Frequency Therapeutics — Hearing Loss Regeneration

[Tezcatlipoca]

The great Tinnitus Talk hivemind believes this to the be case... but in reality... they could regurgitate some remix of the Phase 1/2 trial + the study in their 45 minute timeslot.

It could also be at month-end when they release earnings... nobody really knows, except that we're running out of days in March!

Personally I've been saying tommorow because it makes sense, they'll have momentum and can get a ton of PR. In my opinion there's no better time to drop the report, it's going to be very anticlimactic to release it 2 weeks later when the heat has died down.

 

[Keith Handy]

 

[FGG]

Please results tomorrow...

(Maybe a handful of people will get this one)

 

[vttbx]

The great Tinnitus Talk hivemind believes this to the be case... but in reality... they could regurgitate some remix of the Phase 1/2 trial + the study in their 45 minute timeslot.

It could also be at month-end when they release earnings... nobody really knows, except that we're running out of days in March!

Even Brute was pissed that it wasn't announced by the 15th.

 

[Pharz]

So, March 17th!

 

[Mica Rambin]

I just want the ringing to stop... Please Frequency Therapeutics... Let's make it stop.

 

[athan86]

I hope to have news as soon as possible. I am sure that FX-322 will give tinnitus sufferers a real solution. Once the treatment is available to the public, I will travel anywhere in the world for the drug!

 

[Chinmoku]

I don't know how much longer I can take it, getting worse and worse... please let this work and be available soon.

Good times for a change
See, the issues I had, could make a good man turn bad
so please, please, please
let me - let me - let me
let me get something that works, this time...
Haven't had a dream in a long time
See the life I had can make a good man bad
So, for once in my life, let me get something that works
Lord knows it would be the first time
Lord knows it would be the FX-322 time

 

[AliasM]

What will the prescription criteria be for FX-322?

 

[Diesel]

 

[Diesel]

I see the Future of Hearing Healthcare updated their agenda.

For Frequency Therapeutics it reads:

Recent advances in hair cell regeneration have led to promising novel regenerative therapies, including FX-322 by Frequency Therapeutics, which offered the first evidence of a restored hearing signal in humans in a phase 1/2 clinical trial. This course will cover the biology of hair cell regeneration, the development of FX-322, and the opportunities that hearing regeneration present for the audiologist.​

My expectations about the Phase 2A being released today from this description are low.

https://hearinghealthmatters.org/wp-content/uploads/2021/03/FHH_Session-Details.pdf

 

[Koz]

Please results tomorrow...

View attachment 44003

(Maybe a handful of people will get this one)

I'd gladly watch that movie everyday of my life for an end to this shit hahahaha.

 

[Pero1234]

That seems more like a recap of the Phase 1/2 results followed by some additional "education" for the attendees.

They are still spreading the gospel... building momentum and educating people it seems. I suppose that's why Will McLean is on stage.

Let's hope that they have at least some new insights to share.

 

[Aaron91]

I see the Future of Hearing Healthcare updated their agenda.

For Frequency Therapeutics it reads:

Recent advances in hair cell regeneration have led to promising novel regenerative therapies, including FX-322 by Frequency Therapeutics, which offered the first evidence of a restored hearing signal in humans in a phase 1/2 clinical trial. This course will cover the biology of hair cell regeneration, the development of FX-322, and the opportunities that hearing regeneration present for the audiologist.​

My expectations about the Phase 2A being released today from this description are low.

https://hearinghealthmatters.org/wp-content/uploads/2021/03/FHH_Session-Details.pdf

Sigh. I think you're right....guess I was wrong.

I just don't get why they wouldn't say something here only to come out with results a week later. I know @Zugzug has argued that they may still be glossing over the final details so to speak, but surely a company of this level isn't some kind of 11th-hour merchant that leaves everything to the last minute either. I would expect their results to have been compiled and ready for some weeks now.

In any case, I thought this part was interesting: "and the opportunities that hearing regeneration present for the audiologist."

This is some spin. Even if FX-322 only compliments hearing aids (as opposed to replacing them), how would this create new opportunity for an audiologist? Speculation: are they going to plant the idea of audiologists becoming trained in intratympanic procedures (presumably to meet demand)? @Greg Sacramento, if I recall correctly, you said the market has some concerns about re-training/educating doctors in time to meet the demand.

 

[FGG]

Sigh. I think you're right....guess I was wrong.

I just don't get why they wouldn't say something here only to come out with results a week later. I know @Zugzug has argued that they may still be glossing over the final details so to speak, but surely a company of this level isn't some kind of 11th-hour merchant that leaves everything to the last minute either. I would expect their results to have been compiled and ready for some weeks now.

