Frequency Therapeutics — Hearing Loss Regeneration

[Diesel]

I agree, with the exception of a situation where a large truck is about to back into you and you don't hear the beeps.

But you will hear someone screaming at you to get out of the way.

 

[Koz]

I don't know about a lot of people here, but I'd much rather be able to communicate with other people better (speech recog) than be able to hear 7 - 10 computer generated beeps in pure silence

Nah, there's far more to hearing than just human speech. Pure Tone Average might not mean much to you but that is most definitely not the case for those of us with deeper and wider losses on the audiogram. Certainly more than just a few "generated beeps"

It's fair to say this drug continues to drop down its expectation levels and that is reflected by its stock price and basic end points so far. Shame really because it keeps people making stand up arguments for it like "oh it's okay, at least we hear speech slightly clearer. Deffo gonna go spend X amount of money and get a needle put through my eardrum for that"

This is breadcrumbs, we're already settling for breadcrumbs with what we currently have available - maybe this is subjective but I personally would not invest in any medicine that isn't clinically proven to do far more than just breadcrumbs.

 

[Damocles]

Assuming that this would be a solution, I wonder how many times an eardrum can be punctured with a needle.

https://www.tinnitustalk.com/posts/418839/

https://www.tinnitustalk.com/posts/480317/

70-80 times over the course of one month, and will heal quick enough each time that you can clean your ear canal with an ototoxic cleaning agent the next day.

 

[Diesel]

This is breadcrumbs, we're already settling for breadcrumbs with what we currently have available - maybe this is subjective but I personally would not invest in any medicine that isn't clinically proven to do far more than just breadcrumbs.

If this is breadcrumbs to you, then I'm afraid you're going to have your expectations continually unmet. New drugs are rarely a single-go, cure all for any disease/disorder/etc that they are intended to treat. It takes several revisions of a drug generating cashflow for the developer to get it perfected. Furthermore, regeneration is a relatively new frontier in medicine; so the industry itself may need more time to mature in terms of investment, expertise, and research.

I don't know why so many here continually hold these unrealistically high, "cure level" standards for hearing disorders. It just isn't going to happen that way. These first drugs will follow the same development path as those drugs for non-hearing conditions before them: all will serve a limited scope of patients with specific underlying issues, and overtime development iterations will focus on a wider range of patient populations.

It will be those that get treatment from those "breadcrumbs" to treat their conditions that will be contributing to paving the way to making the drugs more available to a wider population.

 

[Jurger]

I don't know about a lot of people here, but I'd much rather be able to communicate with other people better (speech recog) than be

Nah, there's far more to hearing than just human speech. Pure Tone Average might not mean much to you but that is most definitely not the case for those of us with deeper and wider losses on the audiogram. Certainly more than just a few "generated beeps"

It's fair to say this drug continues to drop down its expectation levels and that is reflected by its stock price and basic end points so far. Shame really because it keeps people making stand up arguments for it like "oh it's okay, at least we hear speech slightly clearer. Deffo gonna go spend X amount of money and get a needle put through my eardrum for that"

This is breadcrumbs, we're already settling for breadcrumbs with what we currently have available - maybe this is subjective but I personally would not invest in any medicine that isn't clinically proven to do far more than just breadcrumbs.

Besides: better PTA on human speech frequencies = better speech recognition. It's not like they don't overlap.

 

[Damocles]

Nah, there's far more to hearing than just human speech. Pure Tone Average might not mean much to you but that is most definitely not the case for those of us with deeper and wider losses on the audiogram. Certainly more than just a few "generated beeps"

It's fair to say this drug continues to drop down its expectation levels and that is reflected by its stock price and basic end points so far. Shame really because it keeps people making stand up arguments for it like "oh it's okay, at least we hear speech slightly clearer. Deffo gonna go spend X amount of money and get a needle put through my eardrum for that"

This is breadcrumbs, we're already settling for breadcrumbs with what we currently have available - maybe this is subjective but I personally would not invest in any medicine that isn't clinically proven to do far more than just breadcrumbs.

Mate, with respect, this is not "breadcrumbs". It's progress.

This is what cellular phones first looked like:

This is what they now look like:

Need I say more?

 

[tommyd87]

Besides: better PTA on human speech frequencies = better speech recognition. It's not like they don't overlap.

Not necessarily. There are people who have got a moderate hearing loss who perform very poorly on the speech recognition components of the tests, while there are people with a severe to profound loss who perform very well with the correct volume being given to them.

There might be an overlap, however it is not as cut and dry as you are claiming it to be.

 

[ThomasRobert]

but I personally would not invest in any medicine that isn't clinically proven to do far more than just breadcrumbs.

As soon as they publish the failed results of the severe hearing loss trial in November I'm buying the dip, it will be great to start again at a position of $4 or $5 per share! My fingers are ready...

