Actinium Pharmaceuticals, Inc.'s (NYSE AMERICAN: ATNM) rally has accelerated into warp-speed, with shares trading higher by more than 62% since the start of September. The better news is that with its update from Monday, those increases show no signs of slowing down.
In fact, its intraday high at press-time of $10.24 per share adds even more value, pushing month-to-date gains past 68%. Why are the bulls taking charge? Because ATNM is better positioned than any time in its history to get its Iomab-B ready for FDA approval.
Earlier this month, they finished a crucial step in the process, completing enrollment for its pivotal Phase 3 SIERRA trial for what they believe will produce a best-in-class drug to treat a targeted unmet medical need. Even better, it could become the only drug of its kind available to provide patients an opportunity to receive life-saving bone-marrow transplant treatments. And that's great news for patients, ATNM, and its investors.
Adding more to the bullish proposition, its SIERRA trial is the only study showing effectiveness in facilitating bone marrow transplant to patients with active, relapsed, or refractory acute myeloid leukemia (AML) age 55 and above. And if the Phase 3 portion of the trial confirms prior results, its Iomab-B will be tapping into substantial treatment opportunities. Factor this in as well- Iomab-B could become the only curative treatment option for this patient population. Hence, the run-up in share price to date could be the precursor of better things to come.
Better still, investors have a compelling reason to take advantage of these potentially undervalued share prices today. Actinium told the markets that data updates from its SIERRA trial could be expected in Q4 of this year. That means ATNM is potentially only weeks away from a catalyst that could transform the company from clinical-stage to commercial-stage. Moreover, with final topline data for durable Complete Remission (dCR) expected in the first half of 2022, there could theoretically be several value drivers along the way. Thus, while milestones are in sight, so are the catalysts that they can become. And in the world of biotech, getting ahead of those announcements can lead to exponential gains.
Of course, data holds the key. And by taking the lead from ATNM, investors may want to stay bullish.
Accelerating Marketing And Development Initiatives
After all, it's usually good advice to follow the lead of companies that may know more than their investors. Typically, insiders buy when things are good, and companies prepare for new programs if data supports them. While insider's purchasing may show on its next filing, what is known is that ATNM is exuding confidence on the development side.
According to its update earlier this month, ATNM is preparing its registration of a Biologics License Application (BLA) for Iomab-B. That's one of those milestones that turn into a catalyst, by the way. For ATNM and its investors, that planned filing is welcomed news. And it follows years of research, patience, and trial persistence.
Lead investigators are confident as well. Dr. Sergio Giralt, Deputy Division Head, Division of Hematologic Malignancies; Melvin Berlin Family Chair in Multiple Myeloma, is on record as saying that the SIERRA trial is an important study in the field of bone marrow transplant, with Iomab-B representing a potentially significant advancement for BMT conditioning.
And he knows what to look for after spending years working on expanding the use of transplants and improving patient outcomes. He expects that given Iomab-B's targeted nature, it has shown the ability to produce effective myeloablation, even in patients with a high disease burden, while also being well-tolerated. The end and hoped-for result can enable more patients, including those with significant comorbidities, to access bone marrow transplant and successfully engraft. And there is plenty of reason to be optimistic.
To date, 100% of patients receiving Iomab-B accessed bone marrow transplants and engrafted without delay. That compared to only 18% of patients receiving salvage therapy on the control arm of the study through 75% of enrollment. In clinical trial speak, that's more than a meaningful difference; it's a statistical one. Better yet, the treatment is supported by an excellent safety profile.
Compared to the control arm in its trial, Iomab-B showed significantly lower rates of serious adverse events, including febrile neutropenia, sepsis, and mucositis in patients receiving Iomab-B. While that's great news for patients, it's also excellent news for ATNM and shareholders ahead of a planned FDA submission. It also completes the package.
With efficacy and safety impressive, and with the SIERRA trial the only active randomized Phase 3 trial to facilitate bone marrow transplant as an option for patients with active, relapsed/refractory AML age 55 and above, most, if not all, of the potential regulatory hurdles are cleared. And by meeting an unmet medical need, robust data in its Phase 3 portion could open pathways for expedited approval and/or compassionate use designations.
That would make sense as the drug could stand alone as the only curative treatment option for this patient population. And even if an ongoing COVID-pandemic keeps the review process slowed, data supporting the drug's approval would be ample fuel to send valuations higher. Investors appear to be doing that from the Phase 2 data and enrollment news already.
A Transformative Moment In ATNM History
And there have been little signs that investor interest is slowing down. During the past six trading sessions, shares have been bid higher by over 41%*, closing higher each of the past six days. Now, as full enrollment helps bring a new data update closer, investors have not been shy to step up interest. (*intraday $10.24, 9/27/21 at 2:04est)
Of course, they are doing so based on the drug candidate's proven record of success. And part of the attraction comes from Iomab-B targeting a significant unmet need of a particular set of patients, particularly those who could possibly be cured of their blood cancer with a bone marrow transplant. As of now, it's not an option for many patients since there is no effective conditioning treatment. Iomab-B is changing that dynamic.
Iomab-B's promise comes from being potentially superior to non-targeted conditioning regimens that could not produce a remission or are too toxic in this patient population. Put simply, without an effective Iomab-B treatment, getting a life-saving bone marrow transplant may not even be possible.
