Frequency Therapeutics — Hearing Loss Regeneration

I have hyperacusis and got my hearing tested on three separate occasions in the past. No problem. Granted, mine is rather mild.

 

I guess we’ll have to learn if FX-322 helps with hyperacusis. If so, it’s a temporary price to pay to have it flare up from some testing to get FX-322 to treat it long term.

 

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.

 

Will FX-322 be more effective for high frequency hearing loss?

I hear fine in the 1 kHz - 8 kHz range but I struggle with 14 kHz - 20 kHz.

I've read somewhere that FX-322 reaches the higher frequency hair cells easier.

BTW, I can't wait for FX-322 to come out in the next couple years. What a relief!

 

This will be more clearly known by the end of Q1/2021.

 

F@#k yes, if tinnitus is lowered, it will be a major breakthrough.

 

What time is Bob Langer doing his presentation tomorrow, and is there a live link to watch it on?

 

The Potential for Restorative Treatments for Acquired Sensorineural Hearing Loss

 

Thanks Diesel.

 

It seems like news on FX-322 is coming in fast... It feels like we might be getting it sooner rather than later...

 

There has to be some positive results?

Does anyone know if Frequency Therapeutics is aware of the results in advance of setting up the readout?

 

It's possible that they have conducted internal analysis. If you recall back in April or May of 2020, they had about 50% filled the 96 participation target. At that time, it was noted that they believed they could achieve primary objectives with only the 50%; to me that was a sign that it's possible they had seen data at the group level that looked like it was trending in a favorable direction all the way back to April of 2020.

Secondly, in the 90-day readout notes on the current investor presentation, they note a partial measures for tinnitus, and impact QOL. The specific use of partial indicates to me that they are acknowledging that they either already know, or expect that TFI and QOL scores continue to improve beyond the 90-day window.

Also, looking back to the Phase 1/2 follow-up (13-21 month follow-up) with the patients that received a single dose. It's likely that Frequency Therapeutics measured those return participants' high-frequency audiogram, and conducted a TFI assessment. Since they didn't obtain a baseline of these measures when patients entered the Phase 1/2, they can't produce the results in any presentation, so they only have that 13-21 month snapshot to work from. I can't speak for their tinnitus, but I suspect that some or all those that had noticed a reduction in their tinnitus were part of the follow-up group; and their extended high-frequency audiograms were probably in thresholds well above what is normally seen in patients with mod - moderately severe hearing loss.

Also, no laws are stopping Frequency Therapeutics from testing FX-322 in non-US countries, where the laws put the liability on patients taking experimental drugs. So, Frequency Therapeutics could have easily partnered with a university in Mexico, India, certain eastern European countries, and southeastern Asian countries that would let them do 90-day "simulation" tests with FX-322 and essentially give them a preview of the Phase 2A outcomes look like. This is surprisingly legal.

Just my $.02 on why they might have reason to be confident.

 

I think they are realizing they need to get a lot of momentum going early in the practitioner, patient, and investor space this year. I've noticed on this forum, Twitter, and on Facebook pages anecdotes where patients' doctors are still scoffing at FX-322 or don't know about it at all. It's certainly early, and they have reason to be skeptical or not know about it. But for this drug to be "market ready," it needs practitioners and patients primed for treatment well in advance.

Also... a little hype doesn't hurt

 

It's listed as starting 2pm. You know the time zone?

 

US Eastern Time @ 8AM.

 

Cool, so it's 2pm my time. Thanks.

 

Are there any shareholders of FREQ here?

I know a few here who have bought into it and it is incredibly high risk. I remember Auris Medical going public and all the hype about their drug AM-101 and thinking this company could be worth billions. That's the risk of these biotechs, you can literally lose 99.8% in a quick amount of time.

Imagine making a shitload of cash and curing your tinnitus; chronic long term sufferers who invested - you earnt it!

 

I've considered it but prioritizing other stocks right now.

 

Ticker: VOO FTW.

 

To my fellow-investors... Can you lose “99.8% of money” if you set a stop-limit order? An order to sell automatically when stocks drop below a certain price?

