study are expected to be released any day now in Q4 of 2022 as well, and there is no guarantee that this data will end up being positive.

Conclusion

The final conclusion is that Actinium Pharmaceuticals is a great speculative biotech play to look into. That’s because it has two catalysts which are expected in Q4 of 2022. This provides investors with two potential opportunities to see a boost in shareholder value.

Both of these catalysts deal with different drugs in the pipeline as well. One deals with Iomab-B, and then the other pertains to Actimab-A. These aren’t just the only two drugs in the company’s pipeline either. It is applying its radiotherapy technology towards other indications, including solid tumors. Plus, there is also the possibility that its technology can be used as a preconditioning agent for other treatment options. For example, it also has the potential to apply its radiotherapy technology towards gene therapies and CAR-Ts as well.

With proof of concept established with both Iomab-B and Actimab-A in hematological malignancies, plus two data readouts expected in Q4 of 2022, these are the reasons why I believe that Actinium Pharmaceuticals is a great speculative biotech play to look into.