Frequency Therapeutics — Hearing Loss Regeneration

[Keith Handy]

Being speculative here, but what's the likelihood that they've reviewed the 90-day data already and made these moves in accordance with that? I guess I'm just wondering if the data didn't look favorable, would they still have brought these individuals on board?

I think a lot of us are thinking this.

 

[patorjk]

Being speculative here, but what's the likelihood that they've reviewed the 90-day data already and made these moves in accordance with that? I guess I'm just wondering if the data didn't look favorable, would they still have brought these individuals on board?

Very unlikely, they probably didn't get the data until recently (and even then they still have to process it), see this post: [1]

These moves have probably been in the works for a while now. However, I think their announcements have been purposefully timed to keep hype high and to provide some news before the actual results.

[1] https://www.tinnitustalk.com/posts/577249/

 

[Diesel]

Being speculative here, but what's the likelihood that they've reviewed the 90-day data already and made these moves in accordance with that? I guess I'm just wondering if the data didn't look favorable, would they still have brought these individuals on board?

There's a few things that they can do, and not disclose to the public:

1. Conducted interim analysis of the Phase 2A trial in 2020. I suspect that they did so in May when they debated extending the trial... The reason they wouldn't release it is because the data would be deemed as "incomplete" / "inconclusive" by investors and doctors; and would be a PR issue. But, it may have been looking good already at that time, so confidence is high.

2. Conducted "shadow" FX-322 trials of the Phase 2A in countries that permit universities/private entities to apply experimental drugs on everyday people. They could have recruited a sample set of people that had moderate losses, given them 4x doses, and did a 90-day follow-up. Totally legal in may South East Asian countries.

3. They don't care that much about the multi-dose issue; and know that the single dose effectiveness still warrants full production. And, they'll figure out the multi-dose problem / extended gel / different delivery after the current version is on the market.

4. They just have brass... You know what...

 

[Orions Pain]

Being speculative here, but what's the likelihood that they've reviewed the 90-day data already and made these moves in accordance with that? I guess I'm just wondering if the data didn't look favorable, would they still have brought these individuals on board?

Agree. It'd be sort of strange to release a statement like this so close to the readout date if the data wasn't promising. I think people like this also don't take position offers lightly as they have a reputation to uphold.

 

[Diesel]

Agree. It'd be sort of strange to release a statement like this so close to the readout date if the data wasn't promising. I think people like this also don't take position offers lightly as they have a reputation to uphold.

This is also important to consider. Having worked with / for execs for my entire career, these folks don't just take "trust us" when considering a role in leadership. The recruiting process is very much mutual... they want to know they're joining a company with legitimate potential, and want to preserve a career looking forward. Both of the most recent hires are mid-career, and have a favorable track record, so I doubt they just joined Frequency Therapeutics for a paycheck without understanding the long-term outlook.

 

[FGG]

There's a few things that they can do, and not disclose to the public:

1. Conducted interim analysis of the Phase 2A trial in 2020. I suspect that they did so in May when they debated extending the trial... The reason they wouldn't release it is because the data would be deemed as "incomplete" / "inconclusive" by investors and doctors; and would be a PR issue. But, it may have been looking good already at that time, so confidence is high.

2. Conducted "shadow" FX-322 trials of the Phase 2A in countries that permit universities/private entities to apply experimental drugs on everyday people. They could have recruited a sample set of people that had moderate losses, given them 4x doses, and did a 90-day follow-up. Totally legal in may South East Asian countries.

3. They don't care that much about the multi-dose issue; and know that the single dose effectiveness still warrants full production. And, they'll figure out the multi-dose problem / extended gel / different delivery after the current version is on the market.

4. They just have brass... You know what...

Can you elaborate more on number 2? I have never heard of that and didn't realize this was an option. Can they really do this without disclosing results?

1) Why wouldn't every drug company do this?
2) Is this how companies sometimes come up when Phase 2 multi dosing cohorts?

Interesting.

 

[Keith Handy]

4. They just have brass... You know what...

...cochleas.

 

[Diesel]

Can you elaborate more on number 2? I have never heard of that and didn't realize this was an option. Can they really do this without disclosing results?

1) Why wouldn't every drug company do this?
2) Is this how companies sometimes come up when Phase 2 multi dosing cohorts?

Interesting.

Yes! I have read a few articles about testing drugs in the developing world, I'll check the browser history on my old laptop. I'm sure any of the Google-Elite here can find them. There are ethical concerns, but companies test drugs in countries like Vietnam, Cambodia, Thailand, Laos, and others nearby where the government oversight is particularly lax. It's more likely that Astellas (or a subsidiary) would be involved in this effort in coordination with a local university / hospital. There isn't anything illegal about it, but often why first-in-human trials are conducted in these countries, especially when the safety in the human model isn't well understood.

I would speculate that many of these companies do this; but through subsidiaries, or by a specific university.

 

[Jrblovsky]

Holy shit. If it booms and we all get better, you should host a party for Tinnitus Talk members. There could be a cake that says "fuck TRT" on it.

