Good morning, ladies and gentlemen, and welcome to the Palatin Technologies First Quarter Fiscal Year 2018 Update Call. As a reminder, this conference is being recorded. Before we begin our remarks, I would like to remind you that statements made by Palatin that are not historical facts may be forward-looking statements. These statements are based on assumptions that may or may not prove to be accurate and actual results could differ materially from those anticipated due to a variety of risks and uncertainties discussed in the Company’s most recent filings with the Securities and Exchange Commission. Please consider such risks and uncertainties carefully in evaluating these forward-looking statements and Palatin’s prospects. Now I’d like to introduce your host for today, Dr. Carl Spana, President and Chief Executive Officer of Palatin Technologies. Please go ahead, sir.

Good morning, and welcome to the Palatin Technologies first quarter fiscal year 2018 call. I’m Dr. Carl Spana, CEO and President of Palatin; with me on the call today is Steve Wills, Palatin’s Executive Vice President, Chief Financial Officer and Chief Operating Officer. On today’s call, we will provide financial and operating updates. I’m now going to turn the call over to Steve, who’ll provide the financial updates. Steve?

Thank you, Carl, and good morning, everyone. Starting with the first quarter ended September 30, 2017, significant and recent highlights include: On September 6, 2017, we announced the signing of a collaboration and license agreement with Fosun Pharma for exclusive rights to develop and commercialize bremelanotide in the territories of mainland China, Taiwan, Hong Kong and Macau. Under the terms in the agreement, we received $4.5 million in October, consisting of an upfront payment of $5 million, less $500,000, which was withheld in accordance with tax withholding requirements in China. Fosun is also required to pay us a $7.5 million milestone, based on regularly approval in China, and up to $92.5 million in sales-related milestones, plus Fosun is also obligated to pay us tiered royalties on annual net sales, ranging from high-single digit to low-double digit royalties. All development, regulatory, sales, marketing and commercial activities and associated cost in the license territory will be the sole responsibility of Fosun. We continue to work closely with AMAG, on completing the tasks and activities necessary to file a New Drug Application, an NDA, with the Food and Drug Administration, the FDA. Filing the NDA with the FDA is targeted for the first quarter of calendar year 2018. Getting into our operating results, regarding the first quarter fiscal year 2018 financial results, Palatin reported net income of $10.6 million or $0.05 per basic and diluted share, for the quarter ended September 30, 2017, compared to a net loss of $13.1 million or $0.08 per basic and diluted share for the same period in 2016. The difference in financial results between the three months ended September 30, 2017, and 2016, was primarily attributable to the recognition of $26.9 million in license and contract revenue during the 2017 period, pursuant to our license agreements with…

Thank you, Steve. I will start our first quarter fiscal year 2018 operational update with bremelanotide and then cover our pipeline programs. In the past quarter, we completed all remaining clinical activities at a very productive pre-NDA meeting with the Division of Bone, Reproductive, and Urologic Products of the FDA. We are now working with AMAG Pharmaceuticals, our North American licensing partner, to complete the New Drug Application for bremelanotide and we anticipate filing with the NDA in the first quarter of calendar 2018. Our development of bremelanotide outside of the North American market will only be done in the context of a partnership. Last quarter, we closed a licensing deal with Fosun Pharmaceuticals, granting them exclusive rights to bremelanotide in the China territory. We are working with Fosun to support the bremelanotide development and regulatory activities. We have ongoing discussions with multiple potential partners from multiple territories, anticipate closing of an additional licensing transaction by calendar year-end 2017, and others in the first half of calendar year 2018. Palatin’s other drug development efforts are primarily focused on our natriuretic peptide program, for cardiovascular and fibrotic diseases, and our melanocortin autoimmune and anti-inflammatory disease program. Regarding our melanocortin obesity and diabetes program, we are reviewing of our development and business development strategy, including assessing the pursuit of humans for rare genetic deficiencies resulting in life-threatening metabolic disorders in orphan drug designations. Our website, www.palatin.com, has detailed descriptions of our development programs including mechanisms of actions, supporting science and commercial potential. So on today’s call, I will only provide a brief update. Heart failure fibrotic diseases remain major health problems in need of new treatments. We have developed multiple compounds that regulate the natriuretic peptide system, that can address these indications. PL-3994 is a selective agonist at the natriuretic peptide A…

Thank you. [Operator Instructions] And we’ll take our first question from John Newman with Canaccord.

