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I've added this to the portfolio over the last couple weeks.
I see three outcomes:
1)crash and burn if the safety data is bad
2)multi-bagger potential if safety data is good and hence platform technology is valuable, but HepB is not successful
3)moonshot if HepB drug is successful and platform is as effective as it seems right now
Great risk-reward, IMO.
Prospectus presentation
Link
Some new material in linked presentation. I think it's a good idea that they have gone ahead and highlighted the platform possibilities as future upside (diabetes, etc.). Also, well done on management's part by highlighting the near term catalysts. This investment at today's price is very much like a venture capital investment in terms of getting in on the ground floor, but unlike VC the story has near term significant catalysts. The market likes platform stories as long as the payoff is not too far in the future.
Assuming the financing goes off at 10 cents and a 50:1 ratio, the stock will start out post-financing at $5/share and have a $35MM market cap. I think it will take little time at all for the stock to triple from there. That would be a $100MM market cap and still be a compelling investment story going forward. The old market cap high of $150MM should be well within reach prior to Phase 2b results ($22.5/share post-split and 45 cents pre-split. That's a 350% return from current levels inside of a year...
The thing to do is to separate the past and look at the investment going forward. The science is impressive and it's a new CEO going forward.
I will likely be participating in the offering or at least buy additional shares in the open market as I like the story still and the valuation is as good as it gets for new money.
I've been on board with this plan for 9 months now. Only wish they would have done it sooner.
The only real remaining question is the pricing on the financing and amount of dilution. Are current shareholders going to retain 50%, 40% or 30%? $25MM @ 0.15 share would equal 60% of new outstanding shares leaving 40% to current shareholders.
Just my gut feeling, but I think things will be looking much better for the share price in the coming months.
I don't normally sign over my shares unless I fully agree with the person that is going to speak for me. I have had philosophical differences with one of your group leaders. For example, the company absolutely should have done a reverse split and financing 6 months ago. It's obvious now, but your group was stupidly fighting that at the time.
Pretty much as simple as that. Too much I disagreed with...
That's right, the insiders are not able (even if they wanted) to buy right now with all the material, nonpublic information they have on the ongoing financial negotiations. However, it would be nice to see the management/board step up and put some skin in the game when the deal does happen.
Unfortunately, PYMX is out of time (and good options anyway) to try a more non-standard equity offering. Presumably, they have researched those options prior to this point and found them lacking. One of the problems has always been the lack of large investors and liquidity. Raising $18 million from small retail each year was never going to work. If PYMX is to continue as a going concern, Edward Smith (or a new guy) is going to have to be capable of attracting the larger investors necessary to get the company to the point where it can partner the products.
Letter from the CEO is on the PYMX website as the PR explains...
One of the potential scenarios that is coming within the month is a recapitalization (secondary offering). This would include a reverse stock split and the influx of at least $18.5 million in cash through the issuance of new shares. It's likely the new owners would own somewhere around 50% or more. So for simplicity sake let's just ballpark that the stock shows enough life and the new shares are issued at 19 cents and 100 million shares are issued to raise the $18.5 million. That gives current owners 50% of the "new" company and the new investors 50%.
Now the company has 200 million shares O/S versus the current 100 million. (ignore the RS in this thought exercise as it is immaterial to this calculation).
What is a company worth with enough cash to run two Phase 2 trials - each addressing a significant need with all the unique positives that all remaining investors here already know all about? Anybody could find lot's of examples of at least $100 million for companies with less potential - and it's not too hard to argue for a $200 million market cap. Obviously it wouldn't happen overnight as the new management would need to deliver on the plan and build confidence with the investment community, but say in 12 months right before the new trial results are released?
$100 million market cap would be 50 cents a share - back to a buck at $200 million mkt cap. The first target is not an unreasonable one at all. I still think a re-cap is the most likely course forward and I think it could make sense with the right man running the show (no comment on whether Smith is the man, although the letter today was a step in the right direction.)
Obviously a partnership would only further help the cause.
Could be interesting times ahead. Although could be worth nothing still...
Agreed, obviously. Although, usually they don't go to the trouble of going the interim route if a buyout deal is imminent.
I think it means a financing deal is planned. Good news for investors as that is not a bad route all things considered. Right now, I'd give up 50% of the company to go another year and see results on OM and the single dose ABBBSI trial. Not pretty, but this company was nearly ridden into the ground by poor financial management and our options are not that great right now.
