Actinium Pharmaceuticals Inc (ATNM)

[Pharmboy46]

Looking forward to seeing ATNM go higher for a change. Been invested for about 5 years! I thought they might have had something good to report shortly after the split, but, sadly we were taken down.

[cardmaster114]

Short covering is going to drive it higher, been a great trade.

[Pharmboy46]

Agreed- sadly my average is much higher-but am relishing the news du-jour! Hopefully this the start of a trend. I’ll gladly take the 20 price target even if it’s been lowered a bit!

[cardmaster114]

What a steal when it dipped below $ 6.00.

[Pharmboy46]

Finally a little news to the positive! Still long and strong- but it’s been a tough road to hoe! Is this mic on?

[Pharmboy46]

I hope the light at the end of this long road isn’t a freight train heading directly towards us! One step forward and two back with this company.

[Kam8]

Amazing post. Thanks

[svknight]

A Light at the end of a long dark tunnel ??? Bueller... Bueller... Bueller

https://seekingalpha.com/article/4439328-actinium-a-story-of-delays-and-promises-about-to-come-to-fruition

[blukky]

That's a good question.
Markets up big and ATM down big.

Ma average is 12.83 on this. Deeeeep reeed

[GoodGuyBill]

Why isn't the pps increasing?

[GoodGuyBill]

Why isn't the pps increasing?

[Windbag1014]

Pivotal Phase 3 SIERRA Trial Data Showing 100% Bone Marrow Transplant Engraftment in Patients Treated with Iomab-B presented at the 2021 Virtual SNMMI Conference


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

[timberwolf7]

So what sparked this morns activity?? Seeing no news, and vol in the pre wasn't showing a lot of interest taking place...

But just enough to push the price up tho...

[timberwolf7]

never sold 'put' options...

But if I was going to consider it, maybe the Jan 7.5s at $1.95/sh?? Means I could get the shares at $5.6/sh??

But IF the PH 3 goes as anticipated, wouldn't expect that I will be able to make a buy at $7.5... after Dec..

[Kkhors]

Don’t forget to sell the $7.5 puts as well.

[timberwolf7]

The lack of 'news' or "PR" is forcing me to sell covered calls on the shares I hold.

But the lack of PR/news is also keeping the 'volatility' premium on the calls quite 'low'... But that said, did sell the Aug 10s for 75 cents/sh..

So making a little something as the share price flounders waiting for something to break this 'silence'..

But now have to hope they don't do a data release/dump before Aug so that I can keep the shares...

Have another one (CRMD) that we were expecting to get their FDA approval over with, that was going to be a source for rolling gains into ATMN in anticipation of their PH 3 completion... Think this one has been 'quiet', FDA really screwed CRMD from a Feb approval to a 4th qtr resubmission over issues at their selected drug manufacturer..

[blukky]

I hate this silence.

[timberwolf7]

and like you, I still own shares, but much less than before because I am waiting for another one to have its fun at the FDA for approval.

Plan is to sell some of that one post approval and start laddering up the share count on ATNM.. Be a nice time to buy some on these pullbacks.

Still selling covered calls on the shares I do hold, with contracts expiring here in May...

Looking to sell another round after that...

Like a few I have been in, demands a lot of patience, at least in this ones case, given what we know already, there should be a reward in the end for holding on..

[blukky]

I've longer and bigger invested into this company. Holding shares since June 2018.
Down about 35% and hope that one day this company will have a real and selling Product or licenses.

I hate the silance on this board. LOL

[timberwolf7]

Good to see its still 'chugging' along... selling covered calls on the shares isn't as lucrative as it was towards the end of last year. But going to keep doing it, keep building up a bigger position..

Wondering if they will try for another 'PH 3 readout' in June/July. Give them more data than they had in Dec to 'work with'..

Given how well the PH 2 'worked', doesn't make sense to make them take the PH 3 all the way.. But thats just my 2 cents..

