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All I can say, is at least they are being honest.
Sold everything. About an $18k loss.
Might buy post-RS drop. Just to see if they can actually do a RM or acquisition.
But that stung, in the tip of my…
Agreed - very shady stuff was done. Even with those folks who did the deeds gone, it's going to be extremely hard for them to recover any real value. And pushing for a R/S to get - back into good graces with the trading platform is another bad sign.
Also - that bit in the letter about merging into another corporation also has a stench about it. Nothing good is going to happen in anything like a reasonable period of time.
Time to cut losses. Luckily have some gains from elsewhere that a tax-loss here can help offset.
Todays news tells us that this has been a fraudulent company from day one.... time to just keep and eye out for the numerous lawsuits that will be filed in the next couple of weeks..... Be a while but I am sure we will all get our bread crumbs of penny's on the dollars when the dust settles.
Very sad day for all who had faith in this.
I am out now and the reason is once the RS is completed, there will be really nothing to hold it up... They will be around $2.00 give or take and will drop from there in time... an announcement of them returning to Phase III with the OAK trial will keep it trading at that level....but the longevity of the re-trial will have it drop... thats when I will get back in... I will try and judge the lowest I think it will go and then buy as much as I can depending on my status when that happens....
I still feel this will be a very successful drug when all of the mistakes are corrected and it gets approved... which it will... only now we are looking at 2024 IMO
Best of luck to you as well...
If you looking for a bounce play in the biotech world look at VTGN... it has taken a major beating today, closed yesterday at $1.13 currently at .15, on a phase III results... but with two other in the pipeline and the problem with the drug that failed fixable it too will bounce back IMO... strictly my opinion nothing really but my DD to back that up with.
Good luck to you.
I expect the split sometime in November, keep an eye on it as you might get a seriously low buy point to hold into the phase III (eventual) trial.
Basically only done to keep the NYSE listing requirements, not for dilutive purposes.
Will continue to hold for now, as I don’t currently need the tax loss. I can always take that when needed.
Likely I will average down on any decline.
I am thinking along a similar line.
I recently took some gains elsewhere. Will probably liquidate some losses & regroup & Ampio is probably one loss in the near term.
These biotech companies are starting to act much better when they have good news, I have six biotech stocks and every one of them is up! We may have seen the bottom in biotech
Some will say its just an authorization to do a RS... for me thats all I need to hear... as they have stated if they do another phase III it will be a two year venture, I will of coarse be back in at some point in time... Good Luck to you as well Limey
Shitty news....best of luck
So long everyone, best of luck to you all... I will be removing myself as mod as I have just finished selling off my holdings.. RS is not what I want to go through. Its been fun and we should have all been dancing in the street now but alas thats not how it always works out.
You are right, plain and simple the positive numbers were not far enough in front of the other options that are currently out there to warrant spending any more money on it. Plus Covid is going to be more under control now then it was when they first started. I am hopping they use their funds to find ways for it to work on other more predominant lung and breathing issues like COPD, Asthma and raspatory failure brought on by other issues.
People are going to see several up ticks and sell offs as we move forward. There is still the investigation to be delivered to shareholders, still a decision on how they will handle a re do on the Phase III trial.... if they do the complete redo on the Phase III its a two year process... and that is what I hope they do... if they do that they will have a much better shot at getting an approved drug that will be worth millions. Short cuts like they just did with the un-blinding of the data almost always dont sit well with the FDA.
Some may do it and some may not, but its going to be an opportunity to flip this over the next several months... Good Luck To Everyone as we move forward.
I'm guessing they said it 'didn't' work against COVID because the larger data set just didn't have the numbers to support saying otherwise, rather than trying to shift blame to problems in getting patients. I actually view their straightforward & no nonsense statements in that letter rather than trying to blow smoke at us.
There may have been small effects in the tests with COVID, and they specifically state something about trends in the secondary pre-specified endpoints in the letter, but they didn't have the statistical power (technical term - not just 'power') to resolve small effects from background noise.
I just hope that this regrouping and refocusing works, and that they can pick a focus for the near and mid future, and get the work done and done correctly next time out.
One thing that still doesnt make sense is them saying that it didnt work in COVID. That just bothers me. They easily had the narrative that they couldnt recruit patients but why say it doesnt work. I feel that was a rookie mistake.
I think they would likely increase the AS long before considering a split.
Under 300 million AS.
Good to know company has sufficient cash available for the months to come and at this point this price level could be interesting, but assuming the scenario that company can be avoided using RS in the future
Hard to say what the outlook truly is, but at least at 12 weeks Ampion showed significance.
Saline is an active therapy, and a useful one for inflammation, both in joint and prolotherapy.
I remain hopeful.
As just a trading thought- I see these levels as a gift.
