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And the other one was me. I didn't predict the company would commit fraud in my opinion. On April 8th, 2022, the company filed an 8-K with the SEC stating that they laid of 30% of their workforce. In the filing they state: "These changes will preserve capital, ensuring that the Company is...

I for sure am. I was prepared to accept the failure of FX-322 but for the company to decide to scratch the entire FX-345 program in one fell swoop as well, especially when no patients even made it to the 90 day testing window based on their first dosed patient in December, absolutely pisses me...

Yea, I’m selling most of my shares. I was not anticipating them discontinuing both FX-322 and FX-345 at the same time. They went from having 3 shots on goal to now only having 1. I took a huge financial loss but also just sad from a tinnitus sufferer’s perspective.

I'm holding long term, I pay no attention to the short term price fluctuations. No insider has bought any shares in the last year and a half.

There really isn't much to elaborate on. The stock has had dozens and dozens of 10% up and down days over the last 2 years for no reason at all. The stock ran up over 100% in a month and people are reading into a 10% drop.

No.

It means the stock went down 10% today; it's the nature of small market cap, no revenue generating biotech. The study's primary completion date was on December 30th, so I'm sure they've unblinded sometime in the last month so there are probably a select few at FREQ that already know that results.

Really depends what share price we end up at right before data drop. I think it's reasonable that we could double up overnight to anywhere from $10 to $20 on good data. If FX-322 proves efficacy, it revalidates their entire platform and it's game on from there. If FX-345 also comes back with...

Looks like you may benefit from FX-345 based on where your notch is and if FX-345 penetrates as deeply as they are predicting. As for Viagra & hearing loss, I can't say I know anything about it.

Correct, they haven't changed the formulation for FX-322. You may look at it as "but only showed improvements in word recognition scores" but that is not how the audiology community & FDA sees it. FDA has already said they will accept word recognition improvements as the primary trial endpoint...

Its completely fair to be skeptical. Just keep in mind that the brain can do some weird and amazing things. I'm not going to discount the chance of that guy's improvement actually being from the drug simply because it occurred seemingly instantly. It very well could be the case that the cochlear...

That is the whole point of FX-345. Its an improvement on FX-322 in that their goal is to get the compounds deeper into the cochlea so that they can reach more hair cells and potentially see a more efficacious response.

Purely speculation on my part but to me it seems that is sort of a sweet spot for FX-322 responders. The biggest factors at play are the cochlear penetration of the drug and how the overall functionality of the subjects cochlea is before treatment. Since FX-322 only reaches the higher...

Yes, that is actually a pretty accurate description of what some of the science has found is occurring. Tuning out the noise: Limbic-auditory interactions in tinnitus When I say the brain is "rewiring", I'm referring to the gating mechanisms you mention. It seems that those who suffer from...

Administration of FX-322 didn't reverse his disease instantly, it occurred approximately 30 days after treatment. 4 weeks is not an unreasonable amount of time for immature hair cells to start to communicating with the brain. Who is to say the hair cells didn't start working sooner than 30 days...

What science or clinical data do you have to prove that hearing can only come back gradually after regenerative treatment? There are too many unknowns for you to be able to dismiss that patient's experience. We don't know if the cochlear hair cell connects to the nerve before the hair cell is...

With the nature of how they are regenerating the hair cells, it is supposed to be permanent. You may have read "responses lasted 1-2 years" but that does not mean the responses didn't or couldn't have lasted longer than that, it just means 1-2 years was as far out as they tested so far to date.

FREQ is currently targeting the moderate to moderately-severe range of hearing loss patients in the noise induced and sudden etiologies for the Phase 2b trial but that doesn't mean it can't be tried by patients outside of those ranges once it is successfully commercialized. The company had a...

Yes.

I believe it's about 9 patients or so they are truly only testing for safety on first. Once it appears safe in the first subset of patients, they will continue the trial and dose the remaining patients and then they will also be testing for hearing outcomes such as audiograms and WR tests but...

