Frequency Therapeutics — Hearing Loss Regeneration

Hello! Do you think that with the second wave of COVID-19 in the United States, the testing of the FX-322 could be even further delayed?

 

It wasn't an exclusion factor so it's possible.

 

Highly likely.

 

Interesting stuff. Reading the actual text, I think FX-322 would be applicable under SEC 524B - Eligibility, provided the Phase 2A data meets significant primary and secondary endpoints.

“(3) a disease or condition associated with morbidity that has a substantial impact on day-to-day functioning."

The full text: https://www.congress.gov/bill/116th-congress/senate-bill/3872/text?r=2&s=1

The challenge would be the length of time this bill is going to sit in both houses before landing on the President's desk, and implemented at the FDA. Could be well after Phase 2A data is released in 2021, rendering it useless.

The good news is, it seems to have some support from both sides of the aisle; and a Trump or Biden presidency would likely pass it.

TBH, this is the type of legislature the tinnitus community should be working to get behind.

 

It is I think definitely going to be supported by both parties. Got no idea why it wouldn't. I was also aware both parties pretty much support this type of stuff, see the over the counter hearing aids etc.

For an outsider (I am in Australia) does this then mean you can obtain the drug after phase 2 if you want assuming that the trial demonstrates positive results?

 

The more likely looking factor is whether hyperacusis can be mentioned in the trial results. There is a possibility it won't with this trial as hyperacusis is actually not a target of it. I think they thus can't make claims which haven't gone through the process.

 

Agreed.

Also, it might not be very useful as far as FX-322 goes, but it seems like it could help us access things like the Hough Pill or OTO-413 faster.

As I understand it, if you have noise-induced hearing loss, you likely not only have inner/outer hair cell loss, but synapse damage as well.

 

Does ototoxic medication cause damage to hair cells or synapses or both? If so, are people with damage from ototoxic meds going to need FX-322 and OTO-413??

 

Does anyone know if there were any anecdotes of tinnitus improvement for participants in the Phase 1/2 study?

 

No there were not; only speculation.

A few of the more chatty folks in this thread (myself included) have gathered that perhaps the tinnitus questionnaire was added to the Phase 2A because there was some patient feedback from the Phase 1/2 of improvements. However, "qualitative" feedback cannot be included in the outcomes from the trial.

My personal perspective: Considering what we continue to learn about the thought process behind the Phase 2A from the leadership at Frequency (through recent conference interviews); it's likely that they included secondary outcomes including: TFI, HHIA, and HSI to help quantify the "qualitative" improvements observed from the Phase 1/2. We know recently that Frequency has continued to communicate with the Phase 1/2 participants.

One thing is for certain, FX-322 did not make tinnitus worse or cause tinnitus for any of the participants in the Phase 1/2. It would have clearly failed from a safety standpoint, and wouldn't be a secondary outcome measure in the Phase 2A.

 

Thanks for the clarification. I didn’t see any mentioning of tinnitus in the Phase 1/2 results and wanted to make sure I hadn’t missed it if it was addressed.

I think you’re right, and it’s logical to presume that there was positive qualitative feedback regarding tinnitus improvement in Phase 1/2. Adding it to Phase 2a, even as a secondary outcome measure, wouldn’t make sense unless they had some indication of a connection between hearing regeneration and tinnitus. As mentioned many times, in theory, one would stand to think these two items should be directly correlated.

I can’t wait for the Phase 2a results to be announced. I’m optimistic as the safety profile and word score improvements from Phase 1/2 looked promising. I hope four injections yield the results we are looking for. Hopefully, we know more by the end of this year.

 

Every ototoxin is different and some are poorly studied. Which ototoxin are you referring to?

 

No, the closest we have are people with hearing loss and tinnitus who get a hearing aid or cochlear implant. It does seem to a have a beneficial effect on some of these patients. If that’s the case I see no reason why restoration of natural hearing wouldn’t have that (or even more beneficial) effect.

 

Thanks. I hope that it will improve hearing and as a consequence improve tinnitus.

 

15 per cent drop in share price today... Why? Or is this normal for biotechs?

 

I can conclude convincingly from my perspective that as the hearing loss has gotten worse, the tinnitus has gotten worse as well. This would be a pretty positive indication they are inherently linked.

