Unveiling The Potential Of Istaroxime W/ Windtree Therapeutics' SEISMiC Extension Study

Benzinga

Craig Fraser, CEO of Windtree Therapeutics, Inc., was recently interviewed by Benzinga.  Windtree is advancing late-stage interventions for cardiovascular disorders to treat patients in moments of crisis.   Using new scientific and clinical approaches, Windtree is developing a multi-asset franchise anchored around compounds with the ability to activate SERCA2a, which is critical in patients experiencing acute cardiac events. Its lead candidate, istaroxime, is being developed as a first-in-class treatment for cardiogenic shock and acute heart failure.   Mr. Frasier discussed his company’s recent deal with Lee’s Pharmaceuticals which will help Windtree to develop and commercialize its therapies.

Transcript

00:00 Welcome it's Michael Murray with Benzinga sitting down today with Craig Frazier from

00:06 Wintree Therapeutics. We're discussing the regional licensing deal for Istiroxime and

00:10 the dual mechanism circa 2a activators and some of the other things they're doing in

00:14 the greater China region. Craig, it's an absolute pleasure to have you with us. Appreciate you

00:18 sitting down with us as always and taking the time for what we're sure is a very busy

00:21 season. How are you doing?

00:23 Very happy to. Thanks, Michael.

00:25 It's our pleasure, Craig. Thank you for being here. And to set the scene and jump right

00:28 into it, can you briefly describe this agreement that we talked about in the intro here and

00:32 what it provides for Wintree Therapeutics?

00:35 So the agreement is a deal that's worth up to about $138 million in value. That includes

00:43 various milestones as well as having on top of that up to double digit royalty. Within

00:50 that about $100 million of that is specifically related to the programs and so forth that

00:56 we have focused on heart failure. Also within there is about a little over $3 million that

01:03 that's much earlier pre-development and so forth slash up front type of type of payments

01:08 as well embedded within that. The deal itself covers our lead asset Istiroxime or Ista for

01:16 short, as well as the next generation, what we call circa 2a activators that while Ista

01:24 is an IV for hospitalized patients, the next gen products building on that novel mechanism

01:30 also have oral bioavailability. So they would they would tap into the chronic heart failure

01:35 markets as well. And of course, the deal covers for all costs of development, regulatory costs,

01:43 commercialization costs, manufacturing and so forth, which is a big deal for us as well.

01:49 And they're a portion of the global work when we're operating there also. And we'll work

01:54 together through typical governance committees, which we does have a final say with regard

01:59 to protocols and so forth. But they're a great partner and we're looking forward to fast

02:07 forwarding a lot of development because of because of this deal.

02:11 Terrific. Now, Craig, can you describe the drugs and the target indications that are

02:14 included in this agreement as well for some more context here?

02:17 Yeah. So I mentioned this, our lead asset is the Roxane has been under development initially

02:25 for people hospitalized due to their heart failure, what we call acute heart failure.

02:31 And more recently for the most severe manifestation of heart failure, something called cardiogenic

02:39 shock. And it has three positive phase two, two and heart failure and more recently, cardiogenic

02:46 shock. It's been dosed in over about 300 patients in these phase two studied and more more than

02:53 that. And it's just been producing a really attractive, positive, very consistent profile

03:02 across many, many measures of people in the hospital and moments of crisis and critical

03:07 care because of a of a failing heart. We have a fast track designation from the FDA for

03:13 heart failure and cardiogenic shock. And when we met with the FDA kind of coming out of

03:18 those meetings, we discovered that we study in cardiogenic shock. There's a pathway that

03:24 can be faster and cheaper. And now with this positive data, we as a company, Wintry, have

03:31 jumped all over that as our lead indication, even though heart fires, this big, massive

03:36 market, it just takes a lot more money, a lot more capabilities and time. And cardiogenic

03:42 shock can move fast and cheap and a super attractive. So and I'll come back to it. That's

03:47 what this deal enables us to tap into and do both. But heart fire is a condition where

03:55 about eight million people in the US have it. We probably have all had relatives with

03:59 heart failure where the heart just cannot meet the body's demands. It's not strong enough,

04:03 squeezing well enough and so forth. And when they come into the hospital, it's the number

04:09 one reason for hospitalizations in the US and Europe, close to a million and a half

04:14 admissions per year. And they come in about one out of 12 of these people are going to

04:20 be going into cardiogenic shock where their heart is failing so much that their body's

04:25 not even adequately fusing and flow to vital organs like the brain and kidneys. That's

