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Windtree Therapeutics, Inc. (NASDAQ: WINT) is a biotechnology company developing treatments for severe cardiovascular disorders. It is targeting patients with acute heart failure (AHF) and cardiogenic shock (CS), as heart failure remains one of the leading causes of death in America.

Windtree’s leading drug product candidate is istaroxime, a first-in-class treatment that is being developed for indications in AHF and cardiogenic shock. The company has already successfully completed three positive phase 2 trials for istaroxime and is advancing to the next stage of development.

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Transcript
00:00 (upbeat music)
00:02 - Hello, I'm Eric Curtis,
00:03 Chief Operating Officer at Wintry Therapeutics.
00:06 Wintry is a biotechnology company
00:08 focused upon late stage interventions
00:11 in cardiovascular disease
00:13 for patients in their moment of crisis.
00:15 And our NASDAQ symbol is W-I-N-T.
00:18 And we have a franchise of drug candidates
00:21 focused upon something called CERCA 2A activation.
00:25 Now what is CERCA 2A and why is it important?
00:28 Well, CERCA 2A is a drug development target
00:30 and it's involved in the regulation of the relaxation
00:35 and the contraction of the heart.
00:38 And when you get these two functions
00:40 working together properly,
00:42 you can get improvement in pump function.
00:45 And that's important in a disease state
00:47 called heart failure.
00:48 And so at Wintry, we're very interested in heart failure
00:51 and simply defined heart failure means
00:53 that the blood is not being pumped properly by the heart
00:56 in order to have the body function the way that it needs to.
01:00 And so when you think about heart failure,
01:02 many of you may have had perhaps a grandparent
01:04 or an older relative that had heart failure.
01:07 It's very common throughout the world.
01:09 There are millions of patients that have heart failure.
01:12 And as you think about the way
01:15 that the heart failure progresses,
01:17 sometimes it can become acute.
01:20 And that means that the patient's symptoms
01:22 have become so bad that they need to be treated
01:25 at the hospital, oftentimes rushed to the hospital
01:28 because when fluid builds up in the lungs,
01:31 because there's not good blood flow and functional heart
01:33 having an effective way that pumps blood,
01:36 this fluid can build up in the lungs
01:38 and it causes a very difficult way to breathe.
01:41 So patients get rushed to the hospital
01:43 and it's an urgent situation, it's an acute heart failure.
01:46 And what we see here with our drug candidates
01:49 is great potential to treat acute heart failure.
01:51 I'm gonna tell you about our two classes
01:54 of drug candidates now.
01:56 And the first one is,
01:58 the whole entire class is called circuit to a activators.
02:01 And the first class of those circuit to activators
02:03 is called the dual mechanism circuit to a activators.
02:07 And those two mechanisms of action are,
02:09 the first one is that the drug candidate
02:12 works upon the strength of the contraction
02:15 or the beating of the heart to strengthen that,
02:17 which is very useful when you have heart failure
02:19 because your blood's not pumping effectively.
02:22 And the second mechanism, which is very crucial,
02:25 is the circuit to a targeting.
02:27 And in this situation, what it does is it,
02:30 the circuit to a relaxes the ventricles of the heart
02:34 or the filling chambers of the heart.
02:36 So that in between heartbeats,
02:38 they can more completely fill with blood.
02:40 And so when the strength of the contraction comes
02:42 and you have a full ventricle,
02:44 this is a way that a optimal heart can function
02:47 and pump function improves,
02:48 thereby helping to improve a heart failure itself.
02:52 And so we have this dual mechanism at work
02:55 and with a circuit to activator.
02:57 And what we envision for the development plan
03:01 is for the inpatient or the acute heart failure patient
03:06 to be treated with an intravenous or an IV formulation
03:10 of the dual mechanism circuit to a activator.
03:13 And when they become stable
03:14 over the course of some period of time,
03:17 number of hours, or perhaps a couple of days,