Partnering makes sense as well, but that's difficult to pull off at these market cap levels.
Just my uninformed thoughts...
Nic is gone. Little disappointed the board didn't already have the new CEO lined up as obviously time is of the essence. Possible that the plan is liquidation, but why not just go ahead and do it already? Possible that a buyout offer is on the table, but then why wouldn't Nic stay another couple of weeks and finish it off?
Finally it's quite possible that investors have agreed in principle to invest capital in return for new leadership. That's the likely answer in my opinion.
Good news if that's the case even with some dilution.
Cowen and Company 33rd Annual Health Care Conference
Mar 4–6, 2013
Location: Boston Marriott Copley Place
------------------------
Polymedix plans to present again to the investment community finally. See above.
Here's a guess that they plan to have some sort of financing arrangements announced by then and hopefully clinical trials initiated as well or at least be imminent.
The time between clinical trials has taken way too long, but that can be forgiven with a reasonable financing/partnership and a successful single dose trial.
Time for action.
Lot's of people selling... This next month or two should be interesting as the company still has a lot of potential, but significant risk as to whether they can realize it. Should know something soon now.
Anyway, it's about time for some news regarding go-forward plans from the company. Q1:13 is here and they've got a ABSSSI Phase IIb and an Oral Mucositis trial to fund and get started. Both high reward programs for this mkt cap so we'll see.
Haven't sold a share, so holding for now. The position has become quite underweight due to the share price drop, but I am not adding until I see the forward plan and approve of it.
Almost go time, folks.
Yeah, I am still in the stock, just not on the board much any more. There's nothing really all that interesting to discuss. Just waiting for the financial situation to clarify itself.
Although, I do love the price action today! Maybe next week we will see some follow-through?
This was important news today as I was somewhat concerned about what the FDA would say about the single dose design. That is a big deal. Now let's announce a partnership and send the stock really soaring!
Updated corporate presentation on the website. Some new slides have been added and, IMO, it is well done. I continue to like the story and potential here. Just need to find the right investors. Whenever the funding concerns can be addressed the stock should have plenty of room to the upside. Cheap stocks can always get cheaper, but the risked valuation disconnect with the current market cap is pretty large. At the current price, I can even see an equity raise causing the share price to move up on the news. Anyway, ready for something to happen on the financing side...
We are probably still a few months out, but any guesses as to dosing in the 2b trial? Here's my guess:
0.4 mg/kg x 3 days
0.4 mg/kg x 1 day
1.0 mg/kg x 1 day (could also see this being 0.8 mg/kg x 1 day)
Enough to extend the runway into 2014. 35 million shares? It would likely be something like that. Maybe with the shutdown of 60056, expenses will be lower and $10 million will be enough. A reverse split would also be a part of it if I was running the company.
Then again, if I was running the company, I would take the best partnership deal I could get and move on down the road. Spend my time monetizing other assets that are currently being ignored. Do a co-promote deal and retain the option to build a sales staff with brilacidin. That way you build up the company slowly, but reduce the growing pains. Leverage that sales staff with follow-on products.
The financial uncertainty is what is killing the stock. Do something (partnership hopefully) and get brilacidin into that Phase 2b trial. ASAP.
Not anything earth shattering. There was additional information on the side effects and the fact all 6 patients came from 3 of 21 sites. Not hard to guess the implication there... It would be interesting to see if those three sites were E European or Canadian... Site 309 had 3 of 8 patients with it so something is clearly odd about that one.
Also a little more information released on the patient populations. As we knew already, the middle dose group sure had some anomalously high exclusions...
60% stock offering
39% partnership
1% begin Phase IIb trials
0% bankruptcy
It's also the first link in the latest press release.
Posters are now on website.
Phase IIa trial
ICAAC presentation from yesterday
ICAAC 2012 Host Defense Proteins
Very good summary presentation. Lots of information packed in for anyone interested. Phase II details are in poster today.
The market right now only cares about the finances, but we should be getting close to finding out about that too.
Regulatory path for pneumonia
Here's an interesting post from the Antibiotics - Perfect Storm blog which discusses the regulatory path ahead for antibiotics like brilacidin in the pneumonia indication. Also briefly discusses daptomycin and it's failure in pneumonia.
