Greetings and welcome to the Catalyst Pharmaceuticals Inc. Third Quarter 2017 Financial Results Conference Call. [Operator Instructions]. It is now my pleasure to introduce your host, Ms. Ali Grande, Chief Financial Officer. Thank you, you may begin.

Good morning, everyone, and thanks for joining our conference call. On today’s call, we have Pat McEnany, Chairman and Chief Executive Officer; Dr. Steve Miller, Chief Operating Officer and Chief Scientific Officer; and Dr. Gary Ingenito, Catalyst’s Chief Medical Officer and Head of Regulatory Affairs. Before we begin, I would like to remind you that in the following comments and in the Q&A session, we will make statements about expected future results, which may be forward-looking statements for the purposes of the federal securities laws. These statements relate to our current expectations, estimates and projections, and are not guarantees of future performance. They involve risks, uncertainties and assumptions that are difficult to predict and which may prove not to be accurate. Actual results may vary. These forward-looking statements should be considered only in conjunction with the detailed information contained in our SEC filings, including the Risk Factors described in our Annual Report on Form 10-K. At this time, it is my pleasure to turn the call over to Pat McEnany, our Chief Executive Officer.

Thank you, Ali. Thanks to everyone for joining us this morning. Welcome to our third quarter 2017 results call. We look forward today providing our three and nine month results as well as updating you about our recent development activities. After I make a few opening comments Steve will provide a status report on our development pipeline and Ali will review our financial results for the third quarter in the nine months of 2017. We will then take your questions at the end of the call. I want to start today's call by saying that I'm very pleased that we had completed enrolment in our LMS-003 trial which is our second Phase 3 evaluating Firdapse for the treatment of LEMS. This is a tremendous accomplishment for Catalyst sbsut more importantly this is a significant milestone for patients and their families who have been waiting for such a long time for potential FDA approved treatment program for LEMS. I'd like to thank the cross functional teams at Catalyst who work so diligently to completing enrolment in this very important trial as well as the investigators patients and families who have participated. As we have previously announced we expect to report the top line results from LMS-003 in early December. As soon as we have the top line results from the LEMS LMS-003 trial, assuming they are positive we plan to hold a confirmatory pre-NDA meeting with the FDA to discuss our proposed NDA filing package. In our meeting request if it's granted we expect to hold that meeting in January 2018. Further we are currently expecting to resubmit an NDA for Firdapse, LEMS in the first quarter of 2018. In addition to the LEMS trial we are progressing forward in our trial evaluating Firdapse in patients with Congenital Myasthenic Syndrome or…

Thank you, Pat. Good morning everyone. As Pat touched on we have moved forward in our second Phase 3 of amifampridine phosphate known as Firdapse for the systematic treatment of LEMS. This trial has just recently completed enrolment and we're expecting top line results of early December. CAD was completing the enrolment with 26 subjects and based on power calculations it is expected to provide adequate statistical power. The co-preliminary endpoints of this trial are Quantitative Myasthenia Gravis or QMG and Subject Global Impression or SGI. These are the co-primary endpoints that were employed in our previous clinical trial and the investigators in this clinical trial were very familiar with the proper use of this endpoint assessments, although we won't know until we unblend the data from trial we're cautiously optimistic that the outcome of this trial will be positive. As we previously stated this clinical trial was designed as a small trial employing three clinical trial sites in two geographical locations. The small size of this trial will enable Catalyst to complete final data monitoring, lock the database and report results in early December which is a relatively fast path top line data for Phase 3 clinical trial. As we recently announced we have also completed the three abuse liability studies that the FDA requested in 2016. These studies a physical drug dependence study, a drugs self-administration study and a drug discrimination study also showed no evidence of abuse potential. A complete abuse liability assessment will include not only these three studies but also a pharmacological target analysis of known pharmacological targets of abuse and analysis of clinical adverse events for signs with these potential both of which Catalyst already has. In the results of our confirmatory Phase 3 trial, I'm sorry if the results of our confirmatory Phase…

