Frequency Therapeutics — Hearing Loss Regeneration

[tbuzz89]

Secondly, Dr Lustig's reply concerning expectations with tinnitus was more like a prayer than an informed response as if hearing loss/restoration and tinnitus is totally unrelated. Not impressed.

How concerned should we really be over this? Are we thinking that his tone of response inferred bad news on the tinnitus front, or did he realize that he had to keep his mouth shut on this topic prior to the release dates in March/May?

 

[FGG]

How concerned should we really be over this? Are we thinking that his tone of response inferred bad news on the tinnitus front, or that he realized he had to keep his mouth shut on this topic prior to the release dates in March/May?

Not at all. It was an avoidant, non answer. It was a weird exchange as clearly the caller wasn't asking if he would be thrilled or not. In any case, Frequency Therapeutics will release some data by the end of March and they already had positive Phase 1 anecdotes.

 

[Diesel]

How concerned should we really be over this? Are we thinking that his tone of response inferred bad news on the tinnitus front, or did he realize that he had to keep his mouth shut on this topic prior to the release dates in March/May?

It seemed more uninformed, IMO.

 

[FGG]

Correct me if I'm wrong, but wasn't Dr. Lustig just a guest panelist and not directly involved with Frequency Therapeutics or FX-322?

Correct. He was actually on the Novartis trial though.

 

[Gb3]

I think what we'll see, and Frequency Therapeutics has outlined this somewhat, is the concept of annual hearing checkups. Someone like us will come in with a problem like tinnitus, get a more comprehensive hearing test (and charged more), then get the FX-322 series of injections based on the assessment. From there, the ENT will recommend annual visits to check on wear of hearing, and determine if another round is needed. This will be no different than glasses where people have eye exams every so often to get their lenses/contacts updated.

It's an awesome opportunity to have a patient for life and keep their hearing at optimal condition. Right now, it's really just managing decay.

Exactly.

I mean we have LASIK now, but people still wear glasses.

 

[Drachen]

Exactly.

I mean we have LASIK now, but people still wear glasses.

Mm, I don't know if you can make that same analogy. LASIK is much more expensive compared to glasses, and it's anticipated that a run of FX-322 will be around the same price as a hearing aid.

I genuinely don't see a future for hearing aids if FX-322 can produce, at minimum, an equal effect. And I'm pretty sure if FX-322 works as it is expected to work, it will be a much more effective process.

 

[Gb3]

Mm, I don't know if you can make that same analogy. LASIK is much more expensive compared to glasses, and it's anticipated that a run of FX-322 will be around the same price as a hearing aid.

I genuinely don't see a future for hearing aids if FX-322 can produce, at minimum, an equal effect. And I'm pretty sure if FX-322 works as it is expected to work, it will be a much more effective process.

Nobody knows how much it's going to cost. My hearing aid cost $50 after insurance.

 

[tbuzz89]

Nobody knows how much it's going to cost.

Insurance companies are generally more inclined and willing to cover drugs over devices. Once FX-322 comes to market and is scooped up by big pharma in the US, negotiated rates will follow almost in tandem.

 

[Lucifer]

Insurance companies are generally more inclined and willing to cover drugs over devices. Once FX-322 comes to market and is scooped up by big pharma in the US, negotiated rates will follow in tandem.

Hopefully the rates are cheap and not $5,000 per shot.

 

[Drachen]

Hopefully the rates are cheap and not $5,000 per shot.

I don't think you need to worry, honestly. $5,000 per shot would be pretty ridiculous unless that's all you needed, and even then that's a bit much. I'm not some expert economist, but I would assume they'd want to take advantage of the massive market they have waiting for this, and it's not even close to being just rich people.

 

[Lucifer]

I don't think you need to worry, honestly. $5,000 per shot would be pretty ridiculous unless that's all you needed, and even then that's a bit much. I'm not some expert economist, but I would assume they'd want to take advantage of the massive market they have waiting for this, and it's not even close to being just rich people.