Rebooting Pneumonia at the FDA
I was recently invited to participate in another meeting with the FDA at the Brookings Institution. At the last meeting (summarized in a previous blog) Janet Woodcock made the extraordinary admission that the FDA would have to reboot in order to get antibiotic development out of the cellar in the US. Helen Boucher pointed out that this reboot would have to encompass all aspects of anti-infective development – both the traditional development pathways where FDA guidance has made development infeasible as well as identifying new pathways forward to address areas of key unmet needs for new antibiotics. Both Janet and Helen are right! I am hoping that this reboot will be a major topic of discussion at the upcoming meeting.
With that in mind, I have recently been considering what a reboot of the guidance for community acquired pneumonia trials could look like. Here are my thoughts.
First, rather than jumping into endpoints like symptomatic response at day 4 as the FNIH and FDA have suggested, lets step back. The justification for this entire step is to align modern trials with 80-year-old placebo-controlled trials to justify the NI margin. Of course, even with a staggering 40% treatment effect, we end up with a margin of just 10% - how did that happen? FDA magical discounting – that’s how. But the clinically relevant endpoint is cure at test of cure – when the patient is sent home needing no further therapy for their pneumonia. That’s the endpoint that patients and physicians care about – not whether they are feeling better on day 4 or not. What are the data that these two endpoints, for any given patient, are well aligned? Lets look at a pharmacometric analysis of the treatment of pneumonia in patients stratified by PORT score and determine the treatment effect in a modern context.
Then there is the issue of prior antibiotics. The FDA says none. This is based on the famous daptomycin trial. Daptomycin failed in pneumonia because it is inactivated by surfactant. Prior antibiotics masked, but did not completely hide, the inferiority of daptomycin to ceftriaxone in these trials. The FDA is putting all their eggs in the daptomycin basket with no confirmatory data. In fact, the data from the ceftaroline trials might argue that patients with getting prior antibiotics are sicker and do less well overall than those not receiving them.
But prohibiting all prior antibiotics makes trials potentially unethical – how can you delay antibiotics for very sick patients when you know this might increase their risk of mortality? It also makes it impossible to enroll American patients in trials – but these are the very patients the FDA wants us to study.
Europe (EMA) says prior antibiotics are OK – but wants sponsors to try and limit this to a single dose and they want to explore the effect of the prior antibiotic on the clinical response at the endpoint. Great – FDA – harmonize with Europe! Then lets explore (that is - it is not a review issue!) the effect of prior antibiotics in several trials and see where the data lead us.
So here is a potential design for the FDA (and EMA too) –
CABP patients as defined (EMA addendum)
The primary endpoint is clinical outcome at test of cure. The NI margin is 10% for the ITT population. One could add the identical endpoint for the microbiologically documented population with an NI margin of 15% with the population pooled over two trials as has been recently suggested by the FDA.
A secondary endpoint could be the clinical outcome in those patients not receiving prior antibiotics with an NI margin of 15%.
Exploratory endpoints could include –
Examine the difference in clinical outcome both at TOC and at the early 4 day endpoint between no prior and prior abx – both in control and test arms.
Compare the TOC endpoint vs. FNIH early endpoint for within patient and overall consistency.
These outcomes can be explored within the ITT and the microbiological documented populations.
This proposal recognizes the lack of clinical relevance for the early endpoints in community acquired pneumonia. It also deals with the infeasibility of prohibiting all prior antibiotics while exploring the effects of prior antibiotics on non-inferiority studies in this indication. The proposal allows for the development of oral-only antibiotics by allowing the study of less severely ill patients for those drugs. Currently, the development of antibiotics available only by the oral route is not possible at the FDA. And the proposal harmonizes the EMA and FDA guidances overall.
I hope we will be able to discuss this proposal and others with the agency at the Brookings meeting in August.
Malaria press release. Not material news to the near-term share price, but incrementally positive nonetheless.
PolyMedix and University of Pennsylvania Collaborate to Develop New Class of Defensin-Mimetic Antimicrobial Compounds to Treat
Today : Tuesday 31 July 2012
PolyMedix, Inc. (OTCBB:PYMX), a biotechnology company focused on developing innovative therapeutic drugs to treat patients with serious acute-care conditions, today announced that it has received the second phase of a grant from the National Institutes of Health (NIH). This grant will continue to fund collaborative work with Dr. Doron Greenbaum, Assistant Professor of Pharmacology at the University of Pennsylvania, to support the development of defensin-mimetic antimicrobial compounds for the treatment of malaria.