Hi, guys. Good morning, thanks for providing all the information today and the update. I’m wondering, if you can talk about your launch plans for bremelanotide next year. I know that you’ll be submitting the filing in early 2018. But you’ll have some time, obviously, to continue to prep the market before FDA approval. Just curious if you can talk about the type of things that should be focused on during that time? Thanks.

Sure. I’ll let Steve handle that one, since he’s working more closely with AMAG on that, because AMAG is really responsible for most of those activities. Steve?

Yes. Hi, John. As Carl mentioned, I mean, this is more AMAG show regarding the activities, preparatory to the launch and obviously the launch. What I can tell you right now, there is definitely an enhanced education and efficacy program going on at AMAG. That you can actually see with multiple third parties out there. No question, our priority is to get this NDA filing in, in the first quarter. Other items being done, say, behind the scenes are really moving forward and advancing the reimbursement landscape, and also the pricing. And just working with the patients, a nice way to coming attractions, and just make sure the patients, the many various health care providers are as educated and informed as possible for this treatment, when, as Carl mentioned earlier, we anticipate approval in the first quarter of calendar 2019.

Okay, great. Thanks. And maybe you can talk a little bit about the – what you’re looking to see in the Phase IIa trial or PL-3994, just the types of things that you’d like to see in order to give you confidence to continue to push that program forward?

Sure. Thanks, John. There are a number of things that we’re really looking to see. This is a IIa study, it’s in – importantly, it’s in patients that have preserved ejection fraction. And for those that aren’t aware, heart failure with preserved ejection fraction, as of today, has no FDA-approved product. So it really represents probably the largest untapped market in the heart failure space. So this is a study in which we are looking for really two types of parameters. It’s a single dosing study. So we’re looking for one, our effects on pulmonary capillary wedge pressure, and other hemodynamic properties that we can measure in the clinic setting. And secondarily, these patients will be having a cardiac biopsy. So what we’re looking forward there is clear evidence that in patients that have preserved ejection fraction, that the natriuretic peptide system is really functioning normally, i.e, that the compound gets in, it’s hitting its receptor and the cardiac tissue and that the downstream signaling pathways are all functioning in a normal way. That will give us a lot of confidence that we should be able to then treat these patients on a long-term basis and potentially have a positive outcome. So that’s really the two broad categories that we’re looking for data. So with that being said, it is kind of an interesting and important study, because again, there are no FDA-approved products for this patient population and we do think this mechanism has a lot of potential and we’ll get it very good look in these patients and get to really see that this system is working and has a potential to essentially impact their disease.

Great. Great, thank you. I’ll jump back in queue.

Great, thanks, John.

And we’ll take our next question from Michael Higgins with Roth Capital Partners.

Thanks, everybody. Good morning, guys. How are you?

Pretty well.

Good.

Couple of questions this morning if I could. First, as it relates to the regulatory views in the U.S. and Europe. I think you talked about the similarities, potential differences in what those two regulatory bodies are looking for? I think, you just, kind of, give us a summary of how that looks again? Thanks.

