A few other examples provided below. UPE is more competitive with Luoxis as it doesn't require drawing blood (non-invasive), but provides a systemic ORP readout. Like Luoxis, it is in validation stage. The ThermoSci Coularray is a currently marketed device based on multiplexed readout of individual biomarkers. A recent review of UPE (PLoS One. 2014; 9(2): e87401) concluded that "overall quality of this literature is good and the use of this approach for determining inflammatory and oxidative states of patients indicate the growing use and value of this approach as both a medical and research tool." Also note from the article that UPE has been studied for many years in clinical trials. It would be useful to see what the business plan is for Luoxis and when they expect to start formal clinical trials and produce revenue.
From the Metabolomics Centre, Netherlands:
The relation between oxidative stress and inflammation is well recognized but not very well understood in terms of the loss of homeostasis, the early stage of disease and the progression of disease.
However, various new techniques are available to monitor oxidation/reduction within biological systems by both invasive and non-invasive methods. An interesting non-invasive option is the measurement of ultra low level luminescence/ ultra-weak photon emission (UPE). The association of UPE and production of Reactive Oxygen Species (ROS) and oxidative stress is currently developed for both basic biomedical research and clinical application. The development of techniques and methodology to study spontaneous ultra-weak photon emission in human and animals is carried out in a scientific cooperation of different specialized institutes.
Moreover recent developments in metabolomics enable the measurement of biological molecules with a direct link to oxidation/reduction processes by using electrochemical detection. This so-called Coularray technology enables the profiling of body fluids of biochemical components
The value of Luoxis is something that was not even briefly covered by the professional analysts. It deserves consideration. One question is what advantage does the technology provide over existing and/or competing devices/technology and what is that worth? Currently, it is in the validation stage (correlations of ORP with Disease X). The lack of coverage may be due to the fact that current analysts and their staff are drug-focussed, not medical device experts. Comparions with Carmel Diagnostics, non-invasive, cheap breath analyses such as from Pulse Health, and others (Probiox, Zentech) would be helpful.
Another consideration is that IPO's are expensive. Perhaps a faster and cheaper means is via partnership, albeit trading short term capital raise for long term profits.
rock - we had this issue on another biotech board and solved it by moving to boardhost. It requires a couple of administrators to warn, then disable posters who don't obey the rules. I've had a few requests off-board about it, but don't have the time to administer due to starting a major project.
Ignore can work, but it is indeed as annoying as all those nonsense automated posts that yahoo finally put an end to. As long as I am in the stock, it doesn't exist in a vacuum and the window of opportunity for Ampion is limited IMO. That of Optina even more so. So, I hope Knoll and others can convince MM to set this up for an exit by the time vials of Ampion are marketed.
Good to hear from other knowledgeable members. While I agree with much of what you stated, MM did dilute his shares last March as it was clear late 2013 he could not get funds by partnering Zertane. But it's also true that he stated at the shareholders meeting that he has no "desire" to further dilute. The company declared in the last 10Q that they were resourced only to 1H2016, so a raise must be made 2Q ahead of that: "we believe our capital resources at September 30, 2014 will be sufficient to fund our currently planned operations into the first half of 2016." But, there is no chance that they would raise capital prior to STRIDE finishing. If things go well, it would be at least partnered by the end of the year anyway, if not sold in 2016.
The FDA does require 20wks per trial protocol and results are masked, so there is no way that there are enough results to get approval. Our next major event is the release of results for STRUT/Phase II in March, since that will provide a good estimate of efficacy vs multiple saline injections, the key to approval. If Optina happens to exceed expectations with an announcement of partnering interest, it's a great bonus.
Steve - Any thoughts based on the 2nd part of today's action? 1.4M shares and no large afternoon trades. There were more multi-K share buys than sells in the last half-hour or so.
exactly. Ampion will succeed in spite of management mistakes. AF and most SA are poorly researched, crafted for the ignorant, but apparently are useful manipulation tools.
Steve - Granted that the prior 3 days were near 2M shares, but isn't ~900K halfway through today's session significant? It's always curious to see if long-term accumulation can be separated from trading or short covering. Thanks.
I haven't seen the details, but Phase IIb beat Synvisc. The slow-release corticosteroid appears to be key. We would have to see the KL-4 response to see if it's a threat to Ampion sales. TPX-100 Phase II will be done at the end of Q3. That has shown significant regenerative capability in preclinical models. The date isn't far from what Bar-Or implied for the MRI results from STRUT (Q3). Then there are the ongoing anti-NGF studies for OAK pain by J&J.
You're right - time matters. The unmet need for Optina was reduced when Lucentis was approved for DME and Fovista showed significant efficacy in VEGF-resistant AMD. That's when enrollment numbers started dropping. Luckily, we don't have that problem with Ampion, so if they don't get too greedy and strike a deal, we can all profit.
Exactly. No serious investor is bothered by SA articles or posts on any MB for that matter.
If you still feel the need, quote from recent PRs re:MM comments about future financings and the fact that burn rate should be reduced post-Optina and post-mfg facility buildout. The Isolagen lawsuit settlement was described in the Sep 25, 2008 8K filing. MM has shown a number of flaws as CEO of AMPE, IMO, but translating the Isolagen conflict to AMPE is hyperbole. What matters now is his ability to be realistic about company value and move these assets into stronger, more-experienced hands.