The second phase of this grant provides funding of up to $1 million per year for three years to support the discovery of a lead anti-malarial product candidate. This phase was awarded after the team of PolyMedix and the Greenbaum laboratory successfully completed a first phase which included generating proof-of-concept data for the defensin-mimetics through in vitro and in vivo efficacy testing. PolyMedix's defensin-mimetics rapidly target the digestive vacuole of the parasite that causes malaria, Plasmodium falciparum, via a unique mechanism distinct from other anti-malarial agents, essentially starving the parasite of food. The data from in vitro and in vivo testing showed PolyMedix's defensin-mimetics potently killed the Plasmodium falciparum, in infected human red blood cells, without damaging uninfected red blood cells. Encouraging in vivo activity was also seen with a potential lead compound on malaria parasite clearance and animal survival in a mouse malaria model. These data were presented by PolyMedix's collaborator on the grant, Dr. Doron Greenbaum earlier this year at the Keystone Symposia on Drug Discovery for Protozoan Parasites.
"We are pleased that the NIH has awarded us the second phase of this malaria grant," commented Dr. Richard Scott, Vice President of Research at PolyMedix. "This additional funding allows us to continue our preclinical testing with Dr. Greenbaum to develop a compound to potentially treat malaria, a major unmet medical need."
Dr. Doron Greenbaum, Assistant Professor of Pharmacology at the University of Pennsylvania, commented, "Resistance has developed to many current therapies for malaria. Targeting parasite membranes rather than proteins using PolyMedix's defensin-mimetics represents a highly innovative and novel approach for treating parasitic diseases. I look forward to collaborating with PolyMedix on this grant."
Malaria is a devastating global disease with up to 3 billion people exposed, and causes more than one million deaths each year as resistance to current therapies continues to increase. Malaria is caused by a parasite called Plasmodium, which is transmitted to people by infected mosquitoes. In the human body, the parasites multiply in the liver, and then infect red blood cells. According to the World Health Organization, the inappropriate use of antimalarial drugs during the past century, including poor management of use, deployment of drugs on a large scale and use as monotherapies, has contributed to the current situation of unacceptably high levels of resistance. This growing resistance to antimalarial medicines has spread very rapidly, undermining malaria control efforts.
The research described above was funded by the NIH, is solely the responsibility of the authors and does not necessarily represent the official view of the National Institute of Allergy and Infectious Diseases or the National Institutes of Health.
Editor's Note: Dr. Greenbaum has no financial interest or other relationship with PolyMedix, apart from their scientific collaboration.
About PolyMedix, Inc.
PolyMedix is a clinical stage biotechnology company developing a novel class of antimicrobial agents – defensin-mimetics, small-molecule mimics of host-defense proteins - for the treatment of serious infections. PolyMedix's lead infectious disease drug candidate is brilacidin (formerly PMX-30063), the first of this new class of antibiotics which imitates the mechanism of natural human immunity, and exploits a method of bacterial cell killing which has not shown bacterial resistance in multiple preclinical studies. Brilacidin has completed a Phase 2 clinical trial in patients with acute bacterial skin and skin structure infections (ABSSSI) caused by Staph aureus bacteria, including methicillin-resistant Staph aureus (MRSA). In the study, all evaluated doses of brilacidin showed efficacy comparable to the active control and were safely administered.
PolyMedix's product portfolio also includes its PolyCides®, antimicrobial additives to materials, such as cosmetics, plastics and textiles, to create self-sterilizing products and surfaces, and delparantag (formerly PMX-60056) and other preclinical anticoagulant reversing agents. PolyMedix's compounds have been internally discovered using a proprietary drug design technology.
For more information, please visit our website at www.polymedix.com.
I don't have an opinion on the long term potential of this approach. However, as far as competitive threat is concerned regarding Polymedix, I have no concerns. Ten years down the road (when this approach could potentially be approved) brilacidin will either be entrenched as the drug of choice or it won't be, but that will be based on the merits of brilacidin without regard to anything that is not already in the clinic.
Even more generally, I am not really concerned with any other product out there. There is a need and market for multiple antibiotics. Brilacidin just needs to prove up it's own potential without stumbling along the way for commercial success.
Most antibiotics struggle with differentiation, but brilacidin should have plenty of angles to profitably differentiate itself. Single day dosing is one of those angles I am very interested in, for example. They just need to prove it works and we won't have to worry about any other competition.
