Frequency Therapeutics — Hearing Loss Regeneration

[frpp]

I'm not sure if I have shared this patent app lately. It was updated back in October. I haven't read it all, but looks like a broader application for Progenitor Cell Activation. Gets interesting around page 40.

https://pdfaiw.uspto.gov/.aiw?Docid=20200316089&homeurl=http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2%26Sect2=HITOFF%26p=1%26u=%252Fnetahtml%252FPTO%252Fsearch-bool.html%26r=1%26f=G%26l=50%26co1=AND%26d=PG01%26s1=%2522frequency%2Btherapeutics%2522%26OS=%2522frequency%2Btherapeutics%2522%26RS=%2522frequency%2Btherapeutics%2522&PageNum=&Rtype=&SectionNum=&idkey=B360D427747D

Something might be wrong. I can't get anything but a single page.

 

[annV]

Something might be wrong. I can't get anything but a single page.

You need to click "Full Document" on the left hand side.

I attached the full thing as PDF.

 

[GBB]

Many professional money managers bought shares at low prices. From that point they knew that enthusiasm from retail - Dick and Jane with subject matter conditions would invest. From this, volume was low, but price did move up with the help of Dick and Jane.

Then money managers, not hedge funds thought that price was becoming a little too expensive for Dick and Jane to continue investing so they took some profit. They also wanted a small shake out from retail - Dick and Jane before reinvestment. All professional managers, including bio hedge fund managers will be watching the investors' presentations on January 19, where price may go back up a few points.

From there on, any data that would support future FDA approvals will drive the price up considerably. Any approvals will rocket price.

I have a different take on this, which is only informed by my own experience, and as such should be regarded as an opinion.

My best friend works at a hedge fund. I also work at an asset management firm though not as an analyst or portfolio manager. I don't believe hedge funds in general think about retail investors as a meaningful contributor to their thesis on a stock at all - only other retail investors do. If anything funds are thinking about sell side analyst rating changes, and maybe other large institutional players investing in or unwinding positions, though this is more at an aggregate scale, "the market", not at the level of any other rival fund in particular.

It's really not about other individual actors and predicting their behavior - it's about identifying that there will be a change in EPS or a multiple - a catalyst for price movement - well ahead of time in order to position yourself to profit when the rest of "the market" catches up. You are either in time to position yourself or you're not, but hedge funds aren't making incremental dollars off of breaking down the rest of the market into trenches and somehow gaming the psychology of retail investors, or anyone else for that matter - this would be far too complex and prone to failure compared to just having a good thesis e.g. this stock will grow as it launches a new product that will do more unit shipments than the expectations of the street, or this stock will tank as it fails to meet analyst forecasts because distribution channels are already backed up with excess inventory.

There is a flipside to the thematic, idea-driven investing I'm describing; a more trade-driven style that relies on short-lived intraday positions, options and derivatives, but generally this has more to do with math, agnostic to the identity of other investors, and is winning you dollars at the margins, or used to hedge risk, rather than serving as your primary revenue driver.

There may be funds that don't function in the way I describe, but my buddy's boss is a billionaire with an 80m apartment on Park Avenue, so I am speaking from somewhat of a unique vantage point.

 

[tommyd87]

Many professional money managers bought shares at low prices. From that point they knew that enthusiasm from retail - Dick and Jane with subject matter conditions would invest. From this, volume was low, but price did move up with the help of Dick and Jane.

Then money managers, not hedge funds thought that price was becoming a little too expensive for Dick and Jane to continue investing so they took some profit. They also wanted a small shake out from retail - Dick and Jane before reinvestment. All professional managers, including bio hedge fund managers will be watching the investors' presentations on January 19, where price may go back up a few points.

From there on, any data that would support future FDA approvals will drive the price up considerably. Any approvals will rocket price.

