Frequency Therapeutics — Hearing Loss Regeneration

[ThomasRobert]

Any morning now we wake up, the results will be out guys.

 

[Padraigh Griffin]

This is so interesting - I was born 11 weeks premature and spent the first 10 weeks in a neonatal unit but I'm not sure if I would have been fitted with hearing protection. I read that neonatal units actually tend to be quite noisy too. I wonder if that could have contributed to cumulative noise damage.

My twin boys were born 17 weeks premature and I can confirm that they had no specific hearing protection. Neonatal is indeed very loud 24/7. Unfortunately the stress of two extreme prematures is one of the reasons I am currently here as the tinnitus was brought on from the anxiety and insomnia.

As an aside I am very quietly (pardon the pun) confident that Frequency Therapeutics is on to something from a tinnitus perspective. It could be a far bigger market than taking on the hearing aids directly. Only the next few weeks will tell.

I know someone who was born very premature and lost her sight at the age of nine, and I wonder if that was likewise due to an unprotected vulnerability in the neonatal period. On that same note, I wonder if Frequency Therapeutics' regenerative technologies have any applicability down the road for retinal restoration.

That is due to Retinopathy of Prematurity, which is extremely common in very premature babies. It has a lot to do with Oxygen saturation from breathing support/ventilation during the early stages due to lack of lung development in prematures.

 

[Keith Handy]

Any morning now we wake up, the results will be out guys.

Wake up from what... sleep? I think you're making an assumption here.

 

[Jim Vasilakis]

How likely is it that my tinnitus is caused by a -5 dB drop in the 4 kHz range? My ENT says that it's the likely cause of my tinnitus although I haven't done a 16 kHz audiogram yet.

In the hypothetical scenario that my tinnitus is caused by the -5 dB dip in the 4 kHz range, then will FX-322 not work for me?

 

[Diesel]

How likely is it that my tinnitus is caused by a -5 dB drop in the 4 kHz range? My ENT says that it's the likely cause of my tinnitus although I haven't done a 16 kHz audiogram yet.

In the hypothetical scenario that my tinnitus is caused by the -5 dB dip in the 4 kHz range, then will FX-322 not work for me?

FX-322 showed improvements on the audiogram at the 8 kHz range. If we see continued improvements on the audiogram at and above 8 kHz from the Phase 2a trial, it's reasonable to think that FX-322 will eventually help at 4 kHz.

 

[Zugzug]

How likely is it that my tinnitus is caused by a -5 dB drop in the 4 kHz range? My ENT says that it's the likely cause of my tinnitus although I haven't done a 16 kHz audiogram yet.

In the hypothetical scenario that my tinnitus is caused by the -5 dB dip in the 4 kHz range, then will FX-322 not work for me?

It's definitely possible to be the cause of the tinnitus. It largely depends on how sensitive your brain is to changes.

We don't know how well multiple doses helps push the medicine deeper. Most people's conservative opinion is that their current formulation won't help ranges outside of 8 kHz + that much. But we still don't know. The results are supposed to be extremely informative with large sample sizes and detailed analysis at each frequency.

 

[Nobody19]

So what kind of information can we actually expect from this 90 day data analysis?

 

[Diesel]

So what kind of information can we actually expect from this 90 day data analysis?

 

[patorjk]

Their Events and Presentations sections still shows their February 2021 presentation:

https://investors.frequencytx.com/events-and-presentations

I wonder if this signals that the results will happen sometime soon rather than towards the end of the month. If they were planning on having the results at the end of the month, I would assume they would release an updated March 2021 presentation. However, if the results were to happen soon, I would assume they'd want their March 2021 presentation to contain info about those results.

I admit that I may be reaching a little here, but it's interesting that they didn't update the presentation. It would be a little odd if they released a March 2021 presentation towards the end of the month.

 

[Diesel]

Their Events and Presentations sections still shows their February 2021 presentation:

https://investors.frequencytx.com/events-and-presentations

I wonder if this signals that the results will happen sometime soon rather than towards the end of the month. If they were planning on having the results at the end of the month, I would assume they would release an updated March 2021 presentation. However, if the results were to happen soon, I would assume they'd want their March 2021 presentation to contain info about those results.