 

[Frankie Toledo]

I don't know why so many here continually hold these unrealistically high, "cure level" standards for hearing disorders. It just isn't going to happen that way. These first drugs will follow the same development path as those drugs for non-hearing conditions before them: all will serve a limited scope of patients with specific underlying issues, and overtime development iterations will focus on a wider range of patient populations.

 

[Lucifer]

Does anyone have the ClinicalTrials.gov link for the Phase 2b trial?

Are they testing audiograms in Phase 2b?

 

[Philip83]

Does anyone have the ClinicalTrials.gov link for the Phase 2b trial?

Are they testing audiograms in Phase 2b?

Link and info is in the press release above.

 

[Gb3]

Does anyone have the ClinicalTrials.gov link for the Phase 2b trial?

Are they testing audiograms in Phase 2b?

They are contacting people themselves.

 

[Nobody19]

Does anyone have the ClinicalTrials.gov link for the Phase 2b trial?

https://clinicaltrials.gov/ct2/show/study/NCT05086276?

 

[patorjk]

As soon as they publish the failed results of the severe hearing loss trial in November I'm buying the dip, it will be great to start again at a position of $4 or $5 per share! My fingers are ready...

I think Frequency Therapeutics thinks that study will fail too. I found this quote from the press release interesting:

"In November, we look forward to presenting the detailed clinical findings that support the design of FX-322-208, as well as discussing our broader R&D efforts as we expand our pipeline in hearing loss as well as other disease areas where we have seen real promise from our technology."

My guess is they're going to pair the failure news with the details that support their new design. They'll need to present something that's pretty convincing too - right now they only have 1 drug. I could see them going under $3. Unless you felt really confident about Phase 2b, I would think twice about putting money in. I don't see this company having any kind of run-up when Phase 2b nears its completion. I can only see them going up if Phase 2b is a success.

 

[Diesel]

I think Frequency Therapeutics thinks that study will fail too. I found this quote from the press release interesting:

My guess is they're going to pair the failure news with the details that support their new design. They'll need to present something that's pretty convincing too - right now they only have 1 drug. I could see them going under $3. Unless you felt really confident about Phase 2b, I would think twice about putting money in. I don't see this company having any kind of run-up when Phase 2b nears its completion. I can only see them going up if Phase 2b is a success.

I think the severe trial is already priced in. The price didn't move after the ARHL trial. Based on their balance sheet, it's priced about right. Any reactionary dip would rebound back to the current price in a short timeframe.

Also, if they really thought it was a failure, why bother including, "The Company will maintain flexibility in the overall FX-322-208 design in order to be able to include additional etiologies and severities based on pending results from its ongoing FX-322 study in severe subjects (FX-322-113)."

 

[Street Novelist]

https://clinicaltrials.gov/ct2/show/study/NCT05086276?

Nebraska, Texas and Virginia... God Almighty! How do they choose the sites? Why do they not put them in more states with a large population? No California, Florida or New York. I just do not understand their strategy.

 

[Lucifer]

https://clinicaltrials.gov/ct2/show/NCT05086276

Here's the link to the ClinicalTrials.gov for FX-322 Phase 2b trial.

From the information gathered there will be 124 participants with the trial starting this month with the expected study completion date of November 2022. They will be measuring speech recognition, audiograms and tinnitus level.

 

[OptimusPrimed]

Nebraska, Texas and Virginia... God Almighty! How do they choose the sites? Why do they not put them in more states with a large population? No California, Florida or New York. I just do not understand their strategy.

Those places have high rates of gun use = hearing loss.

 

[d'Wooluf]

I don't know why so many here continually hold these unrealistically high, "cure level" standards for hearing disorders.

Let's see. There's everything Frequency Therapeutics ever said until about a year ago.

 

[Street Novelist]

Nebraska, Texas and Virginia... God Almighty! How do they choose the sites? Why do they not put them in more states with a large population? No California, Florida or New York. I just do not understand their strategy.

I just read the press release. It says it will have 25 centers to administer the drug. So, maybe these 3 are just the first and more will come.

 

[Nobody19]

Good to see improvement in TFI are still being monitored.

 

[Ed209]

I don't know why so many here continually hold these unrealistically high, "cure level" standards for hearing disorders. It just isn't going to happen that way. These first drugs will follow the same development path as those drugs for non-hearing conditions before them: all will serve a limited scope of patients with specific underlying issues, and overtime development iterations will focus on a wider range of patient populations.

I think people hold these views because so many were getting waaaaaay too ahead of themselves in the early days of this thread (there was constant cure talk). When anyone tried to reign in the expectations somewhat, they would be jumped upon and told to stop being negative, etc. The cure mentality became almost cult-like and that's why you're still seeing over-expectations to this day. Frequency Therapeutics didn't help matters, either, because their early promotional materials were a little overly optimistic as well, in my opinion.