I agree, look at the COVID-19 vaccine where each shot is around $10-20 per person. If millions of people around world suffer from hearing loss, tinnitus and hyperacusis, then surely the price will be lower, however we must take into account the specialist time it takes to inject the FX-322 shot so I would say the price of FX-322 per shot will be around $500-$1,000 in the best case scenario.

 

[Drachen]

I would say the price of FX-322 per shot will be around $500-$1,000 in the best case scenario

Doable, honestly. Very doable. It's certainly a chunk of change, but to restore one's hearing and inner peace is well worth the cost. Money exists to be spent, and it should certainly be spent on your health.

I do sincerely hope there are some sort of initiatives that will be in place to help those lower-income sufferers get their chance as well.

 

[twa]

I do sincerely hope there are some sort of initiatives that will be in place to help those lower-income sufferers get their chance as well.

I worry about the lawn crews that I see every day without ear protection using lawn mowers and leaf blowers all day long.

 

[Born To Slay]

Doable, honestly. Very doable. It's certainly a chunk of change, but to restore one's hearing and inner peace is well worth the cost. Money exists to be spent, and it should certainly be spent on your health.

I do sincerely hope there are some sort of initiatives that will be in place to help those lower-income sufferers get their chance as well.

Hopefully it'll be covered by Medicaid in the US.

 

[Michael01]

Doable, honestly. Very doable. It's certainly a chunk of change, but to restore one's hearing and inner peace is well worth the cost. Money exists to be spent, and it should certainly be spent on your health.

I do sincerely hope there are some sort of initiatives that will be in place to help those lower-income sufferers get their chance as well.

There's schemes like the NDIS here in Australia that will pay for such things and look into getting you the relevant appointments with the doctors you need to see as well. But you need to apply and be accepted which can be difficult for some people.

 

[paul mclean]

They have to set conservative expectations that there is a planned pivotal trial. If the FDA approved the drug early, they will certainly forgo any more trials and get the drug on the market. Frequency Therapeutics is a publicly traded company, trials are extremely expensive and take years to recoup the costs, a product on the market brings positive cashflow to be invested in future products/innovations in the pipeline.

Ah I see. I was just going off what Carl LeBel said on the Tinnitus Talk Podcast. He pretty much said Frequency Therapeutics would be doing Phase 3 no matter what.

So do you think they'd just scrap it if they got approved? I think it would still be handy for them to have the data.

 

[AfroSnowman]

I agree, look at the COVID-19 vaccine where each shot is around $10-20 per person. If millions of people around world suffer from hearing loss, tinnitus and hyperacusis, then surely the price will be lower, however we must take into account the specialist time it takes to inject the FX-322 shot so I would say the price of FX-322 per shot will be around $500-$1,000 in the best case scenario.

Really, unless the price is significantly more than a new car, I would happily take out a loan if that is what it took to really decrease my tinnitus. If it was a $200,000 drug treatment I don't know what I'd do.

 

[Lucifer]

Ah I see. I was just going off what Carl LeBel said on the Tinnitus Talk Podcast. He pretty much said Frequency Therapeutics would be doing Phase 3 no matter what.

So do you think they'd just scrap it if they got approved? I think it would still be handy for them to have the data.

They can still do the pivotal trial while FX-322 is out in the market if they get Breakthrough Therapy designation after the Phase 2a clinical trials.

 

[Lucifer]

Really, unless the price is significantly more than a new car, I would happily take out a loan if that is what it took to really decrease my tinnitus. If it was a $200,000 drug treatment I don't know what I'd do.

If it was $200,000 for FX-322 shot I would have no clue what I would do either, but if millions of people around the world suffer from hearing loss, tinnitus and hyperacusis, then the drug would be cheap to manufacture. The only cost we have to take into account is the specialist injecting FX-322 into our ear.

 

[frpp]

Really, unless the price is significantly more than a new car, I would happily take out a loan if that is what it took to really decrease my tinnitus. If it was a $200,000 drug treatment I don't know what I'd do.

I'd go full Breaking Bad in this scenario.

 

[Bill Arsenault]

Seriously. As a music person, those tested frequencies are spaced entire octaves apart, meaning there are 11 untested notes in between each pair, and that's not taking into consideration the continuum of intermediate frequencies between all the notes.