[GoodGuyBill]

Actinium Announces Completion of Enrollment of Second Dose Cohort in Actimab-A Venetoclax Combination Trial for Patients with R/R AML

- Proof-of-concept Phase 1 data expected in 2H:2021 will evaluate safety, response rates, MRD negativity and cytogenetic profiles
- Complete response in patient with TP53 and other mutations and one partial response reported in patient with poor risk adverse cytogenetics reported in first dose cohort with subtherapeutic dose of Actimab-A with venetoclax

NEW YORK, March 25, 2021 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") today announced that initial patient enrollment in the second dose cohort in the Phase 1 portion of the Actimab-A venetoclax Phase 1/2 combination trial in fit and unfit patients with relapsed or refractory Acute Myeloid Leukemia (r/r AML) has been completed. The Phase 1 portion of the trial is a 3 + 3 dose escalation study to determine the maximum tolerable dose of Actimab-A that is to be studied in the Phase 2 portion of the study. Based on the progress of enrollment, Actinium expects to complete the Phase 1 portion and present further proof-of-concept data in the second half of 2021.

First-in-human data from the first dose cohort of 0.5 µCi/kg of Actimab-A and Venetoclax were presented at the 62nd American Society of Hematology annual meeting in December 2020. Patients enrolled in the first dose cohort had a median of 2 prior therapies (range 2-3) and a median bone marrow blast percentage of 30% (range 20 - >60). All 3 patients had poor risk disease with adverse cytogenetics, and each patient had an additional high-risk marker (FLT3-ITD+, antecedent JAK2+ myelofibrosis, or TP53 mutation). One patient who had multiple genetic mutations including IDH2, RUNX1, TP53 and others, achieved a complete remission with incomplete blood count recovery (CRi) after the first cycle of Actimab-A and venetoclax. Next generation sequencing at the end of the first cycle showed that the patient was negative for the known IDH2 and RUNX1 mutations. In addition, another patient achieved a partial response after one cycle of Actimab-A and venetoclax. There were no Actimab-A related dose limiting toxicities or nonhematologic Grade 3 or greater related AEs reported in the first cohort.

Dr. Mark Berger, Actinium's Chief Medical Officer, said, "We are encouraged by the strong progress we are making in this novel combination trial and excited to be studying Actimab-A with venetoclax. Venetoclax has emerged as a standard of care and backbone therapy for patients with AML who are both fit and unfit, however, patients with relapsed or refractory disease have poor outcomes and therefore need better treatment options. Based on the synergistic mechanism of action and preliminary clinical evidence from the first cohort, we are optimistic that Actimab-A in combination with venetoclax can improve outcomes for patients with relapsed or refractory disease using the unique targeted radiation mechanism of Actimab-A. We look forward to presenting data from this cohort of patients as well additional clinical data from the Phase 1 portion of the trial and working to advance this novel combination in the clinic."

In a poster presentation at the American Association of Cancer Research (AACR) Annual Meeting 2019, Actimab-A was shown to be synergistic with venetoclax in venetoclax resistant cell lines, by depleting Mcl-1, a protein shown to mediate resistance to venetoclax. Further, the induction of direct AML cell death via double-stranded DNA breaks via the radioisotope Actinium-225 in Actimab-A provides a second mechanism for enhancing synergistic potency with venetoclax. Venetoclax is a B-Cell Lymphoma 2 (Bcl-2) inhibitor that is jointly developed and marketed by AbbVie and Genentech and is approved for patients with AML, Chronic Lymphocytic Leukemia (CLL), and Small Lymphocytic Leukemia (SLL). Despite its approval in AML, venetoclax has produced low response rates of 19% as a single agent in R/R AML.1 A Phase 2 trial studying Actimab-A as a single agent produced a 69% overall response rate in older unfit patients with newly diagnosed AML.

Sandesh Seth, Actinium's Chairman and CEO, added, "This trial is an exciting evolution of our Actimab-A program and application of the isotope Actinium-225. Actinium-225 is a potent medical isotope that can kill a cancer cell with a single alpha particle hit, emits four alpha particles in its decay and can cause double strand DNA breaks for which cancer cells have no known repair or resistance mechanism. Its energy is also emitted over a very short path length equal to a few cells in diameter enabling precise cell killing while sparing normal cells to limit systemic toxicities. With clinical experience in nearly 150 patients, robust IP and a clinically validated supply chain, we are leaders in the rapidly growing field of targeted alpha radiotherapy and specifically Actinium-225. Through continued clinical progress and innovation driven by our R&D efforts, we are committed to advancing our leadership position in the field of Actinium-225 based therapies and applying them with the goal of improving patient outcomes."

