The bullish sentiment pushing Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) shares higher isn't slowing. The stock held close to its monthly highs despite bearish market conditions weighing heavy on smallcap biotechs. Since the start of Q4, ATNM shares are higher by over 52% at press time, reaching $11.30 on Friday on higher than average volume. Perhaps the better news is that ATNM continues to decouple from weaker broader market interests, a sign showing that when companies provide good news, they can still be rewarded. That appears to be the case for ATNM, who has given investors plenty of reasons why its rally can continue. Thus, while reaching multi-month highs may be in fashion, upside momentum may stay the trend.
Recent updates support that proposition. They indicate ATNM is scoring the type of data needed to get its potential best-in-class drug treatments to market. For ATNM, its drug presents a case where being different is good, which is why investors and patients may want to stay interested in the company and its science. ATNM is, after all, targeting a massive need with hopes of providing treatment opportunities to patients resistant to or untreatable by current cancer treatment regimens and therapeutics. The better news is that clinical results to date are indicating ATNM can do more than “target” the intended indications; they are showing a unique ability to effectively treat them with targeted radiotherapies, which could translate to frontline opportunities, a potentially enormous revenue stream, and best of all, a life-saving treatment option for patients.
Thus, the phrase “win-win-win proposition” may be more than an appropriate analysis in ATNM's case; it's one they can deliver.
Phase 3 Clinical Update This Quarter
Investors certainly believe that could be the case. They have been bidding shares higher following a corporate update that showed they are on schedule to release additional clinical trial updates this quarter. Now that December has been ushered in, those updates could be imminent. And what's the best fuel for stocks that already benefit from a bullish tailwind? More good news. Thankfully, that's precisely what ATNM and its investors may get. In fact, if precedent is met, ATNM is about to add to prior clinical data that has already separated its clinical trial candidates from other potential treatments. Not only is the data compelling; it’s showing an ability to save lives, which could validate its potential as a frontline treatment targeting indications needing improved standards of care. In some cases, ATNM will do more than improve the standard of care. By developing a drug leading to survival, they can create a new one.
An update last month suggests they are on track to meet that goal. A significant growth catalyst could be on the horizon, with ATNM highlighting that data from its ongoing late-stage clinical trials to treat patients resistant to particular cancer treatments is cumulative in nature. In other words, an already promising drug candidate is apparently getting better. Moreover, with topline data from its Phase 3 SIERRA trial expected by the end of this month, investors won't be waiting long to score what could be a transformative achievement for the company. Remember, this update would be more than a clinical milestone reached; it may be the one that presents the validating data required to pave a road to near-term regulatory approvals and bring life-saving therapeutics to patients with no current treatment options.
Recent trading activity indicates investors expect the best. They have reasons to believe so, noting prior clinical updates showing the potential for Iomab-B to become a standard of care treatment for relapsed or refractory (r/r) acute myeloid leukemia (AML) patients with active disease. The drug and treatment’s differences are its advantages, with the primary one being that ATNM's Iomab-B's targeted radiotherapy is alone in giving patients with active AML an opportunity to receive potentially curative bone marrow transplants (BMT). Without it, at least in most cases, the disease would need to be in remission. The even better news is that Iomab-B therapy may significantly lessen the adverse effects of conventional non-targeted chemotherapy, which is debilitating mentally and, more so, physically due to the damage it can cause to healthy tissues.
Contributing to the optimism is that Phase 3 Iomab-B is on track to meet its trial endpoints, including scoring positive data comparing outcomes between elderly patients with active r/r AML who receive Iomab-B and subsequent BMT with those who receive a physician's choice of salvage therapy. The overarching endpoint for the SIERRA trial is durable Complete Remission (dCR) of at least 180 days; secondary endpoints will examine Overall Survival and Event-Free Survival. Recalling precedent, they are again in play.
ATNM's Precedent Fuels Bullish Speculation
There aren't many reasons, if any, to expect that ATNM won't deliver another set of positive trial news. And if that data posts as expected, ATNM will strengthen Iomab-B's resume by adding to trial data presented at the annual meetings of the American Society for Transplantation & Cellular Therapy and the Center for International Blood & Marrow Transplant Research. That presentation showed data indicating a 5x greater difference in the number of patients potentially evaluable for the dCR primary endpoint at 100-days post-BMT in the Iomab-B arm compared to the control arm at maximum enrollment. Most impressive, the data demonstrated that 100% (66/66) of patients receiving Iomab-B accessed BMT and engrafted without delay, and 100% (40/40) of patients crossing over to receive Iomab-B proceeded to BMT. Compared to the control arm, patients receiving Iomab-B also experienced 5% to 10% lower rates of 100-day, non-relapse transplant-related mortality. There's more good news.
Iomab-B patients experienced a sepsis rate of only 5.3% compared to the control arm's rate of 23.7% - a statistically significant advantage with life-saving implications. Moreover, as the only CD45-targeting drug candidate in Phase 3 clinical development, Iomab-B has earned an Orphan Drug Designation from the U.S. Food and Drug Administration and the European Medicines Agency. Those designations can accelerate the approval process, attract business partnerships, and help fund ongoing trials. ATNM is deserving of all three, especially with Iomab-B being the only known route to a bone marrow transplant for patients with active disease.
