Greeting and welcome to the Catalyst Pharmaceuticals Incorporated Second Quarter 2015 Earnings and Corporate Update Conference Call. At this time all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions]. As a reminder this conference is being recorded. It is now my pleasure to introduce your host Ali Grande. Thank you, you may begin.

Good morning and thank you for joining our conference call. To begin, on today's call we have Pat McEnany, Chairman and Chief Executive Officer and Steven Miller, Chief Operating Officer and Chief Scientific Officer. On this call we will be making forward-looking statements involving known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including those described in Catalyst's annual report on Form 10-K for the fiscal year 2014 and its other filings with the U.S. Securities and Exchange Commission could adversely affect Catalyst. All forward-looking statements are qualified in the interim by these cautionary statements and Catalyst undertakes no obligation to revise or update this presentation to reflect events or circumstances after that date -- after the date hereof. At this time it is my pleasure to turn the call over to Pat McEnany, our Chief Executive Officer.

Thanks Ali and good morning everyone and thank you for joining us today. I would like to welcome everyone to our second quarter results and update call. On today's call I will give you an update of our activities and progress so far this year including our recent NDA submission in Firdapse's pre-commercialization activities and infrastructure preparedness ahead of the potential FDA approval. Steve Miller will provide status report on our pipeline and give scientific updates. Following Ali will give a brief review of the financial results for the quarter. Lastly we will take your questions. Recently we announced the initiation of a rolling submission of a new drug application to the FDA for Firdapse for the treatment of Lambert-Eaton myasthenic syndrome. As you know, Firdapse has received Breakthrough Therapy Designation from the FDA for the treatment of LEMS as well as the Orphan Drug Designations for LEMS and congenital myasthenic syndrome. Our rolling NDA submission for Firdapse marks an important step forward in our reference to provide a safe and effective FDA approved treatment option for patients in the U.S. who develop LEMS which is a rare, debilitating, and in some cases can be a life threatening disease. We expect to complete the submission of the NDA in the fourth quarter of 2015. At which time we will be requesting a priority review of our application. Given this timeline we would hope to receive approval of our NDA by midyear 2016, and we expect to continue to work closely with the FDA as we seek approval of our NDA. We will also continue to provide access to Firdapse through our expanded access program as part of our commitment to ensure that all eligible patients have access to Firdapse. We recently announced the appointment of Gary Ingenito as Chief Medical…

Thanks Pat and good morning everyone. After the recent commencement of our rolling NDA submission of Firdapse for LEMS we are continuing the exploration for additional indications including congenital myasthenic syndromes or CMS and a sub group of Myasthenia Gravis patients that are zero positive for the MuSK antibodies. As Pat mentioned last quarter we announced top line results in open label proof-of-concept trial of CPP-109 or vigabatrin used to treat patients suffering from Tourette's Disorder that were refractory to all other previous treatments. One of four patients demonstrated a very clear, clinically significant reduction in tics, and two others showed about a 25% reduction in tics. The eight-week clinical trial was designed as an open label trial to evaluate the potential effect of GABA-aminotransferase inhibition as a mechanism for reducing tics in patients with treatment refractory Tourette's Disorder. Vigabatrin was used as a research surrogate to demonstrate the utility of GABA-aminotransferase blockade, with the expectation that upon successfully demonstrating the utility of this mechanism, further development activities would focus on the potentially safer, more potent GABA-aminotransferase inhibitor, CPP-115. We believe that the clinical results from this small open label trial despite its limitations are encouraging and warrant further investigation. The only formerly approved medications to treat Tourette's Disorder are first generation antipsychotic drugs which block D2 dopamine receptors. However, they are infrequently used in clinical practice because of their severe and unacceptable side effects. The GABA-aminotransferase inhibitor class drugs may offer new hope to treatment-refractory Tourette's Disorder patients who have no other options. In March the FDA granted Orphan Drug Designation to Firdapse for treatment of congenital myasthenic syndromes and as previously noted we continued to explore the potential to treat a sub group of Myasthenia Gravis patients with Firdapse. Myasthenia Gravis animal models that are zero positive for…