On the one hand, that seems like a logical safety measure to put on your high risk stocks. On the other hand, you still hear horror stories from people who lost everything.

Were they just too lazy to put a stop-limit order? Or does a stop-limit not work when stocks crash (because there is no one to buy?)

I would like to know for sure before it happens

 

When the share price reaches the stop-limit price you set it triggers the sell or buy order but does not guarantee the execution of the order. So yes you need a buyer if you are a seller and vice versa. FREQ is still a highly speculative stock, though I do own a few shares to keep me interested.

 

For those of us who don't understand oral English, can you please make a summary of this Q&A that will be happening in two hours?

Thanks

 

Frequency Therapeutics Appoints Quentin McCubbin, Ph.D., as Chief Manufacturing Officer

WOBURN, Mass.--(BUSINESS WIRE)--Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage biotechnology company focused on harnessing the body’s innate biology to repair or reverse damage caused by a broad range of degenerative diseases, today announced the appointment of Quentin McCubbin, Ph.D., as chief manufacturing officer. Dr. McCubbin will oversee Company technical operations, leading drug product formulation, chemistry manufacturing and controls (CMC) and supply chain, to support the development of Frequency’s pipeline of product candidates.

Dr. McCubbin joins Frequency from Cerevel Therapeutics, a clinical-stage biotechnology company where he served as head of technical operations. Prior to Cerevel, he spent 19 years at Takeda/Millennium Pharmaceuticals in various roles progressing in responsibility, including six years as vice president of pharmaceutical sciences and global head of process chemistry.

“Quentin’s background and leadership in technical operations will be critical as we prepare for larger studies in support of our lead FX-322 program that aims to treat the most common form of hearing loss, and as we look to diversify and expand our clinical pipeline with a program for remyelination in multiple sclerosis,” said David Lucchino, Frequency’s President and Chief Executive Officer. “I am excited to have Quentin join our leadership team and believe his operational and technical expertise will play an essential role as we look to advance and commercialize a medicine for the tens of millions of patients in the U.S. with sensorienural hearing loss, and aim to leverage the broad potential of our progenitor cell activation platform.”

Frequency’s lead product candidate FX-322 is designed to treat the underlying cause of sensorineural hearing loss (SNHL) by regenerating sensory hair cells by activating progenitor cells already present in the cochlea. Sensory hair cells are responsible for filtering, tuning and converting sounds, enabling people to clearly understand sounds and speech. The Company plans to share interim day-90 group-level data from its Phase 2a study of FX-322 late in Q1 2021, and is planning an end-of-study data read-out in late Q2 2021.

Dr. McCubbin began his career as a chemist, completing a post-doctoral fellowship at Imperial College in London. He earned his B.S. and Ph.D. in chemistry from Monash University in Australia. He is an inventor on several patents and has published numerous peer-reviewed articles.

“I’m excited to join Frequency at this critical point in the Company’s evolution and to have an opportunity to play a role in advancing potential novel treatments for such profoundly vexing medical conditions,” said Dr. McCubbin. “Frequency’s platform and small molecule approach provides a unique opportunity to pursue a broad range of degenerative diseases and I’m thrilled to be a part of something with the potential to improve quality of life for so many.”

Link:
Frequency Therapeutics Appoints Quentin McCubbin, Ph.D., as Chief Manufacturing Officer

 

Today's presentation:

"We are getting quite a number of questions regarding tinnitus"

 

From Carl LeBel in the Q&A:

FX-322 pivotal trial is expected to be 2022.

 

I hope they have a huge backlog of eligible patients for when they start so they can fill it up and finish it ASAP and perhaps cut the study time from 210 days to 90 days.

2023 is going to be lit.

 

I know this has been covered, but what does pivotal trial mean? After this, FX-322 can go to market? Do you think that the pivotal trial will be completed in 2022?

 

I thought the 3rd phase of the trial was in process. What does this mean?

Thank you,
twa

 

Is that what they said?

 

Yeah I'm sure all the regulars here and lurkers were on that webinar.