 

With Frequency it seems normal. There have been several instances where it'll jump 10% or drop 10% for unknown reasons (I think on Thursday last week the stock jumped by a little over 10%). The stock is basically back to where it was 2 weeks ago, so the drop could be some people taking their profits.

Looking at insider trades, the only recent ones I see are by Christopher Loose (Chief Scientific Officer), who's been selling 4,500 shares every two weeks since April. He currently holds 170,782 shares. At the current rate he's selling, he'll have around 139,282 shares when the Phase 2a top-line results are released (assuming they get released at the end of September). It makes me uneasy when insiders sell, but as along as they keep most of their shares it's a good sign. After all, if Phase 2a fails, he loses a ton, so he's probably making sure all his eggs aren't in one basket.

 

Part of the game for biotechs. Very volatile due to the risk involved - most biotechs fail. Many biotech investors are in one day and out the next solely due to gut feelings, especially since it’s hard for many investors to understand the science behind these products enough to feel comfortable. Even though Frequency has considerable cash on hand, they don’t yet have revenue-generating products to be profitable. See their negative net margins, which are common for the industry. Their cash is tied up in R&D and costly clinical trials to seek approval. Biotechs burn through their cash reserve.

Also, since it’s an ongoing double-blind study, not even the study staff is aware of the results at this point. Currently, the drop in share price is under 12%. This will change too much to monitor, especially since we’re a good deal of time away from learning the results of Phase 2a.

 

Have had a look and actually am seeing that there has been quite a similar slide in biotech today. Thus I think that this is a trend. Nothing noticeable to worry about and I actually think that this is more towards the general sentiment to this area of the market.

 

Normal.

 

I think that's because he currently wants cash rather than the shares since it seems somewhat highly likely he has had his pay partially put into this. I think it is completely normal. Notice how new companies do this often on account of the fact that flicking shares to someone simply is cheaper than trying to pay them cash which will be much more useful and also valuable.

 

Very normal.

It's incredibly common to see "insiders" periodically sell positions for drugs (even ones that turn out to be blockbusters).

Trust me, if it wasn't, anyone could be an easy millionaire looking at the filings and investing in biotech and that's very much not the case.

 

This probably means we have to wait then until the complete study is finished. And I thought we would maybe already get some appetiser this fall.

 

I've made over a £1,000 buying and selling Frequency Therapeutics in the past 3 weeks. The other day I held stock for 1 hour and 15 minutes and made £340. I normally invest long term, but this is paying for my treatment if they succeed and I guess I'm reaping my cash I wasted in the past on so called tinnitus treatments. All part of the game I guess (I'm new to short term trading).

Anybody else having success? I would invest long term as long as the science progresses and things go well. The benefit of this stock is that I regularly read about the company.

Obviously, my biggest hope is for this to succeed, if I didn't suffer from tinnitus I probably never would have heard of this company. Dark clouds, silver linings I guess. I'd rather have a cure for tinnitus though than a million.

 

I've been holding long, buying a few shares monthly over time, relying on cost average.

Although I believe that the PCA approach looks promising for a number of treatments over the very long term, I'll probably sell the gains for the treatment.

 

With how obessively I've been watching this company it probably would make sense for me to do short term trading (they're up 6% today). I have a long position, but what you're saying makes a lot of sense. Next time it dips I may try this.

 

Do you guys think that hearing restoration could also curb or possibly erase ETD symptoms?

Mine started shortly after my tinnitus did, and at times it's more annoying than the tinnitus itself.

I'm not very well versed on what causes ETD but I can't help but think it's related to hearing loss in some way, at least for me.

 

I don't think it would have any effect on ETD. ETD really has nothing directly to do with the cochlea.

 

Your ETD symptoms are ear fullness and popping I assume? That’s more likely middle ear muscle spasms than ETD. It’s a very common misdiagnosis. The middle ear muscles are controlled involuntarily by the brain stem based on auditory input, so if the input is restored it could potentially be corrected.

 

Those are exactly my symptoms. Thanks so much!

Sometimes I can get the fullness to go away after popping them, but normally only for a few seconds, and a few minutes at the most.

I've never had these issues before, it's just too much of a coincidence to not be related. Just one more reason to look forward to FX-322.