[GoodGuyBill]

Actinium Announces Initiation of Patient Enrollment in Iomab-ACT Trial for Targeted Conditioning Prior to CD19 CAR T-Cell Therapy

https://ir.actiniumpharma.com/press-releases/detail/393/actinium-announces-initiation-of-patient-enrollment-in

- CAR T-cell therapy manufacturing commenced with Iomab-ACT conditioning and patient treatment scheduled for early Q2:2021
- Clinical proof-of-concept data expected in 2H:2021 from first of its kind trial funded by NIH STTR grant

NEW YORK, March 24, 2021 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") today announced that its collaborator, Memorial Sloan Kettering Cancer Center ("MSK"), has commenced patient enrollment in the Phase 1 study evaluating Iomab-ACT for targeted conditioning prior to treatment with MSK's CD19 targeted CAR T-cell 19-28z. Iomab-ACT is a low dose version of Actinium's Phase 3 drug candidate Iomab-B, a CD45 targeting antibody radiation conjugate ("ARC"). Actinium and MSK were jointly awarded National Institutes of Health Small Business Technology Transfer grant funding for this first ever trial to evaluate ARC-based targeted conditioning prior to CAR-T therapy. The scientific rationale for this trial builds on preclinical data published in 2020 and is further supported by clinical observations from the SIERRA trial to justify combining MSK's 19-28z CAR T-cell therapy with Iomab-ACT. Manufacturing of patient CAR T-cells has commenced and patient conditioning with Iomab-ACT followed by 19-28z CAR T-cell infusion is expected early in the second quarter of 2021, with proof-of-concept data expected in the second half of 2021.

[timberwolf7]

Not holding as many as before.. Selling the monthly covered calls while the PH 3 progresses.

Wondering if there will be another readout in say June/July timeframe (ie, more data points than they had in Dec)..

Plan of attack is to hang onto the ones I have, sell the calls and watch the chart for activity, company for 'news'. Otherwise, we have to ride this to Dec for the end of the PH 3 (scheduled end date)...

oh well, been a long ride, but they are closer... all I can ask for besides that the data is as good or better than the PH 2 results..

[timberwolf7]

Not holding as many as before.. Selling the monthly covered calls while the PH 3 progresses.

Wondering if there will be another readout in say June/July timeframe (ie, more data points than they had in Dec)..

Plan of attack is to hang onto the ones I have, sell the calls and watch the chart for activity, company for 'news'. Otherwise, we have to ride this to Dec for the end of the PH 3 (scheduled end date)...

oh well, been a long ride, but they are closer... all I can ask for besides that the data is as good or better than the PH 2 results..

[Pharmboy46]

Added 500 sh today at 8.05. Hope to reap benefits soon!

[Pharmboy46]

I wish, I’ve owned this for years- I hope we are poised for greatness. I’m still trying to figure out why we’re getting beaten up today?

[kjsdisty]

Watch this one, you’ll be amazed

[timberwolf7]

nice move off that $8.3 range buy signal to around $9.4.. See if it continues to fill the 'gap'..

[timberwolf7]

Buy signal triggered on ATNM...

added some shares this morn... but going to be a 'long' 6 months min to the next PH 3 POTENTIAL data readout...

Plan to sell calls on the shares tho while I hold them and 'wait'...

and build up the positions

[timberwolf7]

Covered Calls

Well now that the possibility that they might have asked for a halt to the PH 3 passed in Dec, the 'value' of the calls has fallen massively.

From getting a $ or more (9 - 15% return) for the calls, the best I could do was get 30 cents for the Feb $10s...

So did unload some of the shares, and moved them into a much more lucrative covered call trade for at least this month..

So since it appears that maybe the next 'timeframe' for things to warm up, might be mid year (another readout on the PH 3 with more enrollment??),
will hold off adding shares back now till I see demand for the shares pick up in the chart...

Way baby bio developments go isn't it.. requires a lot of patience and creativity to make something while the wait takes place..