Another source of optimism to me is the continued rapid growth in antibiotic sales in the emerging markets. Antibiotic sales in these markets have already outpaced the US market by over 30% and are rapidly approaching the point where they will be equal to Europe and the US combined. These markets will become more and more attractive to companies who are poised to exploit them. This indicates that more companies will re-enter the antibiotic R&D arena as Sanofi-Aventis has recently done.
On Sepsis...
Phase I clinical results showed that it was possible to safely administer PMX-30063 without any serious side effects at single or multiple doses that exceeded those associated with full efficacy in animal models of infection. PMX-30063 has been shown to be effective in a variety of rat and mice models, including the thigh burden model, sepsis model and granuloma pouch model. Compared to vancomycin, PMX-30063 showed comparable to greater efficacy.
That would certainly be an interesting target. I'm not sure brilacidin wouldn't have a reasonable shot itself at showing efficacy if used early enough. Management keeps talking about bacteremia as an objective and that can be a precursor to sepsis. Couple that with the anti-inflammatory properties of brilacidin and you might have a drug that is better than placebo.
I haven't heard this target discussed, but maybe a future indication is a possibility. That's one of the exciting things about this drug and technology...lot's of potential uses and upside! Who would have thought that gurgling brilacidin would potentially help with oral mucositis? Not nearly the same stretch for me to see brilacidin help with sepsis.
The next few years should be very interesting...
I've got no problem with questions and yours don't seem foolish. My question to you was serious as well. I wasn't sure if you had looked into the overall cancer potential. I just remember from an annual report or somewhere that they have investigated cancer potential before. And I have seen cancer-related patents for PYMX, but couldn't tell you the MOA or anything about them.
I have not been a long term owner of this stock either. I bought in last August. Almost one year, next month.
It's interesting from a science perspective. Question for you: do you know what is different about it from the other cancer patents they have? I have done nearly zero research into their cancer potential outside of oral mucositis, so not sure what's new. It seems like antiangiogensis was the prior target, so they may have a few oars in the water in oncology... But the cash flow potential is way too far into the future to influence stock price for the next 3 years at least.
However, skimming the patent you linked, the broad spectrum of susceptible cancers and large markets were intriguing. The selectivity struck me as low, but not too sure about that one way or the other.
Could be promising in 2015 when brilacidin is approved by the FDA and investors are looking for what's next.
I am personally going to try to get a small licensing deal done for a specific product from them..
lets see the results..
keep you posted
Just because I am buying doesn't mean I am extremely confident in the outcome. It's a calculated bet. I haven't seen any more safety data than you have.
It is still between a 1% and 2% holding and I have no plans to increase above 2%. Like you, I've already got enough personally.
Not sure this sell-off is illogical. Like I said, I expected the long, slow, quiet summer to cause lot's of panic and selling in August. People eventually give up. It either happened early or it could base at these levels or lower for another 8 weeks. I am looking for a rebound in September and later when ICAAC and the other conferences roll around. We should also be getting more news flow at that time regarding additional clinical trials. Hopefully a big partnership around that time as well.
Just to be clear, this is a risky stock. I wouldn't put too much of my portfolio into it or any other single stock. It's hard to come back from a 50% crash in the overall portfolio... My fund is having a pretty good year, so that also makes it easier to add at times like these.
Somebody finally decided enough was enough? Maybe somebody became disillusioned with the chances of Bo's shareholder committee getting 50% of the voting shares? Margin call from the general market decline and this was the best stock to dump for somebody for tax purposes? Technical trader playing the breakdown of $0.30? Somebody making a bet that there will be an equity financing soon?
Don't know. Don't really care. I am going to use this to finish adding to my position if I can. I figured the capitulation sell off would be later in the summer (August), but this is going to be good enough if it stays in the low 20's for awhile. Bought another 159,000 shares so far...
What would you define as the west? I assume you would include Canada and the U.S. Would you also include Europe? Australia? Any former Soviet countries?
My estimate of the sale price would be $.40 to $.50, which would leave most of us in the red, in my opinion.
torpedoes, I don't have any idea. It's pretty common now days, so I would guess not. I don't think the FDA has a problem with it either, especially in Phase 2 trials. I was originally concerned with the idea, but I've come around based on the type of trial and endpoints. In my opinion, Bocamp on the Yahoo board, is overstating the concern. This is not an obesity, depression, alzheimer's, etc. trial so to get too worked up about it is off base. And large shareholders already knew it was going to be predominantly E European before the results, so to insinuate that is the reason for the sell-off isn't right either.
