Frequency Therapeutics — Hearing Loss Regeneration

[Greg Sacramento]

Once again from several days ago, it's the NASDAQ and not FREQ. I don't buy economic reporting as reason. It looks more like government pressures against high tech. The selloff is almost at crossroads for now, but a steeper NASDAQ decline could happen in the following days to weeks.

 

[Tezcatlipoca]

What a ride, hopefully we are going to like our destination.

 

[Street Novelist]

So, does anyone know what Frequency Therapeutics said yesterday?

 

[scotty03874]

So, does anyone know what Frequency Therapeutics said yesterday?

I would also like to know... Did anyone record it?

 

[Zugzug]

Hey people, where do you know from, that I am also an IT security expert!?!

Are you the "Toby" they are referring to in the Diffie-Hellman key exchange? If so, they misspelled your name. BTW, this is all in fun; I love you.

 

[Matchbox]

I don't know if the stock dropped due to bad results or some ETF sell off.

 

[FGG]

I don't know if the stock dropped due to bad results or some ETF sell off.

Look at the IBB. Biotech as an entire sector is hurting a lot lately...

Anyway, there is no news yet.

 

[NewLionel]

FREQ earnings expected to drop in the news... big enough drop today though. (I know nothing about stocks)

 

[FGG]

I would also like to know... Did anyone record it?

I doubt anyone paid the $200 conference fees to watch it but you never know...

 

[Matchbox]

It tends to soar on results, so I had worries it was more targeted insiders ditching on knowledge we don't have.

I don't care if it hits zero so long as they can get their drug to market for us all.

 

[leledany]

Are they announcing something bad news tomorrow evening with the market closed and weekend coming? I smell something bad, they want to avoid panic selling IMHO.

 

[acufenero]

From Twitter:

 

[tommyd87]

FREQ earnings expected to drop in the news... big enough drop today though. (I know nothing about stocks)

There could be something negative, however I have had a look and noticed that it seems pretty much all US biotech firms have dropped today and dropped by a few percent.

 

[FGG]

Are they announcing something bad news tomorrow evening with the market closed and weekend coming? I smell something bad, they want to avoid panic selling IMHO.

Who says they are announcing tomorrow? If there is "panic selling" it's literally the entire biotech sector.

Pick about 10 random small tech biotechs. All of them are way down.

Novavax is actually down on really good news (their US trial finished enrollment and vaccines could be available by May).

 

[FGG]

From Twitter:

View attachment 44046

What does this mean? "Responders" to what? And what is the response? What's the context?

 

[Keith Handy]

From Twitter:

View attachment 44046

I don't understand what this is.

 

[Gorbeh3]

From Twitter:

View attachment 44046

I'm having trouble interpreting this.

Can you link the tweet?

 

[Greg Sacramento]

The IBB was down 3.10 %.
NASDAQ was down 3.00 %.
NASDAQ 100 — heavy weighted in tech, but not biotechnology.

FREQ
Earnings forecast has not changed for the last 24 trading days. A mixture of retail and fund selling today, but only 3% ETF and index selling.

Heavy selling with large orders in last hour and more so in minutes to the closing bell.
Market makers are trying to raise price in afterhours with only two buys — the rest is market marker playing — be careful, don't get suckered in paying more than closing price without news.

 

[FGG]

From Twitter:

View attachment 44046

Okay I found the source:

If even legit at all (who labels a graph with such low info) it actually seems like this could be from Otonomy and not Frequency Therapeutics. $OTIC, like $FREQ is in her pinned update and the numbers line up with OTO-413 results too.

Edit: She also says in the comments something about more results in 2022 so that doesn't fit with Frequency Therapeutics at all either...

 

[Aaron91]

Okay I found the source:

View attachment 44050

If even legit at all (who labels a graph with such low info) it actually seems like this could be from Otonomy and not Frequency Therapeutics. $OTIC, like $FREQ is in her pinned update and the numbers line up with OTO-413 results too.

Edit: She also says in the comments something about more results in 2022 so that doesn't fit with Frequency Therapeutics at all either...

