FDA Approval Could Mean Big Things for Actinium Pharmaceuticals

With a potential upside of 773%, learn why Actinium Pharmaceuticals might just be biotech’s next generational breakout.

Targets

$11.32

< 1 WK

$12.62

< 2 WKS

$13.94

< 1 MO

$15.17

> 1 MO

What You Should Know

Biotech Stocks

Biotech stocks can start as little known afterthoughts and turn into explosive disruptors on the cusp of revolutionizing medicine in months, weeks, or even days.

For example, did you even know who Moderna was 2 years ago?

On March 20, 2020, Moderna was nothing but a little-known biotech innovator developing an experimental vaccine trading at $30.05. Within the last 52-week period (as of 4/7/22)? It hit a high of $497.59 for a move of over 1,500% (2).

Amidst the continued carnage of the worldwide health situation, many biotech stocks have seen their shares skyrocket to incredible highs in 2022 year-to-date (as of 4/7/22):

  • Pulmatrix, Inc. 1,530.06%
  • Celsion Corporation 863.16%
  • Baudax Bio, Inc. 723.27%
  • Voyager Therapeutics, Inc. 230.07%
  • CTI BioPharma Corp. 110.89%

Get this, though.

How many well-respected analysts gave them a price target showing significant upside potential (4)?

Are any of those stocks in the midst of a Phase 3 trial that could potentially cure one of the most debilitating forms of cancer we know- relapsed or recurrent, acute myelogenous leukemia (AML)?

Meet Actinium Pharmaceuticals (NYSE: ATNM). This clinical-stage biopharmaceutical company could completely revolutionize medicine. All by developing targeted radiotherapies that deliver cancer-killing radiation with cellular-level precision.

Based on recent history, when biotech companies find a solution, the results can be life-changing. Keep a very close eye on this company as its Iomab-B treatment progresses through Phase III SIERRA trials.

That’s why we put together this comprehensive research report on Actinium Pharmaceuticals (NYSE: ATNM), which we’re thrilled to send your way. We’re about to reveal the top 5 reasons to strongly consider this company ASAP.

We have a long track record of finding diamonds in the rough. Actinium Pharmaceuticals (NYSE: ATNM) could be our latest and greatest find.

News

Actinium Pharmaceuticals continues to be a major disruptor in biotech. Check out some of the latest news and developments.

Financials

Chart Analysis

$ATNM is showing some of the same patterns as the strongest moving stock squeezes we’ve seen over the past 30 days. The incredible late-November push coupled with sitting squarely on the golden fibs and the 100 EMA on the daily. By all appearances, we’re approaching the same RSI level where we squeezed over 100% just a few weeks ago. Ready for the next leg up!

Top 100 stock by search volume (Webull)
Sitting at the Golden .618 Fibs since late November
Strong support at the $10 level
Approaching oversold area on RSI
Support picked up at the EMA 100 on daily chart
Sustained daily volume of 250k indicates a strong secondary push off the golden fibs

Actinium’s Iomab-B Nearing Treatment with SIERRA Trials

When you want to find a biotech play, you have to think this way- “don’t talk about it, be about it.”

Well, Actinium isn’t just talking the talk, they’re walking the walk.

On September 15, Actinium announced enrollment for its pivotal Phase III SIERRA trial of Iomab-B was complete (1).

SIERRA is a 150-patient, multicenter, randomized trial studying Iomab-B, an antibody-radiation conjugate comprising an anti-CD45 antibody and radioactive iodine-131 (I-131), compared with salvage chemotherapy inactive, relapsed, or refractory acute myeloid leukemia (AML).“

Iomab-B was developed to address the significant unmet need of patients who could benefit and possibly be cured of their blood cancer with a bone marrow transplant but could not receive a transplant because non-targeted conditioning regimens could not produce a remission or are too toxic in this patient population.

We are confident that Iomab-B will squarely address this unmet need given its targeted nature and ability to deliver high amounts of radiation directly to the bone marrow resulting in myeloablation while sparing healthy organs,” said Dr. Avinash Desai, Actinium Pharmaceuticals’ Executive VP, Clinical Development (9).

The company’s Chief Medical Officer, Avinash Desai said (17):

“The remarkably consistent and high rates of BMT engraftment together with the low rates of non-relapse transplant-related mortality at day 100 with Iomab-B through 100% enrollment give us great confidence in SIERRA.”

