Frequency Therapeutics — Hearing Loss Regeneration

[patorjk]

This is indeed troubling. I just checked my eTrade Insider Activity and it looks like Loose has been dumping 4.5k shares regularly every 2 weeks since April 8th. He owns a total of 187,282 shares, and to date has sold 18k shares. So he's sold around 10% of his holdings since early April.

In total, 3 different insiders have been selling shares: Christopher Loose (18k), Joel Marcus (27.8k), and David L Lucchino (~30k).

The fact that all of their trades are small, the fact that they're close together is odd, especially Lucchino's trades. It's like maybe they're not trying to trigger any alarms?

I can't really see any positive way to read this, if more insiders start selling, I think it means big trouble. My guess is that they're going to miss their self imposed September deadline and need to prolong the study by several months.

I can't see them having inside info on the study itself - though maybe it's possible?

Another possibly is that maybe they think a big crash to the whole market is coming later this year and they want some cash on hand (I know many people who think this), but you'd think they'd be wealthy enough that they already have plenty of cash.

Whatever the case, if this stock was going to be a 10x-er, you'd think they'd want to hold onto all of their shares and possibly be buying more.

I'm still holding my FREQ shares, but now I'm worried.

 

[Croaker]

I wouldn't read too much into it. The price is where it was about a week ago basically. These speculative biotech stocks bounce like crazy. Maybe he needed a new sports car or his dealer was having a sale.

 

[FGG]

This is indeed troubling. I just checked my eTrade Insider Activity and it looks like Loose has been dumping 4.5k shares regularly every 2 weeks since April 8th. He owns a total of 187,282 shares, and to date has sold 18k shares. So he's sold around 10% of his holdings since early April.

In total, 3 different insiders have been selling shares: Christopher Loose (18k), Joel Marcus (27.8k), and David L Lucchino (~30k).

The fact that all of their trades are small, the fact that they're close together is odd, especially Lucchino's trades. It's like maybe they're not trying to trigger any alarms?

I can't really see any positive way to read this, if more insiders start selling, I think it means big trouble. My guess is that they're going to miss their self imposed September deadline and need to prolong the study by several months.

I can't see them having inside info on the study itself - though maybe it's possible?

Another possibly is that maybe they think a big crash to the whole market is coming later this year and they want some cash on hand (I know many people who think this), but you'd think they'd be wealthy enough that they already have plenty of cash.

Whatever the case, if this stock was going to be a 10x-er, you'd think they'd want to hold onto all of their shares and possibly be buying more.

I'm still holding my FREQ shares, but now I'm worried.

A lot of their "salary" is in stock and people want to spend money on this or that (second homes, boats, etc). All of the insiders still own the vast majority of their FREQ stock.

 

[xyz]

I wouldn't read too much into it. The price is where it was about a week ago basically. These speculative biotech stocks bounce like crazy. Maybe he needed a new sports car or his dealer was having a sale.

Yes, hopefully it's because of the sports car and not because they see that their phase 2 trial turns out like Audion's one.

 

[Diesel]

Let's stop with the speculation.

Insiders selling stock almost always means nothing.

Usually they do it to diversify. Many insiders setup plans to regularity dispose of vested interest in a company and move it to a regular 401k-type plan. If you notice a regularity to the selling of insider stock, that's the case. Look up the FORM 3 for all of the directors. You'll see they all have been awarded stock lots that are staggered in their vesting schedule.

Institutional investors sell stock from IPOs usually once it reaches a certain % gain.

Note that even though these shares/amounts look large to us mere mortals, they're a fraction of the institutional holdings in the firm, and/or by the insiders themselves.

Seriously, don't look into it too much.

 

[Joly]

I hope that it's not the end. It's impossible for me to live with tinnitus and hyperacusis the rest of my life. I'm so sad. I would like to see the end and to have a real life. I miss my old life.

 

[Lucifer]

Ahh shit. I'm worried now. Hopefully they are selling their shares just so they can buy that sports car lol.

Maybe they want some quick cash so that later on they can buy the shares back again in the future.

 

[FGG]

Let's stop with the speculation.

Insiders selling stock almost always means nothing.

Usually they do it to diversify. Many insiders setup plans to regularity dispose of vested interest in a company and move it to a regular 401k-type plan. If you notice a regularity to the selling of insider stock, that's the case. Look up the FORM 3 for all of the directors. You'll see they all have been awarded stock lots that are staggered in their vesting schedule.

Institutional investors sell stock from IPOs usually once it reaches a certain % gain.

Note that even though these shares/amounts look large to us mere mortals, they're a fraction of the institutional holdings in the firm, and/or by the insiders themselves.

