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Topline Summary and Update
Actinium Pharmaceuticals, Inc. (NYSE:ATNM) is a biotech company focused on developed radiolabeled biologics to help treat patients with different forms of blood cancer. They have been on a straight-lined path to approval for their radiobiologic Iomab-B for over a year now, and today I want to provide an update after their most recent quarterly filing and EHA presentation, with a focus on the investment thesis as the company has maintained a holding pattern over the regulatory landing strip.
Pipeline Updates
Iomab-B
At EHA 2024, the company updated findings from SIERRA, in particular highlighting the improvement in overall survival among patients with TP53-mutated AML who received Iomab-B followed by a bone marrow transplant compared with those who received no Iomab-B. The medians were 5.49 and 1.66 months, respectively.
Granted, this is a relatively small patient population, with only 24% of those enrolled in the study having a TP53 mutation, but this is a molecular aberration that is associated with poor outcomes. The long-term update also highlights the favorable chance of proceeding to a bone marrow transplant, since all patients who received Iomab-B were able to get one, compared with just 18% of those in the control arm.
In all, these findings continue to support the potential approval of Iomab-B for patients with relapsed/refractory AML, which has been an ongoing conversation with the FDA, per their latest quarterly filing. ATNM anticipates that approval for Iomab-B is attainable by 2025, although of course no filing has yet been submitted, and this will likely represent an important catalyst as it sets a timeline for an approval decision.
Actimab-A
Not for nothing, ATNM isn’t resting on the development of Iomab-B alone. They’re also working on another AML-focused agent, the CD33 antibody-radiolabel conjugate Actimab-A. This is currently being assessed in early-stage clinical trials for relapsed/refractory disease, either in combination with multiagent chemotherapy or venetoclax.
The most recent news surrounding Actimab-A was the presentation of preclinical evidence supporting the combination of this agent and inhibitors of menin as synergistic anti-AML approaches, further expanding the potential backbone of Actimab-A in R/R-AML.
On the clinical front, an SNMMI Annual Meeting presentation of phase 1 trial data of Actimab-A plus CLAG-M showed preliminary evidence of activity and tolerability for the combination, with an overall response rate of 65% among the 23 patients treated to date.
Financial Overview
As of the most recent quarterly filing, ATNM held $84 million in cash and equivalents, with long-term deferred revenue from their collaboration agreement of $35 million yet to be received.
Their operating expenses for the quarter reached $9.6 million, and after almost $1 million in interest income, the net loss recognized by ATNM was $8.7 million. Given this cash burn rate, the company has an implied cash runway of approximately 9 to 10 quarters, not considering potential milestone payments.
Strengths and Risks
Strength – A strong chance at approval with positive late-stage data, no change there
The findings from SIERRA have been relatively unequivocal in showing that Iomab-B adds something valuable to the AML standard of care, helping to take more patients to transplant, and even helping to overcome adverse molecular features. Provided they don’t have any major manufacturing issues or unresolved clinical questions, I feel that approval is a strong likelihood for the agent once they do finally get the submission completed.
Strength – Cash position still strong enough to get Iomab-B to approval
As of right now, there is still sufficient cash runway to get a filing ready and seen through the FDA, assuming relatively normal timelines and no other significant delays or setbacks with regulators. Radiopharmaceuticals definitely have extra manufacturing concerns that must be addressed, so the risk of a delay due to questions from the FDA is quite real, in my mind, but if things go well, ATNM currently has enough cash on hand to make it to the market, or at least to make it to a catalyst that puts them in a position of strength to raise funds.
Risk – No BLA yet means uncertainty about approval and timelines
ATNM has remained relatively quiet on guidance as to when we can expect to see an approval, relegating updates to SEC filings suggesting optimism for a 2025 date. I think this is a completely reasonable timeline for approval, particularly if the BLA submission can be completed before the end of this year.
However, the market does not tend to like uncertainty, and this quiet period has not been kind to the valuation of ATNM, which has drifted downward throughout the last quarter despite positive data updates and what, I feel, is a strong likelihood of eventual approval. Delays mean sideways trading at best, and we don’t know when that pattern will change.
Bottom Line Summary
ATNM being in something like a holding pattern as they continue to work toward a BLA submission creates an interesting opportunity for those still looking to find promising biotechs. At a market capitalization of just over $200 million, it would seem as though investors are not valuing this company as a promising late-stage entity on the cusp of an approval, which is what I truly think it is.
Given the data updates we’ve seen for Iomab-B, a promising future for Actimab-A and the march toward a first approval (which is obviously not a guarantee but looks like a strong chance to me), I continue to feel that ATNM is very much worthy of consideration in your portfolio. There’s a chance that they continue their selloff until the filing of their BLA, but these prices are definitely a bargain if and when they attain approval for Iomab-B.