I admit that I may be reaching a little here, but it's interesting that they didn't update the presentation. It would be a little odd if they released a March 2021 presentation towards the end of the month.

They seem to only update the presentation when it is warranted, because it has to be filed with the SEC. I suspect that the morning they release the PR on the 90-day readout, they'll also file a spanking-new deck with all the 90-day data for people like us to scan through and over-analyze, and debate here on Tinnitus Talk what it all means until June.

 

[GlennS]

Some have mentioned that Frequency Therapeutics has already issued patents for regenerating hair follicles

You mean... like... curing baldness?

 

[FGG]

Does anyone remember when they announced they would release 90-day data? How much data did they have at that point?

I keep coming back to the fact that they aren't required to release interim data, so I can't imagine they'd want to unless they very strongly suspected it would be good...

 

[Diesel]

You mean... like... curing baldness?

View attachment 43792

Yes.

 

[wwtsai]

Does anyone remember when they announced they would release 90-day data? How much data did they have at that point?

I keep coming back to the fact that they aren't required to release interim data, so I can't imagine they'd want to unless they very strongly suspected it would be good...

They made the announcement in their October 29, 2020 press release.

Frequency Therapeutics Announces Expanded FX-322 Clinical Development Program and Upcoming Day-90 Phase 2a Analysis

 

[Diesel]

Does anyone remember when they announced they would release 90-day data? How much data did they have at that point?

I keep coming back to the fact that they aren't required to release interim data, so I can't imagine they'd want to unless they very strongly suspected it would be good...

I believe it was in the Oct 29, 2020 Press Release when they first announced the 90-day release being "Late Q1 / 2021"

Frequency Therapeutics Announces Expanded FX-322 Clinical Development Program and Upcoming Day-90 Phase 2a Analysis

They originally mentioned in March of 2020 when COVID-19 first hit, that they acknowledged they had not fully recruited (later confirmed in May that they had about 50% enrollment), but "We do believe that, if necessary, we could achieve the key objectives of the study with fewer subjects than originally designed."

Frequency Therapeutics Provides Business Updates and Reports Fourth Quarter and Full Year 2019 Financial Results

I think at this point, they had done an interim analysis.

Also, in 2019 when the Phase 2A was announced. They had also communicated that they were prepared to do an interim analysis over the summer of 2020 (obviously, pre-COVID-19 delays).

 

[AfroSnowman]

I know the stock price means nothing, but I'd sort of feel better if it stopped dropping.

 

[Diesel]

Let's all be mindful of what is probably going on at Frequency Therapeutics:

They still have not done their Year-End/Q4 2020 business update (last year it was on March 26th). These take a lot of work for a company to compile, review for compliance, and submit.

It's possible that they include the Interim Analysis as part of the Year-End announcement. It's also likely that they're working up other marketing materials to reinforce the findings in the Phase 2A 90-day. The firm has been quick to communicate the benefits of FX-322, so they may want to have that marketing pipeline in place prior to the announcement. They're already producing pretty high quality videos from the Phase 1/2 data, these are typically 2-4 week long projects to do motion-graphic projects like they have shared recently.

Hopefully they don't wait until March 26th again, but I am optimistic that it will be worth the wait.

 

[Tezcatlipoca]

Let's all be mindful of what is probably going on at Frequency Therapeutics:

They still have not done their Year-End/Q4 2020 business update (last year it was on March 26th). These take a lot of work for a company to compile, review for compliance, and submit.

It's possible that they include the Interim Analysis as part of the Year-End announcement. It's also likely that they're working up other marketing materials to reinforce the findings in the Phase 2A 90-day. The firm has been quick to communicate the benefits of FX-322, so they may want to have that marketing pipeline in place prior to the announcement. They're already producing pretty high quality videos from the Phase 1/2 data, these are typically 2-4 week long projects to do motion-graphic projects like they have shared recently.

Hopefully they don't wait until March 26th again, but I am optimistic that it will be worth the wait.

I think it'll be sooner, they have a big conference coming up on the March 17th, they're even sponsoring it; It makes sense for them to release the data before that date so they can boast about it.

 

[Drachen]

I know the stock price means nothing, but I'd sort of feel better if it stopped dropping.