Thanks, Steve. For the quarter ended September 30, 2017 Catalyst reported a GAAP net loss of $4.2 million, or $0.05 per share, compared to a GAAP net loss of $4 million, or $0.05 per share, for the same period in 2016. For query, all references made to per share results on this call refers to basic and diluted shares. Since our liability-classified warrants expired in May 2017 there was no change in the fair value of liability-classified warrants during the third quarter of 2017. So our non-GAAP results for the quarter was the same as our GAAP results that is a net loss was $4.2 million, or $0.05 per share. In comparison, non-GAAP net loss for the third quarter of 2016 was $3.8 million, or $0.05 per share, which excludes non-cash loss of $107,000 for the change in fair value of liability-classified warrants. Research and development expenses were $2.7 million, for both the third quarter of 2017 as compared to 2.5 million in the same period in 2016. We expect that our R&D spend will continue to be substantial throughout the balance of 2017 and into 2018. General and administrative expenses for the third quarter of 2017 totaled $1.6 million compared to $1.4 million in the third quarter of 2016. We expect G&A expenses excluding pre-commercialization expenses to remain consistent for the balance of 2017. We also expect pre-commercialization expenses which are reported as part of G&A to increase for the balance of the year and into 2018 as we began to prepare for a potential late 2018 early 2019 launch of Firdapse. As a development stage biopharmaceutical company, Catalyst had no revenue in either the third quarter of 2017 or 2016. During the quarter ended September 30, 2017 Catalyst received proceeds from excessive [ph] of warrants of approximately $1.4 million. At September 30, 2017 Catalyst had cash and investments of $33.9 million and no debt. Although there can be no assurance, we believe that these resources will be sufficient to support our planned operations through at least the next 12 months. More detailed financial information and analysis may be found on the company’s quarterly report on Form 10-Q which was filed with the Securities and Exchange Commission yesterday November 08, 2017 and can be found on the Investor Relations page of our website at www.catalystpharma.com. I will now turn the call back to Pat.

Thanks, Ali. We are very pleased with the progress we have made with Firdapse this quarter. We look forward to reporting the top line results for LMS-003 trial in early December and subsequent to that to a potential NDA submission in the first quarter of 2018. We will continue to provide updates on the LEMS, CMS and MuSK MG trials as they become available as well as our other development activities. I look forward to keeping our stakeholders updated as I believe we are on the verge of our goal of bringing Firdapse to patients in need. This will be the end of our formal portion of the meeting and we'll turn it over to the Operator for questions.

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

Thanks for taking my questions, Pat. You know relative to that trial with a completed enrolment I'm wondering if you've any perspective on the conduct of the protocol you know obviously not having looked at the data but also with regard to say some of the patient characteristics either you know average experience with Firdapse or diagnosis any way to characterize the patient?

Let me first state about characterizing the patients, as you will recall from the design of this trial all of the patients were invited from our expanded access program. What that means is that all of the patients have been on Firdapse for a period of time. Some for short periods of times, others for very long periods of time so they all had experience with the medication and we're being successfully treated and stayed on the medication because they thought they were benefiting from it. With regard to the overall execution of the trial we're very pleased with the execution of the trial. We had no dropouts in this trial, we did have two rescues in the previous trial but there were no rescues in this trial. We felt that the execution was done very well by the investigators both investigators were experienced investigators from a previous clinical trial and all of the patients were showed up for their visits on time and all the medication was taken as it should have been taken and it appeared that the overall execution of this trial was very good, very clean.

I'm wondering if you have experience with any of those patients having come off the trial if they've gone back into the expanded access program and them relative to the expanded access program have you seen any change of interest in that program in terms of new patient starts since you've started out this Phase 3 trial.

Well our expanded access program has been enrolling patients and continues to enrol patients. I don’t know if the clinical trial itself actually accelerated the enrolment but we've always had a stream of patients coming into the expanded access program.

With regards to the outcome of the patients or did they all go back into the expanded access program? The answer is yes, single patient upon completion of LMS-003 opted to go back into the expanded access program and continue on Firdapse.

Okay. And then relative to the regulatory strategy you spoke about including some information on CMS in the initial but that you would talk to the agency whether or not actual data would slow that. I guess I'm wondering why you might consider complicating this regulatory strategy, wouldn't it just be easier to pursue and [indiscernible] CMS following the initial LEMS NDA or is this topic of discussion given the breakthrough therapy designation with the agency already?

Charles, Gary Ingenito, our CMO and Head of Regulatory will answer that question for you.

