Frequency Therapeutics — Hearing Loss Regeneration

[Diesel]

Right, the audiogram--I know how flawed it is. But I'm talking about real life too. Can you really lose 30-50% of your hair cells before you start to lose any hearing (as in minor or major hearing loss that affects your daily life)?

I think it might depend on the person, their relationship with sound, and how quickly the loss takes effect. I would suspect that a musician who notices losses over the course of a year might be more impacted when compared to someone who happens to work in a noisy environment that over 5 years has to gradually turning the TV up louder.

I'd also like to know if that 30-50% is evenly distributed across the cochlea, or did they observe it in a more centralized location? How many people come on Tinnitus Talk every day saying they have "perfect hearing on the audiogram", but didn't get tested beyond 8 kHz. Is it possible that the 30-50% missing is concentrated in the high frequencies, and that's why it's not showing up on the normal audiogram?

 

[weab00]

More like 6 to 8 weeks, no?

 

[Lucifer]

More like 6 to 8 weeks, no?

Depends when they release the results. If they release the FX-322 Phase 2a clinical trial Day 90 results on the 31st March then it will be about 8 weeks minimum. I really hope they don't delay it any further.

 

[Diesel]

More like 6 to 8 weeks, no?

It's obviously going to be March 22nd.
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3.22

 

[RichieTheKid]

I am grateful that FX-322 has positive results as the prospect of even just improving a bit is a blessing. It's better than nothing.

But my question is, when FX-322 comes out, how does one go about getting it? Do we have to rule out conditions first etc? Just wondering what the actual process will be like.

 

[Diesel]

I am grateful that FX-322 has positive results as the prospect of even just improving a bit is a blessing. It's better than nothing.

But my question is, when FX-322 comes out, how does one go about getting it? Do we have to rule out conditions first etc? Just wondering what the actual process will be like.

You'll go to the ENT with complaints of hearing loss + related symptoms (tinnitus, distortion, muffled sound). They'll do the multitude of hearing tests. The hearing tests may or may not reveal hearing loss. Since FX-322 is fairly safe to use, they'll suggest that many see improvements in hearing after using it, so they will suggest to trial treat. Then they'll have you return to monitor improvements.

It will be almost the same process as those who got steroid injections, just instead they get a drug that actually works.

 

[Diesel]

If my math is correct, Frequency Therapeutics should have the raw Phase 2A Day-90 data in their possession by the end of this week.

 

[Keith Handy]

If my math is correct, Frequency Therapeutics should have the raw Phase 2A Day-90 data in their possession by the end of this week.

It takes 7 weeks to crunch it?

 

[Diesel]

It takes 7 weeks to crunch it?

They have said "Late Q1," which I interpret as any day from February 16th - March 31st.

There will be a fair amount of data to analyze, even though it is at the group level. They'll want to make 100% sure they are producing a statement/presentation about the data that is accurate and relevant. It'll also be reviewed internally by management, compliance, and probably others for final approval. There's also a lot of work that goes into the PR, presentation, etc to be considered.

It's possible they may rush it out with their quarterly update due mid-February, but I think a March release may be more likely considering the importance of the data.

 

[Jrblovsky]

They have said "Late Q1," which I interpret as any day from February 16th - March 31st.

There will be a fair amount of data to analyze, even though it is at the group level. They'll want to make 100% sure they are producing a statement/presentation about the data that is accurate and relevant. It'll also be reviewed internally by management, compliance, and probably others for final approval. There's also a lot of work that goes into the PR, presentation, etc to be considered.

It's possible they may rush it out with their quarterly update due mid-February, but I think a March release may be more likely considering the importance of the data.

Any corporations I have worked for release Q1 data on April 1 if that is how their fiscal year is calculated. It can vary depending on multiple variables.

Noobs reading this forum are going to think FX-322 will be available this year when that doesn't seem at all possible.

 

[Lucifer]

Any corporations I have worked for release Q1 data on April 1 if that is how their fiscal year is calculated. It can vary depending on multiple variables.

Noobs reading this forum are going to think FX-322 will be available this year when that doesn't seem at all possible.

It could be possible for them to release FX-322 next year depending on whether the results are positive in March and if they can get Breakthrough Therapy status.

 

[Diesel]

Any corporations I have worked for release Q1 data on April 1 if that is how their fiscal year is calculated. It can vary depending on multiple variables.

Noobs reading this forum are going to think FX-322 will be available this year when that doesn't seem at all possible.

To clarify, their Q4/2020 Quarterly Update will be on / after February 8. They have consistently in quarterly updates included forward looking statements and additional data about FX-322.

World Hearing Day is March 3... It would also be a good day to make a splash announcement about a hearing drug.

The more exposure the drug gets, the more people will ask "when"... seems normal to me.

 

[Guywithapug]

To clarify, their Q4/2020 Quarterly Update will be on / after February 8. They have consistently in quarterly updates included forward looking statements and additional data about FX-322.

Looking at Frequency Therapeutics' website, it appears that the 90 day analysis is planned for late Q1 and the study readout for late Q2 of 2021. So conservatively I would think by July 2021.

If FX-322 doesn't receive Breakthrough Therapy status, I'm thinking an additional 6 months for Phase 2b with readout and 1 year for Phase 3, maybe more. So if all goes well I believe the soonest it could go to market will be approximately mid-2023. That seems plausible?