[timberwolf7]

I have another one CRMD that is set up for an FDA decision date on Feb 28th. Depending on how high that one jumps with its small float (30 Million shares), I am planning on rotating some of those gains out into ATNM...

and on that note, while the one you referenced 'added' shares, my chart is slowly developing a buy signal for me.. I will likely add a little more once the bottom confirms its in at the current level. Cause that big 'gap' from $8.5 to $10.50 is just begging to be 'filled'. And that would be a nice 'bonus' gain relative to where it was..

[timberwolf7]

agree, their downstream developments COULD be the value adders to the 'first up' one...

They got tagged pretty good I suspect because they didn't get an early halt and there might have been some looking to score on the 'possibility' of a binary event. But now slowly putting in a 'low' now, with the question being, where's it going to find support at now that they have to plod their way thru another 'portion' of the PH 3. I have my latest round of covered calls set to expire for another nice monthly 'dividend', but Febs are looking a little 'bleak' in terms of the return. Cause I do intend to sell another round now that we know they are likely to be 'calm', but sure would like to see the $12.5s offering a better price (might do the $10s and hope the share price doesn't ascend back over it till after mid Feb)..

So, it moves forward and I probably shouldn't say this out loud, but I am ok with it doing what its doing, staying 'quiet' in a market that is full of overvalued, overhyped companies just looking for a place to have a share price train wreck...

[stockguard]

Hal Mintz Stocks Portfolio
They acquired 4.64% of $ATNM`s float in recent new filling today.
https://hedgefollow.com/funds/Sabby+Management

[stockguard]

Seems like a very simple value proposition. Fits my sweet spot of being scientifically de-risked. Radiotherapy is a very real thing now in other areas, oncology definitely lends itself to it. Can hit both CD 45 and CD 33 and will be able to do both at once as well. Have shown dose response as expected. Side effects superior to alternative treatments. Safe for patients over 60. About a $100 M MC. Tiny company has this therapy in 10 of the largest transplant centers across the US which bodes well if/once approved.

[timberwolf7]

Well its the 'game changing' therapy that got my attention in the first place, and why I am sticking around...

Yep, the 'early' halt potential was there, but at the same time, would have been more surprised if it had been halted than to continue to completion.

Guess I should have sold the $15s for Jan instead of the 17.5s 'just in case' (smile)...

but have to admit, I do like the $65 target price over my $20 one...

[stockguard]

Actinium Announces Successful Pre-Planned Ad Hoc Interim Analysis of Phase 3 SIERRA trial
- 100% rate of BMT and engraftment in patients receiving therapeutic dose of Iomab-B and lower rates of sepsis and sepsis related Grade ≥3 adverse events compared to patients receiving salvage therapies at 75% enrollment recently highlighted in oral presentations at ASH 2020 Annual Meeting

- Independent Data Monitoring Committee recommends SIERRA continue as planned to full enrollment of 150 patients; trial is currently over 75% enrolled

- SIERRA trial remains the only randomized Phase 3 trial to offer potentially curative bone marrow transplant as an option for patients with active relapsed or refractory AML

More here-Tables to review
https://www.prnewswire.com/news-releases/actinium-announces-successful-pre-planned-ad-hoc-interim-analysis-of-phase-3-sierra-trial-301198869.html

[stockguard]

From December 8th at Benzinga Global Small Cap Conference Day 1 Recap:
Actinium Pharmaceuticals Says SIERRA Trial Has Demonstrated All Patients Receiving Therapeutic Dose Of Iomab-B Have Been Able To Go On to Bone Marrow Transplant
Actinium Pharmaceuticals Says Estimates ~176K Patients/Year Diagnosed With Blood Cancers Treatable With Bone Marrow Transplant But Only 23K Transplants Performed In 2018, Says Looking To Address Access Gap With Iomab-B
Actinium Pharmaceuticals CFO Steve O'Loughlin Notes Co.'s ARCs Enable Targeted Radiotherapy Directly To Cancer Cells; Says Has Over 130 Patents That Protect Candidates Through 2037 And Beyond
Actinium Pharmaceuticals CFO Steve O'Loughlin Highlights Co. Balance Sheet; ~$48M In Cash, Which Can Fund Operations Through 2021
Actinium Pharmaceuticals CFO Steve O'Loughlin Says Co. Led By Iomab-B, Which Is In Phase 3 SIERRA Trial; Has Also Expanded Into Bone Marrow, Transplant CAR-T And Gene Therapy
Actinium Reports 67% Overall Response Rate In First Cohort In Actimab-A Venetoclax Combination Trial In Relapsed And Refractory AML At ASH 2020