I'm obviously not an audiologist so I cannot make excuses or give reasons for this.

But I see your point.

Out of the 16,000 frequencies in the extended testing spectrum, it seems that they are only actually testing a fraction of them.
And then you get told you have hidden hearing loss, like you're the problem.

On the other hand, who is really going to sit still and endure and pay for a test of all 16,000 frequencies.
Or even 1,600.
Maybe 160 could be tolerable once in a lifetime - because 16 out of 16,000 seems senseless.

The current audiogram is clearly an extreme compromise that does not work in the patient's favor in any way but comfort.
I suppose it can be useful to check if a human has some hearing left at all and things like that.
But it comes off like a bad joke for precision testing of human hearing and cannot be taken seriously.

It reminds me of those Graphic Stereo Equalizers that some Hi-Fi enthusiasts might still use at home, but that are considered completely useless in a recording studio where they use the more precise Parametric EQ along with digital sweeping methods to first find the trouble spots.

 

[Diesel]

@Lucifer @AfroSnowman @frpp

FX-322 probably won't be obscenely expensive. It's a small molecule drug. Langer himself has reiterated that the benefit is that they're cheap and easy to make in volume.

It's made up 2 small molecules and the delivery gel. We know one is Valproate Sodium, which is about $30 per 50ml. The proprietary molecule is unknown. And the polymer delivery gel they use sounds like it's a standard gel, so probably not that expensive.

 

[Fields]

I'd go full Breaking Bad in this scenario.

How about Breaking Even?

Fortunately, in most European countries, we won't have to worry about the cost too much. Finding an ENT who's willing to prescribe the treatment is probably going to be the hardest part.

 

[Aaron91]

@Lucifer @AfroSnowman @frpp

FX-322 probably won't be obscenely expensive. It's a small molecule drug. Langer himself has reiterated that the benefit is that they're cheap and easy to make in volume.

It's made up 2 small molecules and the delivery gel. We know one is Valproate Sodium, which is about $30 per 50ml. The proprietary molecule is unknown. And the polymer delivery gel they use sounds like it's a standard gel, so probably not that expensive.

Not to mention, the procedure itself is very quick and doesn't require surgery or any high-tech equipment to perform it. In fact, it's kind of insane to imagine that 2/3rds of the treatment to potentially all these problems is a needle through the ear with a molecule that was first made 140 years ago and has been used in medicine for 60 years.

I'm still worried though that if FX-322 turns out to be the real deal when it comes to treating all hearing associated issues - age-related, noise-induced/ototoxic/severe hearing loss, tinnitus and hyperacusis - then they might hike the price because they know they can, especially with no competition on the market. And no, I don't consider hearing aids or cochlear implants to be competition if FX-322 turns out to treat all of the above.

 

[Diesel]

I'm obviously not an audiologist so I cannot make excuses or give reasons for this.

But I see your point.

Out of the 16,000 frequencies in the extended testing spectrum, it seems that they are only actually testing a fraction of them.
And then you get told you have hidden hearing loss, like you're the problem.

On the other hand, who is really going to sit still and endure and pay for a test of all 16,000 frequencies.
Or even 1,600.
Maybe 160 could be tolerable once in a lifetime - because 16 out of 16,000 seems senseless.

The current audiogram is clearly an extreme compromise that does not work in the patient's favor in any way but comfort.
I suppose it can be useful to check if a human has some hearing left at all and things like that.
But it comes off like a bad joke for precision testing of human hearing and cannot be taken seriously.

It reminds me of those Graphic Stereo Equalizers that some Hi-Fi enthusiasts might still use at home, but that are considered completely useless in a recording studio where they use the more precise Parametric EQ along with digital sweeping methods to first find the trouble spots.

I'm not as well read on what recommendations researchers may have on improving the audiogram, but I would think that there would be some emphasis on "upgrading" it to produce tones or bands of tones where vowel and consonant sounds are common. We've seen the "speech banana" that show where letters live on the audiogram, most of the letters are somewhere in between two tested tones.