And the company’s press release added more:

  • Consistent 5-times greater difference between Iomab-B vs Control arm at each 100-day NR-TRM (non-relapse transplant-related mortality) interim analysis of the SIERRA trial.
  • Control arm therapies failed to achieve remission in 83% of patients with just 14% of patients being potentially evaluable at 100-day NR-TRM for the primary endpoint compared to 100% BMT engraftment with Iomab-B and 70% of patients potentially evaluable for the primary endpoint.
  • Unmet need in relapsed and refractory AML demonstrated by 66% of patients enrolled in SIERRA having received and failed targeted therapies prior to enrollment.
  • Significantly lower rate of sepsis (p=0.002) and lower rates of febrile neutropenia in patients receiving Iomab-B compared to salvage therapy in the control arm.

With this info coming out at the 63rd American Society of Hematology Annual Meeting and Exposition (ASH), could it help spark additional interest in Actinium?

In short, if things continue progressing the way they are, Actinium Pharmaceuticals (NYSE:ATNM) could be a game-changer.

The SIERRA Trial is the ONLY Randomized Phase 3 Trial to Offer Bone Marrow Transplants

The company’s SIERRA trial for Iomab-B is a 150-patient, randomized 1:1 pivotal Phase 3 trial studying Iomab-B compared to physician’s choice of salvage chemotherapy in patients age 55 and above with active, relapsed, or refractory AML or acute myeloid leukemia (9).

Cool right?

Here’s the kicker, though. This trial is believed to be the ONLY randomized Phase 3 trial to offer BMT, the only potentially curative treatment option, to this patient population (9).

Plus, Iomab-B is a radiotherapy that targets cells expressing CD45. This protein is found only on blood cancer cells and immune cells, including bone marrow stem cells, with the radioisotope iodine-131. It is intended to be a targeted conditioning agent to enable potentially curative BMTs (9).

This could completely revolutionize the medical community…especially when you consider how impressive trial data already looks (12):

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  • 100-percent engraftment consistent throughout interim analyses at 25 percent, 50 percent, and 75 percent of patient enrollment despite heavy leukemia burden before Iomab-B treatment.
  • Personalized Iomab-B therapy enables targeted delivery of radiation to the bone marrow enabling myeloablation in a well-tolerated manner.
  • Iomab-B delivers high amounts of targeted radiation to the bone marrow with minimal impact on other organs resulting in lower rates and severity of adverse events.

Wake up and smell the Iomab-B. If all goes according to plan Actinium Pharmaceuticals (NYSE:ATNM) could completely transform cancer treatment.

Their Patent Portfolio Is Being Strengthened With International IP

Why limit yourself to one domestic market if you have such a potentially strong treatment candidate that could change the entire world?


Actinium recently announced that its intellectual property portfolio around Iomab-B has been further strengthened internationally (13).

  • In the EU, Actinium has been issued a patent covering the composition and methods of administration of Iomab-B, an Antibody Radiation Conjugate (ARC) comprised of apamistamab, a CD45 targeting antibody, and the radioisotope iodine-131. The issued patent in the EU is expected to have a useful life through 2036.

  • In addition, Actinium has been granted a patent covering the same composition and methods of administration claims in Japan.

According to Dr. Dale Ludwig, Actinium’s Chief Scientific Officer:

“We are excited to expand our already robust patent portfolio with these key patents in the EU and Japan. As the only CD45 ARC for targeting conditioning in clinical development, these international patents, together with our U.S. patents lay the foundation for aggressive development of Iomab-B for BMT conditioning and Iomab-ACT for conditioning prior to cell and gene therapies. Iomab-B is well characterized and supported by extensive clinical data across multiple clinical trials and indications.”


“Our ARC approach has significant advantages over other approaches such as monoclonal antibodies or antibody-drug conjugates that require payload internalization, making them impractical for targeting CD45. We look forward to continuing to build our leadership position in targeted conditioning led by Iomab-B and remaining at the forefront of innovation in targeted radiotherapy.”

Analysts Are Going Crazy Over ATNM’s Potential Upside

While the ATNM stock did pull back in recent months, it may have caught strong double bottom support around $4.41.

With new, potentially exciting developments within the company, the stock may have the potential to retest prior highs around $20 a share.

Many analysts are also not just going long on this stock. They’re going all in. William Blair, for one, gives the stock an “Outperform” rating with a risk-adjusted fair value of $11.12 per share value (10).


Blair also stated that the “company finished the second quarter with a cash level of $81.9 million, which according to our estimates will likely sustain company operations into the first half of 2023, potentially beyond the Phase III SIERRA trial top-line readout” (10).


Most importantly, “Pending positive results from the Phase III SIERRA study and successful regulatory interactions with the FDA, [​​Iomab-B] is poised to disrupt the $600 million preconditioning market in the United States and Europe” (10).