[stockguard]

12:05 ET - Investors flee Actinium Pharmaceuticals after an interim analysis of its Phase 3 study of Iomab-B for bone marrow transplant conditioning, but Maxim Group says they should be buying. Actinium terms the pre-planned analysis successful and says the study's independent data monitoring committee recommends that it continue to full enrollment. Analysts at Maxim think investors may have been expecting to see data on the primary endpoint of six-month durable complete remission or for the trial be stopped for efficacy. Maxim notes that endpoint data was only viewed by the monitoring committee, not Actinium, and that the panel's recommendation that the trial move forward to completion is overall positive, and "we would be buyers of ATNM shares on today's weakness." Actinium down 23.2% to $8.23. ([e-mail])

[stockguard]

ATNM H.C. Wainwright keeps Buy on Actinium amid 'headline disappointment'
H.C. Wainwright analyst Joseph Pantginis reiterates a Buy rating on Actinium Pharmaceuticals with a $65 price target after the independent Data Monitoring Committee recommended that the SIERRA trial continue as planned to full enrollment of 150 patients. The analyst attributes today's stock selloff to "headline disappointment" that the study was not halted for efficacy, despite the "strong" clinical efficacy and safety profile of Iomab-B to date. However, it is important to highlight that for this relatively small study targeting 150 patients in total, the statistical hurdle was quite high for this Data Monitoring Committee look, Pantginis tells investors in a re search note. The final p-value required for success still remains 0.046, adds the analyst. Pantginis continues to project a positive outcome for SIERRA and believes that the readout could come in mid-2021. SIERRA could deliver "game-changing therapy" for active relapsed or refractory acute myeloid leukemia, says Pantginis.
10:29 EST ATNM
Actinium selloff today 'clear buying opportunity,' says JonesTrading
JonesTrading analyst Soumit Roy reiterates a Buy rating on Actinium Pharmaceuticals with a $40 price target after the company announced that the Data Monitoring Committee recommended for the continuation of the Phase 3 SIERRA trial in active relapsed or refractory acute myeloid leukemia to completion. Actinium did not receive the unblinded primary and secondary endpoint efficacy data from SIERRA, Roy tells investors in a research note. Regarding today's stock weakness, the analyst says that given the "robust" efficacy data from SIERRA at 75% completion, there was expectations among investors that SIERRA could get terminated earlier before full completion. However , Roy points out that the Data Monitoring Committee's decision was based on less than two-thirds of the total trial size, so the trigger for early stoppage was higher than the two-times threshold for six month disease control rate at 100% enrollment. Most of the pressure on the stock today is due to selloff from retail investors and is a "clear buying opportunity," Roy says. Actinium shares in morning trading is down 25% to $8.04.

[Fosco1]

Okay,

As expected (and explained in previous post) we did not have an early termination for efficacy.

The good thing is that we did not have either early termination by the IDMC for lack of power. This was a possible outcome.

So the phase III trial will continue till 150 patients are recruited. This is the best possible outcome, the other and only one, as we explained in previous post, was for the trial to stop for futility in the control arm

The market does not like the news but the market was expecting something that could not happen.... what a shame and a waste of money : people just do not want to listen to things that don't please them ... In any case I would wait a little bit before buying back, the end of phase III is no way near with covid around
GL All
Fosco

[Kkhors]

Guess the extended time frame was considered worse than the positive results.

[svknight]

And yet the stock is down 20%.... go figure.

[Kkhors]

https://www.benzinga.com/news/20/12/18951029/actinium-reports-successful-pre-planned-ad-hoc-interim-analysis-of-phase-3-sierra-trial

[timberwolf7]

December corporate presentation... (new)


https://d1io3yog0oux5.cloudfront.net/_2f67d780b719265f184fcd94a8d0a877/actiniumpharma/db/206/944/pdf/Actinium_InvestorPresentation_December_Final_12.08.2020.pdf

[timberwolf7]

interesting 'market open' pattern that appears to be repeating itself..