Any future trial initiation gets us moving to .50+ again, and hopefully $1-2 as trial progresses.
With that mindset, I’m still a buyer.
Agreed. Clear and to the points. Doesn't really make excuses or big promises. The company may still be screwed in the long run, but it's clear where they think we are.
Interesting push back above some resistance.
Can't find anything why are we up right now? Anyone?
Ampio Pharmaceuticals CEO Mike Martino Issues Letter to Stockholders
4:30 PM ET 6/2/22 | Dow Jones
ENGLEWOOD, Colo., June 2, 2022 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunomodulatory therapies for the treatment of pain resulting from osteoarthritis in the knee and potentially other articular joints, today released the following letter to stockholders from its Chief Executive Officer, Mike Martino.
Dear Fellow Stockholders,
On behalf of the board and management team, we appreciate the support and patience you have demonstrated over the last several weeks. The purpose of this letter is to answer the questions we can currently answer in the context of our previously announced process to evaluate strategic alternatives for Ampion(TM) and Ampio. It is important to note that we won't comment about the earlier announcements regarding personnel and governance changes. Additionally, this letter does not address the previously announced internal investigation, which is ongoing. We know these questions are top of mind for many investors, but we simply cannot speak about these issues at the present time.
I would like to start with AP-013, a randomized, saline-controlled, double-blind Phase 3 clinical study evaluating the efficacy of an intra-articular injection of Ampion(TM) in adults with pain due to severe osteoarthritis of the knee ("AP-013") and key steps we are taking to determine if it's appropriate to conduct an additional trial or set of trials. Let's start with the evidence we have reviewed from the trial results. Compared to baseline, Ampion-treated patients have shown clear evidence of reduction of pain and improvement in function as early as 2 weeks after dosing which lasted up to 24 weeks. However, the saline control that Ampion was evaluated against in AP-013 and earlier trials is an active control, not a placebo, and it showed benefit as well. As a result, the pre-specified intent-to-treat population analysis of AP-013 did not demonstrate a statistical benefit of Ampion when compared with saline on either pain or function over the 12-week efficacy analysis period. According to the agreed upon Special Protocol Assessment ("SPA") with the United States Food and Drug Administration ("FDA"), the AP-013 trial was required to demonstrate a statistical benefit of Ampion when compared with saline on both endpoints (i.e., pain and function).
Additionally, while the per-protocol analysis of AP-013 was initially encouraging, additional scrutiny of the data and methodology supporting the analysis showed that the per protocol analysis was flawed. In particular, that analysis disproportionately captured the best performers from the Ampion-treated population and the worst performers from the saline-treated population. This is purely the result of applying the major protocol deviation criteria included in the protocol. However, the resulting per protocol analysis cannot be used as a basis for submission of a biologics license application to FDA.
On the positive side, we have reconfirmed that the AP-003-A trial, which reflected an enrollment of 329 symptomatic moderate-severe osteoarthritis of the knee (OAK) patients, demonstrated a statistically significant decrease in pain at 12 weeks compared to saline (p=0.004). Additionally, Key Opinion Leaders we've consulted with remain optimistic about the potential for designing a clinical trial that can show a beneficial effect, but there are obviously challenges that will need to be evaluated and weighed against other potential strategies available for Ampion and Ampio as a company.
We now have data in more than 1,500 Ampion-treated participants, and a like number of saline-treated patients, and we are merging all the data into a meta-analysis to inform potential designs for any future trial that we may conduct. We believe this will increase the probability of designing a trial in which Ampion may achieve a statistically significant benefit, and all design elements of the trial are currently under review, including endpoints, the statistical analysis plan, inclusion/exclusion criteria, improved subjective methods for evaluating pain at baseline, and trial monitoring and reporting elements.
It is also important to remember that AP-013 was intended as a confirmatory trial to AP-003-A. If our trial design is substantially different from our previous trials, we may be required to perform two pivotal trials.
Additionally, the trial may need to be conducted under a Special Protocol Assessment (SPA) with FDA, with an agreed to statistical analysis plan. Until we gain more regulatory clarity, partnership discussions are understandably on hold. However, several potential partners have indicated their willingness to re-engage once we gain that clarity. The potential need for two pivotal trials, the regulatory pathway, and partner interest are among the top factors that we are considering as we evaluate our strategic alternatives.
Moving on to the COVID-19 program. As reported in May, we have found no clinically meaningful treatment effect signals from the Company's three COVID-19 clinical trials; AP-017, AP-018 and AP-019. In other words, we were unable to detect a statistically significant difference between Ampion and placebo for the primary endpoints of the trials, which were mortality and time to mechanical ventilation. Signs of potential Ampion benefit were seen in a few prespecified secondary endpoints. However, most of the secondary endpoints did not show a treatment benefit.