Seriously, don't look into it too much.

Seriously. This is completely a normal move. If this sort of thing ever signified anything literally anyone could get rich buying puts in biotech.

 

[ASilverLight]

Genuine question.

Say my tinnitus is actually noise induced but I have no significant/detectable hearing loss, are there still chances FX-322 could work to quieten my tinnitus? That is if it all goes to plan and we'll see a release...

 

[all to gain]

It's hard not to speculate about this. Worst possible case senarios will already be running wild.
Let's hope for the best, but, yeah, this is worrying for some of us.

 

[BBakkers]

@Diesel

I agree!

 

[UKBloke]

Insiders selling stock almost always means nothing.

I agree. It's very important to separate share trading in a company from that company's productivity/product development etc.

If, as @patorjk says, Loose started offloading around April 8th, then he did so when price was around $15.10 per share, which was four days after it had tanked from its recent high at circa $21.00, which quite frankly is not very good trading if one's aim is to buy low and sell high. That said, if he sold again today after price had retraced back up to around $20.00, he's redeemed himself.

All I see here is a little speculation in one's own stock, folks; nothing nefarious. I'm quite sure development of FX-322 will remain on track.

 

[FGG]

Genuine question.

Say my tinnitus is actually noise induced but I have no significant/detectable hearing loss, are there still chances FX-322 could work to quieten my tinnitus? That is if it all goes to plan and we'll see a release...

If it ends up being hair cell damage, yes. If it's synapse damage, you will need a different drug. Unfortunately, current testing isn't very helpful for ruling in/out either in mild cases.

 

[ASilverLight]

If it ends up being hair cell damage, yes. If it's synapse damage, you will need a different drug. Unfortunately, current testing isn't very helpful for ruling in/out either in mild cases.

Thank you. Should it be noise, let's just pray that it's cell damage for me and that this drugs gets released soon. I'm having incredibly tough moments, and I need to hold onto the hope of this (or a synapse) drug being released within a few years.

 

[Lucifer]

Thank you. Should it be noise, let's just pray that it's cell damage for me and that this drugs gets released soon. I'm having incredibly tough moments, and I need to hold onto the hope of this (or a synapse) drug being released within a few years.

Me too. I hope my issues are due to hair cell damage and not synapses.

 

[DoNotGoGentle]

Genuine question.

Say my tinnitus is actually noise induced but I have no significant/detectable hearing loss, are there still chances FX-322 could work to quieten my tinnitus? That is if it all goes to plan and we'll see a release...

Have you had a full range hearing test?

 

[Nobody19]

Me too. I hope my issues are due to hair cell damage and not synapses.

Researchers at Stanford discovered that when you implant stem cells into the ear and they grow into hair cells, the nerve cells regrow:



(Around the 29 minute mark).

The video is 8 years old though, and they use a different approach to restoring hair cells than Frequency. But maybe the same thing will happen!

Off-topic: the researchers at Stanford Initiative to cure hearing loss are amazing, I've donated to them in the past and will certainly do so again.

 

[Philip83]

Yes, hopefully it's because of the sports car and not because they see that their phase 2 trial turns out like Audion's one.

What happened with the Audion trial?

 

[serendipity1996]

Researchers at Stanford discovered that when you implant stem cells into the ear and they grow into hair cells, the nerve cells regrow:

(Around the 29 minute mark).

The video is 8 years old though, and they use a different approach to restoring hair cells than Frequency. But maybe the same thing will happen!

Off-topic: the researchers at Stanford Initiative to cure hearing loss are amazing, I've donated to them in the past and will certainly do so again.

Essentially, Frequency's drug is a hair cell regeneration drug - it addresses synaptopathy IF there is corresponding hair cell damage so the renewed hair cells will also possess the nerve connections. However, it won't in places where there is only synaptopathy and no hair cell damage. However, Otonomy and Pipeline have synaptopathy drugs in the pipeline.

 

[Croaker]

Essentially, Frequency's drug is a hair cell regeneration drug - it addresses synaptopathy IF there is corresponding hair cell damage so the renewed hair cells will also possess the nerve connections. However, it won't in places where there is only synaptopathy and no hair cell damage. However, Otonomy and Pipeline have synaptopathy drugs in the pipeline.

What could damage the synapses and leave the corresponding hair cells alone? Ototoxic drugs? Or can acoustic damage do that too?

 

[serendipity1996]

What could damage the synapses and leave the corresponding hair cells alone? Ototoxic drugs? Or can acoustic damage do that too?