I'm speculating, but if they did something like this, it might be a better indicator of understanding where word score deficits taking place. For example: if the patient had a deficit on the audiogram in the range where they hear ch, k, t, sounds, it's likely those words with this sounds on the word score test are where they are deficit.

 

[paul mclean]

The proprietary molecule is unknown.

It's CHIR99021. Wikipedia mentioned Frequency Therapeutics on this page in the past but it seems it has been edited.

 

[Keith Handy]

Out of the 16,000 frequencies in the extended testing spectrum

There isn't a fixed number of frequencies like that, though, and our perception of pitch is not linear, it's logarithmic. So the pitch difference between 1,000 Hz and 2,000 Hz is the same as the pitch difference between 4,000 Hz and 8,000 Hz. Nonetheless, a doubling of pitch is still kind of a large jump; when you play a note on a piano and then play the next higher note (including all keys, black and white), the increase in pitch is about 6%.

 

[Diesel]

Not to mention, the procedure itself is very quick and doesn't require surgery or any high-tech equipment to perform it. In fact, it's kind of insane to imagine that 2/3rds of the treatment to potentially all these problems is a needle through the ear with a molecule that was first made 140 years ago and has been used in medicine for 60 years.

I'm still worried though that if FX-322 turns out to be the real deal when it comes to treating all hearing associated issues - age-related, noise-induced/ototoxic/severe hearing loss, tinnitus and hyperacusis - then they might hike the price because they know they can, especially with no competition on the market. And no, I don't consider hearing aids or cochlear implants to be competition if FX-322 turns out to treat all of the above.

Looking at the investor presentation, it's clear they want it to be reimbursed by US Health Insurance, could be Medicare or private. That puts a theoretical ceiling on what the price could be for a series of injections. I haven't done the rough estimate, but if the price of a series of injections was cheap enough to save the insurance company on addition costs related to declining hearing, that would probably give you a rough idea of what it would cost.

The other comparison might be to the cost of hearing aids. If a series of injections, let's just say 2x shows a similar improvement to your standard $2000 hearing aid, they might position it as a rough alternative. Or, if 2x injections allows the patient to go with a cheaper/less powerful hearing aid, the difference in cost might be a good place to determine what they might ask for FX-322. For example, a patient needs hearing aids that are $4000. With a series of FX-322 injections, they'll only need $1000 hearing aids.

Although many commentators here do not see hearing aids as competition, it's clear that Frequency Therapeutics absolutely does. They have a whole section about it in their 10-k. I suspect doctors and patients will use an established product to make comparison and decisions. So, from a business standpoint, they'll probably use hearing aid pricing to figure out what FX-322 should be priced.

My guess has been fluctuating, and may change based on the Phase 2A results.

Diesel Estimate:

$2,000 per set of 2 injections before Insurance co-pay/discount, not including procedure fees.

 

[patorjk]

I'm still worried though that if FX-322 turns out to be the real deal when it comes to treating all hearing associated issues - age-related, noise-induced/ototoxic/severe hearing loss, tinnitus and hyperacusis - then they might hike the price because they know they can, especially with no competition on the market. And no, I don't consider hearing aids or cochlear implants to be competition if FX-322 turns out to treat all of the above.

I don't see the price being too outrageous. The hearing aid market is about to get a lot more competitive since over-the-counter hearing aids will be coming within the next few years. This will mean FX-322 won't just be competing against prescription hearing aids, which can cost $2k+, but with ones more affordably priced at maybe $100 (and no doctor visit!). Plus there's speculation that brands like Apple will be entering this market.

So if FX-322 were to cost $20k per injection, almost no one would get it when they could instead get a $1k Apple hearing aid. I think the market will basically force them to make the price reasonable (my gut is $1k per injection). Plus, if these market forces fail, there's still OTO-6XX on the horizon, which will provide direct competition.

 

[Diesel]

It's CHIR99021. Wikipedia mentioned Frequency Therapeutics on this page in the past but it seems it has been edited.

That's interesting.

CHIR99021 retails for est. $30 /1mg
Valproate Sodium est. $3 / 1mL

So if FX-322 is equal parts Valproate Sodium and CHIR99021, at retail prices we're looking at... what?