Serafina:  Hi I’m Serafina and we’re coming at you from Angel MD’s Alpha Conference over in Napa, California.  I’m joined today by Dr. Ben Shapiro, CEO of Otomagnetics.  Thank you so much for being with us today.

Ben: My pleasure, thank you.

Serafina:  I’m looking forward to hearing all about it.

Ben:  Thank you.

Serafina:  So let’s start from the top; tell me about how this technology was born out of your lab.

Ben:  So we have a lab that can magnetically manipulate therapy; we can use magnetic fields to put the therapy in the right place on the body.  And we got phone calls from clinicians essentially asking can you deliver the therapy to the inner ear?  Can you deliver it to the eye?  So it really was a clinical need that was communicated and that we responded to by creating this.

Serafina:  So the need preceded the technology.

Ben:  Exacly.

Serafina:  That’s interesting.  What was the technology being used with before?  I take it these are spot on super magnetic.

Ben:  In the field these magnetic nanoparticles have been used systemically.  In the first clinical trials they were done with something like this: the entire patient would get the magnetic nanoparticles and then they would hold a magnet near a tumor and then kind of focus the therapy to the tumor.  So it was appropriate for inoperable, shallow tumors and the entire patient would be getting loaded with chemotherapy with magnetic nanoparticles and we turned that around.  So what we did is now we have a topical therapy where we have it close to the target on the surface of the eye or in the ear canal, just a little tiny amount close to where it needs to go, and then we can magnetically inject; we can magnetically deliver.

Serafina:  That’s awesome.  So you’re changing the paradigm of drug delivery here.

Ben:  Exactly.

Serafina:  So in the past were these medicines being injected into the body parts?  Was it systemic?  What are we talking about here?

Ben:  Depends on the indication, right?  It depends on the indication.  So for example patients with macular degeneration get monthly needle injections into the eye which not something that people like obviously.

Serafina:  Not particularly, no.

Ben:  Not typically right?  It can be something painful and unpleasant.  And then for middle ear infections, kids who have recurrent and chronic ear infections get a surgery under general anesthesia and they get a tube put in.  For the cochlear it’s very hard to reach so those patients have a trans tympanic procedure it’s called, or inter tympanic procedure, and it’s not very effective, not enough drug goes in.  So depending on the indication there’s different reasons why it doesn’t work or what they do or why it’s invasive and so we’ve picked the ones that have the biggest unmet need where we’re like okay, we can now deliver this non-invasively, easily, rapidly and have the therapy have a therapeutic effect in a non-invasive way.

Serafina:  Got it.  So there’s obviously lots of different indications for this therapy, where are you focusing your efforts now?

Ben:  We’re starting with the middle ear and the inner ear first.  So for a child middle ear infections, for chronic and recurrent middle ear infections, and for the inner ear we have a fairly large NIH contract where it’s for kids and adults who are about to get chemotherapy – so carboplatin chemo – and that is known to cause hearing loss, so we can protect against that.  And so those are the two indications for the ear and then for the eye we have pharma companies that are interested in delivering their therapies into the eye but without sticking a needle.

Serafina:  And we’ll get back to that because I’ve noticed you have support all across the board; we’ve got big pharma, NIH, FDA so we’ll come back to that.  So does this completely negate the use of Tympanostomy tubes – very invasive – or is this a combination of things.

Ben:  I think you want to be thoughtful about how you address the need of the patients.  So a Tympanostomy tube is a surgical treatment for a child that has essentially an ear infection and so we would want to clear those ear infections but if some patients don’t respond we still have the option of doing the Tympanostomy tube.

Serafina:  Got it.

Ben:  So basically we want to stay in front of Tympanostomy tubes and reduce the number.  So we’re not going to say every single patient would no longer need a Tympanostomy tube ever, but if we can reduce the number of patients who are getting a surgery under general anesthesia for kids – young kids – the infection is the size of a quarter of my fingernail and getting general anesthesia, it’s crazy actually.

Serafina:  There’s a reduction of pain value and then also there’s a huge cost savings associated with this technology as well.

Ben:  Yes there will be a cost savings, there’s pain; the tubes that are in the eardrum they reduce hearing, they can damage hearing over time.

Serafina:  The quality of life factor.

Ben:  If you’re a parent that’s not what you want to hear.

Serafina:  So now let’s get back to the wide scale support.  When was your first interaction with pharma?  I’ve noticed – and if you don’t mind me saying this – Pfizer, big pharma, is a huge supporter of this technology.  How did that initiate?

Ben:  I think the pharma companies are very sophisticated.  They recognize that if you can improve the patient experience, if you can reduce the invasiveness of something, if you can deliver it to a new target, that that would improve their ability to treat patients.  It would improve their ability to market their products to new classes.  Basically the conversation with pharma is you have compounds and we can deliver them to new targets or take a delivery that is currently invasive and make it noninvasive and therefore give them a competitive edge over the other pharma company that is still using needles for the eye.

Serafina:  So you’re saying and I’m hearing patient-centered design is really what’s going to take pharma one step further.

Ben:  Right, right.

Serafina:  And as it should be.

Ben:  Right, exactly, right.  So we’ve had all these talks about if you can focus on the patient and deal with the patient needs then everything else kind of lines up, that’s obviously the right way to view it, to think about it, and to focus on doing it.

Serafina:  This technology was born out of your lab so were you looking into venturing into this marketplace as an innovator, as an inventor of a drug delivery system?

Ben:  It’s a funny story.  So my lab had been doing a lot of – we started out sort of as a pure bio-engineering lab and were doing a lot of work and then we got very good at manipulating cells and just very good at placing things in the right place.  And at some point we kind of had the thought of this is for chemo and for eye diseases and ear diseases and just being able to put the therapy in the right place.  And so we got into this magnetic drug targeting field years back and then started leading it – being one of the leading groups – and then that was off in the clinicians and collaborators contacting us and saying well we’ve seen your nice results in XYZ, can you do ABC?

Serafina:  Everything lined up.

Ben:  Right.  And so that’s nice because then I’m not coming up with an answer – we’re not coming up with a hammer and going around looking for a bunch of nails, right?  We have people coming to us and saying here’s a problem – there’s a real patient need – can you fill this gap?  And that’s just a much more satisfying place to be.

Serafina:  So what are your targets for 2018?

Ben:  We’re going in, we’re going to get the results that we need.  We’re going to continue with our safety program, we’re going to continue with our pre-clinical and clinical program.  We’re going to have continued conversations with the FDA.  The goal is to go through the scientific and regulatory and business milestones that we need to get this to patients as quickly as we can.  And Angel MD has been fantastic in helping with that, not only from the point of view of support from an investment point of view, but this network of clinicians that they have – just in the room next door you meet new people like can you do this and we have advice on this and we’ve thought about this.  You guys know this, it’s not just the investor support, it’s also the expertise that gets provided.

Serafina:  Well thank you so much Dr. Shaprio.

Ben:  My pleasure.

Serafina:  I really enjoyed connecting with you and I’m sure we’ll hear more about Otomagnetics in the future.  Once again that was Dr. Shapiro from Alpha Conference.  Thank you so much.

Ben:  Thank you.