The advantages to doing it in the West that I completely agree with are two-fold 1) better compliance and 2) higher percentage of MRSA patients. I am particularly fond of point 2 as brilacidin could perform much better than daptomycin in that population group. We are likely looking at increased timelines and costs as the downside. I am neutral regarding the locality of the next Phase 2, but the large pivotal trials need to be in the West with the higher MRSA populations.
Europe Leads the Way!
The European Medicines Agency (EMA) has just released their long-awaited addendum to the antibacterial guidance they released late last year. It is an amazing document compared to the guidance documents released in the last few years by the FDA in the US. Clearly, this was the work of a very thoughtful group of smart individuals who kept trial feasibility high on the priority list of considerations. They also worked hard to avoid the FDA trap of justifying non-inferiority margins at the expense of real-world considerations like trial numbers and endpoints.
In general, the EMA addendum uses clinical response at test of cure as their endpoint. No fuss, no bother. Their suggested non-inferiority margins for various indications are as follows:
Complicated UTI – 10%
Community-acquired Pneumonia – 10%
Complicated Skin and Skin Structure Infection – 5-10%
Complicated Intra-abdominal Infection – 12.5%
Hospital-Acquired Pneumonia and/or Ventilator Associated Pneumonia – 12.5%
In my view – these trial designs are all quite feasible in terms of patient numbers with two possible exceptions – anything less than a 10% margin (the 5-10% for skin infection) is probably not realistic and 12.5% for HAP/VAP is, in today’s world, is also probably not feasible. There is even a feasible pathway forward for an oral only antibiotic for community-acquired pneumonia - an option that does not exist at the FDA (at least for now).
The EMA allows for up to 24 hours of prior antibiotic therapy within the 72 hours prior to enrollment. They recommend that only a single dose be allowed for UTI and CAP patients – but that is still quire a feasible approach and stands in stark contrast to the FDA. The EMA also suggest that sponsors perform an “exploratory” analysis of patient who received and did not receive antibiotics. This suggests to me that this will not be a review issue at least for now – but it behooves sponsors to confirm this during their discussions with the EMA.
In another amazing coup – the EMA recognizes the efficacy of antibiotics for Acute Otitis Media in children similar to those studied in two placebo controlled trials as published in the New England Journal last year (see my blog on this). This means trials (non-inferiority design) for antibiotics can once again be carried out in children with AOM – a situation that was going to be impossible under the requirement for a superiority design. This is a critical move on the part of EMA because it opens an entry indication for treatment of pediatric infections that has been unavailable since 2003 or so.
Finally, in another startling development presaged by their general antibacterial guidance, the EMA opens the door for various superiority or open enrollment designs for the approval of agents rarely causing infection where the medical need is high. This will include antibiotics active against specific pathogens where resistance is a major problem and antibiotics tackling key resistance mechanisms that may still be rare today. In their addendum, the EMA clearly recognizes the difficulties in carrying out such trials and the inherent risks in approving such therapies, even with a limited label, based on small numbers of treated patients. But they also recognize the public health risk of the lack of antibiotics to address these highly resistant pathogens and are paving a pathway forward for sponsors to develop these needed products. The EMA notes (as does the FDA actually) that it is up to sponsors to come forward with specific proposals – but this addendum clearly shows that the EMA is open for business and, more importantly, for protecting the health and safety of patients around the world. The FDA has to reboot their entire approach to achieve what the EMA has already done – and we’re not there yet!
So – the antibiotic waters in Europe are warm! Come on in!!
Next week – the Innovative Medicines Initiative explained.
Posted by Antibiotics - The Perfect Storm at 10:58 AM
I hear you. More times than not, the market is right.
The full analysis of the Phase 2 data this fall hopefully puts to rest any lingering concerns regarding the safety data. That's the main risk outside of financing that I am concerned about.
