Good morning, ladies and gentlemen, and welcome to the Palatin Technologies Third Quarter Fiscal Year 2018 Results Conference Call. As a reminder, this conference is being recorded. Before we begin our remarks, I would like to remind you that the 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 you to your host for today, Dr. Carl Spana, President and Chief Executive Officer of Palatin Technologies. Please go ahead, sir.

Thank you. Good morning, and welcome to the Palatin Technologies' Third Quarter Fiscal Year 2018 Call. I am 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. Now, I'm 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 third quarter ended March 31, 2018, significant and recent operational and financial highlights include: with respect to bremelanotide, which is under development for female Hypoactive Sexual Desire Disorder of HSDD. In March 2018, our exclusive North American licensee for bremelanotide, AMAG Pharmaceuticals submitted a New Drug Application, NDA to the FDA and we anticipate that the FDA will notify us in June that this NDA submission is accepted for review. We have licensed bremelanotide to Fosun Pharma in the China region and Kwangdong Pharmaceuticals in South Korea. In addition, we are in discussions with multiple potential partners for other territories and anticipate closing additional bremelanotide licensing collaborations in the second half of calendar 2018. With respect to our other Melanocortin receptor programs under development for inflammatory bowel diseases, we received FDA clearance of an IND application for PL-8177 for Ulcerative Colitis and in February 2018 initiated subject dosing and first in human clinical studies. In April 2018, we presented pre-clinical oral formulation data on PL-8177 at the 2018 Keystone Symposia on the resolution of inflammation in health and disease. In May 2018, we presented positive pre-clinical melanocortin 1 agonist data at the TIDES Meeting Conference. Going into the financial results regarding our third quarter, fiscal year 2018 financial results, Palatin reported a net loss of $0.7 million or $0.00 for basic and diluted share for the quarter ended March 31, 2018, compared to a net loss of $3.6 million or $0.02 per basic and diluted share for the same period in 2017. The difference in financial results between the three months ended March 31, 2018 and 2017 was mainly due to the decrease in total operating expenses of approximately $4.3 million that is offset by a decrease of $1.8 million…

Thank you, Steve. I will start our third quarter fiscal year 2018 operational update with bremelanotide, our lead clinical product. Bremelanotide is a first in class melanocortin agonist which is the only on-demand drug to complete Phase 3 clinical trials for Hypoactive Sexual Desire Disorder. The product is formatted as a simple single-use subcutaneous auto-injector, self-administered by the patient approximately one hour prior to sexual activity. Working with AMAG Pharmaceuticals, our North American licensing partner for bremelanotide, we completed a new drug application for bremelanotide which AMAG submitted to the FDA in March 2018. We anticipate that the FDA will accept the bremelanotide's NDA for full review before the end of the second quarter of calendar 2018. We are currently working with AMAG to support the bremelanotide new drug application and if all goes well, we anticipate FDA approval of bremelanotide in march 2019. Outside of North America, we are working with our Chinese licensee Fosun Pharma and our South Korean licensee Kwangdong Pharmaceuticals to advance bremelanotide development in those territories towards regulatory filings. As Steve mentioned, we also have ongoing discussions with multiple potential partners for other territories and anticipate closing additional bremelanotide licensing collaborations in calendar year 2018. Moving on to Palatin's other drug development efforts, we are primarily focused on our Melanocortin Program targeting autoimmune and inflammatory diseases and our naturally peptide program for cardiovascular fibrotic diseases. We have developed new families of highly specific and selected melanocortin 1 receptor agonist with broad application and inflammatory in autoimmune diseases including inflammatory bowel disease, dry eye, uveitis and rheumatoid arthritis. Activity in melanocortin 1 receptor controls immune system disregulation by inhibition of the Anti-Kappa B [ph] and down regulation of pro-inflammatory cytokines. PL-8177, our lead clinical development candidate for Ulcerative Colitis is a Phase 1 clinical trial or…

Thank you. [Operator Instructions] We'll take our first question from Joe Pantginis with H.C. Wainwright.

Hey, guys. Good afternoon, or good morning, so I should say. A couple of quick questions on the bremelanotide. First, what is the potential timing that you're looking for an ADCOM? But more specifically, what are the lead questions do you expect from the panel? Thanks.