How did we go from "positive results" for inhaled Ampion in the 40-patient AP-014 trial to "no signal" in these trials? In general, small exploratory studies may show a large treatment effect because of the small denominator and should always be viewed as hypothesis generating rather than definitive. Historically, across all drug development categories, only a minority of phase 2 trials can be confirmed in larger phase 3 trials. This is the reason why FDA requires two successful pivotal phase 3 trials. Specific to Ampion, the AP-019 trial enrolled 129 participants and could not show a beneficial effect of Ampion compared with placebo as only 3 deaths or progression to respiratory failure occurred (the original primary endpoint). The AP-017 trial which studied intravenous Ampion compared with placebo enrolled only 35 participants and had a very slow enrollment rate. We determined that the evolving treatment landscape combined with the reduced incidence and severity of COVID had significantly curtailed our ability to enroll the required 200 subjects and, as such, the trial was closed because of the projected time to completion and financial commitment. AP-018 was a small Phase 1 study to document safety that enrolled 32 patients and failed to show a benefit.
Given these results and the changing Covid treatment landscape, we believe it would be an unwise use of investor funds to continue the COVID-19 program at this time. As a reminder, AP-017 and AP-019 were initiated on the premise they might support an Emergency Medical Use Authorization (EMUA) in what was then a bleak landscape for Covid treatments. However, several treatments have recently been approved for the treatment of COVID-19, including antibodies that inactivate the SARS-cov-2 virus that causes Covid, as well as drugs that prevent viral replication, and corticosteroids that have demonstrated a reduction in the severity of the disease. Additionally, the prevalence of vaccines and multi-shot vaccination protocols and the diminishing severity of emerging variants of Covid-19, such as Omicron, have all converged to confer immunity and reduce the number of ICU patients requiring respiratory support. These developments make Covid prevention and treatment a very crowded competitive space in which Ampion simply hasn't demonstrated sufficient benefits to be competitive.
I would like to highlight the following positive takeaways which should not be minimized. We now know that nebulized (inhaled) Ampion has an excellent safety profile, which can potentially open up additional target indications that involve lung inflammation which are potentially more promising than COVID-19. Additionally, we have been issued four significant patents in the space. If, how or when we continue to pursue development of Ampion for treatment of respiratory inflammation has yet to be determined; although, I can say it is not a near term project or priority.
Turning briefly to the financials, as of March 31, 2022, we had $28.8 million of cash and cash equivalents. We will be burning $1.2-$1.3 million per month through September 2022 primarily due to required close-out costs for all prior trials, both OAK and COVID-19 related. After September 2022, we project a burn rate of approximately $1.0 million per month, which we will seek to trim further (though as previously mentioned, Ampio is a very lean organization). Based on our current cash position and projection of operating expenses and capital expenditures, we believe we will have sufficient liquidity to fund operations into the second half of 2023. However, this estimate does not include the cost of funding new trials or programs or any other strategic alternatives nor any expense reductions. Rest assured we will be taking a very hard look at any additional expenses prior to committing to them.
To conclude, we are working diligently to evaluate all options to deliver value for stockholders, including but not limited to, additional trials for Ampion, evaluating other opportunities in our pipeline, leveraging our bioprocessing capability, and considering business development opportunities. We look forward to providing you future updates as our evaluation of these alternatives continues.
About Ampio Pharmaceuticals, Inc.
Ampio Pharmaceuticals, Inc. is a biopharmaceutical company primarily focused on the advancement of immunology-based therapies for the potential treatment of multiple inflammatory conditions (e.g., osteoarthritis of the knee (OAK) and other articular joints). Ampio's lead drug is Ampion(TM).
Forward-Looking Statements
(MORE TO FOLLOW) Dow Jones Newswires
June 02, 2022 16:30 ET (20:30 GMT)
Not sure the CEO who has been running this for the past 6 months is the guy to get us across the finish line... I preferred Mike the old CEO over this guy, lets remember it was under the current CEO that the submission that was rejected by the FDA happened. But not sorry to see the management that they let go leave either.
Wow lots of big wigs getting the axe today.... Maybe we have enough money to finish the trial now haha
There are some big buys going thru moved from 17 to .20+ rather quickly...
Looks like they... the MM's.... are playing games with it.... doing the something today as it did on Friday... moving up and then falling back down.
Hopefully the bottom is in. We need to retake and hold .53.
Never mind nothing seems to be happening... no news anywhere that I can find.
Maybe something coming out soon... been a surge in buying just now almost 300,000 shares in the past twenty minutes
I sent him an email but received no reply back... yet. I agree with you, if any long time investors recall Mike never wanted to go for a BLM he want to do the trials until we were ready for submission as a approved drug. He would not have allowed this mess to have happened.
If old CEO steps back in, we see .50+ in short order.