Folly, I agree with you that we all want the same thing here and that is to see the share price increase substantially from these levels!
what I would like to see is a group of PYMX Shareholders get together and make a takeover bid
Folly,
This is not close to an effective way to wake anybody up. I know you live across the pond, but over here the whole class action system has run amok. It's a complete and gross waste of resources, that primarily exists to feed the leeches. Nothing good will come of this for shareholders. I just did a quick search looking for an Economist article I had read recently and came across this one that references the one I was looking for. Class Action Lawsuit Epidemic
With that said, the good news from a shareholder standpoint is that it has no chance of going anywhere. The lawyers will get bought off for $1.2 MM or so and go on their merry way. No chance in hell anyone can prove statistically that the trial should have been shut down earlier. They didn't even enroll 40/18 patients yet in the two trials and had varying dose levels for the ones enrolled.
Carl Icahn-type pressure exerted towards a partnership/buyout may be needed in time, but a class action suit will get us nowhere. It doesn't even help if you are the vindictive sort as this won't touch management.
I am comfortable slowly adding to my position and waiting a few more months to see what kind of progress management can make on a partnership. It's time for a partnership and I think they know that as well and are working towards that end.
I think brilacidin is approvable with the data we've seen to date. It needs to be confirmed in larger trials, but that's always the case at this stage of drug development. What's not always the case is a true potential blockbuster drug (>$1B annual sales).
Bankruptcy is highly unlikely. (IMO) But it is a risk that shouldn't entirely be discounted.
Equity dilution is the risk I am worried most about. Or the fact that since PYMX has limited financing options, big pharma decides to play extreme hardball on the partnership negotiations. This drug should command a premium in the world markets which should make it attractive as a partnership candidate, but partnering is sometimes a crapshoot.
Odds that are worth what you paid for them:
30% chance of limited dilution (large int'l partnership, other licensing opportunities come to fruition) - 10-20 bagger in 3-4 years
60% chance of heavy dilution (current owners reduced to fraction of ownership in future operating cash flow positive company) - fraction of 10 bagger in 3-4 years
10% chance of bankruptcy in less than 3-4 years
Oral mucositis is still risky, but the antibiotic has a low risk of both commericial and regulatory success, IMO.
I still have a hard time grasping why PYMX stock price is so low. The risk to rewward ratio seems so enticing. The 30063 market seems so large that it's worth a bet for pennies a share that the drug really works.
What am I missing? The Phase II results overall were positive and the stock dives?
Do you think it's is something that management is just not telling us?
HansG- Unfortunately, no, 30063 does not show activity against tuberculosis. The lead compound there is PMX-10070.
In this message board intro, I linked a post on Other Opportunities - XDR TBR that includes a couple of links to the 2009 PYMX presented data on tuberculosis. It seems to me PMX-10070 could be a big moneymaker since resistance is such a big deal for that disease and the overall market is huge in China/India.
Antibiotic Investment - Alice in Wonderland!
Perfect Storm Blog
I spend a good deal of time talking with investors and even more time with pharmaceutical companies large and small and with the regulatory agencies. I am beginning to notice a trend among the three groups of clients that I would like to share.
In the antibiotics world, there seem to be two general classes of investor. There are those who want to invest in “early” stage companies – usually preclinical through phase I – and those interested in “late” stage opportunities – those that are phase III ready or even later. Everything in between is up for grabs between the two groups and depends on the size of the fund, experience of investors and, in fact, the financial situation of the opportunity.
But I am always confused by all this. Take Novexel for example. Novexel was acquired by Astra-Zeneca for up to $500MM prior to completion of its phase II trials – so the acquisition was based mainly on preclinical and phase I data. There is still the possibility for such acquisitions to occur given the reliability of these early data. In fact, Novexel raised a late round of funding during the phase II trials to position itself to be ready to go to phase III but also to strengthen its negotiating position during potential M&A discussions. Two new investors came in at this point and did very well since the AZ buyout occurred within about a year to their investment. Is Novexel an example of something between early and late?
The world is now about to completely change. It is clear, at least conceptually, that there will be a regulatory pathway for the development of antibiotics for “unmet” medical needs. For me, this means the treatment of patients with serious infections caused by pathogens resistant to reliable efficacious therapy – so called extensively-resistant or pan-resistant strains of Gram-negative bacilli. The development pathways being discussed would allow for rapid testing of a small number of such patients leading to some sort of approval with a restricted label. At the same time, companies would have to demand a high price for such products since the target population will be small and therefore the margin for each course of therapy would have to be high. Have we seen this approach before? Of course – think oncology. But in the case of antibiotics – we can actually save lives whereas for oncology products we mainly prolong life by some rather small amount of time.
