Frequency Therapeutics — Hearing Loss Regeneration

[Gb3]

Then how do we explain the word score increases?

I have an almost perfect word score but I have high frequency hearing loss and can't understand people with a lot of noise in the background.

 

[Guywithapug]

Then how do we explain the word score increases?

I'm curious as to why there is a relatively fast drop off in word scores after the 90 days result? Hopefully the gain is sustainable.

Also hoping we see a higher dB gain, possibly with multiple doses as others have suggested but with lower frequencies than 8 kHz too.

 

[Diesel]

I'm curious as to why there is a relatively fast drop off in word scores after the 90 days result? Hopefully the gain is sustainable.

Also hoping we see a higher dB gain, possibly with multiple doses as others have suggested but with lower frequencies than 8 kHz too.

After a year+ time passed between follow up? I suspect that it is because the hair cells that didn't get treated by the drug continued to deteriorate and lose performance. So they probably started missing words that consonants below 8 kHz. It's not on the slide, but Frequency Therapeutics notes that those that saw the 8 kHz gain retained it at the follow-up, so those regenerated hair cells might as well be good as new.

 

[Diesel]

I guess you're right. I feel like more doctors would get behind it if it shows increases in the audiogram. Being that seems to be the current standard of measure from what I have seen.

Unfortunately most of the tests today are centered on monitoring the deterioration of hearing or the assignment of a hearing device. No test is designed to monitor regeneration.

I am optimistic that we'll see an improvement at lower frequency bands in the audiogram. The skeptics will come out of the woodwork if 4 doses of FX-322 doesn't go into the mid ranges below 2 kHz; even though we may see improvements to perfect word scores in quiet and noise.

 

[FGG]

I'm curious as to why there is a relatively fast drop off in word scores after the 90 days result? Hopefully the gain is sustainable.

Also hoping we see a higher dB gain, possibly with multiple doses as others have suggested but with lower frequencies than 8 kHz too.

The last bar was measured more than a year later (and as late as 21 months), I wouldn't say that's a fast drop off.

This has been brought up before a few pages ago but we can tell it's not hair cell loss a year later because the audiograms did not change in this same time frame.

A lot of theories were floated around but I personally think it's plausible that their brains may have been used to listening better when they had worse hearing loss. At 90 days you had the benefit of new hair cells and harder working brain. A year later, you might get "lazier". The reason I think this is a possibility is that Otonomy excluded people (as in it was a definite exclusion parameter) with musical training from their trials. Presumably because they could discern words better with the same degree of hearing loss than someone who didn't have that background. Enough where they bothered to exclude them.

The other possibility is there is an unknown acute benefit to the drug that fades with time (anti inflammatory?).

Either way, they retained most of their benefit chronically which is great news. I wonder what re-dosing a year or two later would do.

The last subject is a weird example. They went below baseline. But it was 21 months later for them and who knows what may have happened in that time frame.

 

[Cernuto]

Some people's hearing fluctuates from day-to-day? I know my tinnitus does. Do they take this in to account when they do the hearing tests? I would imagine the most accurate results would be to take an average of multiple tests performed days apart?

 

[Guywithapug]

The other possibility is there is an unknown acute benefit to the drug that fades with time (anti inflammatory?).

Either way, they retained most of their benefit chronically which is great news. I wonder what re-dosing a year or two later would do.

Very plausible theory. An acute benefit would explain the drop off but to see a positive retention is encouraging.

I am very hopeful that multiple doses will produce cumulative results.

 

[Aaron91]

The last bar was measured more than a year later (and as late as 21 months), I wouldn't say that's a fast drop off.

This has been brought up before a few pages ago but we can tell it's not hair cell loss a year later because the audiograms did not change in this same time frame.

A lot of theories were floated around but I personally think it's plausible that their brains may have been used to listening better when they had worse hearing loss. At 90 days you had the benefit of new hair cells and harder working brain. A year later, you might get "lazier". The reason I think this is a possibility is that Otonomy excluded people (as in it was a definite exclusion parameter) with musical training from their trials. Presumably because they could discern words better with the same degree of hearing loss than someone who didn't have that background. Enough where they bothered to exclude them.

