Auris Medical IPO

Ok, I realise this would usually end up in your spam box, but this is of specific interest to people here. It looks like Auris Medical (who runs AM-101 and AM-111) is going to go public. I'm going to try to buy shares simply to support that company. Any company working on tinnitus meds gets my support. Even though AM-101's results are a bit underwhelming.

I absolutely have zero affiliation with that company.

 

I hope puts are listed on this stock before the AM-101 results are posted... I work in finance, cashing out before the efficacy of their products are proven... scummy in my opinion, as their whole business enterprise could be worth essentially nothing if the trials fail; it's not like other types of firms that have underlying assets of value.

 

I work in finance too. I am in full agreement with your statement above (i.e. "hollow assets"). But, I will go even further and state that the background for doing an IPO is not understood from my viewpoint. They are already well funded for the initiatives (AM101+AM111) they are pursuing. So why the extra capital - are they expanding their product portfolio (not to my knowledge, at least)...? See:

http://www.bioworld.com/content/auris-medical-gets-51m-hearing-disorder-drugs-1
http://www.hearingreview.com/2014/07/auris-medical-announces-proposed-ipo-nasdaq

Right now, Otonomy is probably Auris Medical's biggest competitor; Otonomy claims to be working on a product deemed to be superior to AM101 (the active component being Gacyclidine for OTO-311). Auris Medical's advantage is that they are further ahead than Otonomy (who only recently acquired the rights and assets for OTO-311).

It should be noted that Thomas Meyer, CEO AM, himself invested CHF 8M in Auris Medical. He must therefore believe in his company. But I would not want to invest in AM at this point (and I actually do hold stock in 6 other pharmaceutical companies - so it is not as if I wouldn't be willing to invest...).

I recently did a market analysis of the major players in the otology market segment. I will attach it again here for those who are interested (it contains clinical trial data too).

 

They don't need capital like you said at this stage... the only other reason is for Mr Meyer and the employees with stock to "cash out", "interesting" they are doing this before results are released to say the least.

 

...But I do like their stock market ticker symbol, EARS

 

@Cor Going public is a great deal for both Auris Medical and Otonomy. But I would not invest in either company at this point. A lot of smaller biotech companies--especially those with only a few products--will get a pop on opening day and for a few days afterwards then rapidly fade away. The short sellers will come in and beat it down relentlessly. I've seen small biotechs go from $50 to $3 in few months--all from shorting.

Just saying....

Of course, these companies--or one of them--could be different. If you feel strongly about investing, you should wait a few days then buy maybe ten shares and see if the shorts start circling--like buzzards on a dead coyote! Buying long dated options is also a safer way to play, if the companies offer them. If they do, it will be perhaps a month before the options are available for trading.

Of course, I could be totally wrong.... So I will also watch and wait!

 

Thanks to all you financial types for weighing in (from someone who has trouble balancing her checkbook).

I was at my monthly ear clinic appointment yesterday (where they are doing an AM-101 trial), and everyone was all abuzz about this Auris announcement.

 

If you're really pessimistic you could think they're going public to cash in because they know AM101 is failing Not entirely unrealistic.

But im able to take a loss, so im going to be positive and buy a little stock just because im happy to see someone investing in tinnitus meds. I have no idea how much stock is actually going to be available to individual investors. My broker said he could at least get some, so we'll see.

@attheedgeofscience thanks for the market analyses, i'll read it tonight. I hold a lot of stock in bio companies, but nothing in otology. Since I got 'struck' by tinnitus my interests are shifting that way.

 

Yes, my point was for people who can't take a loss. I'll get a little of both stocks, EARS and OTIC (Otonomy), the latter also plans to go public soon. But I will wait for the initial pop and gauge institutional and public interest. Going public is a good thing for tinnitus sufferers. The more visibility and successes these companies achieve the greater the interest in further venture capital. A virtuous cycle since nothing succeeds like success.

In general, it's been an excellent year for biotech, which is also why the companies are going public. Though I posted it on the Autifony thread, I'll repost here about Wall Street's latest love affair with biotechs.