So Charles, I mean there are a lot of similarities in with the [indiscernible] types of CMS and LEMS in terms of inadequate release of acetylcholine which again causes from a mechanistic perspective those to be like diseases from symptom review and this is also being done with the actual request of the FDA who has encouraged us to submit this argument and have a discussion with them which I believe is because there are no approved drugs for the CMS population and that we would like to see that they have access to an FDA approved medication.

Charles, additionally we will have an opportunity to vet this with the FDA in the pre-NDA meeting that we expect in January. So if it appears that it's complicating our filing to your point will exclude that and later file an SNDA.

That makes sense to me, and final question regarding commercial plans I believe you started some initial activity there. Should the Firdapse and the NDA be turned around relatively quickly which you have commercial supply and then secondarily could you outline at least initial steps in terms of how you might commercialize the drug, I know you had started in the past but do you have any thoughts there or not and then I will hop back in the queue.

Yes, as you know Charles we put together the commercial plan about two years ago when we thoughts that we would launch in summer of '16 and unfortunately our plans were delayed but a lot of the work has already been conducted with regard to pricing, market access, market research, our patient services program that we expect will be world class sales force sizing, gross to net calculation. So the playbook was ready so we've pulled that off the shelf. We have dusted it off and we're now going through the exercise of refreshing, all of that information to see if it's changed in any way over the last two years. So we think the playbook is in good shape and as you know we anticipate that we can bring this drug to market ourselves and we intend to. We believe that we can reach the prescribers with 15 to 20 specialized sales force and five [indiscernible] and so the plan is now being reworked. We anticipate being in full swing by the first of the year and actually employing a lot of what we've learned over the last couple of months about the changes if you will in the marketplace and lastly with regards to inventory or launch supplies we are in very good shape and we will be ready and if we get a quicker review than a priority review which would really be nice we'll be in position and ready to launch.

[Operator Instructions]. Our next question is coming from Scott Henry of ROTH Capital Partners. Please go ahead.

A couple of financial questions. You earned less cash than I would have expected in Q3 and the question is do you think you could possibly have cash to get you through an approval decision? Obviously assuming the data is good and the filing is on track but it started to look like you will I just wanted to get your thoughts on that.

The quarter to quarter, decrease in cash is a little deceiving because we did have a number of outstanding warrants that were exercised during the third quarter and so you know we can't look to extrapolate that for the year but we anticipate that we will operate to the budget for this year which we've discussed a burn of about $20 million for the year and I think that's about where we will be, but based on projected year-end cash, I would say to you that we have enough cash to get through to an approval, the answer is yes but we do have some extraordinary or new expenses for us for calendar 2018 which we are finalizing our '18 budget as we speak. We will have new additional expenses for the MuSK MG study which will kick-off early Q1 which is what I'll call an extraordinary expense for us and we will see instruct [ph] to burn more cash in preparation for the launch and all the pre-commercialization activities that are currently underway. To answer your question we have enough cash to get I believe to get to a launch, I'm not sure we want to burn down the balance sheet that close so.

And staying on the financials, how should we think about the amount of pre-commercial cost in Q4, I mean should we be thinking about $1 million to $2 million, I'm just trying to recollect the way it went the first time around. Just any color on how we should ramp that into the fourth quarter.

Yes, there aren’t large expenses in the fourth quarter for pre-commercial activities. These are really activities that as I mentioned earlier that are refreshing work there was done previously. So I would say $1 million to $2 million in Q4 for commercial and pre-commercial activities is probably a fair number.

And then the final question on Myasthenic Gravis file, how should we think about the follow up from that trial, just enrol in 12 months, I'm assuming it's a pretty quick turnaround similar to LEMS for that trial but just wanted to confirm that.

Well as Pat stated we anticipate we can enrol the trial in approximately 12 months. The other thing I think you're asking about with regard to follow up is what happens after that and the answer is that we will file the clinical trial as a supplement to an NDA to seek that additional indications to an approved NDA.

Thank you. At this time I would like to turn the floor back over to management for any additional or closing comments.

Yes, thank you. Let me conclude today's call by saying that I'm confident that we're on the right path to deliver innovation and for Catalyst to be a forerunner in developing treatments for rare neuromuscular diseases. We've accomplished a great deal in the first nine months of this year and I look forward to updating you on our progress on future calls. As always I'd like to thank our employees for their dedication and performance. Thank you.

Ladies and gentlemen thank you for your participation. This concludes today's conference. You may disconnect your lines at this time and have a wonderful day.