It's from their patent, which I've only just come across for the first time. I've linked it further below with some new nuggets of information.

 

[Gb3]

Hypothetically speaking, let's say someone's tinnitus continued to improved or went away but they were done with all the follow ups. How does this get relayed to Frequency Therapeutics?

 

[Aaron91]

COMPILATION OF NEWLY FOUND PHASE 1 DATA

I ended up spamming the thread so decided to just compile everything into one post and delete everything else.

Originally in response to @acufenero:

Eagle-eyed @pharmacreep on Twitter also just shared the original source. It's a 326-page patent I hadn't seen before:

International Patent Application

I'm going through it now, but suffice to say I think there's some stuff here we haven't seen before. Already learned something new:

"Furthermore, 2 of the 6 FX-322 -treated responders demonstrated a >5 dB at both 6 and 8 kHz on day 90 post injection (Figure 9B)".​

I had no idea they had 2 patients responding at 6 kHz on the audiogram. Was anyone else aware of this? I knew the pharmacodynamics showed it gets that far but didn't realise it was in any therapeutic quantity. Probably wasn't statistically significant but I still think that could be really promising. I find this quite exciting because the biggest dip on my audiogram is at 6 kHz!

Also, check this out:

"In addition, three subjects reported an improvement in tinnitus."​

That's at least 50% of patients who didn't have a WR ceiling effect seeing improvement in their tinnitus.

It would also appear the hearing loss onset for all 6 patients was mixed - also good news. The respondent who went from 14/50 to 34/50 (68% improvement from baseline) in WR had hearing loss from 1997. The patient who had hearing loss from 2017 saw a 97% improvement - 26/50 to 47/50.

Looks like we may also have some insight into dosaging:

"No difference in treatment effect was observed between the 2 dose volumes of FX-322. This is likely because as long as the round windows are covered diffusion into tissue sites should be concentration dependent as described by Pick's Law of Diffusion."​

I wonder whether this may explain why they didn't go for a higher dosing in Phase 2? Or could they have increased small molecule concentration in the polymer without changing dose?

 

[Ed209]

Who says they are announcing tomorrow? If there is "panic selling" it's literally the entire biotech sector.

Pick about 10 random small tech biotechs. All of them are way down.

Novavax is actually down on really good news (their US trial finished enrollment and vaccines could be available by May).

Sell on news. Happens all the time. There's nothing more annoying than reading a brilliant RNS only to see the price tank in response, but that's the stock market for you.

The NASDAQ is down 3%, so there's a sector wide drop for sure, but Frequency is down around twice as much as what many others are at the moment, and I'd attribute that to investors getting anxious about the impending news. The spike in US bond yields will also concern investors as well as the runaway inflation that's currently happening.

 

[FGG]

Thinking about this more, just labelling "% responders" makes way more sense with OTO-413, too, because that's the number who responded to "at least one speech in noise test". Otonomy used at least 3 different tests.

Otonomy also recently are restarting an additional Phase 1/2 using a different speech in noise protocol, presumably to use the one that best matches the improvements they were seeing.

She won't say which company but this makes way more sense to be Otonomy considering Frequency Therapeutics would label the graph as to what they were responding to among other things and she mentioned results in 2022 as well.

 

[Diesel]

Okay I found the source:

View attachment 44050

If even legit at all (who labels a graph with such low info) it actually seems like this could be from Otonomy and not Frequency Therapeutics. $OTIC, like $FREQ is in her pinned update and the numbers line up with OTO-413 results too.

Edit: She also says in the comments something about more results in 2022 so that doesn't fit with Frequency Therapeutics at all either...

Can't help myself... It's from their patent application. Data from the Phase 1/2.

https://patentimages.storage.googleapis.com/1f/4b/8f/186fc27f72963e/WO2020210388A1.pdf

BTW... this is a great read... they have covered their bases in serious detail for FX-322... also, note section [0221]. Talk to you all later!

ALRIGHT... PACK IT UP...

"[0664] In addition, three subjects reported an improvement in tinnitus. All three of these subjects were in the cohort that had improved word recognition scores."