All this means to me is that it's a good idea to buy, buy, buy as it'll inevitably shoot to the moon after the successful results!

(Kidding, of course.)

 

[Aaron91]

View attachment 43787

Just a point on this for everyone to keep in mind. As you will notice, it says "group level" data. This is because they are only unblinding themselves at the group level. Carl LeBel said in the presentation that they wouldn't unblind themselves at the individual level until the full readout. Hopefully this pre-empts any speculation as to why they may not divulge any specific data beyond the group level.

 

[paul mclean]

In that case @Diesel, I will just assume it's going to be on the 26th of March now. 17 days ain't that long, 2 and a bit weeks. I am quite excited now and I'm praying they smash this out of the park.

Let's go Frequency Therapeutics!

 

[Diesel]

I think it'll be sooner, they have a big conference coming up on the March 17th, they're even sponsoring it; It makes sense for them to release the data before that date so they can boast about it.

Yeah, I had thought about that... how embarrassing would be it to sponsor the Hearing Healthcare Conference, pay for 55 students to attend, headline the event with a "Hair Cell Regeneration Advancements" presentation hosted by one of the founders, and the trial ends up being a goose egg... not likely, I suppose.

 

[Diesel]

Just a point on this for everyone to keep in mind. As you will notice, it says "group level" data. This is because they are only unblinding themselves at the group level. Carl LeBel said in the presentation that they wouldn't unblind themselves at the individual level until the full readout. Hopefully this pre-empts any speculation as to why they may not divulge any specific data beyond the group level.

This also means that they can provide a group-level baseline. So, let's all just look for the 4x group page and see how good it gets...

 

[Zugzug]

This also means that they can provide a group-level baseline. So, let's all just look for the 4x group page and see how good it gets...

Are we sure they are providing like a formal report of the interim results? Could it be just a press release with the tests and p values?

 

[Diesel]

Are we sure they are providing like a formal report of the interim results? Could it be just a press release with the tests and p values?

Carl LeBel mentioned in the January webinar that we should expect to see group level averages that show both % of improvement and a numeric improvement from baseline.

They can't show p-val without individual scores known.

I would expect something like:

The 1x group had a baseline average of 26 words, and at 90 days averaged 46 words.

and

The 4x group had a baseline average of -50 dB at 8 kHz and averaged -10 dB at 90 days.

and

The 2x group had a tinnitus baseline average score of 28 and at 90 days improved to 10.

 

[twa]

I asked my audiologist about my extended audiograms where I clearly have some hearing loss and asked her how bad it was was. She said that it was hard to answer because there really aren't accepted medical standards for what hearing sensitivity at those ranges are supposed to be.

Is this right or is the 20 dB of loss still considered the standard?

I asked 2 audiologists and one PA about the scores because mine are right on the line. They all said there is a standard of deviation for testing. So even though my scores are slightly different they allow for differences in testing within 5-10 dB.

 

[Tezcatlipoca]

Carl LeBel mentioned in the January webinar that we should expect to see group level averages that show both % of improvement and a numeric improvement from baseline.

They can't show p-val without individual scores known.

I would expect something like:

The 1x group had a baseline average of 26 words, and at 90 days averaged 46 words.

and

The 4x group had a baseline average of -50 dB at 8 kHz and averaged -10 dB at 90 days.

and

The 2x group had a tinnitus baseline average score of 28 and at 90 days improved to 10.

Can you imagine improving your score from 28 to 10? At that point it becomes the "meh" tinnitus.

 

[FGG]

Yeah, I had thought about that... how embarrassing would be it to sponsor the Hearing Healthcare Conference, pay for 55 students to attend, headline the event with a "Hair Cell Regeneration Advancements" presentation hosted by one of the founders, and the trial ends up being a goose egg... not likely, I suppose.

This honestly makes me suspect the 17th is the date they will announce data.

 

[scotty03874]

Can you imagine improving your score from 28 to 10? At that point it becomes the "meh" tinnitus.

That would give me my life back!

 

[Diesel]

Can you imagine improving your score from 28 to 10? At that point it becomes the "meh" tinnitus.

That would be a clinically meaningful improvement in terms of TFI. A 10 or less describes people that only hear it in quiet rooms and probably aren't bothered by it daily, maybe even weekly.