Frequency Therapeutics — Hearing Loss Regeneration

Ouch man, but yeah keep holding out! Nice article with good info. Yeah I mean this is definitely a big market with no competition besides Otonomy so far. Either one getting approved would be huge and lots of profit. But yeah everything aside I try to be realistic, there’s definitely no guarantee this or Otonomy will pass but there is a good chance. $2.00-$3.00 a share is a good buy in for FREQ. For Otonomy I’m waiting for one more dip below $2.00 and I’m all in.

 

Many hearing aid users report a decrease of their tinnitus when their hearing aids are in. That fact along with the theory of residual inhibition strongly suggest that a restoration of signal reduces tinnitus.

 

I get residual inhibition. My tinnitus screams when I wake up and then actually quietens and disappears when sound is introduced and then reappears in silence.

So with that in mind, my brain must be getting the signal via damaged nerves but I have never been able to work out why the tinnitus comes aggressively back in silence. Hence why I don’t understand why new nerves along these broken ones will sort out the problem, at least in my case.

 

The most I can offer as an explanation to your concern is that the replacement and or transdifferation these hair cells would go through will replace the damaged connection as they are all part of the same system. Mind you this is all very unproven for humans and most mammals. However, in birds it has been shown to fully repair and replace damaged hair cells in the cochlea.

http://www.cochlea.eu/en/research-lines/regeneration

This link explained the process well for my understanding. This sort of thing has been attempted for a long time but is still quite promising.

 

There's a trading adage out there that goes, "Don't try and catch a falling knife". So I agree with your statement above in that regard because it relates to that. But I think it's important to parse out the phrase, "It's impossible to time the market", because in this context a generalised statement might confuse people.

In my circa 10+ years day-trading Forex on a leveraged account, and studying price-action, I'd say the only thing we have in our favour is market timing. And in that respect, at least as far as market entries are concerned, timing the market is everything.

In PA terms, if you think of a H1 double-bottom (classic market-turning/corrective PA), it's impossible (as you say) to predict when the market will create the left swing-low. Having said that, it's important, in fact I believe incumbent on retail traders/investors to recognise when/that it might form. And if it does eventually form (and a double-bottom is of course only one of any number of things the market might go on to do) start to take note.

Trading a double-bottom is about waiting for retests of the first swing low, and if the pro-money in the market does that and turns the price back up north, a retail PA trader can enter on the close of a bullish PA. In that respect (in my view at least) we have the dictionary-definition of timing the market.

There's a few caveats. I reckon the most important one from a PA perspective is that even the best timed entry doesn't guarantee a winning trade. Another caveat is that there is a different mindset between investing and trading. Purchasing FREQ stocks we're evidently talking about investing, however, I do think it's wise (particularly when placing one's hard-earned cash into the market) to try and apply a retail trader's mindset too with some basic PA study.

Finally, as a more generalised observation I would say FREQ's current trend for lower prices does not reflect the company's ability to produce a product that's going to work for us. Those two things are mutually exclusive.

 

The share price is very low right now. Why? Something wrong with the product?

 

This could be a result of pro-money driving prices lower (even selling to itself) to buy back at bargain-bucket prices while it accumulates stock between a price range. Without doing a deep dive on that we just don't know right now.

I would say, no. As of today, it looks like their product is doing everything they said it would. I'm very optimistic about Frequency Therapeutics. Hopefully some further trial results this year.

 

I hear about 75% of people with tinnitus can experience residual inhibition according to one study I've read. I'm curious about people without residual inhibition, could it be the hearing range is so dead there is no residual inhibition or is tinnitus unrelated to hearing loss? I myself have partial residual inhibition, with the high pitch tone not seeming to respond with residual inhibition.

 

The broader market believes that FREQ's technology is dead/completely failed based on the fact that the share price is so far below cash value. This stems from the fact that the company made the statement "did not demonstrate improvements in hearing measures versus placebo" when they released their Phase 2 results last year. While technically true that it did not demonstrate improvements versus placebo, it is because the placebo group also showed statistically significant improvements in word recognition scores and they did not have a reliable baseline in which to compare their statistically significant responders in the FX-322 group to. Add the fact that the placebo group was only 1/3 the size of the drug group, the companies explanation for why they had placebo responders is completely plausible.

I'm buying as many shares as I can right now as I think the market is completely wrong on FREQ and I believe it will return back to $30+ a share once they re-establish efficacy with the new Phase 2 as well as if they get promising results from FX-345. Look at the 5 year charts on biotechs like MRTX or AXSM, both were trading for only a couple dollars a share at one point and went on to see $50 to $100+ a share in a couple years time. I think FREQ will do the same.

 

In general the stock market has been rough for the past couple of months. That certainly has not helped FREQ. Hopefully in short time the market will improve to an extent that will make things better for everyone involved.

 

Yeah, along with that, I do think people might be a bit disappointed the deepest it goes is around 12 kHz. That and there are also more companies making hearing drugs now.

 

It's likely it gets down to 10 kHz or 8 kHz as the Phase 1/2 responders saw very mild audiogram improvements at 8 kHz.

Almost all of FREQ's competitors are pursuing a gene therapy approach of some kind and I don't know of any that are pursuing a small molecule approach like FREQ is doing. Otonomy is addressing the nerve synapse side of things with OTO-413 but they aren't a direct competitor as they aren't addressing hair cells.