In any case, I thought this part was interesting: "and the opportunities that hearing regeneration present for the audiologist."

This is some spin. Even if FX-322 only compliments hearing aids (as opposed to replacing them), how would this create new opportunity for an audiologist? Speculation: are they going to plant the idea of audiologists becoming trained in intratympanic procedures (presumably to meet demand)? @Greg Sacramento, if I recall correctly, you said the market has some concerns about re-training/educating doctors in time to meet the demand.

I don't think audiologists are going to get trained to do IT injections. I think this would likely be referring to EHF audiograms, WIN testing etc personally which are not done very often currently because hearing aids don't address these things.

 

[innergflow]

I'm hopeful, I just want my quality of life to stop decreasing. I want to stop worrying.

 

[Aaron91]

I don't think audiologists are going to get trained to do IT injections. I think this would likely be referring to EHF audiograms, WIN testing etc personally which are not done very often currently because hearing aids don't address these things.

Good point, that would make much more sense.

 

[Diesel]

ven if FX-322 only compliments hearing aids (as opposed to replacing them), how would this create new opportunity for an audiologist? Speculation: are they going to plant the idea of audiologists becoming trained in intratympanic procedures (presumably to meet demand)? @Greg Sacramento, if I recall correctly, you said the market has some concerns about re-training/educating doctors in time to meet the demand.

I see the opportunities for audiologists as follows:

- To monitor hearing health as it improves from regeneration = more regular visits
- Ability to advertise for preventative care (most people go to audiologists AFTER they have a problem)
- Ability to provide more customized solutions - address hearing-in-noise tests when hearing is normal, for example, or offer a "total assessment" package for testing hearing performance
- Deeper integration with firms & industries where hearing loss risk is high

 

[FGG]

I see the Future of Hearing Healthcare updated their agenda.

For Frequency Therapeutics it reads:

Recent advances in hair cell regeneration have led to promising novel regenerative therapies, including FX-322 by Frequency Therapeutics, which offered the first evidence of a restored hearing signal in humans in a phase 1/2 clinical trial. This course will cover the biology of hair cell regeneration, the development of FX-322, and the opportunities that hearing regeneration present for the audiologist.​

My expectations about the Phase 2A being released today from this description are low.

https://hearinghealthmatters.org/wp-content/uploads/2021/03/FHH_Session-Details.pdf

And here I am thinking "why would audiologists want to hear the same Phase 1 info again..." And then it occurred to me. They wouldn't be. Audiologists aren't following this as closely as we are. Even the Phase 1 info would be news to a lot of them who aren't following this like sufferers are.

At least we know they will release data by March 31st...

 

[Diesel]

And here I am thinking "why would audiologists want to hear the same Phase 1 info again..." And then it occurred to me. They wouldn't be. Audiologists aren't following this as closely as we are. Even the Phase 1 info would be news to a lot of them who aren't following this like sufferers are.

At least we know they will release data by March 31st...

Yes, and considering the anecdotes just from this site of ENTs/Audiologists that haven't even heard of FX-322, or had dismissed it... Frequency Therapeutics has a lot of work to do gaining adoption and understanding regardless of the Phase 2A outcome. The idea that FX-322 is going to kill their jobs isn't a great way to do that, and they need to be pushing for education well before the product is in its ready state.

Probably from now until FX-322 "1.0" is released, we should expect Frequency Therapeutics to continue messaging that the drug works in conjunction with hearing aids, and in ways that devices simply do not provide a benefit. This minimizes the industry / professional shift that may cause rejection, while also supporting adoption from a business standpoint.

 

[Greg Sacramento]

I can only make a personal judgement for Northern California excluding San Francisco. Audiologists have strong ties/agreements and support $ with hearing aid firms. Most Otorhinolaryngology are clinics even with hospital association. Patients are lined to the walls and only receive a 15 minute visit. Most are not very smart or caring. Rude and often say take this prescription for some antidepressant (less now because of black box warnings) and there's nothing we can do for tinnitus. They don't want to state cause if cause was from healthcare. They don't want to be involved with lawsuits. Most don't do injections.

Otologists and Neurologists and other specialists are few and far between and wait time is long for non-emergency.

 

[ThomasRobert]

The frustration in regards to the release of Phase 2 results is reaching boiling point...

 

[Diesel]

Now that I think about it, there is a secondary issue that perhaps they will address in the near future. That problem is distribution and fulfillment. In the US alone, looking at all the available ENT/Otologist/Hospitals that provide hearing care, and considering the potential initial market of 5-10M patients that may initially seek out FX-322 treatment, it doesn't seem like there will be anywhere close to enough locations to handle appointments for assessment + treatment + follow-up.