I don't really know enough about ototoxicity but acoustic trauma can certainly lead to widespread cochlear synaptopathy without hair-cell loss, which has been termed 'hidden hearing loss' by Charles Liberman (he's devoted a great deal of research to this topic!). This typically occurs prior to hair cell loss as far as I know - the prevailing consensus used to be that acoustic trauma that led to a temporary threshold shift was not indicative of any permanent underlying damage but actually Liberman has shown that it can result in widespread loss of cochlear nerve fibers resulting in hidden hearing loss. This also isn't really diagnosable on a standard audiogram either.

https://pubmed.ncbi.nlm.nih.gov/28087419/

 

[Croaker]

I don't really know enough about ototoxicity but acoustic trauma can certainly lead to widespread cochlear synaptopathy without hair-cell loss, which has been termed 'hidden hearing loss' by Charles Liberman (he's devoted a great deal of research to this topic!). This typically occurs prior to hair cell loss as far as I know - the prevailing consensus used to be that acoustic trauma that led to a temporary threshold shift was not indicative of any permanent underlying damage but actually Liberman has shown that it can result in widespread loss of cochlear nerve fibers resulting in hidden hearing loss. This also isn't really diagnosable on a standard audiogram either.

https://pubmed.ncbi.nlm.nih.gov/28087419/

So Otonomy with OTO-413, Hough Ear Institute's pill, and Pipeline's PIPE-505 are the closest to solving this issue? Looks like Otonomy is the furthest along with a product in phase 1/2 right now.

Anybody know which of these might not be a good idea to try, like how Audion's product was dangerous since it depleted the support structure?

 

[Jaysterk]

I hope that it's not the end. It's impossible for me to live with tinnitus and hyperacusis the rest of my life. I'm so sad. I would like to see the end and to have a real life. I miss my old life.

You won't. Even if FX-322 fails. This technology IS the future and more than likely a cure. Being able to regrow hair cells is way beyond our current "ear" tech. It's like saying, that because the people that came before the Wright brothers failed, we will never have discovered flight.

 

[xyz]

What happened with the Audion trial?

They said on their trial website that they intend to publish their phase 2 trial results by 30/4/2020 but did not do so. There was only a short summary on some EU website that 1/3 had hearing improvement and they plan to have something in the market in 7 seven years. But that was all very vague. Also many here have emailed them or tried to call them, but no reply.

 

[Flamingo1]

Researchers at Stanford discovered that when you implant stem cells into the ear and they grow into hair cells, the nerve cells regrow:

Frequency researchers discovered this too. Newly grown hair cells will connect with synapses.

 

[serendipity1996]

Frequency just posted on Twitter that they will be presenting virtually at 2 upcoming investor/healthcare conferences on June 4 and June 9.

More info here: https://investors.frequencytx.com/n...peutics-present-upcoming-investor-conferences

 

[ASilverLight]

Have you had a full range hearing test?

No. I had a standard hearing test which showed no signs of hearing loss at all. I'm not sure in which thread it was linked (perhaps here?) but someone linked to the most reliable online test for extended ranges which I took with quality headphones capable of producing up to 20 kHz; I can easily hear up to 17.5 kHz on very low volume with those. Speech in noise isn't an issue either. So who knows.

I know online tests aren't the most reliable.

 

[AtlasFainted]

So Otonomy with OTO-413, Hough Ear Institute's pill, and Pipeline's PIPE-505 are the closest to solving this issue? Looks like Otonomy is the furthest along with a product in phase 1/2 right now.

Anybody know which of these might not be a good idea to try, like how Audion's product was dangerous since it depleted the support structure?

I heard from @HootOwl Hough Pill's purpose is being redefined (something to do with recovering from cochlear implants I think) for faster approval. OTO-413 seems smiled upon so far with some of the more well read and up to date users on this forum.

I haven't heard much about Pipeline's drug but it has its own thread in this forum (so do the others).

Personally I still can't believe how messed up the process is to get a promising drug from development to the market.

I'm so mind boggled that something like the Hough pill can sit for 5 years collecting dust (before another 5 years+ for trials) that I'm actually thinking about doing work in the pharmaceutical sector to do what I can to change things.

The broken process of what it takes to get a life-changing therapy to the market and the people that need it should be put under a magnifying glass. It makes my stomach churn.

 

[Cernuto]

I see this very active thread about FX-322 is full of a lot of speculation. I am very skeptical yet I will try it as soon as possible if there is any hint of relief. Why is that? I have hope that some day there will be a cure, which is what keeps me going.

 

[Clmnt]

I'm sure there will someday be something for tinnitus. The question is when