Otonomy OTO-413 — Treatment of Hidden Hearing Loss

Discussion in 'Research News' started by Michael Larsen, Jan 9, 2018.

    1. Aussie Lea
      Dramaqueen

      Aussie Lea Member

      Location:
      Melbourne Yarra Valley
      Tinnitus Since:
      09/2013
      • Good Question Good Question x 3
    2. Pero1234

      Pero1234 Member

      Tinnitus Since:
      02/2018
      Cause of Tinnitus:
      home theatre system + high pressure washer
      What does this mean for private stockholders?

      Otonomy, Inc. (Nasdaq: OTIC) today announced that it received a letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC (Nasdaq) indicating that the company’s shares would be suspended from trading on Nasdaq effective at the open of business on December 23, 2022. Following such suspension, the company’s shares will be traded on the OTC Pink Market.

      Should we sell what we have left? Will there be some kind of automatic payout at current market price? Or will we lose everything?
       
    3. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

      Location:
      Prison
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      -
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      -
      That’s what I’m worried about. If the company is gone completely, who ends up owning OTO-413 if they haven’t sold it yet? Would it be possible to buy the IP of OTO-413 once they are shut down completely or would it be too late?

      I don’t want a good drug to be shelved completely forever when it offered benefit at the 0.3 mg dose.
       
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    4. Artemis2K
      Kick ass

      Artemis2K Member Benefactor

      Location:
      South Carolina
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      2012
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      I had tinnitus for as long as I can remember. Got bad later.
      I know that there's some controversy with Hough Ear Institute, but didn't they pretty much repurpose a drug that was originally intended for Alzheimer's from a different establishment? I'm certain there's many examples like this.

      I wouldn't worry about the BDNF drug. Everything should be fine. The only downside is time. :)
       
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    5. CW Dragon
      Depressed

      CW Dragon Member Benefactor

      Location:
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      I hope someone buys their IP at dirt cheap and can use the savings to put into more trials/development. One thing I always wondered about the best respondents on the successful 0.3mg April Phase2A trial from last year is their lifestyle. I'd love to know about their diet, supplement intake, exercise routine, sleeping habits, and ear protection and if that was also a huge factor in their success. I wish they had gathered this information and could release it to us.

      20112441-16490354163583422_origin.png
       
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    6. Artemis2K
      Kick ass

      Artemis2K Member Benefactor

      Location:
      South Carolina
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      2012
      Cause of Tinnitus:
      I had tinnitus for as long as I can remember. Got bad later.
      BDNF is being researched on so much right now. There is definitely value. I think some company will see the results as a glass half full and take the opportunity.
       
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    7. patorjk
      No Mood

      patorjk Member Benefactor

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Several reasons
      Otonomy released an SEC form today that detailed how they're selling off their assets. Here's the info related to OTO-413:
      • On January 23, 2023, Otonomy entered into an asset purchase agreement with Spiral Therapeutics Inc. (“Spiral”) pursuant to which Otonomy agreed to sell and assign to Spiral (a) data related to OTO-104 (also known as OTIVIDEX), a sustained-exposure formulation of dexamethasone, (b) patent rights, data and know-how related to OTO-510, an otoprotectant, and (c) data and inventory related to OTO-413, a sustained-exposure formulation of BDNF, and all related rights and causes of action with respect to such assets. In exchange for assigning these assets to Spiral, Spiral agreed to pay Otonomy a one-time payment of two hundred fifty thousand dollars ($250,000). The parties agreed that stockholder approval of the dissolution of Otonomy is a closing condition of this asset purchase agreement.
      • On January 23, 2023, Otonomy entered into an asset purchase agreement with Dompé farmaceutici S.p.A. (“Dompé”) pursuant to which Otonomy agreed to sell and assign to Dompé certain patents and patent applications related to Otonomy’s OTO-413 program and related rights and any causes of action to enforce such transferred patents. In exchange for assigning these patent rights to Dompé, Dompé agreed to pay Otonomy a one-time payment of one hundred fifty-six thousand dollars ($156,000). The parties agreed that filing a Certificate of Dissolution with the Secretary of State of the State of Delaware is a closing condition of this asset purchase agreement.

      I'm not sure I understand the difference between what Dompé bought and what Spiral Therapeutics bought. Spiral seems to have had a lot of overlap with Otonomy though, so it makes sense that they'd want their assets. However, the fact this stuff sold for so cheap means it's probably viewed as not very valuable.

      Interestingly Otonomy's gene therapy drug (OTO-825) netted them the most money ($5 million). I don't know a whole lot about it other than it's related to the GJB2 gene and that Decibel Therapeutics and Akouos are also is working on drugs for it.
       
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    8. KoolKat

      KoolKat Member

      Location:
      USA
      Tinnitus Since:
      2013
      Cause of Tinnitus:
      HeadPhones/ Noise induced
      So that's it, huh. The Otonomy chapter is officially closed for good. Wow. Feels sad. I always thought this would be the company to save us...
       