 

[Diesel]

Looking at Frequency Therapeutics' website, it appears that the 90 day analysis is planned for late Q1 and the study readout for late Q2 of 2021. So conservatively I would think by July 2021.

If FX-322 doesn't receive Breakthrough Therapy status, I'm thinking an additional 6 months for Phase 2b with readout and 1 year for Phase 3, maybe more. So if all goes well I believe the soonest it could go to market will be approximately mid-2023. That seems plausible?

I was referring to the 90-day readout being in March. Frequency Therapeutics has stated late Q2 for Phase 2a data. Q2 ends on June 30.

They've stated the FX-322 Pivotal Phase is planned for 2022, which many speculate will be a Phase 2b/3 and include all three designations from the Phase 2a and both Phase 1bs currently running. It's also inferred on the deck used in the 1/19 webinar. They've also got a Chief Manufacturing Officer installed already. Usually firms are not focusing on manufacturing until Phase 3. So, they're ahead of schedule on that relative to peers.

Personally, I think if the Pivotal Phase starts and ends in 2022, then mid-2023 is reasonable.

I am also getting more optimistic about Breakthrough Therapy status which could shorten the Pivotal Phase and FDA approval timeline.

 

[Guywithapug]

Personally, I think if the Pivotal Phase starts and ends in 2022, then mid-2023 is reasonable.

I am also getting more optimistic about Breakthrough Therapy status which could shorten the Pivotal Phase and FDA approval timeline.

That would be glorious, even if it doesn't help me, which I'm hoping it will since some of my cochlear hair cells got damaged due to toxins.

Let's cumulatively cross our fingers that Frequency Therapeutics are sitting on a revolutionary drug!

 

[Philip83]

$FREQ is soaring three days straight now...

 

[Flyingsheep]

$FREQ is soaring three days straight now...

Glad I finally took a position a couple of weeks ago. Looking forward to the upcoming quarterly update in terms of positive news for this drug and stock prices as well.

 

[scotty03874]

Let's cumulatively cross our fingers that Frequency Therapeutics are sitting on a revolutionary drug!

Amen. Let's hope so...

$FREQ is soaring three days straight now...

Insiders might be pushing it...

 

[dd314]

Insiders might be pushing it...

There was quite a lot of insider selling last month, but the day after the CEO sold $1 million worth of stock, he gave a presentation at the JP Morgan Health conference and since then they've hired a new Chief Manufacturing Officer. So getting some mixed signals.

 

[FGG]

There was quite a lot of insider selling last month, but the day after the CEO sold $1 million worth of stock, he gave a presentation at the JP Morgan Health conference and since then they've hired a new Chief Manufacturing Officer. So getting some mixed signals.

Didn't @Diesel determine the "insider selling" was pre-planned scheduled selling with stock being giving as salary?

 

[Diesel]

There was quite a lot of insider selling last month, but the day after the CEO sold $1 million worth of stock, he gave a presentation at the JP Morgan Health conference and since then they've hired a new Chief Manufacturing Officer. So getting some mixed signals.

Nothing burgers. Common for execs/directors of publicly traded companies.

Those insider sales are part of a 10b5-1 program setup by the company with the SEC to ensure the execs are not selling on inside information. The sale amounts are predetermined over 6 months in advance. They all also look like options that had been vested for the past 2 years. It appears to be part of the compensation plan, since many of the new execs have also been awarded options that vest a few years from now.

 

[patorjk]

$FREQ is soaring three days straight now...

This is all just my own personal speculation, but if there's good data I think the stock price will go parabolic. My judgement may be clouded since this therapy applies to me, but it really seems revolutionary.

As for the recent run, I think it's a mix of FOMO and people who've been on the sidelines. Someone lamented to me that they thought about getting in at $18 a share but decided to wait until the results were closer.

 

[Jrblovsky]

It will be either a miracle drug or a flop.

 

[weab00]

It will be either a miracle drug or a flop.

Just like all of these drugs.

 

[Jrblovsky]

Just like all of these drugs.

Truth. Good thing it only takes one working drug to make a difference.

 

[Diesel]

It will be either a miracle drug or a flop.

Certainly won't be a flop with significant results after the Phase 1/2 + Long-Term review already out. It will be a disappointment if multi-dosing doesn't produce stratified results.

 

[Jrblovsky]

Certainly won't be a flop with significant results after the Phase 1/2 + Long-Term review already out. It will be a disappointment if multi-dosing doesn't produce stratified results.

Well hopefully it shows good results. Hopefully they have real gains, like 20 dB or 30 dB in a certain frequency. If they don't have real gains, it really won't do anything for people with hearing loss.

 

[Diesel]

Well hopefully it shows good results. Hopefully they have real gains, like 20 dB or 30 dB in a certain frequency. If they don't have real gains, it really won't do anything for people with hearing loss.

Then how do we explain the word score increases?

 

[Jrblovsky]

Then how do we explain the word score increases?

I guess you're right. I feel like more doctors would get behind it if it shows increases in the audiogram. Being that seems to be the current standard of measure from what I have seen.

 

[Princebeyel]

I would kill to have better word scores.