People became too emotionally involved with the outcomes of the trials, and this led to a dramatic disappointment. The current goals are far more realistic, but I think it's unlikely that it will help with long-term chronic tinnitus (just a personal opinion).

 

[Pero1234]

How Frequency Therapeutics communicates is different from say Otonomy...

They seem / seemed very confident. Otonomy & co more cautious.

People's high expectations were also a result of that overly positive tone in communication imho.

 

[ColinUK]

I think people hold these views because so many were getting waaaaaay too ahead of themselves in the early days of this thread (there was constant cure talk). When anyone tried to reign in the expectations somewhat, they would be jumped upon and told to stop being negative, etc. The cure mentality became almost cult-like and that's why you're still seeing over-expectations to this day. Frequency Therapeutics didn't help matters, either, because their early promotional materials were a little overly optimistic as well, in my opinion.

People became too emotionally involved with the outcomes of the trials, and this led to a dramatic disappointment. The current goals are far more realistic, but I think it's unlikely that it will help with long-term chronic tinnitus (just a personal opinion).

I'm sorry though it's not really people getting ahead of themselves. Did you hear the interviews with Carl, do you see the Twitter feed from FREQ? They don't exactly market themselves by saying that we are hardly going to do anything, that the goal is that we have really minuscule improvements for a small subset of people.

So if anyone has the wrong idea of what FREQ is putting out, than the blame of that lies on FREQ and I would argue to say that if this statement is true then they are basically misleading their investors as well.

 

[Jurger]

I'm sorry though it's not really people getting ahead of themselves. Did you hear the interviews with Carl, do you see the Twitter feed from FREQ? They don't exactly market themselves by saying that we are hardly going to do anything, that the goal is that we have really minuscule improvements for a small subset of people.

So if anyone has the wrong idea of what FREQ is putting out, than the blame of that lies on FREQ and I would argue to say that if this statement is true then they are basically misleading their investors as well.

Back in the day people on here wanted to petition Trump to get this drug...

And even now, Frequency's monthly presentation still displays this drug targeting the 20,000 to 6,000 Hz area of the cochlea. I would be happy with getting PTA improvements in that range, but they haven't shown any.

 

[Ed209]

I'm sorry though it's not really people getting ahead of themselves. Did you hear the interviews with Carl, do you see the Twitter feed from FREQ? They don't exactly market themselves by saying that we are hardly going to do anything, that the goal is that we have really minuscule improvements for a small subset of people.

My comment above was in relation to Diesel's question of why so many have unrealistic expectations. If you were around in the earlier days, you'd have seen how stupidly over-the-top people were getting, and I think this feeds into the expectations of today. There was talk of going to Washington and stuff, to get it expedited, and this was before any trial results were even in. It was ridiculous, and extremely naive, but it set a trend in motion and a degree of expectation amongst the community.

So if anyone has the wrong idea of what FREQ is putting out, than the blame of that lies on FREQ and I would argue to say that if this statement is true then they are basically misleading their investors as well

They went overboard with their press releases, no question about it, and they did this whilst the directors were dumping millions in stock. There's no law against it (it's a grey area), but it wasn't a good look and is arguably unethical. They all sold out near the top and left the retail investors holding the bag.

Back in the day people on here wanted to petition Trump to get this drug...

That was one of the stupidest things I've ever seen on this forum.

 

[Keith Handy]

I think people hold these views because so many were getting waaaaaay too ahead of themselves in the early days of this thread (there was constant cure talk). When anyone tried to reign in the expectations somewhat, they would be jumped upon and told to stop being negative, etc. The cure mentality became almost cult-like and that's why you're still seeing over-expectations to this day. Frequency Therapeutics didn't help matters, either, because their early promotional materials were a little overly optimistic as well, in my opinion.

People became too emotionally involved with the outcomes of the trials, and this led to a dramatic disappointment. The current goals are far more realistic, but I think it's unlikely that it will help with long-term chronic tinnitus (just a personal opinion).

Please show me an example of someone here being "jumped on" for being "too negative."

 

[Tau]

Back in the day people on here wanted to petition Trump to get this drug...

And even now, Frequency's monthly presentation still displays this drug targeting the 20,000 to 6,000 Hz area of the cochlea. I would be happy with getting PTA improvements in that range, but they haven't shown any.

My damage is only in the high frequency region, so this would be a godsend.

 

[Ed209]

Please show me an example of someone here being "jumped on" for being "too negative."

There's a quote here

In all seriousness, though, it happened all the time. You would have to read through the thread.

 

[Exit]

Please show me an example of someone here being "jumped on" for being "too negative."

That @Toby1972 guy was pretty much jumped on when he tried to warn us about fishy stock movements a month before results.

It really doesn't matter and is human nature to defend your only hopes for a normal future.

I always wish there was good news when I visit the research threads.