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    9. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      This honestly seems about right in terms of sale price. Consider what an asset pricing sheet for the patents / know-how would look like. They have zero projected return, since no market value was established. And, since the work is incomplete because they're selling mid-trial, more expenses/investment is needed to make any of these patents (products) marketable. I have seen sales in tech/manufacturing for patents (batteries, chip designs, mechanical designs) that end up going for $1, because the forecasted liabilities are so high to get the stuff tested and validated.
       
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    10. Jupiterman

      Jupiterman Member

      Tinnitus Since:
      04/2022
      Cause of Tinnitus:
      Sudden loud noise
      $156k

      If this wasn’t so serious, I'd be laughing.

      All these years of research and hope, and this is what it comes down to, an amount that would struggle to buy a decent apartment?

      Embarrassing for Otonomy, heartbreaking for us.

      The glimmer of hope is that these new acquirers somehow enhance the OTO-413 formula to make it work.

      It's down, but not out.
       
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    11. Jonno02
      Wishful

      Jonno02 Member Benefactor

      Tinnitus Since:
      2022
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      Loud music / ETD
      The chapter is over but the book isn’t finished. Their work may be continued on and something may still come of it.
       
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    12. PastryBear

      PastryBear Member

      Tinnitus Since:
      2007
      Cause of Tinnitus:
      GJB2
      Same, especially OTO-825 :')
       
    13. patorjk
      No Mood

      patorjk Member Benefactor

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Several reasons
      OTO-825 was picked up by Prevail Therapeutics, which is an affiliate of Eil Lilly:

      On January 27, 2023, Otonomy entered into an asset purchase agreement with Prevail Therapeutics Inc., an affiliate of Eli Lilly and Company (“Prevail”), pursuant to which Otonomy agreed to sell and assign to Prevail certain patent rights, data, know-how, regulatory filings, inventory and contracts in connection with Otonomy’s GJB2 gene therapy product, OTO-825. In exchange for assigning these assets to Prevail, Prevail agreed to pay Otonomy a one-time payment of five million dollars ($5,000,000). Prevail further agreed to assume certain liabilities of Otonomy related to the transferred assets. The parties agreed that, among other things, filing a Certificate of Dissolution with the Secretary of State of the State of Delaware is a closing condition of this asset purchase agreement. On January 27, 2023, Otonomy also agreed to terminate its collaboration agreement with Applied Genetic Technologies Corporation (“AGTC”) related to OTO-825 and to acquire AGTC’s rights in certain data, know-how, patent rights and inventory, which will be included in the assets Otonomy has agreed to assign to Prevail. The termination of the collaboration agreement with AGTC and AGTC’s assignment of certain assets to Otonomy will become effective immediately prior to the closing of the asset purchase agreement between Otonomy and Prevail and in consideration for such termination and assignment by AGTC, Otonomy has agreed to make a one-time payment to AGTC of approximately one million one hundred fifty thousand dollars ($1,150,000) on the closing of the asset purchase agreement between Otonomy and Prevail.​

      OTO-825 was originally a partnered program between Otonomy and AGTC, but apparently now it's going to solely under Eli Lilly. What makes this very interesting is that Eli Lilly bought Akouos a few months ago. Akouos is a small gene therapy hearing biotech, and they are working on their own drug which would be a competitor to OTO-825.

      The parts of Otonomy's pipeline that weren't picked up were OTO-313 (tinnitus) and OTO-6XX (hair cell regeneration/repair). I'm a little surprised by OTO-6XX, but now I wonder if they just didn't have anything substantial after the hair cell regeneration stuff fell apart.
       
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    14. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

      Location:
      Prison
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      -
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      -
      Who exactly is going to perform the OTO-413 trials if they were to restart it, Spiral Therapeutics or Dompé?
       
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    15. Artemis2K
      Kick ass

      Artemis2K Member Benefactor

      Location:
      South Carolina
      Tinnitus Since:
      2012
      Cause of Tinnitus:
      I had tinnitus for as long as I can remember. Got bad later.
      I want to say Spiral Therapeutics since they paid more, but I'm confused too.
       
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    16. tomytl
      Grumpy

      tomytl Member Benefactor

      Tinnitus Since:
      10 Years
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      unknown
      I'm really not sure anymore but I thought OTO-6XX was licensed from Quark Pharmaceuticals.

      They had some hair cell regeneration preclinical candidate called QP-HL3.

      Quark Pharmaceuticals - Pipeline (archive.org)

      Quark Pharmaceuticals also closed. But if you google QP-HL3 you can find a test site (in the URL it says "pipeline-2-test"), which looks like the old Quark Pharmaceuticals site:

      Pipeline – Lepton Pharmaceuticals

      Looks like Lepton Pharmaceuticals doesn't really have QP-HL3 in their portfolio for now.

      Like I said, it's all speculation.
       
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    17. patorjk
      No Mood

      patorjk Member Benefactor

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Several reasons
      OTO-6XX was initially a joint program with Kyorin. Otonomy paid them $1M for a compound that regenerated hair cells in a preclincial model. However, further preclincial work didn't pan out. They then pivoted to hair cell repair. This was what they were working on prior to the company closing.
       
    18. tomytl
      Grumpy

      tomytl Member Benefactor

      Tinnitus Since:
      10 Years
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      unknown
      OK, so I was wrong.
       
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