 

[Zugzug]

Hypothetically speaking, let's say someone's tinnitus continued to improved or went away but they were done with all the follow ups. How does this get relayed to Frequency Therapeutics?

It doesn't really matter, other than maybe a better internal idea. All of the statistical testing is performed significantly more conservatively than their visions of what will happen. The "plan" has to be made in advance; otherwise it would be too tempting to morph all of the statistical testing and significance levels to fit an agenda.

Just as an example, if they were to care about the person's tinnitus that improved after the study timeline, would they also care about the person who put on headphones and got worse? Would they say "well, the person who improved was from our drug, but the person who worsened was from their own negligence"?

Not only that, TFI is, frankly, a sub optimal metric for tinnitus. It feels like we are testing new science against older metrics. That's because that's exactly what we are doing lol. Even the Words-in-Quiet and Words-in-Noise tests are pretty crude. Frequency Therapeutics, unfortunately, has to keep testing under these conditions because it's the only way to measure "clinically meaningful," based on data that was established before the advent of hearing regeneration.

 

[Diesel]

According to the patent doc, with 1 injection from the Phase 1/2... 6/15 FX-322 Responders shows improvements greater than 5 dB at 8 kHz. 2/15 showed improvements greater than 5 dB at 6 kHz and 8 kHz.

So, I think we might know what to expect from multiple injections... at the very least, a notable increase down to 6 kHz per each injection...

I need to buy more stock ASAP.

I'd like to know what @FGG, @Aaron91 and @Zugzug are thinking after pouring over this patent doc...

 

[patorjk]

Okay I found the source:

View attachment 44050

If even legit at all (who labels a graph with such low info) it actually seems like this could be from Otonomy and not Frequency Therapeutics. $OTIC, like $FREQ is in her pinned update and the numbers line up with OTO-413 results too.

Edit: She also says in the comments something about more results in 2022 so that doesn't fit with Frequency Therapeutics at all either...

It's FX-322 phase 1 data, however, it's missing a critical definition: [1]

A responder definition was created while blinded that required both an improvement in audiometry (>5dB at 8 kHz) and a functional hearing improvement in either WR or WIN (>10%) compared to baseline.​

The placebo responders most likely barely met the this criteria, which is why they didn't maintain their responder status.

One bit of good news out of this: All 6 of the FX-322 responders saw an improvement at 8 kHz. Previously I think it's only been mentioned that the 4 statistically significant responders had improvements at 8 kHz (I could be wrong, but I haven't heard much about the 2 non-statistically significant responders).

[1] https://patentimages.storage.googleapis.com/1f/4b/8f/186fc27f72963e/WO2020210388A1.pdf

 

[Tezcatlipoca]

Hypothetically speaking, let's say someone's tinnitus continued to improved or went away but they were done with all the follow ups. How does this get relayed to Frequency Therapeutics?

I think they would return to inform the trial sites about the development, usually clinical trial participants establish a relationship with the doctors.

I think they had long follow ups in Phase 2, like 210 days or something

 

[Diesel]

I was just thinking about this 90-day release from the Phase 2A. If I'm understanding it correctly, it won't be an apples-to-apples readout with the Phase 1/2.

In the Phase 1/2, the schedule went as follows:

Day 0: Baseline Test + Single Injection
Day 15: Follow-Up 1
Day 30: Follow-Up 2
Day 60: Follow-Up 3
Day 90: Follow-Up 4

In the Phase 2A, the schedule is as follows:

Day 0/Week 1: Baseline + Injection 1
+2 Week: Injection 2
+3 Week: Injection 3
+4 Week: Injection 4

Post-Injection 4 Follow-Ups:
Day 15: Follow-Up 1
Day 30: Follow-Up 2
Day 60: Follow-Up 3
Day 90: Follow-Up 4

In the Phase 1/2... that Day 90 follow-up visit was exactly 90 days from the single injection (give or take).

In the Phase 2A... that Day 90 follow-up visit is effectively 120 days from the first injection.

I wonder if this will help show greater separation between the 1X group and placebo cohort in the Phase 2A? Or in the 2X and 4X groups, help show greater stratification?