References:

https://www.pharmatching.com/inforena/targeting-hearing-loss-and-schizophrenia

http://blogs.wsj.com/venturecapital...lar-biotech-valuations-fueling-new-ipo-surge/

http://www.fiercebiotech.com/story/fresh-phase-iii-success-otonomy-shoots-86m-ipo/2014-07-13

http://www.fiercebiotech.com/story/...nd-hope-biotechs-window-stays-open/2014-07-02​

 

If you want to hedge your bets, it's also possible to invest in Autifony - albeit indirectly - via Imperial Innovations. I bought some shares, then 2 days later Autifony got a technology grant of £2.4m and Imperial's shares shot up. Complete fluke on my part and they've settled back down again, but I'm happy to feel at least I'm facilitating some real research, rather than these continual sound therapy 'treatments' that the tinnitus charities seem obsessed with spending their money on!

 

Looking at Auris Medical with financial - rather than medical - eyes, I would make the following observations:

1) AM101 in the phase II evaluation has failed to show a clinical difference in MML (minimum masking levels); subjective improvements - which have been shown - may or may not be considered important elsewhere, but from a financial view-point, only hard facts matter, and if the drug doesn't show a statistically significant difference in MML, then it is irrelevant.
2) AM101 lacks innovation and originality; there is already a similar procedure and compound developed many years ago ie. lidocaine + hyaluronic acid used in intratympanic injections. Why should a different and existing painkiller suddenly produce extraordinary results? Again, I am just looking at this with financial eyes...
3) AM111 has largely flown under the radar, but a quick look at the data reveals that the clinical trials held only consider very acute stages of hearing loss ie. 24/48 hours post onset. For this there is already an existing procedure in place (ie. steriods).
4) Both AM101+111 fail to address the chronic market segment - which is by far the largest (in both inner ear pathology categories: tinnitus and hearing loss).
5) Auris Medical has no other products in pipeline; it has no developed products. Therefore, it exists only by the mercy of a clinical trial success - which statistically does not necessarily happen even if products enter phase III.

For these five reasons, I would not even touch Auris Medical shares with a pair of iron tongs.

I do think that Auris Medical has done a fantastic job of their clinic trial information and handling. They have been aggressive in their rollout. They are also the first company to really move into the undeveloped world of otology therapies. But, "aggression" and a "pioneering attitude" is not necessarily enough to make a market break-through.

 

Well, thank you for your perspective. Are you more optimistic about Otonomy? What about Autifony if it goes public?

 

@attheedgeofscience what signal will it send to other companies if Auris Medical fails and not even tinnitus sufferers will touch it with iron tongs Im buying shares to say 'thank you for trying'. I dont care if I lose the money. But even that is not certain, the world of IPOs can be really weird.

If you look at it only objectively, then I fully agree with you, and even the fact they are doing their IPO right now is kind of suspect.

 

Otonomy Inc. is well funded (as late as April this year, it raised USD 49M on top of the many other rounds of investments it has had). They are little different from Auris Medical in that they have also developed specific/unique drug delivery methods for the middle injections ear by using a polymer based material with transforms from a liquid to a gel at body temperature. Because it is a gel at body temperature and by mixing it with the active drug beforehand, it will become a suspension inside in the ear being slowly released over time (and hence requiring only a single IT injection rather than repeated ones over several days ie. it is "patient friendly" - which is important in pediatrics). Otonomy acquired the rights and assets of OTO311 from NeuroSystec late, last year. The drug, Gacyclidine, is considered more potent than Esketamine in the treatment of acute tinnitus. Otonomy would not have bought the the know-how - including clinical trial data - from NeuroSystec if they did not believe it could be successful. They could just have walked away instead. They didn't. So it must mean that the data produced so far is promising. The drug delivery for OTO311 will likewise be patient friendly in that requires only a single IT injection.

So I am more optimistic about Otonomy. But, I probably would still not buy shares in it; there are so many other companies which are doing well. I would put my investments in those.

