Frequency Therapeutics — Hearing Loss Regeneration

I listened to the entire webcast from this AM - it's here for those of you who haven't listened.

I'm the least intelligent person on this thread BUT F*** people, there are a few things that stand out after listening.

1. Remember that while they were measuring tinnitus, they aren't recruiting for it. How do we even know how many patients had it. What if there were only the two we've heard anecdotes from? Carl LeBel's answers about EHF audiogram and tinnitus were basically "we didn't get anything." Seemed very much an after thought. But it sounds like the entire Phase 2a data is pure trash. Not worried. Re: The FX-322-111 trial, it causes me a little concern but that was only 30 patients. Maybe not one had tinnitus.
2. They announced clinically significant results from the single-dose FX-322-111 trial that also came out today. Not from a previous trial.
3. They're moving forward with single-dose.
4. I bought 500 more shares.
5. Lucchino also mentioned they were combing 'social media' for conversations people were having about not being admitted to the trial based on not hitting the WR criteria.

I don't think this is dead at all. I'm long FREQ.
This reads like massive denial. Buying more shares is straight up reckless. It's your money so do what you want with it of course. Just feels like someone needs to say that doubling down on an investment when the company has completely dropped the ball and the price has plummeted is very high-risk and low reward.

I don't want insult added to injury and inexperienced, emotional investors reading this thread and thinking that's a good idea. It's not. I'm seeing sunk cost fallacy all over the place, everyone is fine with losing it all rather than getting out with at least some money and living to fight another day. That's not rational. The rational move is to cut losses immediately and wait for good news to justify re-investing. And if it keeps bleeding down after you sell, you can decide whether you want to buy back in at a lower price.
 
I still assume FX-322 works (at least in single dose). It looks like they need some more experimenting. Dose, interval, method of delivery. Unfortunately that is hardly possible under the FDA system and of course available budget.
 
Please tell me what I want to know the most.

Did Phase2a improve anyone's dB of EHF?

Didn't they say "there was no improvement in this cohort as a whole"?

Didn't even one person improve the dB of EHF at all in Phase1b FX-322-111? Or did they say that "the subjects as a whole did not improve"?

In both cases, if no one has improved at all, Phase 1/2's 10 dB (8 kHz) and 5 dB (6 kHz) will be fluke, mistake, and meaningless.

The credibility of hair cell regeneration becomes questionable.

I don't know how it was expressed, so please let me know.
 
I still don't understand how WR scores can increase in all groups but it "didn't work".

Does anyone know if they have to do Phase 1/2 again to change it from 4 doses to one?

Or do they just have to do Phase 2 again?

Or best case scenario is FDA allow them to go straight to Phase 3 because of the other studies they've done.
 
They also had improved word scores and can now hear birds sing and crows. We both talked to the same person. They can also tell better where sounds are coming from. They also got only two doses of FX-322. This is an older gentleman who I doubt would lie to get into a trial.

Honestly I heard from someone who's very involved in the trials that they thought it was a miracle that after someone was treated with an unknown amount of placebo or FX-322 they were able to understand what was being said with her back turned while before that she had had to take her mask off to talk to them.

I'm at a loss, I truly am, I'm seriously debating saying to hell with it and just getting cochlear implants, man. I can't go on the way I've been struggling everyday and now there's no telling when this will come out or even be available.
I'm confused. How would they know they only got two doses of FX-322 if everyone, including patients, is still blinded at the individual level? You even then say it was an unknown amount.

I've just woken up and all I feel about this process is complete and utter anger because I've realised there's only one of two possibilities: either this drug doesn't do anything in humans and we've all been misled, or a bunch of selfish, desperate people have knowingly lied to get into the trial and potentially ruined the one and only chance for the rest of us to rebuild our lives. I am livid. If you are one those patients and happen to be lurking this forum, I only have two words for you. No prizes for guessing what those words might be.
 
Frequency Therapeutics will eventually zero in on successfully treating sensorineural hearing loss, it is only a matter of time. It is back to the drawing board to unlock the answers we need, the signal is there.
Thank you! Otonomy is doing their 3rd or something Otividex trial and still haven't given up. People act like failing a clinical trial means that they're just going to accept defeat and go home.

Thousands of successful drugs have failed clinical trials.
 
I'm confused. How would they know they only got two doses of FX-322 if everyone, including patients, is still blinded at the individual level? You even then say it was an unknown amount.

I've just woken up and all I feel about this process is complete and utter anger because I've realised there's only one of two possibilities: either this drug doesn't do anything in humans and we've all been misled, or a bunch of selfish, desperate people have knowingly lied to get into the trial and potentially ruined the one and only chance for the rest of us to rebuild our lives. I am livid. If you are one those patients and happen to be lurking this forum, I only have two words for you. No prizes for guessing what those words might be.
No way have we been misled. The data was reviewed by third parties AND the FDA. Besides, there's the fact that several scientific A listers are on the Frequency Therapeutics Team; they wouldn't ruin their reputations to make a quick buck.
 