I'm not sure if I have shared this patent app lately. It was updated back in October. I haven't read it all, but looks like a broader application for Progenitor Cell Activation. Gets interesting around page 40.

https://pdfaiw.uspto.gov/.aiw?Docid=20200316089&homeurl=http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2%26Sect2=HITOFF%26p=1%26u=%252Fnetahtml%252FPTO%252Fsearch-bool.html%26r=1%26f=G%26l=50%26co1=AND%26d=PG01%26s1=%2522frequency%2Btherapeutics%2522%26OS=%2522frequency%2Btherapeutics%2522%26RS=%2522frequency%2Btherapeutics%2522&PageNum=&Rtype=&SectionNum=&idkey=B360D427747D

I think that there is a high prospect that any benefit from FX-322 will demonstrate the broader effectiveness of Progenitor Cell Activation and as a result will make the share prices higher due to the fact that it will demonstrate that this method will work widely within the whole body.

 

[FGG]

I have a different take on this, which is only informed by my own experience, and as such should be regarded as an opinion.

My best friend works at a hedge fund. I also work at an asset management firm though not as an analyst or portfolio manager. I don't believe hedge funds in general think about retail investors as a meaningful contributor to their thesis on a stock at all - only other retail investors do. If anything funds are thinking about sell side analyst rating changes, and maybe other large institutional players investing in or unwinding positions, though this is more at an aggregate scale, "the market", not at the level of any other rival fund in particular.

It's really not about other individual actors and predicting their behavior - it's about identifying that there will be a change in EPS or a multiple - a catalyst for price movement - well ahead of time in order to position yourself to profit when the rest of "the market" catches up. You are either in time to position yourself or you're not, but hedge funds aren't making incremental dollars off of breaking down the rest of the market into trenches and somehow gaming the psychology of retail investors, or anyone else for that matter - this would be far too complex and prone to failure compared to just having a good thesis e.g. this stock will grow as it launches a new product that will do more unit shipments than the expectations of the street, or this stock will tank as it fails to meet analyst forecasts because distribution channels are already backed up with excess inventory.

There is a flipside to the thematic, idea-driven investing I'm describing; a more trade-driven style that relies on short-lived intraday positions, options and derivatives, but generally this has more to do with math, agnostic to the identity of other investors, and is winning you dollars at the margins, or used to hedge risk, rather than serving as your primary revenue driver.

There may be funds that don't function in the way I describe, but my buddy's boss is a billionaire with an 80m apartment on Park Avenue, so I am speaking from somewhat of a unique vantage point.

You definitely know more than I do but biotech seems to be so different than the rest of the market.

 

[GBB]

You definitely know more than I do but biotech seems to be so different than the rest of the market.

IMO most people on this forum would be best suited by taking all of their money they don't immediately need, putting it in an SP 500 index like VOO, and then not looking at it until they reach age 55. If you are past that then ya do whatever kinds of trades you want.

 

[Greg Sacramento]

I went to a hedge fund medical board where I used to post and did some FREQ procedure talk around 9:30-10:00 am Pacific coast time. I will go back again after the first of the year.

 

[GBB]

Many professional money managers bought shares at low prices. From that point they knew that enthusiasm from retail - Dick and Jane with subject matter conditions would invest. From this, volume was low, but price did move up with the help of Dick and Jane.

Then money managers, not hedge funds thought that price was becoming a little too expensive for Dick and Jane to continue investing so they took some profit. They also wanted a small shake out from retail - Dick and Jane before reinvestment. All professional managers, including bio hedge fund managers will be watching the investors' presentations on January 19, where price may go back up a few points.

From there on, any data that would support future FDA approvals will drive the price up considerably. Any approvals will rocket price.

Also I kind of came off as a pretentious a**hole so apologies.

As an aside let me just say I really respect how much time and effort you dedicate to answering people's medical questions here, and a single one of those posts is worth more than a thousand of my investment comments. I wrote too fast and didn't ask myself whether I should post, just because I could - admittedly a bad habit of mine.

 

[Greg Sacramento]

@GBB No apologies needed - I had given you a like. You have strong research and analytical skills.