Noticing that on the open, its been getting 'hit'.. but manages to recover most if not all by the end of the day.

So went back and looked at the chart for the prior 20 trading days and around 13 of the last 17 show this pattern of drop on the open, and recover thru out the day...

also notice that they now list 13.5 Million shares, up from the 11 Million or so post the r/split..

but on a bigger chart picture, from the Sept low of around $8 after the r/split, it is above the r/split price of around $10/sh...

so all in all its 'holding its ground' for the moment...

but just thought I would mention it, cause again this morn, it opened up with a drop on the open...

wonder, did they have an ATM authorized... too frigging much going on to remember all the details anymore (smile)

[timberwolf7]

Going thru their website this morn...

and after reading thru some of the items on there, the CEOs 2020 letter and I am a wondering if this has a lot more potential than I had realized. My primary interest has been on their PH 3 and its potential to 'make things' better for those needing a BMT..

But their AWE program... was aware of it, but reading some of the write ups this morn..

and it was the CEOs letter... really 'upbeat' about where they have gotten to now...

going to keep selling the calls on a monthly basis... and do some deeper digging and paying attention to those PH 1s as they wrap up, something I tend to gloss over other than the aspect of whether or not they passed and any reasons to be concerned the PH2s might not make it..

[timberwolf7]

IBB and XBI

these two big bio sector controlling ETFs have had one heck of a run since the beginning of Nov..

Due for a 'correction/pause/basing move' already...

Only concern is, while ATNM hasn't really been 'pulled' along with them during this ride, if the sector takes a hit/pullback, whats ATNM going to do.. down 30 cents or so as I type..

[timberwolf7]

New PR from ATNM... this comment in the write up caught my attention. Is this field really growing as they imply, ie, not a niche market, and saying they are the 'leader' rather than just one of the 'players' in this sector??
hadn't ever thought of them being a buyout candidate before this was said... ok, back to my regularly scheduled program of seeing them complete their PH 3...

https://ir.actiniumpharma.com/press-releases/detail/384

"Targeted radiotherapy is witnessing a renaissance driven by strong clinical data emerging in multiple indications. This has resulted in acquisitions, new company formation and investments in new targets to pursue with radiotherapy," said Sandesh Seth, Actinium's Chairman and CEO. He continued, "Actinium is proud to have not only established ourselves as a leader in the targeted radiotherapy field and is the only company pursuing well validated targets in hematology with late stage clinical programs.

[timberwolf7]

for me, ATNM is not:

-a sexy development that wall street can super hype up like a diabetes, cancer or Alzheimer development. So its not one I have seen get a lot of attention since I first got into it in 2016 (note, till the r/split, I was trading runs for gains if I could time it, and then reload. So made something while it was essentially running flat)

-its not even a NEEDED product in that its filling a 'hole' in the health care system. To me, its a BENEFICIAL development, its making something taking place more effective. So its not going to get a lot of attention from the aspect that 'look at how big its market' will be either.

Concluding this way back in 2016, my goal from buying a lot at an initial cost basis of 25 cents, was to see it get to $3/sh on FDA approval. Now that doesn't sound like a lot, but for the share count I was planning on having, $3 was very achievable as most drug approvals see their share prices get caught up in a momentum run with $5-8 at least achieved (before folks start to question things like sales, revenues, etc)

Now? with only 11-14 Million shares outstanding? That $3 target would now be $90, cut that into a 1/3rd to be more 'reasonable' market cap, and its still around a 200% return from this price level.. I can live with ATNM being a little quiet while it finishes up. Especially since I am selling covered calls while I wait.

So to close, is there something nefarious going on? Don't know, but again, I am using Dec 2021 for the completion date of the PH 3 and because of some chatter from management themselves, kind of wondering if there might be a surprise forthcoming (smile).. (as I got on CRMD (Ph 3 halted at the interim/halfway point because of the results) which has an FDA approval date of 28 Feb, current share price of $8.5, expectations of $20-25 based on potential sales, $30-40 if they get approval to expand their market to another sector that shouldnt' require any additional trials because of the identical usage the product would apply to)

[BrownCornSnake]

Is the ad hoc definitely in December?