Frequency Therapeutics — FX-345

Bruce, I got the same email...

"Hello Dear Applicant,

Thank you for signing the electronic medical release form!

We may be in touch later if we run into any difficulty collecting records; that is if the office requires a wet signature, any additional verification, or if they don't have the records that we need to continue. If that happens, we'll inform you right away.

Once we have received all the required medical records, we will submit them for review to a panel of audiologists. They will review your records and determine if the study would be a good match for you. Once that decision is rendered, we'll be in touch again to provide you with their decision and any next steps, if applicable.

Please note that this process can take up to 8 weeks depending on how quickly the clinics process the medical record request. Medical records are shared with the panel of audiologists as soon as they are obtained. However, if you have any questions or concerns in the meantime please feel free to contact us here, at hearingstudy@clarahealth.com.
If you have a copy of your own records, please feel free to email them to records@clarahealth.com to expedite the process and reference study FX-322-208."

 

In my case, after going through the testing for the FX-322 trial, I got feedback the next day. Prior to that, there was maybe a couple of weeks to review my records and schedule the testing - about 1 month start to finish (this was last November/December timeframe).

 

That's the one!

The question is whether to go through with it, if selected. Is FX-345 so much better that it merits waiting for those trials?? And do we think this will help tinnitus, as well? I only have moderate hearing loss...

 

The described difference between FX-322 and FX-345 is the penetration into the cochlea. Where FX-322 is mostly surface level, FX-345 is deeper into the spiral formation where hair cells governing word recognition are located.

 

Thanks. Still not sure whether to participate, or not, if accepted...

 

Honestly, it's just good you sent your information in. Considering the connections between hearing loss and hair cells and hearing loss and tinnitus. It's likely that even non-tested hearing loss can relate to damaged hair cells and thus FX-322 and FX-345 are possible aids in mending if not curing. There is a potential good it can do for tinnitus sufferers now or in the future.

I wouldn't even try to influence your decision whatsoever. I could not give impartial advice as I am almost fanatically hopeful with the potential of Frequency Therapeutics.

 

You said you have hearing loss at 3 kHz and 4 kHz. FX-322 doesn't reach that far. Based on what their slide was showing, FX-345 will.

 

True. I also have a big dropoff at 8 kHz, as well.

 

Thanks. I'll wait to see if I am accepted and go from there.

 

Will be interesting to see how FX-345 does.

 

When do we find out? Are they currently in Phase 1?

 

They haven't started that yet.

 

Based on current timelines given by the company, an IND (Investigational New Drug) application will be filed with the FDA before end of year and a phase 1 trial will be initiated with results expected in the first half of next year.

 

If the trials for FX-322 fail, will they have enough money to proceed with FX-345?

 

This is for FX-345, correct? There is possibility FX-322 could hit the market before that if they have good results, correct?

 

I didn't get accepted...

 

Yes, we will see results for the phase 1 trial for FX-345 regardless of if FX-322 succeeds or not.

 

Yes, that is the timeline for FX-345 currently.

No. If FX-322 succeeds in phase 2, it still needs to go through phase 3 which will likely take another 1 to 2 years. If it passes phase 3, add a 6 month window for FDA approval of the NDA, then we are looking at FX-322 making it to market roughly around 2025 or 2026.

 

They won't fail.

 

What's with the stock price doubling the last three weeks? I don't see any news or press releases that would have been the catalyst.

 

Re: FREQ

Bottom line - I believe the rationale for the market's recent support of the psychologal share price of $1.00 (and not a red-cent below) is as much about giving FREQ the benefit of the doubt than anything else, especially in lieu of all that's gone on there recently (those with access to Level 2 quotes will be able to answer whether or not there's been pro-money accumulation going on).

As a side-note, sub $1 would relegate FREQ to a penny-stock status. And clearly, regardless of volume, there are financial interests at play that are not going to allow that to happen right now, which is good news.

I know there are others on here that whinge conspiratorial about putting stock charts into the open territory of Tinnitus Talk. But sod that. I'm posting a chart here today.

The price we need to watch is $2.21. If the market closes above that price we can start to consider a bullish reversal.

 

Today's close of $2.32 is encouraging. Actually for buyers on a daily chart it's the best PA since mid 2020. If I buy FREQ I'll be looking for a pure price signal on either H4 or D1. That could still be quite some time away, however. Possibly 2-3 months.

 

Hoping they bring the Phase 1 FX-345 trial to Miami, Florida. I didn't go through with the FX-322 trials because it would have been an over 200 miles drive to get there.

 

Are Frequency Therapeutics still planning on starting the FX-345 trial this year? Has anyone heard anything? Starting to get worried...

 

If that's the case that FX-345 goes deeper into the cochlea for speech recognition, why are they saying that FX-322 is aimed at hidden hearing loss and word recognition? I'm sure one of their methods of evaluation of efficacy is a speech-in-noise test.

 

Start of Q4, 2022.

 

The new hair cells would also induce synaptic regeneration, and I assume the brain will open up to additional audio input. What I don't get is how it discerns cilia damage versus synaptopathy. If it wiped clean all hair cells (normal and damaged), I'd actually be down with deafness for some time to allow them all to come back clean and tidy. Below is one of their slides for FX-322 stating a full gamut of recovery: new hair cells, hair cells functioning, new ribbons, new synapses.



The one key feature that really helps is mammals "lost" the ability to restore hearing cells, i.e. they had it at one time but for some reasons: evolution of cochlea to support higher and/or lower frequencies? Maybe that is the case, I guess the animals that our ancestors were hunting had a wide spectrum of frequencies, so we could hear the grunts, howls, and chirps. Not sure of other reasons, I feel we evolved too fast for ourselves and didn't allow evolution to catch up. I bet our ears are more hardened and resilient than when gunpowder was first invented back 1000 (?) years ago.

 

The stuff dreams are made of :-/

 

Yeah, I'm not expecting a lot, baby steps I guess.

 

This is Q4 bro. I'm hoping something happens this month.