I'll admit I know next to nothing about those devices. But isn't she taking a very long time?
She's been taking her sweet time, but barring another pandemic, their current Phase 2 trial should conclude this year with results out middle of next year. Medical devices only need to go through a feasibility and pivotal trial before applying for FDA approval so presumably if the results from this trial are good, they'll seek FDA approval after this.
 
The whole situation stills feels so unreal. I also still cannot get over the fact how FREQ acted so positively over the last weeks and the results have been so bad. Do we have a guess since when have they had the data on their desk? It' s just crazy that they released the paper for Phase 1 with the good results, made new top tier hires for the company and posted many positive tweets while the might have known already that things are bad.

Another question which I asked myself today: So you cannot just sell shares as an insider whenever you want. You have to submit your stock trades a long time in advance. But this does not mean that you cannot still optimise profit. The date of sale/buy is fixed, but if you can choose to release the trial results before or after you sold your stock while knowing what the impact of the results will be on the stock market, this gives some strong reasons to choose wisely when to make the results public...
 
She's been taking her sweet time, but barring another pandemic, their current Phase 2 trial should conclude this year with results out middle of next year. Medical devices only need to go through a feasibility and pivotal trial before applying for FDA approval so presumably if the results from this trial are good, they'll seek FDA approval after this.
Does the device work? At all?
 
Don't give your hopes up. We've seen it in the Phase 1/2 trial, the drug IS working. Maybe just multi-dosing wasn't the right approach. I think there's no one who does his homework right the first time.

5 years ago, we weren't even near to a possible solution. Now there are a lot of companies that want to treat hearing loss. We are very close to something that would help us. It's just a matter of time. Keep on fighting!
 
I think they ran into issues because they weren't allowing the prior dose to effectively settle and proliferate. I think their dosing schedule was way too fast, but I didn't think it would absolutely obliterate the entire point of Phase 2 like it might have.
Someone literally said yesterday in the investor conference that the weekly injection was "too much, too soon."
 
Don't give your hopes up. We've seen it in the Phase 1/2 trial, the drug IS working. Maybe just multi-dosing wasn't the right approach. I think there's no one who does his homework right the first time.

5 years ago, we weren't even near to a possible solution. Now there are a lot of companies that want to treat hearing loss. We are very close to something that would help us. It's just a matter of time. Keep on fighting!
Let's say FREQ goes under (which I don't think will happen), someone will buy the PCA system. There's a myriad of hedge funds and venture capitalists ready to drop millions on this, it's going to be a multi billion dollar business.
 
Please tell me what I want to know the most.

Did Phase2a improve anyone's dB of EHF?

Didn't they say "there was no improvement in this cohort as a whole"?

Didn't even one person improve the dB of EHF at all in Phase1b FX-322-111? Or did they say that "the subjects as a whole did not improve"?

In both cases, if no one has improved at all, Phase 1/2's 10 dB (8 kHz) and 5 dB (6 kHz) will be fluke, mistake, and meaningless.

The credibility of hair cell regeneration becomes questionable.

I don't know how it was expressed, so please let me know.
The answer is no: not one person in their Phase 2a improved on the audiogram, including extended high frequencies. Furthermore, they apparently ran a parallel new Phase 1/2 trial. Again, not one patient improved on the audiogram, including extended high frequencies. Listen to their webcast from yesterday, last few minutes.
 
Since weekly FX-322 doses were too much, do you think fortnightly or monthly doses is a better long term solution with the current delivery method?

Is fortnightly still too frequent to be injected with FX-322?
 
Let's say FREQ goes under (which I don't think will happen), someone will buy the PCA system. There's a myriad of hedge funds and venture capitalists ready to drop millions on this, it's going to be a multi billion dollar business.
I really don't see this happening. Single dose has been more effective with FX-322. It's just how to get FX-322 deeper in the round window whether that is by reformulating or additional doses monthly.
 
I really don't see this happening. Single dose has been more effective with FX-322. It's just how to get FX-322 deeper in the round window whether that is by reformulating or additional doses monthly.
Weed out the fucking liars and inject once every 3 weeks or something. I think they have a real shot a getting this one to market and then FX-322 V 2.0 will be reformulated.

This is a moot point now anyway, they'll try to release it as a single dose treatment; silver lining is that the trials will be shorter.
 
Weed out the fucking liars and inject once every 3 weeks or something. I think they have a real shot a getting this one to market and then FX-322 V 2.0 will be reformulated.

This is a moot point now anyway, they'll try to release it as a single dose treatment; silver lining is that the trials will be shorter.
So not all bad news. I'll be interested to see what the Day 210 results show. It still doesn't make sense to me that we have a positive anecdote that had meaningful improvements in word scores and 3 frequency bands. Also the positive patient has no tinnitus after 5 months from his last FX-322 dose and can hear birds and sing, that is a miracle.

Surely there would be others like him in the trial that are experiencing the same thing as him right now but haven't told Frequency Therapeutics yet.
 

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