But, as noted, ATNM is expecting to change that one-sided proposition. They are banking on Iomab-B's mechanism of action to address that treatment gap through its targeted nature and ability to deliver high amounts of radiation directly to the bone marrow resulting in myeloablation while sparing healthy organs. More than a significant difference, it's a potential life-saver.
Moreover, the long-term benefits are just as significant. Included its endpoint targets, the SIERRA trial evaluates the rate of durable Complete Remission of at least six months in patients receiving Iomab-B and a bone marrow transplant to those receiving salvage chemotherapy. Already noted, ATNM expects to meet its primary and secondary points setting into action its BLA submission to make Iomab-B available to patients as soon as possible after positive topline SIERRA trial results. Remember, that could happen before the end of 2022. That's the marketing side. Approval can come sooner.
Know this, too. ATNM doesn't expect Iomab-B to be a one-treatment market opportunity. Instead, they are confident that Iomab-B will be helpful in other indications needing its targeted conditioning abilities. Thus, Iomab-B isn't a "one and done" value proposition. In fact, with Iomab-B the only CD45 targeting agent in clinical development, and with CD45 expressed in all blood cancers, it could bring massive additional treatment opportunities.
Better yet, because the drug candidate has inherent multi-indication treatment strength, its commercialization efforts could be accelerated, especially with the help of transplant centers and physicians already familiar with Iomab-B's benefits. They are already working with several to potentially expedite the review and implementation process.
Thus, a perfect storm of opportunity for ATNM and its expanding pipeline ambitions could be in play.
Giving Patients Access To Bone Marrow Transplant
Here's the most excellent news about Iomab-B. Through 75% of trial enrollment, ATNM presented data showing a 100% (49/49) BMT access and engraftment rate for patients receiving a therapeutic dose of Iomab-B. That compared to 18% (10/57) of patients receiving physician's choice of salvage therapy on the control arm. Results got more impressive.
Best of all, of all those enrolled in the trial up to that point, 79% (89/113) could proceed to a bone marrow transplant. And that number included a patient population not considered eligible for the procedure with standard approaches due to cross-over. Thus, data overwhelmingly indicate that a significant number of patients can be provided a more than excellent chance to receive potentially life-saving treatment after an FDA approval of Iomab-B.
More importantly, it can treat patients safely, with Iomab-B delivering high amounts of targeted radiation to the bone marrow with minimal impact on other organs resulting in lower rates and severity of adverse events. Even better, this action is happening at the cell level, making the drug attractive to researchers since it does not deliver a massive radiation dose to places other than its targeted cancer cell. Of course, that's by design.
Iomab-B, via the monoclonal antibody apamistamab, targets only the CD45, an antigen widely expressed on leukemia and lymphoma cancer cells, immune cells, and bone marrow stem cells. Once apamistamab is linked to the radioisotope iodine-131 and attached to its target cells, it emits energy that can travel about 100 cell lengths, destroying a patient's cancer cells and ablating their bone marrow. ATNM, though, has found that by carrying iodine-131 directly to the bone marrow in a targeted delivery method, Iomab-B can avoid the side effects of radiation on most healthy tissues while effectively killing the patient's cancer cells.
Thus, the best part about the drug is that it does its job and nothing more. With radiation involved, that's a best-case scenario.
ATNM Earns Right To Boast
To those hanging around ATNM for the past few years, it's taken a while to get to this point. However, with compelling data in hand, both ATNM and investors have earned the privilege to boast about the company's potential future. It took time, a lot of money, and patience. But, investment in biotech comes with that profile. However, the rewards can be exponential, especially for a company like ATNM that could deliver a front-line, best-in-class drug treatment solution to market.
Keep this in mind, too. Iomab-B has been studied in nearly 300 patients for at least six blood cancer indications in multiple trials. Hence, potential questions from the FDA regarding the drug and future indications could already be answered. Remember, Iomab-B didn't show good results; it demonstrated excellent results. Hence, the current rally is warranted.
Furthering that sentiment and specific to its targeted indications, Iomab-B shows a potentially safer and more efficacious method of action than non-targeted intensive chemotherapy conditioning, currently the standard of care in bone marrow transplant conditioning. Notably, at this stage in patients treatment, a bone marrow transplant is often considered the only potential cure for certain blood-borne cancers and blood disorders. Iomab-B, therefore, is critically needed.
Thus, not only is Iomab-B a potentially transformative drug for ATNM, but it could also present the last chance for survival among a particular patient population.
A Break-Out Period In 2021-22
The dollars in play for an approved Iomab-B are tremendous. Thus, don't let the ongoing rally lead anyone to believe they missed the right entry point. On the contrary, Iomba-B could become a billion-dollar franchise that expands into multiple conditioning applications. Moreover, if it becomes the go-to drug only for its targeted indication, ATNM stock could be positioned for considerably more upside. And the update expected in Q4 might be the fuse.
Hence, the obvious is in play. Actinium Pharmaceuticals is on the doorstep to deliver a long-awaited, well-deserved, transformative event. The better news is that investors will get some news on that front in the coming weeks. That means for ATNM and its investors, a near-term catalyst could be very much in play.
Trading ahead of that data may be a wise consideration. The bottom line- those who liked Actinium Pharmaceuticals before should truly embrace its promise now.
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