I could think of a certain tinnitus influencer I could print a huge picture of and we could throw darts at it.

 

[ThomasRobert]

Yes! I have read a few articles about testing drugs in the developing world, I'll check the browser history on my old laptop. I'm sure any of the Google-Elite here can find them. There are ethical concerns, but companies test drugs in countries like Vietnam, Cambodia, Thailand, Laos, and others nearby where the government oversight is particularly lax. It's more likely that Astellas (or a subsidiary) would be involved in this effort in coordination with a local university / hospital. There isn't anything illegal about it, but often why first-in-human trials are conducted in these countries, especially when the safety in the human model isn't well understood.

I would speculate that many of these companies do this; but through subsidiaries, or by a specific university.

Yes, you can watch it in this Netflix series:

Pandemic: How to Prevent an Outbreak

 

[ThomasRobert]

How much would Frequency Therapeutics' stock be hurt if any market crash happens? And how long would it take to recover? Just thinking out loud.

 

[FGG]

How much would Frequency Therapeutics' stock be hurt if any market crash happens? And how long would it take to recover? Just thinking out loud.

It would definitely have some effect. If the overall market crashes, people tend to sell across the board in large quantities so... potentially a lot even.

In addition, biotech can also be as manipulated as everything else but at least it's binary so successful drugs do pop a stock but the degree can vary a whole lot on extraneous market factors.

Anyway, with a successful drug, you'd still make money but with a healthy market, you'd make a lot more.

 

[jeff W]

It would definitely have some effect. If the overall market crashes, people tend to sell across the board in large quantities so... potentially a lot even.

In addition, biotech can also be as manipulated as everything else but at least it's binary so successful drugs do pop a stock but the degree can vary a whole lot on extraneous market factors.

Anyway, with a successful drug, you'd still make money but with a healthy market, you'd make a lot more.

Do you hold your FREQ stock or do you day trade it? Curious if you would like to share your strategy.

 

[FGG]

Do you hold your FREQ stock or do you day trade it? Curious if you would like to share your strategy.

I don't day trade anything. Or do margin plays. I buy and hold. Lately I have been trying holding shorter because I am not in a great financial state compared to when I had my career but my overwhelming preference is to buy early and hold.

I bought FREQ near IPO and I'm holding.

 

[Gb3]

The better hearing would be more of a "bonus" for most of us, though.

I agree. Same here. I'm just saying FX-322 is for hearing loss, which might aid in tinnitus relief.

 

[Jrblovsky]

I agree. Same here. I'm just saying FX-322 is for hearing loss, which might aid in tinnitus relief.

I don't know why researchers have such a hard time with tinnitus. In my opinion it is caused by hearing loss; period.

Yes you have an occasional person with TMJ or some weird condition, but most of the people on the board have tinnitus from hearing loss. Whether it be hidden hearing loss or shown in the audiogram, they have it.

I honestly believe that if the hair cells and synapses can be restored most will see massive improvements with longer term improvements to follow. The brain would have no reason to ring/roar/screech or hiss if it receives the signals it requires.

Honestly I think after treatment the brain will need time to readjust to seeing the signals it has been previously looking for.

Hopefully these new treatments will prove not to let tinnitus be a death sentence any longer.

 

[patorjk]

How much would Frequency Therapeutics' stock be hurt if any market crash happens? And how long would it take to recover? Just thinking out loud.

I'm a little worried about this as well. However, no crash is like a previous one, and since the motto of the new era is "stocks only go up", I have a feeling we're more likely to see a V-shaped crash if one does happen. We may also see a crash that only effects part of the market, especially since there are so many retail investors now. Interestingly the S&P was down slightly in January:

https://ycharts.com/indicators/sp_500_monthly_return

I thought it had been a good month, but I think my FREQ stock may have distorted my perception (that and ARKK, which has been on a tear).

 

[patorjk]

It looks like Frequency Therapeutics has posted 9 job openings to their LinkedIn profile in the last 2 weeks. There seem to be several for the "hearing research biology team".

I wonder if they're working on other hearing drugs?

 

[Diesel]

It looks like Frequency Therapeutics has posted 9 job openings to their LinkedIn profile in the last 2 weeks. There seem to be several for the "hearing research biology team".

I wonder if they're working on other hearing drugs?

It's not like FX-322 will come to market and they'll sit back letting the cash machine start printing money...

They will want to continue to improve FX-322 beyond this first version currently in clinical trials to remain competitive. Years of research and testing will likely be needed to get a V2 or V3 ready. Ultimately, they'll want a single intratympanic injection that fills the entire cochlea with FX-322; they aren't anywhere NEAR that.

It's also possible that there are directions to take this drug that involve more than just regenerating hair cells where they see an opportunity for PCA.

 

[wwtsai]

It looks like Frequency Therapeutics has posted 9 job openings to their LinkedIn profile in the last 2 weeks. There seem to be several for the "hearing research biology team".

I wonder if they're working on other hearing drugs?

Would be great if they included FX-322 with your benefits package lol.