Autifony, I am not really comfortable making an analysis about. If continuous life-long therapy is required in order to uphold the benefits of the medication, then it could mean a hefty price tag to the public healthcare systems around the world. How much of that will handed down to the patients, I don't know. But at the financial level - which is what I am viewing this from - there is a big difference between a one-off treatment as with Otonomy and Auris Medical, and then having to take a drug for the rest of your life. Certainly, Autifony will stand to make a lot of money if their product is approved. As I see it, anyway. But again, Autifony has been reluctant to share much of their company information.

 

Well, that would be reason #6 to my list. But, I cannot really comment on motives I don't fully understand, so it difficult to make a point either way, as I see it; suffice-to-say, they don't need the funding, we can then draw indirect conclusions from that. In any event, I prefer to examine companies by asset value analysis ie. what are they worth in terms of their technology. If a company has a good, solid product, then funding becomes less of an issue in such cases.

 

I highly agree. If you want to invest, invest in this newer treatment. Auris had it's time researching and applying their drug with limited results. Put some money into a new company with, in my opinion, more sound theories.

Besides, I find am101 pretty useless when it has little to no effect on us long term sufferers. I don't see a place for am101 when we have other companies trying to achieve better, more easier treatments.

 

Thank you for your perspective, ATEOS. It is helpful not just from deciding if one should invest in Auris now (a personal decision, dependent on one's resources as well as one's philanthropic beliefs) but also seeing where development might be going in the future.

Another question (you already have answered many): What are your views on the medical device segment of tinnitus treatment, such as vagus nerve stimulation units being tested at UT Dallas? Again, from a financial point. Because money is a big factor in what technologies we will see emerge in the near future.

 

I too will buy some shares of Imperial. How does a person go about just buying shares on the open market? I'm new to it, but I would really like to do it.

 

What does that hearing aid company have to offer?

 

In the UK there are quite a few online sites via which you can invest now. I used HargreavesLansdown.co.uk, basically you transfer some funds from your bank account into a stocks and shares account with them, and then you can buy shares from any listed company for a fixed transaction fee. For any listed, there will be historical performance charts, buy price and sell price etc. I'm sure the US will have similar websites - if you know what you want to buy it's much cheaper than going through a broker. Feel free to PM me if you want any more details.

 

Some people use a broker. Others prefer to do their own transactions. I am of the latter category; the reason is quite simple 1) I know what I am doing because I work in finance, and 2) by handling all the details yourself, it forces you to learn the metier - and there is no substitute for self-knowledge. Being based in Germany, I have a bank account with Deutsche Bank - which is linked with maxblue. After making a request to open a sub-account with maxblue, I can transfer money from my bank account to my maxblue account. Once there is a deposit in the maxblue account, I can trade as much as I want.

Believe it or not, but doing a transaction in shares is the easy part. It is all the indirect consequences of having shares that can become a headache. Why is that? Well, depending on the country you live in, you may or may not have to declare any profit you make upon selling the shares on your tax income statement. Declaring the profit can either be super easy or it can be difficult enough to require tax lawyer assistance (which costs money - requiring you to make even more profits from your shares before it becomes attractive to even consider dealing in shares). As an example, declaring your tax income statement in Denmark is quite easy (and mandatory - everyone must declare and sign their income statement even if they have no additional income). But declaring additional income in Germany is a whole science in itself (declaring a tax income statement is not mandatory however - unless you have additional income ie. if no additional income besides your job earnings, then your tax income statement is considered settled without signature). In Switzerland, declaring income from profit on sale of shares is not required; there is no tax - and the investor keeps all the money for him- or her-self. I am actually unsure about the USA, but given the capitalistic nature of the American market, I am almost certain that you do not need to declare profits made on sale of shares. Which probably also means that you are not entitled to a tax deduction if you make a loss on the sale...

Making a profit on the sale of shares is one way to make money when dealing in shares. But there is also the topic of dividends. Dividends are company profits distributed to shareholders. This can be quarterly, bi-annually, or once per year. A company is not required to pay dividends. When dividends are paid, tax is usually automatically applied depending on country regulations. No tax income statement amendments are necessary, therefore.