Besides medical stuff - I also have a BA in finance/economics - an easy to get degree. Had a government financial/medical compliance position for a couple of years on the East Coast before coming to California where I then worked in hospitals. Started investing in stocks at 12 years old - 55 years ago. I actually did better investing by phone before there were computers. Since getting tinnitus about 12 years ago, I'm almost always selling too early, probably because of pain and fear.

 

[Danad]

Below is an excerpt from an article posted by @annV which suggests a link between improvement of SNHL and reducing/eliminating tinnitus. More evidence in support of FX-322.

 

[FGG]

Below is an excerpt from an article posted by @annV which suggests a link between improvement of SNHL and reducing/eliminating tinnitus. More evidence in support of FX-322.

View attachment 42267

Exactly, in treatable otologic cases of hearing dysfunction, the tinnitus responds to treatment. The stuck in the brain / tinnitus is brain damage (versus maladaptive plasticity to abnormal stimulus) idea is just wrong.

 

[Diesel]

Ok,

Someone's got to ask a question about tinnitus and hyperacusis on the Live Q&A with Dr. Bob Langer on January 19. That panel is a seriously talented bench.

Who's it going to be?

 

[Diesel]

Exactly, in treatable otologic cases of hearing dysfunction, the tinnitus responds to treatment. The stuck in the brain / tinnitus is brain damage (versus maladaptive plasticity to abnormal stimulus) idea is just wrong.

I for one, am borderline excited to see the "stuck in the brain" / "brain damage" notion put to rest in the near future, along with all the other victorian-era beliefs about hearing loss/symptoms.

 

[Princebeyel]

What do you guys think will happen after the good news in March? Any hope for Expanded Access? Or Breakthrough Therapy designation, or they are going to make us suffer a few more years?

 

[FGG]

Someone's got to ask a question about tinnitus and hyperacusis on the Live Q&A with Dr. Bob Langer on January 19. That panel is a seriously talented bench.

Who's it going to be?

I don't hear well on the phone so I can't do it so I nominate... you .

 

[Diesel]

What do you guys think will happen after the good news in March? Any hope for Expanded Access? Or Breakthrough Therapy designation, or they are going to make us suffer a few more years?

Heavy wager on Breakthrough Therapy. Betting against Expanded Access.

I see it as them helping us NOT suffer for the rest of our lives.

 

[Diesel]

I don't hear well on the phone so I can't do it so I nominate... you .

I'll do it.

 

[Princebeyel]

Heavy wager on Breakthrough Therapy. Betting against Expanded Access.

I see it as them helping us NOT suffer for the rest of our lives.

Isn't Breakthrough Therapy designation just like Fast Track status?

 

[Diesel]

Isn't Breakthrough Therapy designation just like Fast Track status?

Breakthrough therapy and fast track designation programs both are intended to expedite the development and review of drugs for serious or life-threatening conditions, but there are differences in what needs to be demonstrated to qualify for the programs. A breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies. In contrast, a fast track designation is for a drug that treats a serious or life-threatening condition, and nonclinical or clinical data demonstrate the potential to address unmet medical needs for the serious condition.

As with the other programs, breakthrough designation is aimed at treatments of serious illness. Like fast track, breakthrough applications may be reviewed on a rolling basis. However, unlike the fast track designation, which may include theoretical and mechanism-of-action rationale based on nonclinical data, or evidence of actual nonclinical activity, breakthrough therapy demonstrates preliminary clinical of substantial improvement over available therapies.Preliminary clinical evidence is generally that which is sufficient to show substantial improvement in effectiveness or safety over available therapies, but not strong enough to establish safety and effectiveness for the purpose of approval.

As with fast track, breakthrough designation earns additional FDA attention, resources and action:

FDA intends to expedite the development and review of a breakthrough therapy by intensively involving senior managers and experienced review and regulatory health project management staff in a proactive, collaborative, cross-disciplinary review. Where appropriate, FDA also intends to assign a cross-disciplinary project lead for the review team to facilitate an efficient review of the drug development program. The cross-disciplinary project lead will serve as a scientific liaison between members of the review team (e.g., medical; clinical pharmacology; pharmacology-toxicology; chemistry, manufacturing, and controls (CMC); compliance; biostatistics), facilitating coordinated internal interactions and communications with a sponsor through the review division's regulatory health project manager." – "In addition, such a product could be eligible for priority review if supported by clinical data at the time of BLA, NDA, or efficacy supplement submission.