 

[Lucifer]

It looks like Frequency Therapeutics has posted 9 job openings to their LinkedIn profile in the last 2 weeks. There seem to be several for the "hearing research biology team".

I wonder if they're working on other hearing drugs?

This must be because the results are looking positive for Phase 2a. Why all of a sudden would they have posted so many job openings. They wouldn't be doing this if the results were negative.

 

[Unknown926]

Hey Team - I just joined so I apologize if I don't post correctly, I'm trying to ask a general question to this thread. I'm sure it's been discussed before in other threads so again I apologize.

My question: What has Frequency Therapeutics said about synapses? I thought I remember them saying their testing showed that the hair cells do well in reconnecting with the synapses or something along these lines?

Their treatment is a 2-molecule combination temporarily waking up dormant progenitor cells to grow into hair cells, but does there need to be anything (maybe another molecule) to also wake up the synapses to fully restore/repair the natural hearing signal? What has Frequency Therapeutics said about this?

Thanks!

 

[Diesel]

Hey Team - I just joined so I apologize if I don't post correctly, I'm trying to ask a general question to this thread. I'm sure it's been discussed before in other threads so again I apologize.

My question: What has Frequency Therapeutics said about synapses? I thought I remember them saying their testing showed that the hair cells do well in reconnecting with the synapses or something along these lines?

Their treatment is a 2-molecule combination temporarily waking up dormant progenitor cells to grow into hair cells, but does there need to be anything (maybe another molecule) to also wake up the synapses to fully restore/repair the natural hearing signal? What has Frequency Therapeutics said about this?

Thanks!

The Progenitor Cell divides, creating a new hair cell in the process. The "new" hair cell re-synapses with the nerve. If it didn't, there wouldn't be a signal for the brain, and we probably wouldn't observe the dramatic word score improvement. They've also observed the cells creating the nerve ending in vitro. The attached picture is from the recent webinar. The red objects are the hair cells. The green lines are brand new synapses extending from the hair cell attempting to reconnect with the nerves.

It's essentially making the cochlea do what it had done exactly in utero. Make the cell, connect the cell to the nerves leading to the brain.

 

[Jrblovsky]

This must be because the results are looking positive for Phase 2a. Why all of a sudden would they have posted so many job openings. They wouldn't be doing this if the results were negative.

They are publicly traded and their CEO has a Board of Directors to answer to.

Now granted I'm sure the CEO and the Board are pushing the development team to make this to be a breakthrough in the industry. People 115 years later still remember that Ford motor company gave us the assembly line. 100 years from now the Detroit Lions will still be known as the worst football team in the United States.

You don't typically recruit major players like the gentlemen from Harvard unless your onto something big. The guy was I estimate making $300k to $400k a year in his previous position. You don't walk from an established employer for a startup unless you know something is going to make you even more successful.

 

[Ela Stefan]

The Progenitor Cell divides, creating a new hair cell in the process. The "new" hair cell re-synapses with the nerve. If it didn't, there wouldn't be a signal for the brain, and we probably wouldn't observe the dramatic word score improvement. They've also observed the cells creating the nerve ending in vitro. The attached picture is from the recent webinar. The red objects are the hair cells. The green lines are brand new synapses extending from the hair cell attempting to reconnect with the nerves.

View attachment 43264

It's essentially making the cochlea do what it had done exactly in utero. Make the cell, connect the cell to the nerves leading to the brain.

That's very true but I think all of us still have good hair cells but dead synapses between them. And for that we have to wait for OTO-413, correct?

 

[Nobody19]

It's also possible that there are directions to take this drug that involve more than just regenerating hair cells where they see an opportunity for PCA.

They're also working on a drug for MS.

 

[Diesel]

That's very true but I think all of us still have good hair cells but dead synapses between them. And for that we have to wait for OTO-413, correct?

Most research points to a mixture of both dead hair cells and synaptopathy. If all people with tinnitus and hearing loss had good hair cells, we wouldn't need FX-322, nor would it have shown an improvement in the Phase 1/2. So, it stands to reason that ALL of us probably have some level of dead hair cells.

Also, the tinnitus improvement anecdotes from Carl LeBel indicate that restoring those dead hair cells may improve the condition.

 

[twa]

I bought 91 shares yesterday at $54.38.

I'm more interested in hearing recovery and tinnitus improvement than money. Money comes and goes. Quality of life is very different. I'll take quality of life over the money.

Very true. So yesterday it was selling at $54.38 per share?

 

[Pero1234]

Very true. So yesterday it was selling at $54.38 per share?

$54.38 is already pretty high. I think you may see it fall back to somewhere in $40s over the next few weeks. I may buy a bit more then. If only I had more cash to spare when it was at $17

I bought FREQ near IPO and I'm holding.

Also holding here. I will ride this one out to the end... come what may.

Do you intend to buy more as the chances for success are improving, when we enter a new phase etc?

 

[FGG]

Do you intend to buy more as the chances for success are improving, when we enter a new phase etc?

If I have the money to, sure.