As for making (good) investments, this is actually not so difficult provided you are not out to make a quick and large profit. The reason professional traders (often) make losses, is because they have timebound investments quotas. Others want to become rich quickly by getting involved in new businesses or new markets (an example could be 3D printing). I stay away from this (and I still make around double digit year-on-year ROI percentages). Key ingredients to good investments:

1) Buy with your head and not with your heart (ie. by wanting to do a good deed by investing in companies dealing in certain products eg. tinnitus cures).
2) Don't buy using borrowed money (even if the borrowed money comes from a reliable source eg. your bank; some banks will even recommend their clients to invest using borrowed money ie. their money; "don't do it...").
3) Spread investments (also known as "hedging"; although the strict definition is slightly different).
4) Make sure you are not dependent on your invested money ie. that you are not required to sell/make a profit by a certain date.
5) Know your market (again, there is no substitute for self-knowledge).

A specific note about investing in certain markets. The pharmaceutical market is notorious for playing dirty games. By far the most common game that pharmas play is promoting their drugs for off-label use. By doing so, they stand to cash in on an already developed product. Which is good for business. Their business. Right until the moment they get a fine for doing whatever illegal activity they are involved in. And then the shares drop, because a fine can easily reach a billion dollars or more. Investing in even established pharmas can therefore be a little "tricky", if you like. Pharmaceutical companies are also dependent on their "pipelines"; if a new product fails a phase-III clinical trial, it means a lot of time and money wasted. A big deal, in fact. So something to think about. Before investing.

 

I recall reading a bit about the vagus nerve device along with the Acoustic CR Neuromodulation device around this time, last year (I believe the supplier of ACRN filed for bankruptcy - haven't checked, however). To me, both of these "therapies" fall outside the scope of normal therapies. Their mode of action is not really understood in both cases. Which is also reflected in the results.

If we look at the Vagus Nerve Stimulation device/therapy, what is it designed to do? But before we do, let's take a look at their description of tinnitus:

"The auditory pathway is organized by what scientists call the tonotopic map, a structural arrangement in which different tone frequencies are transmitted separately along specific parts of the pathway. Hearing loss is the result of a loss in the ability of the auditory system to process certain frequencies. Earlier studies showed that the loss of the ability to hear these frequencies matched patterns of distortion in the neurons of the auditory cortex’s tonotopic map.

This research suggests that tinnitus might be the result of the brain trying to regain the ability to hear those lost frequencies by turning up the signals of neurons in neighboring frequencies. Because there are too many neurons processing the same frequencies, they fire more strongly, more frequently and in concert with each other, even when the environment is quiet. It is these changing brain patterns that researchers believe could produce the perception of whooshing, ringing, or buzzing in the ear that characterizes tinnitus."

To me that is a fairly concrete argument - I'll buy it (for the lack of a better definition, at least).

Now, let's return to their treatment protocol then:

"The new study uses a technique known as vagus nerve stimulation (VNS) that takes advantage of the brain’s ability to reconfigure itself (neuroplasticity). During the therapy, patients wear headphones and hear a series of single frequency tones, paired with stimulation to the vagus nerve, a large nerve that runs from the head and neck to the abdomen. When stimulated, the vagus nerve releases acetylcholine, norepinephrine, and other chemicals that encourage neuroplasticity.

In an earlier NIDCD-funded study using a rat model, the technique was shown to reorganize neurons to respond to their original frequencies, subdue their activity, and reduce their synchronous firing, suggesting that the ringing sensation had stopped. The scientists subsequently tested a prototype device in a small group of human volunteers in Europe and observed encouraging results."

Neuroplasticity? Well, there is a term I have heard before. Both used - and misused... There is no particular reason why neuroplasticity - which is the brains ability to find new neural pathways - should be a cure for tinnitus. I am not saying it isn't, all I am saying is: propose a convincing argument to me for why that should be the case. The article doesn't do that.

