00:00 (upbeat music)
00:01 - Hey everyone, it's Jordan Robertson with Benzinga,
00:03 and today I'm here with CEO Kabir Nath,
00:05 and SVP of Patient Access and Medical Affairs,
00:07 Steve Levine of Compass Pathways.
00:09 How are you guys?
00:10 - Good, thanks.
00:11 Nice to see you, Jordan.
00:12 - You too, thank you.
00:13 - Nice to see you as well.
00:14 Can you introduce yourselves
00:15 and give us a quick intro into what Compass does?
00:18 - Sure, I'm Kabir Nath.
00:19 I'm the CEO of Compass Pathways,
00:21 and just coming up to celebrating a year in that role.
00:24 - And I'm Steve Levine.
00:25 I am Senior Vice President
00:27 of Patient Access and Medical Affairs,
00:29 and I've been with Compass for three years now.
00:31 - Amazing, and Kabir, can you tell us a little bit
00:33 about what you do at Compass, or what Compass does?
00:36 - Absolutely.
00:37 Compass Pathways is a biotechnology company
00:40 that is devoted to generating evidence
00:44 for new innovations, for innovative patterns of care,
00:47 for treatment of serious mental illness.
00:49 And our first program is COMP360,
00:52 psilocybin therapy for the treatment
00:54 of treatment-resistant depression,
00:55 which is our primary focus right now.
00:57 - Steve, tell us about this new CPT-3 code
01:00 and why is it important?
01:01 - Very happy to.
01:02 The CPT-3 code is a form of reimbursement code
01:07 that really is a key milestone along the path
01:09 to trying to create equitable and broad patient access
01:13 to psychedelic treatment, should they be approved.
01:15 - Wonderful, and Kabir,
01:16 how does this fit into Compass's core mission?
01:18 - So right from the start,
01:20 Compass has been founded with a mission
01:22 of bringing access to as many patients as possible
01:26 for innovative treatments.
01:27 And therefore, it's essential for us
01:30 that we work within the system to generate evidence,
01:33 to get to an FDA approval,
01:35 but then beyond that, are able, through reimbursement,
01:38 to ensure that it's available to as many patients
01:40 as quickly as possible.
01:42 The other part I'd say is,
01:44 we have always been looking to the long-term goal of that,
01:48 and that's why we have done this work so far in advance,
01:51 to enable us really to work with providers
01:55 using that CPT-3 code,
01:56 so that by the time we potentially get to market,
01:59 if we're approved, the infrastructure and the ability
02:01 for that reimbursement is already in place.
02:04 - And Steve, how about you?
02:05 What's your take?
02:06 - Building on Kabir's point,
02:07 there are urgent needs that patients suffering
02:11 with severe mental illness are facing right now.
02:13 And as our mission is to accelerate that patient access,
02:17 creating the reimbursement framework
02:19 as early as possible means that as soon as possible,
02:22 post a regulatory approval,
02:24 we can ensure that the patients that are waiting
02:26 will receive the care that they so desperately need.
02:28 - Absolutely.
02:29 And Kabir, can you update us on your development program?
02:32 - Sure.
02:33 So our principal focus right now is our Phase III program
02:36 for treatment-resistant depression.
02:38 And there we have two pivotal Phase III trials
02:40 that are now underway.
02:42 In addition, we have a Phase II program,
02:45 proof of concept in anorexia nervosa,
02:48 and a Phase II program in PTSD,
02:51 a smaller program of 20 patients.
02:53 In addition, as a reminder,
02:55 we generated very robust data from a Phase IIB program
02:59 in treatment-resistant depression
03:01 that was published in the New England
03:02 Journal of Medicine last year.
03:04 And we also have a number of investigator-initiated studies
03:07 in areas like bipolar II, anorexia nervosa,
03:12 body dysmorphic disorder that are all building
03:14 to the body of evidence for COM 360 psilocybin therapy.
03:18 But our principal focus, as I say,
03:20 is the Phase III program in treatment-resistant depression.
03:23 And both of those pivotal trials are now underway.
03:26 - Wonderful.
03:27 And Steve, why is the CPT-3 code so important?
03:29 - CPT-3 codes as one type of CPT code.
03:33 And to define that,
03:34 those are current procedural terminology codes.
03:37 This is the system of codes used to describe procedures
03:42 and services reported by healthcare providers
03:45 to health insurance payers
03:47 in order to be reimbursed for their services.
03:50 Category III codes are a preliminary step
03:53 in order to track the delivery of new services
03:57 so that the work involved in delivering them
03:59 can be adequately described and understood
04:02 and ultimately adequately valued
04:04 with permanent Category I CPT codes.
04:07 - And just to add,
04:08 I think the reason this is so critical to us
04:10 is we recognize that for patients to be able to benefit
04:15 at scale from COM 360 psilocybin therapy,
04:18 it's essential not only that the drug is reimbursed,
04:21 which is work we will undertake,
04:23 but that also the provision of support,
04:25 psychological support during treatment is also reimbursed.
04:28 And we recognized early on
04:31 that it was incumbent upon us, Compass,
04:33 to ensure that that could happen.
04:35 - Absolutely.
04:36 Well, thank you guys so much for being here today.
04:37 That's all I have.
04:38 - Thanks, Jordan.
04:39 - Thank you, Jordan.
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