There are multiple approaches that a sponsor may utilize to show substantial improvement. For example, a head-to-head comparison of the new drug to the current standard of care in an early stage trial may offer enough evidence of a meaningful basis for the breakthrough designation. Early patient data without a direct comparison in a clinical trial study that provides better understanding of disease progression may also suffice. For instance, if a certain cancer type has an 80 percent progression rate in a one-year period, yet a drug in early trials shows a 10 percent progression during the same timeframe, a head-to-head trial to prove substantial improvement may not be needed.

 

[Princebeyel]

Breakthrough therapy and fast track designation programs both are intended to expedite the development and review of drugs for serious or life-threatening conditions, but there are differences in what needs to be demonstrated to qualify for the programs. A breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies. In contrast, a fast track designation is for a drug that treats a serious or life-threatening condition, and nonclinical or clinical data demonstrate the potential to address unmet medical needs for the serious condition.

As with the other programs, breakthrough designation is aimed at treatments of serious illness. Like fast track, breakthrough applications may be reviewed on a rolling basis. However, unlike the fast track designation, which may include theoretical and mechanism-of-action rationale based on nonclinical data, or evidence of actual nonclinical activity, breakthrough therapy demonstrates preliminary clinical of substantial improvement over available therapies.Preliminary clinical evidence is generally that which is sufficient to show substantial improvement in effectiveness or safety over available therapies, but not strong enough to establish safety and effectiveness for the purpose of approval.

As with fast track, breakthrough designation earns additional FDA attention, resources and action:

FDA intends to expedite the development and review of a breakthrough therapy by intensively involving senior managers and experienced review and regulatory health project management staff in a proactive, collaborative, cross-disciplinary review. Where appropriate, FDA also intends to assign a cross-disciplinary project lead for the review team to facilitate an efficient review of the drug development program. The cross-disciplinary project lead will serve as a scientific liaison between members of the review team (e.g., medical; clinical pharmacology; pharmacology-toxicology; chemistry, manufacturing, and controls (CMC); compliance; biostatistics), facilitating coordinated internal interactions and communications with a sponsor through the review division's regulatory health project manager." – "In addition, such a product could be eligible for priority review if supported by clinical data at the time of BLA, NDA, or efficacy supplement submission.

There are multiple approaches that a sponsor may utilize to show substantial improvement. For example, a head-to-head comparison of the new drug to the current standard of care in an early stage trial may offer enough evidence of a meaningful basis for the breakthrough designation. Early patient data without a direct comparison in a clinical trial study that provides better understanding of disease progression may also suffice. For instance, if a certain cancer type has an 80 percent progression rate in a one-year period, yet a drug in early trials shows a 10 percent progression during the same timeframe, a head-to-head trial to prove substantial improvement may not be needed.

Do you think good results could make the wait time for FX-322 shorter than estimated?

 

[Diesel]

Do you think good results could make the wait time for FX-322 shorter than estimated?

I think if the results continue to show clinically significant improvements, and build off the Phase 1/2, it will encourage additional cooperation with the FDA, increased interest from participants, additional investment. All should help move the trials forward at a marginally improved pace.

2023/24 seems like realistic range for the product to hit the market.

 

[Lucifer]

Do you think good results could make the wait time for FX-322 shorter than estimated?

Maybe. Depends on how much time gets shaven off once they get Breakthrough Therapy status which they will most likely get.

Could the pivotal phase be shorter because reviewing patients up to 210 days is a long time? If there have been improvements even up to 210 days, they should decrease the time down to 90 days for the pivotal phase.