03:19 they become stable
03:20 in the inpatient hospitalized environment.
03:23 And then they become ready a couple of days after that
03:26 to be discharged from the hospital.
03:28 They could be discharged on a chronic oral formulation
03:32 of the dual mechanism circuit to a activator as well.
03:35 And this would help to keep them out of the hospital
03:37 returning back to the hospital over time.
03:39 So we think there's a very nice development
03:42 and opportunity here
03:44 for the dual mechanism circuit to a activators
03:46 to be utilized.
03:48 Now here's where the story
03:50 becomes even more interesting though,
03:51 because we have a lead candidate here,
03:55 drug candidate at Wintry called Istiroxime.
03:59 I'll call it ISTA for short.
04:00 ISTA has been through three successful,
04:03 positive phase two clinical trials,
04:07 two in acute heart failure
04:08 and one in something called cardiogenic shock,
04:11 which is just a more severe presentation of heart failure.
04:15 Now ISTA has very similar mechanisms of action
04:20 to the dual mechanism circuit to a activators.
04:23 And so why that's so intriguing
04:25 is because one can view
04:28 the dual mechanism circuit to a activators
04:30 as a potential fast follow on to Istiroxime.
04:35 So what that means is,
04:37 if Istiroxime becomes an approved drug
04:40 through the course of its drug development
04:41 and success, what becomes approved,
04:44 that the dual mechanism circuit to activators
04:46 could learn from those experiences with Istiroxime,
04:51 undergo the same similar type clinical trials,
04:54 but quicker and faster and potentially less expensive
04:58 because of the learnings
04:59 and move through those clinical trials
05:01 to a way to be able to replace Istiroxime eventually.
05:05 And again, with even a more fresh patent life,
05:08 intellectual property life behind it.
05:11 So this could be a very attractive way to think about
05:14 a portfolio of products that we have.
05:17 And so now that I've mentioned intellectual property,
05:20 let me update you on the dual mechanism
05:22 of circuit to activators on that.
05:23 The composition of matter patent
05:25 has been granted by the European Union,
05:28 and there's a notice of allowance from the USPTO
05:31 on its composition of matter as well.
05:33 So very good news there,
05:35 and we'll continue to keep you updated on that.
05:37 Now let me transition to the second family
05:40 or second group of circuit to activators
05:42 we have at Wintry.
05:43 They're called the pure circuit to activators.
05:46 Well, these have a single mechanism of action,
05:49 and it's the circuit to a activator target
05:52 that I was mentioning,
05:52 similar to what I was mentioning before
05:54 with the dual mechanism.
05:56 It's that targeting of the ventricles of the heart
05:59 for the relaxation to more completely fill with blood
06:02 so you get a better, more efficient working heart.
06:05 This time in chronic heart failure,
06:07 this would be the target.
06:09 And so in chronic heart failure,
06:11 there is a type of disease
06:15 called heart failure with preserved ejection fraction,
06:18 which is very much underserved.
06:21 And this would be the target
06:22 for the pure circuit to activators in development.
06:25 And the reason why it's underserved
06:28 is there just hasn't been any new drugs
06:30 that have been successfully developed here
06:31 in many, many years.
06:33 And even though it's a big portion,
06:35 a big percentage of the heart failure population,
06:37 just hasn't seen innovation.
06:39 But we think that pure circuit to a's
06:41 could really make a difference here.
06:43 So that'll be one of the areas of focus that we have.
06:46 And on the intellectual property side
06:48 with the pure circuit to a activators,
06:50 all the composition matter patents have been filed
06:52 with the regulatory authorities around the world.
06:55 And that process is ongoing.
06:57 So we'll keep you updated there.
06:58 You can go to our website to get more information,
07:01 www.WintreeTX.com
07:05 and view our public filings there as well.
07:07 Been great speaking to you.
07:08 Thank you.
07:09 (upbeat music)
07:12 (upbeat music)
07:14 (upbeat music)

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