Other analysts are even more bullish on the stock.


After ATNM announced full enrollment for its Phase III SIERRA Trial, Jones Trading immediately gave the company a $40 price target. (Source 16) Moreover, Jones Trading forecasted Actinium to see approximately $500 million in peak sales by 2032 (16).


But what if I told you that this isn’t even the most bullish analyst call?! H.C. Wainwright gave the stock a $45 price target (4)! That would give it potentially 773% upside (from close 4/7/22) of room to run!


773%!


Based on this rating, H.C. Wainwright says that “the common stock of the company is expected to outperform a passive index composed of all the common stock of companies within the same sector” (4).


But wait, there’s more…


Along with AVEO Technology, ATNM just entered into a research collaboration to develop and study a first-in-class antibody radio-conjugate (ARC) targeting ErbB3, also known as HER3, which is overexpressed in several solid tumor indications with high unmet needs, including colorectal, gastric, head and neck, breast, ovarian, melanoma, prostate and bladder cancers (25).


That could be substantial.


Even more impressive, Actinium just announced it entered into a research collaboration to study Actinium’s Actimab-A targeted radiotherapy in combination with RR-001, EpicentRx’s novel small molecule immunotherapy targeting AML (26).

Sources

1: https://ir.actiniumpharma.com/press-releases/detail/401

2: https://finance.yahoo.com/quote/MRNA/history?p=MRNA

3: https://fknol.com/list/best-performing/biotech-stocks.php

4: Client Provided Analyst Material HC Wainwright

5: https://www.marketsandmarkets.com/Market-Reports/chronic-lymphocytic-leukemia-223.html

6: https://checkrare.com/targeted-therapy-for-acute-myeloid-leukemia/

7: https://www.cancer.net/cancer-types/leukemia-acute-myeloid-aml/statistics

8: https://cancer.ca/en/cancer-information/cancer-types/acute-myelogenous-leukemia-aml/treatment/relapsed-or-refractory

9: https://www.prnewswire.com/news-releases/actinium-completes-enrollment-in-the-pivotal-phase-3-sierra-trial-of-iomab-b-301377219.html

10: Client Provided Analyst Material William Blair

11: https://d1io3yog0oux5.cloudfront.net/_7a9aad056eac4863c502660ef790af6d/actiniumpharma/db/206/944/pdf/Actinium_InvestorPresentation_September+2021.pdf

12: https://ir.actiniumpharma.com/press-releases/detail/398/pivotal-phase-3-sierra-trial-data-showing-100-bone-marrow

13: https://www.prnewswire.com/news-releases/actinium-further-strengthens-patent-portfolio-with-international-ip-covering-the-composition-and-methods-of-administration-of-iomab-b-antibody-radiation-conjugate-in-the-eu-and-japan-301314557.html

14: https://stockcharts.com/h-sc/ui?s=atnm

15: https://stockcharts.com/h-sc/ui

16: Client Provided Analyst Material Jones Trading

17: https://ir.actiniumpharma.com/press-releases/detail/412/actinium-pharmaceuticals-inc-announces-greater-difference

18: https://www.tipranks.com/news/blurbs/maxim-group-sticks-to-its-buy-rating-for-actinium-pharmaceuticals-atnm/

19: https://www.prnewswire.com/news-releases/actinium-announces-multiple-abstracts-highlighting-iomab-b-and-actimab-a-accepted-for-presentation-at-the-63rd-annual-american-society-of-hematology-annual-meeting-301416516.html

20: https://www.actiniumpharma.com/product-pipeline/iomab-b

21: https://www.barchart.com/stocks/quotes/ATNM/opinion

22: https://invezz.com/news/2021/11/09/market-highlights-stocks-react-to-earnings-rele[…]nvests-250-billion-in-autolus-elon-musk-to-sell-10-tesla-stake/

23: https://finance.yahoo.com/news/actinium-pharmaceuticals-inc-announces-greater-123000631.html

24: https://d1io3yog0oux5.cloudfront.net/_6ce8013bee626e168ac4cd2f3de00f02/actiniumpharma/db/206/944/pdf/Actinium_Investor+Presentation_April+2022+%281%29.pdf

25: https://investor.aveooncology.com/news-releases/news-release-details/actinium-pharmaceuticals-inc-and-aveo-oncology-enter-research

26: https://www.prnewswire.com/news-releases/actinium-pharmaceuticals-inc-and-epicentrx-announce-strategic-research-collaboration-to-combine-targeted-radiotherapies-with-next-generation-cd47sirp-immunotherapy-301454275.html

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