 

Good luck Chad with your investment - sincerely.

Insider Confidence has lacked in the last three months.

An informative insider transaction is discretionary and not related to a routine action, such as an options exercise or a payment of stock. An informative buy might be considered bullish, while an informative sell might be considered bearish and Wall Street doesn't like bears.

 

@Chad Lawton, look at FREQ now! To the moon!

 

Hopefully a sizable increase in their stock will lead to better funding for their attempts at curing this ailment.

 

If the bellow is true (it's from the Hough Ear Institute's Facebook page, 14th of February this year) it sure looks pretty good to me.



Now I guess the question is how well the restored cells function and how damaged they were in the first place.

 

For FX-322 what is believed to be happening is PCA is causing support cells to regenerate hair cells where the original cell is missing or damaged. In the case where a cell is missing, the brains not getting signal from anything anyway, so a replacement cell should provide new signal. Where it is damaged is less understood, there hasn't been much detail provided on how damaged the hair cell has to be and/or what happens to that damaged cell. It could be that the new cell grows next to it, or it could be that the damaged cell is removed from the cochlea and the new on takes it place. Too early to know.

 

So is there an overall pro/con list for supporting Frequency Therapeutics?

Pros:

- formerly "impossible" advancement made within community
- possible compassionate use
- some (unverified) have noted improvement in tinnitus
- the development of FX-345
- new techniques to study progress
- new techniques to deliver drug

I'd say the only con would be the lack of results on an audiogram.

I think it wouldn't hurt to be supportive of Frequency Therapeutics because of all the other pros on the list. Yea it sucks they aren't performing the way we kinda wanted them to, but it'd be worse if it didn't work or help anyone at all. Who knows what they might find out in the long run?

* Also if everyone in the trials don't have tinnitus (and we can't confirm how many have it), why are we putting down the possibility it might help us? Have they used it on any groups that had mild or moderate hearing loss?

 

645 pages of discussion based on anecdotal reports of tinnitus improvement in a Phase 1 study in which results for hearing gains unfortunately could not be replicated in a bigger Phase 2.

Surely there are many better prospects on the origin than hair cell regeneration that will honestly take another 6-8 years to come to market.

The main positive is that Bob Langer spin-off companies rarely fail. A 39 out of 40 hit rate is amazing.

The main negative is funding for FX-345 to commercialisation is not looking favourable.

Personally I can’t wait 8 years for a tinnitus ‘cure’.

Plus how will it cure those hyperactive cells in the DCN?

Just don’t get why Frequency Therapeutics is always top of the research forum when Xenon Pharmaceuticals rarely gets a mention.

Retigabine had way more solid anecdotal data that is well documented on a thread on Tinnitus Talk.

XEN-1101 is far more potent, more selective, with a favourable side effect profile.

Why not put our attention there. Phase 3 beginning this year!

Park Frequency Therapeutics until FX-345 Phase1 or 2 is my advice.

 

Yes, they have used it on mild and moderate hearing loss. And yes, people with tinnitus have been in the trials.

 

I really don't know why the community has put so much hope into FX-322. Not only the company didn't mention any indication that it can help tinnitus, but it showed very poor results at improving hearing loss as well.

If it doesn't help raise those damaged frequencies in the cochlea that an audiogram or a frequency sweep would show, then I don't see how a word recognition or whatever, which is subjective test by nature (the patient can fill in the gaps after he heard some syllables) means something other than a vague hearing improvement.

Maybe FX-345 will be far better, but oh well, by 2030 that it will be finishing trials, we would surely have something else already.

 

Does this drug restore hearing permanently or temporarily? I know that hair cells can be lost due to noise, aging, and other reasons but I can see from the corporate presentation that the gained hearing is lost after 1-2 years. Can someone explain why that is please? Is Frequency Therapeutics hiding something from the public? Do they want to make more money by creating a "treatment" instead of a cure? Hmmm...

 

I don't think it will take that long (2030) for FX-345 to be in the market. They are going to start the Phase 1b trial this year and will end in the first half of 2023. Phase 2 trial also takes a year. While Phase 3 could take up to 2 years. So maybe in like 4 years (2026) we might get our hands on this drug.

 

XEN-1101 isn't even being tested for tinnitus. It could possibly help but that's far from certain.

 

No and No.

 

I hope so.

 

I'm one of the few on here that can live with my tinnitus. I'm more interested, at this point in time, in hearing restoration since I know that my hearing will only get worse as time passes. Also, I generally don't like the idea of being on a prescription drug if I can help it. That's why I don't care about Retigabine.

 

FREQ's finally printed a convincing market bottom on the H4 chart and also engulfed that lower high to the left in the process. The opening gap at the bottom is a very bullish sign too. Still a while away for me before I start buying this stock but structurally things are beginning to look interesting.

 

Cool, I understand your perspective but this is a tinnitus forum. There is no proof at all, and no solid anecdotal evidence, that FX-322 or FX-345 will cure tinnitus.

I am just surprised it gets so much attention when other research is closer to solving our collective problem which is ‘tinnitus’.

 

One word for you, that is a big word when it comes to Frequency Therapeutics... ‘Dilution.’