The other possibility is there is an unknown acute benefit to the drug that fades with time (anti inflammatory?).

Either way, they retained most of their benefit chronically which is great news. I wonder what re-dosing a year or two later would do.

The last subject is a weird example. They went below baseline. But it was 21 months later for them and who knows what may have happened in that time frame.

As someone who was musically trained this theory resonates with me a lot. Great observation on Otonomy and subsequent analysis. I do also agree with Diesel though that it may have also been the case that those hair cells which were too distant for the drug to reach in the first place may have died in the interim period, so I imagine it could be a combination of both.

 

[Jrblovsky]

Unfortunately most of the tests today are centered on monitoring the deterioration of hearing or the assignment of a hearing device. No test is designed to monitor regeneration.

I am optimistic that we'll see an improvement at lower frequency bands in the audiogram. The skeptics will come out of the woodwork if 4 doses of FX-322 doesn't go into the mid ranges below 2 kHz; even though we may see improvements to perfect word scores in quiet and noise.

I would estimate that 90 to 95 percent of people with hearing loss experience it at 2 kHz and above. There are many that have residual losses on other corresponding frequencies but if this drug can restore hearing at 2 kHz and above it will help an enormous amount of people. I'm sure the scientists will figure out a delivery vehicle once the dosing show the drug's efficacy.

 

[Flyingsheep]

Some people's hearing fluctuates from day-to-day? I know my tinnitus does. Do they take this in to account when they do the hearing tests? I would imagine the most accurate results would be to take an average of multiple tests performed days apart?

Mine appears to. There are some days I can hear 20 kHz, and other days I cannot. I have no idea what is going on behind that phenomenon.

 

[Lucifer]

We have to remember that in Phase 1b, it was one dose of FX-322 and to see that much of an improvement from one dose is outstanding.

If multiple doses of FX-322 do penetrate deeper in the round window then I can't see how this drug can fail. If it turns out that multiple doses don't work then FX-322 will need to use a different delivery method for reaching deeper in the round window.

A cure to tinnitus, hyperacusis and hearing loss will come out soon.

 

[AfroSnowman]

If the results come in good and FX-322 proves to successfully regenerate hearing, how high could the stock price realistically go?

 

[nocticolor]

FX-322 kind of makes me hope my tinnitus was caused by (hidden) hearing loss lol.

 

[Keith Handy]

Mine appears to. There are some days I can hear 20 kHz, and other days I cannot. I have no idea what is going on behind that phenomenon.

I didn't know anyone over five could still hear 20 kHz.

 

[Keith Handy]

FX-322 kind of makes me hope my tinnitus was caused by (hidden) hearing loss lol.

I would suspect it's usually a factor, even when there are other factors.

 

[Flyingsheep]

I didn't know anyone over five could still hear 20 kHz.

Somehow I still can, despite having screaming tinnitus that normally would be the result of severe hearing loss.

 

[weab00]

If the results come in good and FX-322 proves to successfully regenerate hearing, how high could the stock price realistically go?

The moon.

 

[patorjk]

If the results come in good and FX-322 proves to successfully regenerate hearing, how high could the stock price realistically go?

My gut is that it'll go to $60 by the end of the month (prior to the results), and then to $120 if it shows improvement in hearing and tinnitus. I've read online where some people have a target of $100 by the end of the year, but that seems way too conservative to me.

$120 a share would give them a market cap of $4B, and I think the ultimate market cap of the company (after Phase 3) will be between $10B and $20B (assuming success). Most hearing aid companies currently have similar market caps. There are also a few wild cards in the mix though - mainly the ability to treat tinnitus and the Multiple Sclerosis program (which we'll have more info on later this year).

Side note: This is all just my own speculation and I'm long on Frequency Therapeutics.