Thank you, Steve. For the quarter ended June 30, 2015 Catalyst reported a GAAP net loss of approximately 4.6 million or $0.06 per basic undiluted share compared to a GAAP net loss for approximately 3.2 million or $0.05 per basic and diluted share for the same period in 2014. Excluding non-cash gain of approximately 334,000 attributable to a change in fair value of liability-classified warrants, non-GAAP net loss was approximately $4.9 million or $0.06 per basic and diluted share for the second quarter of 2015. In comparison, non-GAAP net loss for the second quarter of 2014 was $3 million or $0.05 per basic and diluted share, which excludes non-cash expense of approximately $224,000 attributable to a change in fair value of liability-classified warrants. Research and development expenses for the second quarter of 2015 was approximately $2.6 million compared to an R&D spend of approximately $2.1 million in the second quarter of 2014. Research and development expenses increased when compared to the same period in 2014 as we increased activities related to our NDA filing for Firdapse and ongoing studies and trials and decreased activities related to our completed Phase 3 trial for Firdapse. We expect that our R&D spend for the rest of the year will increase as we prepare for and submit our NDA for Firdapse and as we increased activities in our ongoing studies and trials. General and administrative expenses for the second quarter of 2015 totaled approximately 2.3 million compared to approximately 891,000 in the second quarter of 2014. The increase from period to period is primarily due to ramping up of pre-commercial expenses and headcounts as we prepare for the commercialization of Firdapse. At the development stage biopharmaceutical company, Catalyst had no revenues in either the second quarter of 2015 or the second quarter of 2014. At June 30, 2015 Catalyst had cash, cash equivalents, CVs and short-term investments of about approximately 67.4 million and no debt. This includes proceeds from our February 2015 offering in which we sold 11.5 million shares of common stock and raised net proceeds of approximately 34.9 million. We believe that these resources will give us sufficient runway to anticipate approval and subsequent product launch assuming this occurs in 2016. Additionally the company will be presenting at a number of healthcare conferences during the remaining of the year, including the Piper Healthcare Conference in December. More detailed financial information and analysis maybe following the company’s quarterly report on Form 10-Q which was filed with the Securities and Exchange Commission yesterday August 10, 2015, and can be found in the Investor Relations page of our website at www.catalystpharma.com. I would now like to turn the call back to Pat.

Thanks Ali, before we answer your questions I am going to summarize our major goals and potential milestones looking at the coming months. Firdapse has demonstrated how we can provide an important benefit to LEMS patients and continues to demonstrate a favorable safety profile. We have initiated a rolling NDA submission to the FDA and we are continuing to the work with the agency on a pathway to include certain types of CMS in the initial label upon approval for LEMS. We expect to complete the submission of the NDA in the fourth quarter of this year and we’ll be requesting a priority review at that time. We continue to build our commercial capabilities and plan to establish our marketing and sales teams over the next three quarters as our timeline moves closer to a potential FDA approval by midyear 2016. We are working to advance our pipeline in regulatory pathways for potential additional indications for both Firdapse and CPP-115. Also importantly we are currently enrolling LEMS in CMS patients and the expanded access program which continues to provide Firdapse at no charge to patients who meet the inclusion exclusion requirements. With that I’d like to thank all of you for your participation today, and open up the call for questions.

[Operator Instructions]. Our first question comes from Charles Duncan of Piper Jaffray. Please go ahead.

Good morning Pat and the team, congratulations on the progress in the initial filing for the Firdapse NDA.

Thank you, Charles.

Thanks for taking my questions. I have a couple of them, I wanted to first ask you about that Firdapse NDA filing. You are very clear in terms of planning to complete that in the fourth quarter, I am wondering if you could provide us any additional color on the required work to be done to complete that. Are there any scientific studies or anything that need to be done or is this just preparation of the documents?