Timing of an ADCOM, we would anticipate would be this calendar year. And we guess, more towards the latter part of the year; so it could probably be in November-December timeframe, I think that's when the FDA would like to get it done. Although we don't have any direct feedback yet, we would expect that we will receive some of that information when we get letter saying that our filing is going forward. The questions, Joe, always an opinion as to what we think we would ask, but I think the questions will be around how bremelanotide is used, how an intimate drug impacts both desire and distress associated with desire. I think those were the questions. I think there will be questions around labeling, how should the product be labeled appropriately? I don't think there's any real major safety issues coming out of the clinical program. I'm sure there will obviously be a safety officer there as part of the panel that's pretty typical, but I don't have any safety concern that I think they will press on at the panel meeting. I think it's very typical that a panel meeting is held for new molecular entity, particularly first in class and as with bremelanotide is. So I think that's roughly where the FDA will focus. We will see.

And then with regard to looking at Europe, you're obviously looking to obtain EMA advise for the EU pivotal program, I'm assuming. So what if any changes do you anticipate in the protocol compared to the U.S. Phase 3 program?

Obviously, we are approaching them and are in the process of waiting for feedback from the CHMP review group and we feel that the most appropriate way to study bremelanotide in Europe would be the same way we studied in the U.S. and that is using both desire and distress as the co-primary endpoints. We know from prior feedback that we will have populations between pre or post-menopausal -- most likely continue to be separated, so they probably require single trial in pre-menopausal and then one in post-menopausal as separate indications. For us, we want to make sure that we can use the data form the U.S. in support of that filing and so therefore we will make sure the trial really wants us closely to the one that we did in the U.S. as possible.

Moving on, we'll take our next question from John Newman from Canaccord.

My question is regarding the upcoming FDA panel. Just wondering if you think that the panel could actually be beneficial in terms of continuing to draw attention to this disorder as well as highlighting the clinical profile. I think that the last drug that was approved to your -- seem to get a lot of attention in the media despite some of the potential drawbacks. Just curious as to how you think about the panel in that regard.

Just as a point of fact; as a part of ADCOM, by law, they're required to have an open comment period and it has to be pre-scheduled and people submit request to speak and they can also submit written comments if that can be included in submissions to the panels as well. So I expect there certainly will be an open panel session for this product and I think they will put most likely based on the topic. There will be a fair amount of people coming out. I would expect a lot of publicity or public relations around the panel meeting to just by its nature. Obviously we will work with AMAG to do what we can do to influence public opinion to the extent possible by making sure that we have the right experts and what have you riding in and participating in that public comment period. Of that comment period, the public comment period, in ADCOM in general certainly is important to the division as well to the senior members of the FDA. When commissioners have this in front of Congress, they like to have coverage to be able to say that they've had a panel meeting that was supportive of a product. So we will be working as I said, with AMAG to make sure that we have a very robust and well-run panel meeting that really highlights the attributes of bremelanotide and really gets our messages across. I know the team in AMAG is working in the lead on that and I know they're working very diligently on it and people at Palatin are supporting them. But more direct to your point, we do expect that there will be a very robust discussion at the public session.

And one additional question on the commercial aspect of the product. Obviously, we have to wait for an FDA decision, but assuming the drug is approved, do you have plans in conjunction with the AMAG to conduct DTC marketing and if so, at what point after approval do you think it might be appropriate to start thinking about that?

Absolutely. Then Steve can jump in as well. We would expect that AMAG at some point would begin to have direct-to-consumer advertising for the product. It's a product where I think it can be important to success. Certainly, I think we're already there at websites. AMAG has a website up for disease awareness. I think that's very critical as well. So I think we're very comfortable that AMAG will do a good job with using all the available mechanisms to reach patients and practitioners that being direct-to-consumable through prints, probably radio, other sorts of media online. They're very good at that, but the other products they've done a very good job building markets with those types of approaches. When you start that, obviously, that can be discussion that you have with the FDA depending on your label and so on and so forth so I really can't comment on that.

It's Steve, John, not much more to add from Carl other than AMAG, we're extremely comfortable with the collaboration. This is a very significant product for them. They're all about the female healthcare franchises, so it's very synergistic for them. We're really in a supporting role in that regard. I am comfortable with stating that they're already discussing these types of things from the pricing to the specific markets, albeit awareness or education that they're going to be advancing. Frankly, that's more of their call and their timing. We're in discussions from an FYI standpoint where as Carl mentioned they're thinking about it now and there are certain things that are taking place now as we both prepare and again, we're in more in the support role as we prepare for the ADCOM conference and the complete FDA-NDA review process.

At this time that will conclude today's Q&A session. I would like to turn it back over to our speakers for any closing or additional remarks.

Well, I'd like to thank everyone for participating in the Palatin Technology's third quarter fiscal year 2018 conference call. We look forward to updating you next quarter as we continue to make progress. It's an exciting time at the company. Everybody here is working hard and we're excited about the future of the company. So thank you for participating and have a great day.

At this time, that will conclude today's conference. We do thank you for your participation. You may now disconnect.