I have no rumors on that though
It is a pity! a good product performs for bad management, thanks for your value comment
At this point we are just awaiting the internal investigation as to why this idiot CEO unblinded the results from the previous trials only to get kicked in the nuts by the FDA... they should have known that the partial results from the trial that was halted because of the Covid outbreak would not be accepted. I think many are thinking and wanting the same thing I am... that is they boot this clown CEO out and we put our assets up for sale and Ampio is taken over by a real pharma company, we get a bump up on that news and everyone can walk away with a some type of profit.
We are selling for 15 cents share... this has no hope of recovering enough to save it in the next two years...which is how long a new phase III trial for OAK would take.
Is possible to maintain these cheap declining prices during the long new OAK third trial for the months to come into Major exchange without making RS? Can the final clinical trial give the chance to be in NYSE no matter the time of the downturn pricing? At this point, this PPS or less seems attractive assuming the trial in the future would be approved but in case management avoid splitting!
I'll lose money at 70-80 cents - but not nearly as much as I would at 20 cents or less. I'll take the loss at that point and take whatever's left and head on to the next thing with it.
Oh well - that's why you should never invest with money you can't afford to lose.
I am actually impressed with how this traded today.... the Covid aspect was a bust, but thats what trials are for... what we are looking at now is for someone to come along and swoop this up. The clowns running this have no chance of surviving, but the product for OAK is real a mid size pharma would love to have it in my opinion. I think if we see continued buying over the next week or so we will get a price close to 75 or 80 cents a share on a buy out. With all of the averaging down there will be a lot of folks here who can make a profit.
Yeah,.... That ain't good.
I didn’t hear or read. What was the iceberg?
Well based on the Q and the PR on the internal investigation it would seem as if we have "Hit An Iceberg" and the ship is going down.
This whole wretched quarter is on the new CEO, he could not have f**ked this up any more if he had tried.
I’m not sure at this point. Hopefully not another NVTR implosion.
Hourly is a qualified yes. Ideally, .22 holds as support. If not then the lower BB, currently .21 needs to hold with it continuing to curl up. Also need a higher high.
Daily has some positive aspects, but not proven yet. Price is still stuck at or below all moving averages. Volume needs to increase, particularly on the buy side, which it is making an attempt to do. Would like to see today finish green and the volume bar taller than yesterday. Any closes below .21 likely signal more down and the trend continues unless just a one day or intraday occurrence. Just my opinion.
Good question. Hope all is well on your end. Green Trading
Before answering your chart question, I will pose one to you after the following statement.
Many companies fail to reach their potential because of poor management performance not the lack of a viable product.
Can the present management put the pieces together to make AMPE a success?
Cit, do the charts of the Great Chart Sage sayeth we’ve possibly formed a bottom?
Hoping that we just saw it find support a second time, but given the potential length of time until the trial I highly doubt it.
Holding further buys for now.
I’d they push this to single digits I’m going to increase to a 100k share position.
We’ll get a move to $1+ at some point.
Good plan best of luck hope it all plays out for you...
Yeah - there may still be some shorter-term upside (up from this low point anyway) if the COVID data show anything promising. I'm not selling what I am holding either for the time being, unless I take some profit elsewhere and decide to sell for the tax loss break before the end of 2022.
I've got another biomed (CVM) that 'could' take off this year, and if I start cashing some of that out, the tax-losses from AMPE could be useful to cut the tax burden. I won't take my eyes off of AMPE either, and if I do sell, it'll be with the idea that I buy back into incrementally sometime during 2023.
There will be a lot of folks doing the exact same thing...
There is one thing that can possible give us a boost in the PPS as we await this new Phase III trial.... Its the Covid aspect of their drug. For entire second half of 2020 and all of 2021 there were less then five pieces of information put out on the OAK aspect of the drug. The entire focus was on the Covid trials and how this it was going to be a game changer.... Then the new idiot took over and Covid was shelved and not a word as to what was going on with it for months... then on the last earnings call he said they were going to evaluate the data.
If the company can show us any positive results from the trials and possible give us an update on how the drug could be expanded to help other raspatory ailments besides Covid that could send the PPS back up significantly from its current .20 cent range.
Now mind you that would take a bit of intelligence to see that doing an update on the Covid side would indeed help us all... and frankly I dont think this CEO has enough of that, intelligence, to fill a thimble
Only watching this now. I believe in the product and will dive back in at a later date. Good luck all.
Well josey,most likely there will be you, me and a couple others here but it will take some time for more to drift in... I anticipate the next drop will come when the Q is released sometime next ,month..... my biggest concern is a RS being done by this twit.
But since its going to take 18 to 24 months that is something that will happen in the future... doing it now would only result in the PPS being sold back down to under a buck again... my guess is about half way through the trial once it gets under way.
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