While it could potentially be a good pairing for FREQ to pick up some of the OTIC patents, FREQ doesn't have the cash pile to afford it right now. With their own current clinical plans, FREQ will be out of money sometime in 2024 if they get no further milestone payments or raise capital via a...

In that case, then I will have to disagree with the statement you made saying "If FX-322 doesn't work, then there's little chance that FX-345 will." The whole point of FX-345 is to potentially produce more efficacious response in more patients compared to FX-322.

The results of FX-345 are not contingent on the results of FX-322. The company always intended to conduct the FX-345 trial regardless of the results of FX-322. Not working and failing to reach statistical significance are 2 different things. If FX-322 doesn't work, it means the compound has no...

The company has said that they will re-visit multi dosing later on down the road. Their main concern right now is to get it to market ASAP in order to unlock a revenue stream to keep the company funded. They are actually at the very end of Phase 2 and they are counting this 2b study as a...

Agreed. Seems unlikely they will discuss the Phase 2b trial results next week as they still have at least 1 patient that needs to complete their 90 day test.

Previous guidance said they would publish the results in either Q4 of 2022 or Q1 of 2023.

Q1 readout means the data will be shared sometime between January 1st 2023 and March 31st of 2023. The studies' primary completion date is January 6th which means that the last subject will have their 90 day test done on the January 6th. After that the company will compile the data and release...

They word it that way because that is the farthest out they tested subjects. Another way to word it would be to say “the benefits from a single injection were still maintained 2 years later for some subjects.”

That's fair, my mistake. I wasn't aware of that one as they make no mention of it on their pipeline. Most biotechs keep drugs listed on their pipeline after making it to market but it makes sense that they didn't since they sold it.

OTIC was founded in 2008 and has been plagued with failure after failure as evidenced by the fact that they haven't brought a single drug to market over the last 14 years. Otividex, their Meniere's candidate, failed Phase 3... twice. OTO-313, their tinnitus candidate, failed Phase 2. OTO-413...

I will be watching it. Anyone can register to watch. When filling out the form, just say "Retail Investor" for the company you are with.

I can't say I have much interest in discussing if their strategy is suboptimal or not. You have to be able to walk before you can run. We could sit and discuss hypotheticals and theory all day long here but seeing that there are no current pharmaceutical options for hearing loss, it doesn't do...

FREQ is regenerating hair cells from progenitor cells with FX-322, they are not targeting the nerve with their compound. In their pre-clinical work, they have shown that the newly generated hair cells produce synaptic proteins that allow it to connect to the nerve. See slide 37 of their current...

Yes.

Mid-stage refers to the fact that it is Phase 2 which is considered the middle phase. It is referencing the readout we are waiting for in Q1 of 2023.

Biotechs operate year round. If they didn't run trials during holiday season, then they would just be sitting and waiting while burning cash daily.

The tradition used to be that you needed 2 pivotal trials in order to apply for FDA approval but, over the last 15 years or so, approximately 53% of new drugs today get approved by the FDA with only 1 pivotal trial. FX-322-208 is going to be considered a pivotal trial so there is a small chance...

OTO-413 failed at a higher dose. Otonomy Reports Results from Clinical Evaluation of OTO-413 Higher Doses in Patients with Hearing Loss

It's a guessing game as to what adding additional participants could mean. Maybe they have low confidence so they wanted to add more participants for a better chance of seeing some statistically significant improvements. Or maybe they had extremely high demand for the trial and they could fit in...

There still is a chance but for how big or little it is, I don't know. I don't think they'd get to skip it completely but they could end up applying for NDA and running a Phase 3 in parallel with selling it on the open market kind of like what happened with COVID-19 vaccines.

They've done about all they can to make it as reliable a study as possible. To gain admittance you need an audiogram that is at least 6 months old plus 3 consistent testing sessions and on top of that they are audio/video recording every test session in order to have 2nd audiologists review for...