Steve, why don’t you take that.

Its primarily just preparation of the documents for the NDA. As we have previously publicly said, we also continue to gather additional information to support the CMS indication in our initial filing. So there is some ongoing work in that regard as well.

Okay and then in filing that rolling submission, Steve or Pat, did you have any additional FDA interaction regarding the unmet need in LEMS and activity by others to serve this indication or is that not something the FDA would have talked to you about?

Well to begin with, the FDA would never discuss anything that goes on with any other company with us. And naturally they would not discuss with other companies any communications they have with us. They are very compartmentalized in that regard. In terms of had we had any other discussions with the FDA, no. Our instructions and our path forward seemed very clear and we are just pursuing that and assembling the NDA for filing in the fourth quarter as Pat indicated.

Okay and regarding CMS and the inclusion around certain sub groups, the discussion that you had with FDA what were the issues, can you provide any more color on the design and timelines of any additional clinical work or perhaps it isn’t necessary?

Well, I can’t provide any additional details at this time. As we have previously indicated, congenital myasthenic syndromes or CMS is a spectrum of very rare neuromuscular disease. It’s caused by at least 20 known genetic defects affecting the neuromuscular jumps in transmission. They are characterized by fatigable weakness in skeletal muscles with onset generally at or shortly after birth. Certain of these genetic defects appear to adversely affect the calcium transport into the neuron and like the therapeutic effect, a 3,4-DAP on neurons affected by auto-antibodies to calcium channels 3,4-DAP can also be a therapeutic benefit to these genetic defects associated with CMS that have affected calcium transport. Having said that, that is not the entire spectrum of CMS. It appears as though based on the literature that a majority of CMS patients will respond well to 3,4-diaminopyridine. We are, as I pointed out, continuing to collect data on patients that are known to respond to the drug.

Okay and then just a question on expanded access and one quick one for Ali. On the expanded access program, I am sure that you are tracking the use and number of patients in, can you provide us any information on the number of patients and can any characterization of the call it anecdotal experience for that patient in expanded access programs?

Charles we have previously stated that we are not going to talk about numbers where we stand in headcount in the expanded access program. We just don’t want to get into a position of having to update that quarterly. We’re pleased with the progress. It's gaining traction for us. Our rare disease clinical liasons are in the field meeting with KOLs and centers of excellence that have a number of patients that are very interested in joining the expanded access program that had either LEMS or CMS. So I would say to one finding so far as we are surprised at a little bit, this split if you will between CMS and LEMS patients look like CMS is looking like perhaps a larger indication than we thought potentially.

Okay, so it sounds like more CMS than LEMS patients?

No, but it is certainly closer than we thought.

And the awareness is pretty decent of the program and of the indications?

Well like I said its gaining traction. We’re advertising in Muscle & Nerve Publication to neuromuscular specialist who are advertising in Quest which is the NDAs in-house publication that goes out to about 60,000 patients of our program. So we are pleased with the response that we are getting and again its gaining traction.

Okay and quick question for Ali and then I’ll hop back in the queue with the $67 million that you say will last through 2016 including the pre-launch [ph] I am assuming that includes a bill of inventory for Firdapse commercial inventory but does it also come back to the pipeline include fully funding Tourette Syndrome Phase 2?

That depends on the size, the magnitude of the study that we do Charles. I would say to you I think that we have the room within our budget to go to a Phase 2 study, again depending on where we do it and the size of that study. So, it is not like we will need a partner to take this to the next step. We will have the funds available.

Okay, sounds good. Thanks for the added color and looking forward to in the second half of the year.

Thanks Charles.

[Operator Instructions]. Mr. McEnany, there are no further questions at this time.

Okay operator, thank you very much. Thanks for your participation today everybody.

The call has now ended. Thank you for your attendance, you may now disconnect.