Otonomy OTO-313 — Treatment of Tinnitus

As far as I am aware, Otonomy have a meeting to update investors on the financial position of the company for the 2nd quarter of 2022. This takes place on the 25th July 2022.

I've noticed some sharp daily drops of 10% recently, although I have almost zero knowledge of the stock market.
 
As far as I am aware, Otonomy have a meeting to update investors on the financial position of the company for the 2nd quarter of 2022. This takes place on the 25th July 2022.

I've noticed some sharp daily drops of 10% recently, although I have almost zero knowledge of the stock market.
The volume (amount of stock trading hands) has been low or average recently. The drops are most likely people getting scared and exiting before the results are in. The Short % of Float is pretty low (0.83%), you'd think if someone knew something they'd be shorting the stock.

Last year in February they had an earnings release 5 days before the results of Otividex were in. I remember getting weird vibes from Dr. Weber in that webcast, though in it he claimed to be excited for the upcoming results. He seemed to indicate he didn't know them yet. I'm not sure how informed management is of the results before they're released - but I find it a little hard to believe he didn't have any idea of what was coming. I think the earnings call on Monday may give some insight into what's coming, though I'm hoping they surprise us with early positive results right before the call happens, rather than make us wait until sometime in August.

My biggest fear is that there's a high placebo effect. If that occurs it may doom the TFI metric, and we'll be in a bad spot until something better is solidified.
 
As far as I am aware, Otonomy have a meeting to update investors on the financial position of the company for the 2nd quarter of 2022. This takes place on the 25th July 2022.

I've noticed some sharp daily drops of 10% recently, although I have almost zero knowledge of the stock market.
The market is extra sensitive to bad news right now. Even good news that is less good than expected is received as bad news.
 
I don't understand this. What does 0.83% mean? What does a low short % of float indicate?
It just means there aren't a lot of people shorting the stock. You can read more about Short % of Float here.

At this stage, unless there's a spike in volume, I don't expect the stock price to tell us anything.

I'll honestly be surprised if the results aren't good. If they're bad, I can see only 2 reasons being for this:
  • A high placebo effect. It'd mean we'd need to get anyway from the TFI for measuring tinnitus.
  • Their slow release gel doesn't work like they expect it to.
 
Most other stock prices that are nuking are totally different to this one as they rely mostly on the general population having a lot of disposable income which is not so much the case these days.

Totally different fundamental value for this stock where it's mostly all based around if the drugs will work or not.
 
Most other stock prices that are nuking are totally different to this one as they rely mostly on the general population having a lot of disposable income which is not so much the case these days.

Totally different fundamental value for this stock where it's mostly all based around if the drugs will work or not.
You think investors have some early insight that we don't?
 
You think investors have some early insight that we don't?
It is definitely possible and wouldn't be the first time, nor the last. This stock price is not correlated to the general market at all really. Seems like all these biotech share prices only move based off if their products are going to be sold or not.

This share price has been fairly flat the past year.

Massive drop in February, 2021. Whatever happened then? Must have been a failed trial?
 
That was the end of the COVID-19 bull market. Nothing specifically to do with any single stock, which is good news for the company! Bad news for the economy haha.
Didn't they have a product that failed around that time?

They have their investors' financial review this afternoon.
 
That was the end of the COVID-19 bull market. Nothing specifically to do with any single stock, which is good news for the company! Bad news for the economy haha.
The S&P 500 was at an ath in December 2021 but all these type of growth stocks did peak around January/February actually. I keep forgetting that. It was all just a speculative bubble fueled by excessive money printing and hype.

The Otonomy stock price followed pretty much the same path as Cathie Wood's ARKK.

upload_2022-7-25_13-5-54.png
 
The S&P 500 was at an ath in December 2021 but all these type of growth stocks did peak around January/February actually. I keep forgetting that. It was all just a speculative bubble fueled by excessive money printing and hype.

The Otonomy stock price followed pretty much the same path as Cathie Wood's ARKK.

View attachment 51073
The drop was due to a Phase 3 failure in their Otividex drug. This drug was the reason their company was founded many years ago. It was supposed to help Meniere's disease, which their founder, Jay Lichter, suffers from (aside: he also has tinnitus).

The rise in the stock from April '20 to February '21 is primarily due to the success of OTO-313's Phase 1/2 trial and OTO-413's Phase 1/2 trial. In the lead up to Otividex's results in February '21, the stock dropped around 20%. At the time there was a lot of volume. Someone I was talking to emailed their IR team about it and was told it was because a big holder was exiting. Drops before the results could mean nothing though. The stock also dropped 17% before the positive Phase 1/2 results of OTO-313.
 
Do you think that OTO-313 (?) could also reduce somatosensory tinnitus in addition to "central" tinnitus?

Also, I did not see discussion about hyperacusis. If OTO-313 would reduce tinnitus, would it also reduce hyperacusis?
 
Do you think that OTO-313 (?) could also reduce somatosensory tinnitus in addition to "central" tinnitus?

Also, I did not see discussion about hyperacusis. If OTO-313 would reduce tinnitus, would it also reduce hyperacusis?
Here's my take, I'm sure others can correct this:

If the neuro gain sensors from the cells (which connect to hair cells) reconnect to nerves, then the brain would 'in theory' be receiving a properly amplified signal rather than over-amplified one.

If the brain 'gets this' and therefore turns down its own gain of the auditory nerve then I can't see how that wouldn't alleviate hyperacusis as external sounds wouldn't be over amplified.

