Frequency Therapeutics — Hearing Loss Regeneration

Lucchino's and Loose's monthly stock sales are part of a 10b5-1 plan. It's a plan that allows insiders to buy or sell their shares of the firm according to a predetermined cycle and/or calculation. I won't go into the laundry list of reasons why this is plan exists, but it's generally beneficial to the company, insider, and stockholder.

In short: Nothing to worry about. Nothing to see here.

NOW... if we start seeing the same insiders or other NEW insiders buying shares, that may signal upcoming good news.

 

I think if anything should be stickied in this thread, it's this .

If regular insider sales meant anything, literally every small cap biotech would have failed.

 

If you listen to the Tinnitus Talk Podcast about Frequency Therapeutics with their representative Carl LeBel, he speaks about this. At Frequency they think that so called hidden hearing loss is actually hearing loss at the high frequencies that a normal hearing test doesn't test but that it effects speech recognition.

If that is the case and FX-322 restores the hearing at the high frequencies then it indeed will treat hidden hearing loss also.

 

What's a 10b5-1 plan? I'm curious.

 

At Frequency Therapeutics they think that so called hidden hearing loss is actually hearing loss at the high frequencies that a normal hearing test doesn't test but which affects speech recognition.

Carl LeBel suggests that it could be a mix, that FX-322 does actually repair synapses. Or at least sets in motion the process to repair synapses. (Approximately 44 minutes into the interview with Tinnitus Talk Podcast).

I want to go even further. I think that if we have perfect hearing up to 8 kHz we will not have difficulty hearing in noisy surroundings. Just look at the audio spectrum of speech. Not much, if nothing, is happening at higher frequencies.

https://www.dpamicrophones.com/mic-university/facts-about-speech-intelligibility

It makes me wonder why evolution gave us the ability to hear all the way up to 18-20 kHz when we are young.

 

A Guide To Rule 10b5-1 Plans

 

He later was asked about cochlear synaptopathy being a contribution to "hidden hearing loss" and he said yes, both synaptopathy and ultra high frequency losses can be "hidden" losses of hearing.

Frequency's drug acts on the UHF losses.

He's using "hidden hearing loss" different than Charles Liberman (who coined the term) is so there is some confusion. I have seen others use it like LeBel does, however, even if Liberman coined it to mean "cochlear synaptopathy" specifically.

 

Below is a study with a few attached excerpts detailing link between SNHL and tinnitus including correlation of intensity.

https://www.frontiersin.org/articles/10.3389/fnins.2020.00592/full

 

I imagine this correlation would be even higher if they had extended audiograms.

 

Yes, agreed. A nice way to supplement your salary... I'm sure it's just a hedge against things not going well. If things go well you become a billionaire... If things go south you become a millionaire... I'm in the wrong industry. It seems like a win win for him either way. I'd probably do the same thing.

I'm also agreed. It would be nice to see some people buying though...

 

FREQ is almost breaking the highest price since the IPO, whereas it's the norm to show some resistance well before this stage.

FREQ is the best in the business in hearing regeneration - if regenerative cochlear therapy is possible, FX-322 will be the first to get on to market and their method is the best (doesn't deplete support cells).

Otonomy is well behind as are the others in hearing regeneration compared to FREQ.

 

Remarkable statement considering that we don't yet know how Otonomy will try to restore hair cells. AFAIK it's pre-clinical and more information is yet to be released on OTO-6XX regeneration method. Correct me if I am wrong.

 

True, we don't know how Otonomy is regenerating hair cells. FX-322 is currently the furthest ahead though, and is the best that can be seen with public information.

 

It would be wise to invest in FREQ after listening to Carl LeBel. This company WILL one day, sooner or later, breakthrough on a resourceful treatment for hearing loss and tinnitus. This accomplishment is evident in their corporate culture and I trust, for some reason, that they will not subside in this quest.

 

Frequency Therapeutics has shared its Q2 2020 financial results and recent business updates.

https://frequencytx.gcs-web.com/new...tics-provides-business-updates-and-reports-2/

 

Q2 2021. Sad face. Stupid pandemic, slowing vital hearing loss drugs.

 

It's nice that they mention tinnitus in that report.

 

I hate delays. But, I'd rather they take the time to get as much data as possible from the participants Phase 2A.

The breakthrough designation will be worth a 6 - 9 month delay.

 

Very interesting. So another Phase 1/2 study for people with age related hearing loss. Once again an affirmation that they have confidence in their product.

 

Per that release, Frequency are presenting at the American Academy of Otolaryngology meeting in a month, which is good in terms of ENT exposure. A lot of doctors are getting their info on upcoming cutting edge drugs and devices from these meetings.