Trial enrollment completion was announced this morning. With 90 days to go for the last subject + another 30 days or so for them to crunch the numbers, we should see a readout in early to mid February. Frequency Therapeutics Completes Enrollment of Phase 2b Study of FX-322 for the Treatment of...

You're losing the forest for the trees and you're thinking like a tinnitus sufferer rather than a hearing loss sufferer. You have to look at the totality of all the data to see where the value in FX-322 lies. To start, FREQ was told by the FDA that they would need to conduct a number of probing...

Really depends on the closed door conversations the company has with the FDA. It was always considered the tradition that you needed 2 pivotal trials in order to file for NDA but this study looking back over the last 25 years found that approx only 53% of new drugs approved by FDA have 2 pivotal...

I don't really compare OTO-413 to FX-322 as it is comparing apples to oranges in my opinion. They work on completely different parts of the underlying biology. It also depends on which hat you want me to wear. If I put on my personal hearing loss/tinnitus sufferer hat, OTO-413 sounds promising...

Too many people have too high of expectations for this space. Expecting them to cure hearing loss with the first ever drug to be potentially approved in this space is like expecting the field of oncology to have cured cancer on their first try. FREQ was the first one that was able to achieve a...

Don't lose the forest for the trees though. They have seen consistent results from their Phase 1/2 study & their open label study where they saw up to a 40% response rate in particular etiologies & severities. It only feels inconsistent because their later probing studies targeted etiologies &...

Statistical significance is twice the bar of clinical significance. Clinical significance is considered a 5 word improvement, statistical significance improvement is considered 10+ words.

Seeing that there are no other treatments on the market, all they would need to do is show statistically significant improvements over placebo in my opinion.

FX-345 data release has been pushed back to the 2nd half of next year per that slide deck. The most exciting tidbit in that updated slide deck is on slide 18 in my opinion. It states "Potential for FX-322-208 to be considered a pivotal study". This means they can potentially apply for FDA...

See their expanded access policy. FX-322 could be commercially available as early as the end of next year if the FDA accepts their current trial as pivotal. As for the chemical structure, you may be able to dig into their patents to find that out.

To quote the company: "a review by the Company of available historical data from audiograms taken before the study, showed many study subjects with considerably lower baseline WR scores versus historical scores. This effect was observed among patients in all study groups. However, it was...

The largest reason it failed was due to an unprecedented placebo response. The issue isn't that no one responded, the issue is that too many responded in the placebo group. Both the treated group and the placebo group had statistically significant improvements but the company had to throw the...

In their preclinical work, after dosing a mouse cochlea with FX-322, there were 6 rows of outer hair cells present rather than just 3 so this would suggest that dead/damaged hair cells will remain along side the new hair cells that FX-322 induces. It is not removing or repairing damaged hair...

No, higher frequencies are easier to treat than lower frequencies based on their proximity to the round window membrane. The biggest risk I see with FX-345 is that it may be too high of a concentration at the highest frequencies and may be too potent because their preclinical data shows that the...

The new hair cells that are created using FX-322 do form synaptic connections. The original damaged hair cells that are still in place and have lost their synaptic connection before FX-322 administration will not form synaptic connections after FX-322 administration.

Carl LeBel said on the HLAA Q&A earlier this year that their compounds activate both inner and outer hair cells. I speculate that it has more to do with the cochlear anatomy than the compound only targeting 1 type of hair cell. If you look at their treated mouse cochlea image which is currently...

A pure tone average at the Screening Visit of 35-85 dB at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz in the ear to be injected. While it may seem barely significant to you, I can guarantee you it is life changing for the subjects who were statistically significant. Subject 4 for example went from...

Lots of research in recent years is pointing to the ultra high frequencies helping with speech perception, especially in noise. Extended high frequency hearing and speech perception implications in adults and children Extended high-frequency hearing enhances speech perception in noise

This lines up with FREQ's age-related hearing loss trial, they did not see a robust response in that trial which also suggests age-related hearing loss is not caused by sensory hair cells. The share price run up has been on large volume, I'd speculate that institutions are getting back in now...