 

[reggie green]

My gut is that it'll go to $60 by the end of the month (prior to the results), and then to $120 if it shows improvement in hearing and tinnitus. I've read online where some people have a target of $100 by the end of the year, but that seems way too conservative to me.

$120 a share would give them a market cap of $4B, and I think the ultimate market cap of the company (after Phase 3) will be between $10B and $20B (assuming success). Most hearing aid companies currently have similar market caps. There are also a few wild cards in the mix though - mainly the ability to treat tinnitus and the Multiple Sclerosis program (which we'll have more info on later this year).

If that's the case, more companies and research dollars would be getting involved in tinnitus research in the future.

 

[Jrblovsky]

The moon.

If this drug truly works, the stock would be worth a fortune. If this truly ends up being a cure for hearing loss, it will be worth a ton. The stock price could increase 10 fold.

 

[scotty03874]

If this drug truly works, the stock would be worth a fortune. If this truly ends up being a cure for hearing loss, it will be worth a ton. The stock price could increase 10 fold.

I agree. I just bought some ten minutes ago.

 

[AfroSnowman]

Just a reminder to those who are not experienced in trading stocks but might be getting excited about this one.

Most promising drugs fail, sometimes in Phase 3. When they fail the stock price can drop more than 90% almost instantly. I'm long on this as well but for stocks like this I don't put in more than I can afford to lose.

On the other hand how cool would it be to get your tinnitus fixed and make a bundle in one fell swoop?

 

[Lucifer]

My gut is that it'll go to $60 by the end of the month (prior to the results), and then to $120 if it shows improvement in hearing and tinnitus. I've read online where some people have a target of $100 by the end of the year, but that seems way too conservative to me.

$120 a share would give them a market cap of $4B, and I think the ultimate market cap of the company (after Phase 3) will be between $10B and $20B (assuming success). Most hearing aid companies currently have similar market caps. There are also a few wild cards in the mix though - mainly the ability to treat tinnitus and the Multiple Sclerosis program (which we'll have more info on later this year).

Side note: This is all just my own speculation and I'm long on Frequency Therapeutics.

I also agree with this. If the results come out positive, $120 per share is doable since it will be the first drug to cure hearing loss and many people around the world would hear about it if this current Phase has positive results.

If everything works out in the end, $200 per share could be accomplished. This is around a similar price to those companies that are making COVID-19 vaccines.

 

[reggie green]

Would it be faster for FX-322 to get approved in Canada than in the USA?

 

[Diesel]

Would it be faster for FX-322 to get approved in Canada than in the USA?

It will be approved through the US FDA process, then whatever regulatory body in the specific country can accept FDA results or trial results conducted in the country.

 

[Jrblovsky]

Just a reminder to those who are not experienced in trading stocks but might be getting excited about this one.

Most promising drugs fail, sometimes in Phase 3. When they fail the stock price can drop more than 90% almost instantly. I'm long on this as well but for stocks like this I don't put in more than I can afford to lose.

On the other hand how cool would it be to get your tinnitus fixed and make a bundle in one fell swoop?

You're not wrong. Only 15 or 20 percent of new drugs that start clinical trials actually become licensed.

 

[Jrblovsky]

Then how do we explain the word score increases?

View attachment 43168

I was going to ask you about this earlier. What happened to the other 10 people that were in the trial? Did they show no gains or what was the deal with that?

 

[Keith Handy]

Not going to sugar coat this, but the talking heads on the webinar today didn't seem to think FX-322 to be much more than an early stepping stone towards further tinnitus research.

We are putting a lot of stock into a statement of "there were some anecdotes" from the previous trial.

 

[jeff W]

I guess you're right. I feel like more doctors would get behind it if it shows increases in the audiogram. Being that seems to be the current standard of measure from what I have seen.

We don't need them to, they sat on their hands for decades whilst we suffered.

 

[AfroSnowman]

You're not wrong. Only 15 or 20 percent of new drugs that start clinical trials actually become licensed.

Wow. That's actually higher than what I would have guessed.