Let's look at something else from the quote above: "...was shown to reorganize neurons to respond to their original frequencies, subdue their activity, and reduce their synchronous firing,...". What medical device what allow them to diagnose/interpret those specific findings at the neuron level? If their definition of tinnitus is related to loss of hearing at a given frequency, then it does not really explain why people who clearly have noise induced tinnitus, but not noise induced hearing loss, still end up with tinnitus (eg. young people with good hearing attending a concert). What if tinnitus is due to cochlear damage - and not loss of hearing at a given frequency (at least to begin with)? That is why I attempted therapies aimed at restoring cochlear function (to its original state). On the other hand, it could be that the Vagus Nerve team is right - and that it is related to loss of frequencies (but that our primitive audiograms of today just don't deliver the kind of accuracy required). But then, how do they know this? What tests did they run to confirm their findings? I would also make the observation that the Vagus Nerve which is part of the cranial nerve system (I to XII) is not related to hearing.

The treatment is also slightly invasive. As a comparison, an intratympanic injection is a "piece of cake". But the Vagus Nerve implant is a bit more than that. And so is the 6 weeks treatments itself. The "encouraging results" they mention - I believe - refers to a study of 10 or 11 patients (can't remember the exact figure). If I recall correctly, only 4 of them experienced an improvement.

So from a financial point-of-view, the results and the science needs to be better explained before I will place my money in their business. Sorry. And remember, when it comes to investments: buy with your head, and not with your heart...

 

@attheedgeofscience can you buy into an IPO through your maxblue account? I have trading accounts in both the US and NL but neither allow me to buy into this specific IPO. So I have to use a broker at my primary trading bank that can get stock from the underwriter. Else I wouldnt, cause I prefer not to use brokers. They cost money for little benefit Of course, I can just wait until they're normally traded on an exchange but then it's not really about it being an IPO.

I really dont agree with you on your 1). I mean, I support my local cat shelter, and thats not going to make me any money either. Good deeds are not a bad thing. If it was only about investing, sure, you're absolutely right. But for me it isnt. This company is actively working on a cure for something that has so far created one of the most difficult periods of my life.

And in this specific case, if you can buy into the IPO, it's not even certain you're going to lose money. Plenty of investors that aren't really looking into the specifics of their AM-101/111 trials may be lured into this stocks simply by reading the prospectus (if they read anything at all). Who knows what this stock will do after it's public and before their trials end?

ps: this is just for 'fun', i wouldnt risk anything I couldnt easily lose. I tend to invest very risk-averse/longtime.
pps: i may not even do this, because my primary bank is probably going to charge some ridiculous amount to get into the IPO.

 

I don't know. But I don't think so.

True. But financially speaking, supporting your local cat shelter is not an investment, it is a donation.

I also make donations. Nothing wrong with that.

[And donations are (usually) tax deductible - unlike investments...]

True. But then again, neither is capitalism. Capitalism ensures that money goes where the market demands it. It also ensures competition. Which ultimately ensures better products and faster development cycles. And all of that benefits the consumer in the end. Capitalism has nothing to do with government policies such as healthcare/no healthcare. That is politics, and has nothing to do with economics (but many people sure do try hard to blame economics for many things). In the words of Gordon Gekko (Michael Douglas, Wall Street): Greed is good.

Investing in a company that doesn't deliver results is not going to benefit anyone; not you, not Auris Medical, or any of the other tinnitus sufferers around the world. Wishing it would be so, is not going to make it so. Whether Auris Medical will be successful, I don't know, but I have done more than my share of homework to make the comments I made earlier on. I hope that I am wrong, of course.

Absolutely. My comments were not aimed at you - or anyone else - in particular.

 

I am going to read your vagus nerve post more carefully a second time tonight, @attheedgeofscience. I just wanted to thank you for the considerable time and effort you have put into these analyses. I don't have any money to invest right now, even if I wanted to. But I have greatly benefited from your expertise.

 

Some good information in this thread!

I have no idea about any of this stuff so it's good to get a little insight.

 

Auris Medical slashes proposed price

http://www.nasdaq.com/article/auris...s-insider-buying-market-cap-drops-40-cm376783

 

They probably slashed the price because there was not enough interest in their IPO. Which says a lot about the future of this stock. Unless AM-101 magically becomes a successful product (never say never..) i guess the company is doomed to fail and disappear into penny stock territory.

 

I guess this is bad. AM-101 didn't seem to be too effective, anyway.