Palatin Technologies, Inc. (PTN)

F1Q2011 Earnings Call Transcript

November 16, 2010 11:00 am ET

Executives

Dr. Carl Spana – President and CEO

Steve Wills – EVP, Operations and CFO

Dr. Jeffrey Edelson – Chief Medical Officer

Presentation

Operator

Good morning, ladies and gentlemen. And welcome to the Palatin Technologies first quarter fiscal year 2011 conference call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions for the question-and-answer session will be given at the end of the company's remarks. As a reminder, this conference call is being recorded.

Before we begin our remarks, I would you 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 can 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 would like to introduce your host for today's call, Dr. Carl Spana, President and Chief Executive Officer of Palatin Technologies. Please go ahead, sir.

Dr. Carl Spana

Thank you. Good morning. I'm Carl Spana, President and CEO of Palatin Technologies. With me on the phone today is Steve Wills, our Executive Vice President of Operations and Chief Financial Officer and he'll provide us with a financial update and Dr. Jeffrey Edelson who has just joined us recently as our Chief Medical Officer.

This past September Palatin announced a strategic restructuring in which our primary focus would be to advance our phase two clinical drug candidates forward. As part of this restructuring we began a process of closing down our research and discovery activities and putting in place the human resources needed to advance our clinical development programs. These activities are now almost completed.

Earlier today we announced that Dr. Jeffrey Edelson has joined Palatin as our Chief Medical Officer. I would like to welcome Dr. Edelson to the Palatin Management Team and look forward to working together with him to advance our programs. Dr. Edelson has 15 plus years of clinical development in regulatory experience in a variety of senior positions in the pharmaceutical and biotechnology industries.

He most recently held the position of Executive Vice President of Research and Development and Chief Medical Officer of Ikano Therapeutics, a specialty pharmaceutical company. Prior to that, he was a Vice President and Area Head of Novel Therapeutics for Johnson and Johnson Pharmaceutical Research and Development.

He's also the principal of – I'm going to get this wrong Aequanimitas Consulting and Adjunct Associate Professor of Medicine at the University of Pennsylvania. He brings a wealth of experience in clinical areas such as pulmonology, critical care and cardiovascular medicine. Dr. Edelson will be responsible for our clinical and regulatory activities. Later in the call, Dr. Edelson will give an update on our clinical programs.

Before we move forward, I would like to address one further item. As a result of our decision to research and discovery activities Dr. Trevor Hallam, our Executive Vice President of Research and Development has resigned effective December 31st, 2010. During his years with Palatin Dr. Hallam drew on his considerable expertise in pharmaceutical research, discovery and development to make significant contributions to the advancement of our research and development efforts and our product pipeline. We are grateful for Dr. Hallam's efforts and we wish him well in his future endeavors.

Before turning the call over to Steve Wills, I'll provide a brief overview of our programs. For Bremelanotide, our experimental treatment for both female sexual dysfunction and erectile dysfunction, we have conducted three clinical trials in premenopausal women and middle aged men which are our target demographics. The goals of these studies were to characterize the effects of subcutaneous bremelanotide on blood pressure and to show a reproducible plasma exposure level. I'm happy to report that the results of these studies have provided us with the date required to move both of these exciting programs forward.

For PL-3994, our natriuretic receptor A agnonist we have generated very exciting pre-clinical data showing potent bronchodilator activity. We have discussed this data with the FDA and are ready to file a new IND to support phase two clinical studies in asthmatic patients. As a reminder we have already conducted two phase one studies under an open IND for cardiovascular uses. In addition, we have made a good start on attracting potential corporate partners to this program.

For MCR-4 obesity and diabetes program which is part of AstraZeneca, we achieved several important milestones. We have demonstrated human clinical proof of principle that validates the melanocortin-4 receptor as a target for treating obesity we also successfully completed our joint research program transferring lead compounds, back up compounds and assays to AstraZeneca. This program now under the direction of AstraZeneca, is moving towards clinical trials early next year.

Our discovery and research activities have provided us with multiple back up compounds for melanocortin-4 receptor and natriuretic receptor clinical programs. In addition, we now have novel components in both of these areas, ready to move forward into new development for new indications.

With that I'm going to turn it over to Steve Wills who will give us a financial update and then Dr. Edelson will give us a little bit of an update on our clinical programs. Steve.

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