 

[Princebeyel]

I think if the results continue to show clinically significant improvements, and build off the Phase 1/2, it will encourage additional cooperation with the FDA, increased interest from participants, additional investment. All should help move the trials forward at a marginally improved pace.

2023/24 seems like realistic range for the product to hit the market.

Thank you for taking the time to answer my questions.

I feel like my life has basically come to a halt since my hearing loss so apologies for asking the same questions repeatedly.

 

[Diesel]

Thank you for taking the time to answer my questions.

I feel like my life has basically come to a halt since my hearing loss so apologies for asking the same questions repeatedly.

Totally understand. Everyone on this forum has probably put one thing or another on hold as a result of their hearing loss/tinnitus/hyperacusis.

Try to cope for now, and instead of worrying about the time passing and what you're missing out on, think about what you'll want to do soon after you get the goop injected in your ears.

 

[patorjk]

I for one, am borderline excited to see the "stuck in the brain" / "brain damage" notion put to rest in the near future, along with all the other victorian-era beliefs about hearing loss/symptoms.

A lot of work will need to be done to reverse the "stuck in the brain" theory that has made its way through the community. Earlier today I was browsing another tinnitus Facebook group and someone asked if removing their inner ear would help. Over a dozen people chimed in saying that it wouldn't because "tinnitus is in the brain".

I'm also still amazed at how unknown FX-322 seems to be among people who have tinnitus. They'll need to do some serious PR if they're able to make it to market.

 

[FGG]

A lot of work will need to be done to reverse the "stuck in the brain" theory that has made its way through the community. Earlier today I was browsing another tinnitus Facebook group and someone asked if removing their inner ear would help. Over a dozen people chimed in saying that it wouldn't because "tinnitus is in the brain".

I'm also still amazed at how unknown FX-322 seems to be among people who have tinnitus. They'll need to do some serious PR if they're able to make it to market.

What's frustrating is they are half right in that removing the cochlea doesn't fix tinnitus, just like more amputation doesn't fix "phantom limb."

 

[Lucifer]

A lot of work will need to be done to reverse the "stuck in the brain" theory that has made its way through the community. Earlier today I was browsing another tinnitus Facebook group and someone asked if removing their inner ear would help. Over a dozen people chimed in saying that it wouldn't because "tinnitus is in the brain".

I'm also still amazed at how unknown FX-322 seems to be among people who have tinnitus. They'll need to do some serious PR if they're able to make it to market.

The ENT's and specialists better change their mindset fast. FX-322 will be the drug to cure our hearing loss, tinnitus and hyperacusis.

They better not refuse patients for wanting FX-322 if it's going to cure their hyperacusis as they think that increasing input will make things louder but it will do the opposite.

 

[weab00]

What's frustrating is they are half right in that removing the cochlea doesn't fix tinnitus, just like more amputation doesn't fix "phantom limb."

I don't know why it's such a difficult concept to understand. It's like if you burn yourself on a stove, of course it's the brain that's generating the pain signals, but if you address the wound then the pain will subside. Same logic is applicable to tinnitus and hyperacusis. No one's going to tell someone burned in a fire that the signals are just being generated in their head lol.

 

[FGG]

I don't know why it's such a difficult concept to understand. It's like if you burn yourself on a stove, of course it's the brain that's generating the pain signals, but if you address the wound then the pain will subside. Same logic is applicable to tinnitus and hyperacusis. No one's going to tell someone burned in a fire that the signals are just being generated in their head lol.

I think it's because a lot of people don't know that they have hearing loss and (especially standard) audiograms aren't all that diagnostic for hearing loss outside of a certain amount of OHC loss in a certain range. Since tinnitus clearly isn't an external sound, they reason it must be brain damage. I can see the logic there but the fact that tinnitus resolves when the cause is treatable (even long standing tinnitus) should be proof enough that it is a wrong concept.

 

[Street Novelist]

2023/24 seems like realistic range for the product to hit the market.

Jesus, I hope not! If so, they really need to hold the Phase 3/Pivotal trial next year. At least then we would have a great shot at getting the drug. I know I'll be doing all I can to get into the next trial.