Good find. Proves the demand for additional OAK injectable therapies to reduce pain. Evidently, this has more mechanical stress ability than other HA formulations.
Well said. It and its compadres are best ignored by serious investors, regardless of where one is on AMPE outlook. We've had any number of ignorant cheerleaders and pessimists over the 2 year I've owned this. Some names change, but fools they all remain. At least some have been entertaining.
The more interesting aspects are (a) technicals of strong volume up days in a weak market (b) interim data from STRUT and (c) no PR announcing "failure" of Optina. There may be something in the clinical space of competitors (mergers, failures) that could be a factor, but I haven't had time to look into it. It most certainly is NOT some prelude to a secondary. If that comes at all, it would be post-BLA submission.
I would still like to see published results of 3x saline at 20wks on the WOMAC 3.0 Likert scale to be absolutely certain of STRIDE and STRUT success. Meanwhile, there are many here that are happy not to have sold into the panic created with STEP.
At least they had to state they are short. I don't mind having a negative outlook, but at least there needs to be a cogent case laid out. No financial or clinical analysis at all. Just more bunk.
Agree, it's a reasonable guess, assuming they've done good DD but just did not publish the overall competitive landscape. Definitely extensions and/or off-label use will be a low barrier, should the clinicians continue to see many cases of significant improvement. Their (Citi's) conservative views are there mostly since the efficacy and potential patient population can't be properly assessed w/o completion of Phase III. Also, the claims of significant regeneration have to be completely discounted until definitive data is produced.
The DD teams I've been on debate pros/cons both by MOA, ITT, current and near-term potential therapeutics that could take market share. That may be part of the disparity between what MM thinks it's worth and what pharma is willing to pay. But, comparison to HA efficacy and costs (both COG and revenue) so far look great.
This post is well worth sending to the top of the heap of usual do-do.
MS is just indexing, but Knoll and Talkot do serious DD. The latest heavy buying has to be institutional and is supported by renewed option activities. March 6 marks the approximated 20 wk timepoint for Phase II STRUT so this activity seems too early for a buildup to that event, based on past trading.
All current professional reports and data supports weak prospects for Optina commercial prospects, but a Phase IV allowability with a partner could change that. Or, it could just be a good pop on meeting statistical endpoints of Phase III. Either way, we all strongly suspect 3xAmpion will beat 3xSaline in STRUT.
But, it will indeed be interesting to see how many big investors are making big bets on AMPE. There was a serious exit after STEP, with new institutions just taking small positions.
The company has never provided guidance, like nearly every other biotech, pre-approval. Look at the Jefferies and Citi reports for estimated sales, then add 6-9 months due to the delay from STEP.
Again, the 600M is just one datapoint, but I think it’s a reasonable low-end value.
Of course, ANIK’s Monovisc and Orthovisc isn’t the only HA used in OA. Synvisc is the big-dog. But in terms of comparables for valuation purposes it is the closest to AMPE/Ampion per dominant product for each (even if the patient market is somewhat different: more KL2/3 vs more 3/4). If market share is taken from Synvisc (likely given what we know so far), then Ampion valuation of 1-2xANIK might be realistic. This gets to the $1B mark. But, that both marks are POST-BLA submission. BLA’s have very good chance of approval, unlike NDA’s.
From the Apr 15 PR:
“Monovisc received marketing approval from the FDA in February 2014. It is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics, such as acetaminophen….Anika has marketed Monovisc internationally since 2008, with total treatments exceeding 230,000 since inception….As a result of the first commercial sale in the U.S., and under the terms of its license agreement with DePuy Synthes Mitek Sports Medicine, Anika will receive a $5 million milestone payment. In addition to product transfer and royalty fees, the license agreement contains potential additional payments contingent on achieving certain performance and sales threshold milestones.”
I'd agree with Budda - somewhere in the $15-20 range, depending on the magnitude of the effect, with $1-3/sh from Optina if/when a partner is announced with specific milestone payments (not a "potential" marketing/production partner - real money up front). MM has already turned down Ampion deals. So, $10/low-teens pre-BLA submission is not inconceivable unless the entire market takes a dive.
Another sign that big money is involved. For what reason, and for how long remains to be seen.
Ha! 7-handle just means $7 and change. I have to respect technicals - at least volume preceeding price. Also, valuation and price. If the panic of STEP is now behind us and Optina isn't a total disaster, it's logical we return to pre-STEP levels (post-secondary).
It's possible that MM said something to a major investor, but he would be in a lot of trouble if it was in any way material. The FDA does not "leak" anything nor does the agency hired for analyzing the data. Possible, yes, but very improbable, even though I always have the same initial rxn.
Makes sense. None of the analysts have given details about how they computed Ampion sales. So, value based on discounted forward revenue, while done by professionals, has many assumptions hidden.
Given that HA would be a primary competing product, one reasonable comparable is ANIK, fluctuating at around 600M market cap. That would seem to be absolute minimum. Naturally, pharma would have run similar risk-weighted evaluations. So far, MM hasn't considered them credible or at least worth discussing to "close-the-gap" that we know of.