04:31 a medical emergency. You got to get blood pressure rapidly back up and flow to these

04:36 vital organs besides improving the function of the heart. So so we're studying and have

04:43 been studying in both of those areas, including shock, which has super high mortality, 30

04:50 to 40 percent in classic shock. And the deal itself also then covers our next generation

04:58 products that build on that circuit to a activation. That's the novel mechanism and ISTA that causes

05:05 greater relaxation and fill volumes of the heart with blood. And we build out a library

05:11 of compounds. It covers the the dual mechanism, fast follow on to ISTA. We have not in the

05:18 deal, but also these pure circuit to a activators. But they will have oral bioavailability to

05:24 access the outpatient chronic market. And we also have this this product that we're

05:31 not developing currently for genetically associated hypertension, Rasta-Faroxane that we have

05:36 in that deal. And we'll figure out if from what we're going to do with Rasta. So that's

05:42 the drugs. That's the areas of focus in this deal.

05:46 Excellent. Now, Craig, why regionally license these CVS in Asia now and why with Lee specifically?

05:52 That's a great question. You know, oftentimes companies have a decision to make about when

05:58 to do licensing. You know, do you do some regional licensing? Do you hold off to do

06:03 a global license? And clearly for us, as I've said publicly, you know, we're at a phase

06:09 with this, the Roxium in particular, where we're doing the wrap up work. We got two ongoing

06:15 studies right now that you read out here and about two quarters that are that are going

06:20 to put us in phase three readiness, bridging us to phase three. And we have optionality

06:25 to do a big global deal, monetize this whole multi-asset platform or go run phase three

06:30 ourselves for the US and regionalize it. But, you know, China is really unique. It's a very

06:37 unique market. One, it is the largest market for arguably for heart failure and patients

06:43 and so forth. And it's a market where in my experience over the last 34 years, including

06:49 being in really big companies like J&J and Pfizer, where it's where it's great to have

06:54 a local partner who can execute within there. And then we're in a really unique position

07:01 with this to Roxium because we already have a positive phase to be in heart failure in

07:07 Chinese patients and an open IND there. It's so happened that our partner, Lease, is a

07:16 manufacturer as well and a CRO that's been involved in supporting ISTA Roxy. So we had

07:23 a highly capable revenue producing bigger company and Lease. That's a partner that we

07:28 know with a very unique ready to go position in a very unique market like China where Lease

07:36 can get started right into phase three for acute heart fire is what they believe and

07:42 we believe in their plan. So they said, look, while you're doing global shock, we'll get

07:48 started with heart fire. We'll start putting money at this and the circuit to ace. So this

07:53 strengthens the program. It accelerates the program, opens up another front of development,

07:58 heart failure and strengthens our balance sheet and even increases the attractiveness

08:03 of the company by having a lot more deliverables and activity and news potential for for value

08:10 creation or if we do even strategic partnerships with other companies.

08:15 Absolutely. And then finally, even though you've given us context up until this point

08:19 to, can you give us a final recap and larger view here as to why this is a significant

08:23 event for Wintry?

08:24 Yeah, thank you. You know, I believe that it's validating, right? It's validating of

08:31 the very significant opportunity. We know the market opportunities, not other things

08:35 in development. You know, everybody's starting to look back to cardiovascular. That's been

08:40 a general theme in our industry lately. But it's validating of not just the opportunity,

08:44 but the quality of our data. That's what we believe in and our partner believes. The other

08:50 thing is, when you're a small company, it's really good to have somebody else in the boat.

08:56 It just especially these days in the boat with you, partner contributing, contributing

09:02 financially, contributing in the mission capabilities for sure. So so we've gained that as well.

09:09 And I think that's really important to not just be 100% on your own, but be able to have

09:15 that that that bigger brother, if you will. That's that's also part of the whole thing.

09:20 And like I said a moment ago, this does accelerate when you look at our plan, this would accelerate

09:26 development, open up another front and give us more opportunity for value creation. So

09:32 so we're excited about this news. And and I recommend, by the way, people please look

09:38 at our public filings, go to our website, www.WintreeTX.com to learn more. And we have

09:47 a lot of activity going on that we look forward to keeping everybody updated on. It's going

09:51 to be a busy couple quarters.

09:53 Amazing. Craig, can't thank you enough for joining us here today. You and the Wintree

09:57 team always welcome on the Benzinga Network. Thank you so much for joining us and sharing

10:01 what's going on with the company and what we can expect to see next.

10:04 Thank you very much. Everybody have a good day.

10:07 [Music]

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