Sure. I’ll tell you. Look, the FDA has a very standard review process. We provided them with two placebo-controlled randomized trials to launch Phase III studies with identical protocols. Obviously, as we’ve reported, the FC data was outstanding. There was, both clinically and statistically significant for both of those studies. So they replicated as we hope they would. So we’re excited about that. In the second, there is obviously safety and we provided a open-label safety extension. We provided a fair amount of longer-term safety data. So that’s really the core basis of what will be the evaluation for the efficacy and approval safety and efficacy for the U.S. marketplace or by the FDA. The EU, we’ve had discussions with them prior to the start of the U.S. Phase III, and in those discussions, what we have discussed was doing a single study in the EU with the U.S. studies acting as a support for approval. I think that position is only then strengthened by the quality and strength of the U.S. data. We’ve submitted for an updated review of where we are and really what we’re looking to do there is to see if we can do a single EU study and which we would have both pre and post-menopausal women, and that would support approval for a board indication of women with HSDD, irrespective of their status, whether they are both pre or post-menopausal. The argue point is that there is little difference in the way that pre and post-menopausal women experience HSDD, how they respond to treatments for HSDD and there’s not really any real necessary or requirement that they should be separated. Now whether or not they’ll grant us that, we don’t know but that’s the approach that we’re taking and that’s the one that we’re going to push for when we have a meeting with them, which we’d expect to occur in the first quarter of 2018.

And then just a follow-up on that one, if I could. When would you get back to us as to how the outcome of that next meeting will be? And what your expectations going in on the size of that trial? Thanks.

That would be a single trial, it’ll be a little bit larger than – we were anticipating having a two doses of bremelanotide, since the European population can be lighter. So there will be lighter weight women. So we are anticipating having a placebo or lower dose somewhere in the order 1 or 1.25 milligrams, and 1.75 milligram. So if you’re anticipating around 300 or so, patients per arm still be around 900 patients in total. With regards to timing – with regards to update on the regulatory strategy and development strategy in the EU, that will really be dependent on the outcome of our meeting in the first quarter and any subsequent follow-up that’s required. So I would say the earliest that you’ll probably hear from us would be probably late first quarter or around – or on the first quarter update.

Okay. That’s helpful, thanks. And I think there is an update on the penny warrant situation, how many are outstanding quarter and stay at this point? Thanks.

Sure. It’s Steve, Michael. We started at the beginning of the year, so January 1, with approximately $60 million of those penny prefunded warrants. As of today, we’re down to approximately $5 million, and my expectation is that that’ll be $0 by the end of the year.

Okay, great. You had mentioned, I think in previous calls, the potential for bremelanotide PK data by year-end. Might we see that if you can give us an update on that? Thanks.

Can you give me a little more detail on that? Bremelanotide PK data has been – for that has been established. In what context? And maybe I missed something that I said previously.

Sure. There – I think there was additional safety PK data that you were running this year, some abuse liability, drug interaction studies et cetera?

Oh, sure, sure. Okay, yes, sorry. I think there were eight various studies that would support the NDA submission. All of those have been completed. They range from a population PK analysis of abuse liability studies, interaction with drugs, various types of drugs that pre-menopausal women might beyond such as oral contraceptives and that depression so on and so forth. So we haven’t broken out any of those study specifically, but really there are no – there is nothing to report. I mean, they were all great studies, they ran, they indicate that, really, they support a label that should be quite clean from a drug interaction standpoint. We didn’t see any interactions with any drugs that very uneventful. Abuse liability is a clean study program, it looks good. So we really are expecting bremelanotide to go through at a very nice label.

So no surprises there, okay. All right, appreciate it. Thanks guys.

No. Thank you, Michael.

That concludes today’s question-and-answer session. Dr. Spana, at this time I’ll turn the conference back to you for any additional or closing remarks.

Thank you, everyone. This was really – thanks for participating on the call. As always, really get Palatin a lot of enthusiasm and excitement. Bremelanotide is really on the cost of being submitted for approval and we expect a very positive outcome from that. And we’re quite excited about really now seeing the earlier programs moving the clinical trials as we end the year. And we look forward to next year. So a lot on tap for us. And I think we can move it forward without having to tap the capital markets. So as always, we thank you for being on the call. Look forward to updating you throughout the course of the quarter and really updating you next quarter as well. Thank you, and have a great day.

This concludes today’s conference. We appreciate your participation. You may now disconnect.