As regards the somatic element. By the same logic, as other nerves (facial, jaw etc) connect to auditory nerve as well, if the brain had already deamplified the auditory nerve signals as explained above then, in theory, somatic signals would also be reduced too.
 
Do you think that OTO-313 (?) could also reduce somatosensory tinnitus in addition to "central" tinnitus?

Also, I did not see discussion about hyperacusis. If OTO-313 would reduce tinnitus, would it also reduce hyperacusis?
OTO-313 recruited patients with tinnitus of cochlear origin.

They have not tested on central tinnitus or somatic tinnitus, although about 2/3 of people with tinnitus have a somatic component.
 
Otonomy's stock had some eye-popping volume today - 6x the normal amount. In the end there was only a 5% drop in share price, but it looks like investors are getting skittish after last night's earnings call. Not sure why or what to make of it. There were around 3 massive sales of over 100k shares today. Either a few big holders got out, or one big holder lightened their load. There was even what looks like some panic selling at around 1.68. I think a lot of people are worried that someone knows something. On the flip side, for every seller there's a buyer, and the price only dropped 5% when tested with such a heavy load, so there's plenty of people who have confidence.

It may be fruitless to try and read info from the stock market, though until the data is released we won't have much to go on. I still think the results will be good, but it's a bit concerning seeing such pessimism.

As an aside, I took note of this thread's view count at noon (263,159). There's like a dozen of us talking here, yet there have been hundreds of views since 12 o'clock (it's now at 263,651). There are a lot of lurkers in this thread. I think this past Sunday the view count was around 261k. To contrast, I made a post in the Stock Chat for Benefactors section and it's gotten like 10 views since Sunday.
 
Is it possible, within reason, to expect OTO-313 to completely silence tinnitus for some people?
It's possible. In the pilot study it did this for one person. To quote from the case study:
After 26 h of gacyclidine therapy start she noticed an improvement as well as further gradual decrease in the tinnitus intensity down to a barely noticeable level. No side effects were noticed. Six weeks after the treatment the patient reported a slight increase in the intensity of her tinnitus; however, she also reported episodes when she could not hear the tinnitus at all. Overall, she was satisfied and she did not feel disabled by her tinnitus any more.
In addition, in their case studies for Phase I/II in their corporate presentation someone went from a TFI of ~80 to ~17 ("severe to mild"). When the data comes in for Phase 2 we'll see if there's anyone that drops to the silence zone. It's not out of the realm of possibility, but based on everything we know now it most likely just turns down the volume.
 
It's possible. In the pilot study it did this for one person. To quote from the case study:

In addition, in their case studies for Phase I/II in their corporate presentation someone went from a TFI of ~80 to ~17 ("severe to mild"). When the data comes in for Phase 2 we'll see if there's anyone that drops to the silence zone. It's not out of the realm of possibility, but based on everything we know now it most likely just turns down the volume.
Honestly, barely noticeable is all what most with tinnitus need. When people say barely noticeable, it is when they are in a quite room and need to "listen" for it. Lmao if that were most of us with tinnitus, this forum would not even exist.

Who knows, maybe this decade is the last one anyone has to suffer from tinnitus.

So much work being done in the field. You can see how much potential these regen companies see in the field for $ making.
 
I think one big investor 'lightening their load' caused a flutter of action. It rose and stabilised after that, around midday.
 
How many more years are we going to have to wait for OTO-313? I feel my tinnitus is mostly from sound damage, but the vax and ototoxic drugs made it worse. Do you think this would help get my 11/10 reactive tinnitus under control? Maybe help loudness hyperacusis? I am suffering immensely & need the truth of how long I must wait.

Available end of 2024? Will it be effective for chronic sufferers of 2 years and whatnot?
 
How many more years are we going to have to wait for OTO-313? I feel my tinnitus is mostly from sound damage, but the vax and ototoxic drugs made it worse. Do you think this would help get my 11/10 reactive tinnitus under control? Maybe help loudness hyperacusis? I am suffering immensely & need the truth of how long I must wait.

Available end of 2024? Will it be effective for chronic sufferers of 2 years and whatnot?
In Phase 2 trials they are testing on people up to a year from tinnitus onset. Presumably if these results are good they would then (as it would be in their best interests financially of course) to test their drug on cases of over a year in? Remember there are millions of people with tinnitus who are long past a year. I think Otonomy will be well aware of this and will be seeing potential dollar signs.

As for timelines, I had a look; these are some quotes I could find. The first is a more reliable source. The last two are from Quora, so take them as you want.

"New drugs are getting through the FDA process faster. In 2018, the median review time for standard drug applications was 10.1 months."
(Source)

"Most drug companies will have a very good idea if the drug is likely to be approved and will prepare accordingly. My company way prepared to start selling it's first drug 24 hours after it got notice of the approval. Details of manufacturing and distribution had been worked out well in advance."

"This is largely a question of how organized and disciplined a company's supply chain is. The answer to this question is that it could take days, it could take months. It all depends on how well prepared a company is for market launch."

(Source)


As to very specific questions of the different types of tinnitus. If the damage is in the ear and this drug can assist the body to repair that damage, then hopefully that'll get the brain back to interpreting 'correct' signals from ears like it once did, like it had been doing for most of your life beforehand?

That's certainly what everyone wants; Otonomy, the investors and even us sufferers.
 

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