 

Patient enrollment for Frequency’s FX-322 Phase 2a study has been steady over the second quarter of 2020 and based on current projections, the Company expects to achieve target enrollment by early in the fourth quarter of 2020. Based on this timeline, the Company expects to report study data in the second quarter of 2021. [1]​

The study is 7 months long, so if we assume the last person gets entrolled in late October, then the study should complete in May. That means we'll probably see top-line data sometime in late May or early June. I'm glad they're doing things right, but that just seems so far away.

This also means that the results of Phase 2a will happen very close to their Multiple Sclerosis drug submission, which is a little interesting.

They listed some conferences they'll be speaking at this fall, but it seems like there's going to be a drought in news from them between November of this year and May of next year. I wonder what they'll do during this time period.

Four of the patients that were observed to have statistically significant WR scores during the Phase 1/2 study were observed to have maintained the hearing benefit, three of which remained at statistically significant levels. An additional patient who did not achieve a statistically significant improvement in WR during the Phase 1/2 study was also retested and it was observed that the WR score had returned to baseline. The Company plans to share results of this follow-up study at the upcoming American Academy of Otolaryngology – Head & Neck Surgery meeting in September 2020. [1]​

I am mildly concerned about people returning to base-line. However, looking at the slides, even people in the Placebo group improved [2, slide 22]. I wonder if some of the improvement that was seen was due to just getting better at the test. If you do something every 30 days, you're bound get a little skilled at it, but after a year, you're probably back to normal. I'm hoping that's the case and we're not seeing that these haircells don't last. The fact that they're presenting their data at a conference is a good sign. It'll be very interesting to see what the data shows.

[1] https://frequencytx.gcs-web.com/new...tics-provides-business-updates-and-reports-2/
[2] https://investors.frequencytx.com/static-files/6d161090-16f5-49f4-9606-8caceb5a88a1

 

I read that differently, all the people who achieved a statistically significant improvement maintained it. One person saw an improvement but it wasn't statistically significant (which means that person's improvement scores could have been reasonably due to chance unlike the statistically significant ones) and went back to baseline after retested. It seems like the people with statistically significant changes had hair growth and that the effects last.

I would like to know more about that individual. Were he/she's losses profound? It seems like they were the exception and not the norm.

We know it's not a "learning effect" btw because non treated ears didn't improve word scores.

I agree with your time frame. My earlier guess was April but May/June seems more likely.

 

Does this mean then that the 30 September date is no more?

 

Yes, they have been saying there was a COVID-19 related delay for months but have just released an updated estimate of timeline.

 

My guess is that the patients with relatively poor word scores to begin with reverted back to the baseline. They were already trending downward.

We have to keep in mind that FX-322 didn't restore all of their hearing, only the high-frequency. So, it may very well be that areas of their cochlea that didn't receive FX-322 continued to decline. Genetics and other environmental conditions could also play a factor; occupation, recreation, etc.

 

I'm not so sure about this. They're yet to reveal what exactly is planned to "understand other populations that FX-322 may help treat" from the private placement. Frequency is technically free to conduct internally-sponsored trials in a shorter timeframe on patients that do not qualify for the Phase 2A. A 90-day experimental trial over the fall-early winter on patients with age-related hearing loss outside of the US (so not under FDA jurisdiction) may produce some exciting short-term data on new market potential.

Also, there's nothing stopping Frequency from releasing an interim analysis of patients who have already exited the Phase 2A. If I understand correctly, independent data managers with approval of the FDA can be cleared to provide the sponsor with some early top-line data halfway through Phase 2 or 3 trials. If so, this could be provided in the fall/early winter to generate some excitement.

 

The language they use is kind of strange (ex: "the hearing benefit"). 1 of the 4 responders had a word score that dropped from being statistically significant. It'll be interesting to know if the other 3 had drops in their word scores too. We know at least 2 of the 5 people tested had drops in their word scores. If the other 3 maintained a steady level then maybe the other 2 were just flukes (or maybe they weren't protecting their treated ear).

Though I guess another thing to consider is that the 2 people who had drops in their word scores may have had the low dose of FX-322.

 

I didn’t realise they would have a big delay in releasing the results. Didn’t they say they could still release the results with their current data?

Doubtful but I hope they hire Phase 3 participants before they finish their Phase 2a clinical trial.

 

Yes, that date is way too optimistic for COVID-19 obstructions. They're releasing data summer of next year.

 

It'll be interesting how the medical professionals respond to Frequency Therapeutics' information. Will they be excited, cautious, or dismissal? It'll be really cool if some doctors and ENTs who visit Tinnitus Talk can chime in.