Every company and both the EMA and FDA are actively engaged in planning for the development of new antibiotics along these lines. Thus, this year, we will see successful negotiations on such trial designs in Europe certainly – but I am optimistic that we will see this at the FDA as well.
When I speak to investors, they seem completely unaware of this paradigm shift in the antibiotic world. They are still thinking about traditional “early” and “late” stage development. And, for some opportunities, it is clear that has not changed. But for others, the world is topsy-turvy. Early is late! So – investors – the antibiotic waters are warming quickly. Time to get wet! And not only investors – all you pharma companies that got out of antibiotics to jump into oncology – take another look! Antibiotics are oncology only better! BMS, Roche-Genentech, Lilly, Abbott, J&J, Novartis, Merck, - I’m talking to you! Pfizer – I think its not a good time to speak to you . . .
Upcoming Guest Blogs – David Livermore on Breakpoints at EUCAST and David Payne on Explaining the Innovative Medicines Initiative. Stay tuned.
New York City Sees A Rise In Community-Acquired MRSA
Link
Article Date: 14 Jun 2012 - 1:00 PDT
Hospitalization rates in New York City for patients with community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA), a potentially deadly bacterial infection that is resistant to antibiotic treatment, more than tripled between 1997 and 2006, according to a report published in the July issue of Infection Control and Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America.
Most cases of MRSA are acquired in hospitals, nursing homes, or other healthcare facilities. But in recent years public health experts have become increasingly concerned about MRSA infections acquired in community settings like homes, schools, and neighborhoods.
During the study period 3,579 people were admitted to New York City hospitals with CA-MRSA. The rate of CA-MRSA increased from 113 people in 1997, a rate of about 1.5 cases per 100,000 people, to 875 admissions in 2006, a rate of 5.3 per 100,000. Overall, about 20 percent of all MRSA hospitalizations over the study period were community acquired, the study found.
"These findings suggest a substantial increase in the rate of hospitalization with community-acquired MRSA in New York City since 1997," said Amanda Farr, MPH, one of the study's authors. This research was done in collaboration between the New York City Department of Health and Mental Hygiene and Columbia University's Mailman School of Public Health.
When compared with other hospitalizations in the study period, researchers noted that men, children, people with diabetes, people with HIV, and the homeless were more likely to be hospitalized with CA-MRSA than the general population. Residents of the Bronx also had substantially higher rates of CA-MRSA hospitalization than those of other New York City boroughs, likely impacted by a lack of access to primary care health services.
The authors speculated at the increased risk associated with these demographics and co-morbidities. Skin infections and sores are common among people with HIV and diabetes and could open the door to MRSA infection. Males and children may be at higher risk because they are more likely to play contact sports, which are associated with an increase risk of spreading bacteria. Persons that are homeless may have limited access to healthcare, as well as have other risk factors such as lack of personal hygiene and sharing personal items in shelter settings.
The findings suggest that public health efforts to curb community-acquired MRSA should be targeted to high-risk groups.
"Departments of health should educate homeless shelters about CA-MRSA, ways to recognize exposures that lead to transmission and signs and symptoms that should prompt people to seek medical care," the researchers write. "Programs to increase awareness are also needed in the Bronx and other high-risk areas to help residents and healthcare providers recognize signs and symptoms of early infection and implement prompt treatment as well as conduct proper wound care, especially in HIV-positive persons and those with diabetes."
The study reviewed administrative data submitted to New York State Department of Health's Statewide Planning and Research Cooperative System, a reporting system established in 1979 as a result of cooperation between the healthcare industry and government.
If they partner the US rights, then I agree, they will likely go the co-promote route. It would allow them to build up a sales staff for the follow-on anti-infective products, which would make sense from a business perspective. As far as costs, I think its more common that BP takes over all development at that point and PYMX would pay for their associated costs through a BP loan that is paid back through sales or something along that line. They could potentially earmark milestone payments and/or upfront cash to pay for their share of costs. But, whatever, lot's of options...
The only thing that really matters to me is this: when will a partnership deal be announced and how much upfront cash is involved? Before or after an equity financing? Financing options are my only real concern right now. Details and semantics on various types of partnership structures (global vs ex-US, royalty vs co-promote, etc.) is a moot point in my opinion.
Just ink any kind of deal with some meaningful upfront cash within the next 3-4 months and I'll be happy.