This bottleneck may be a problem for Frequency Therapeutics if they're reliant on cash flow from the sale of the treatment. I'm not sure how quickly the hearing care industry can shift to address this? It doesn't seem like it's a very inelastic industry considering the training and experience required to give IT injections.

 

[FGG]

Now that I think about it, there is a secondary issue that perhaps they will address in the near future. That problem is distribution and fulfillment. In the US alone, looking at all the available ENT/Otologist/Hospitals that provide hearing care, and considering the potential initial market of 5-10M patients that may initially seek out FX-322 treatment, it doesn't seem like there will be anywhere close to enough locations to handle appointments for assessment + treatment + follow-up.

This bottleneck may be a problem for Frequency Therapeutics if they're reliant on cash flow from the sale of the treatment. I'm not sure how quickly the hearing care industry can shift to address this? It doesn't seem like it's a very inelastic industry considering the training and experience required to give IT injections.

Others have pointed this out, but it would likely be like LASIK eye surgery. Centers would pop up probably that only address regenerative treatments and could increase patient flow.

 

[Zugzug]

I just don't get why they wouldn't say something here only to come out with results a week later. I know @Zugzug has argued that they may still be glossing over the final details so to speak, but surely a company of this level isn't some kind of 11th-hour merchant that leaves everything to the last minute either. I would expect their results to have been compiled and ready for some weeks now.

I wonder if we are just not viewing this whole thing correctly. Even my otologist (who's a legit expert) at a top hospital said that regenerative medicine is 20 years away. I can't even imagine the education level for audiologists.

It seems whacky to us because we are patients. Like how can we possibly know more about this drug? Sure enough, I would bet serious money that many of us have studied some of the reports a lot harder than many doctors, who are likely too busy and invested in their current practice to take it that seriously until it nears the market. @Greg Sacramento is probably totally right, as always. Huge unmet demand issue.

Regarding my previous opinion about checking results, I know this much. It is 100% par for the course to check over math and statistics results seemingly millions of times. It has nothing to do with being lazy or leaving it to the last minute. For example, I was working on research for years and would sometimes find either mistakes or poorly argued proofs, despite working and thinking about it 24/7.

At math and statistics seminars, it's not at all unusual to present partial results. Some people choose not to do this in special situations where they have fear that audience members could "beat them to the results," but assuming that's not the case, it's a pretty common thing. No one thinks that the person/group is incompetent.

This is obviously different. But I doubt that anyone at this seminar is going to think they are hiding incompetence. They will probably think the opposite -- that they are responsible.

@FGG is probably right that there's little to lose by presenting the science to fresh ears. On the other hand, there's a lot to lose by trying to get too cute and flashy at a seminar.

Another thought is that maybe their thought is that the presenters are unparalleled experts on the pre-clinical and Phase 1 results. Maybe they do have the results, but feel better about presenting education, with little to lose.

@Greg Sacramento makes a great point about earnings, as money actually matters.

 

[Gb3]

Why does it seem like a lot of experts really don't acknowledge the promise of "FX-322", considering this drug is nearing the end of Phase 2? The company itself has stated they plan to move to a pivotal phase next year. Why do experts still say it's going to be 10+ years for regenerative medicine?

 

[Pero1234]

I honestly think ENTs and doctors don't take ANY drugs or treatments seriously until after their efficacy has been proven with Phase 2 results.

There are just too many candidates that fail in Phase 2 or even Phase 3 for them to care.

I talked to my physician about FX-322 after the successful Phase 1/2. He just brushed it off and said that it was too soon to get our hopes up. And the guy even has tinnitus / hearing loss himself!

 

[FGG]

I honestly think ENTs and doctors don't take ANY drugs or treatments seriously until after their efficacy have been proven with Phase 2 results.

There are just too many candidates that fail in Phase 2 or even Phase 3 for them to care.

I talked to my physician about FX-322 after the successful Phase 1/2. He just brushed it off and said that it was too soon to get our hopes up. And the guy even has tinnitus / hearing loss himself!

Part of that is also because most of them don't know anything at all about any new drug until the rep shows up, buys them a lunch meeting and goes over it right before drug launch and the "ask your doctor about..." commercials air.

 

[Guywithapug]

 

[Pero1234]

Part of that is also because most of them don't know anything at all about any new drug until the rep shows up, buys them a lunch meeting and goes over it right before drug launch and the "ask your doctor about..." commercials air.

I have to say that it is exciting and humbling to see all these companies (and people) work so hard for us, without the world even paying attention to them.

I hope it pays off... for us and them!