Tthere are currently nine approved drugs for AML. However, none of those are curative. Therefore, the trial update expected this month could profoundly impact patients who need an alternative to current treatment options. It could also make the recent rally in share price the precursor of higher gains to come. Actually, there's plenty more in the pipeline to support higher valuations.
Pipeline Promise And Potential Keeps Shares In Play
ATNM's Phase 3 SIERRA Trial of Iomab-B may be catching the current headlines, but additional data from other trial interests are expected by year’s end. That includes overall survival data from its Actimab-A CLAG-M combination trial as a potential therapy for patients with advanced AML using the radioisotope’s differentiated mechanism of action in combination with other therapeutic modalities. Actimab-A is the only CD33-targeting radiotherapy under development, and like its other data sets, it is providing ATNM and its investors with reasons to be encouraged about its potential.
Data from the Phase 1 trial showed a 72% MRD negativity rate in patients receiving Actimab-A + CLAG-M, a substantial improvement over the 39% MRD negativity rate in patients treated with CLAG-M alone. Further, the trial reported no 30-day mortality, with an 80% overall response rate (CR/CRp/MLFS) in patients receiving less than four lines of prior therapy with 10 complete remissions across all four dose cohorts. If the data released in the coming weeks remains as potent as it has previously, it could position ATNM to bring multiple life-changing therapies to market. If that's the endgame in the crosshairs, expect current prices to be short of an appropriate valuation. As it is, with ATNM being a late-stage Phase 3 company, the disconnect is already significant.
Strong Balance Sheet Can Expedite Trial Pace
It's made even wider knowing that ATNM is well-capitalized to advance its trials and ambitions. The company reported having roughly $116.3 million in cash and cash equivalents as of June 30, 2022 – an impressive amount for a small-cap biotech company. Better yet, new deals could strengthen that position.
An example- Actinium licensing the EUMENA commercial rights for Iomab-B to Immedica AB brings significant revenue-generating potential. The licensing agreement, which included a $35 million upfront payment from Immedica, could be worth $417 million after sales milestones and mid-20% royalties. Immedica is an independent pharmaceutical company operating in Europe and the Middle East. Its main objective is to market treatments for rare diseases and specific niches in the healthcare industry, making the company a perfect fit for ATNM's offerings. The commercial licensing agreement offers a way for ATNM to build its international presence and treat a more significant proportion of the 21,000 patients diagnosed with AML each year.
Actinium added that its current cash and cash equivalents can sufficiently fund its operations through mid-2025, allowing the company to continue its research and seek out accretive partnerships. There's still more to like about the ATNM story.
Patents, Partnerships, Profits
Foremost is that by capitalizing upon its proprietary technologies and clinical experience, ATNM is diligently working to bring additional and potentially unrivaled targeted radiotherapy treatments to the market. Its programs include evaluations of therapies that target and deplete specific cancer and immune cells to allow for a safe bone marrow transplant, among other gene and adoptive cell therapies. The company is a leading developer of Ac-225-based therapies and has amassed over 190 patents within its intellectual property portfolio. ATNM has presented considerable research regarding its Ac-225 therapies that target CD38 and HER3, as well as the first CD47 immune checkpoint targeted radiotherapy combinations with HER2 in solid tumors and CD33 in blood cancers.
Further, the versatility of ATNM's technologies and research candidates have led to multiple partnerships to accelerate the development of its innovative therapies. These collaborations include a partnership with AVEO Pharmaceuticals (NASDAQ: AVEO) on HER3-targeting radiotherapies for solid tumors, a collaboration with Astellas Pharma (TSE: 4503) focused on solid tumor theranostics, and studies with EpicentRx on CD47 immune checkpoint targeted radiotherapy combinations.
ATNM's partnerships and internal research projects have generated substantial momentum that could carry its transformative treatments to market. Also, given that major pharmaceutical companies like Pfizer (NYSE: PFE) and Bristol-Myers Squibb (NYSE: BMY) prefer to acquire rather than develop, even more deals could be on the horizon.
Q4 Milestones Into Catalysts
Indeed, heading into the final days of Q4, it looks like all systems are a go for ATNM to add to its case of bringing curative therapies to cancer patients untreatable by current methods. Keep in mind, too, that ATNM’s therapeutic candidates and research collaborations are rapidly moving through the development pipeline with substantial progress updates likely in the queue. And with designations that could fuel approvals, these treatment candidates could reach the market and patients faster than many think. That combination is a potent recipe for share price appreciation.
And with confirmatory data potentially in the queue, the ATNM bulls may do more than run the stock higher: they may have reasons to stampede it. Remember, too, it's not only ATNM and its investors that are in the queue to benefit, thousands of patients are as well, which by any measure, can be a gift of a lifetime, literally. With ATNM data suggesting they are on the cusp of delivering revolutionary therapies for diseases with poor treatment availability, the best news is that delivery could happen sooner than later.
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