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Biodel Inc. (NASDAQ:BIOD)

Q2 2014 Results Earnings Conference Call

May 13, 2014 5:00 AM ET

Executives

Paul Bavier - Biodel’s Corporate Secretary and General Counsel

Dr. Errol De Souza - President and CEO

Gerard Michel - Vice President of Corporate Development and CFO

Dr. Alan Krasner - Chief Medical Officer

Analysts

Matt Kaplan - Ladenburg

Marc Stutman - Trimark

Jason Butler - JMP Securities

Operator

Ladies and gentlemen, thank you for standing by. Welcome to Biodel’s Second Quarter Fiscal Year 2014 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After opening remarks, we will open up the conference for your questions. Instructions for queuing up will be provided at that time. I would also like to remind you that this call is being recorded for replay.

I will now turn the conference over to Paul Bavier, Biodel’s Corporate Secretary and General Counsel.

Paul Bavier

Thank you. Good afternoon and welcome to our second quarter fiscal year 2014 conference call. On the call, we will be making forward-looking statements covered under the Private Securities Litigation Reform Act of 1995. These statements may involve risks and uncertainties that are described more fully in our filings with the SEC, which are available on our website.

Forward-looking statements represent our views only as of today, and should not be relied upon as representing our views as of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we disclaim any obligation to do so even if our estimates change.

Joining us on today’s call are Dr. Errol De Souza, Biodel’s President and Chief Executive Officer; Gerard Michel, our Chief Financial Officer and Vice President of Corporate Development; and Dr. Alan Krasner, our Chief Medical Officer. After their prepared remarks, we will open the call to your questions.

Now, I’ll turn the call over to Errol.

Dr. Errol De Souza

Thank you, Paul. Good afternoon, everyone. We are pleased to report on another quarter of rapid progress across our portfolio of pipeline candidates. This afternoon, I will focus on our concentrated ultra-rapid-acting insulin candidate BIOD-531, our glucagon program and our portfolio of ultra-rapid acting recombinant human insulin or RHI and analog-based prandial insulin formulations. We will conclude with a brief overview of our second quarter financial results and have time for questions.

Let me begin with our concentrated insulin program. BIOD-531 is a proprietary formulation of RHI, EDTA, citrate and magnesium sulfate. It’s formulated at a concentration of 400 units of RHI per milliliter.

In February, we provided extensive details on the positive data from the Phase 1 clinical trial. The data showed a unique combination of an initial ultra-rapid absorption profile with prolonged duration of action. These findings confirm the results of our earlier studies in the diabetic swine model.

The Phase 1 clinical trial was a double-blind, four-way crossover design with 13 healthy obese volunteers in which the pharmacokinetic or PK, pharmacodynamic or PD and injection site tolerability profiles. Our BIOD-531 will compare to Humulin R U-500 or U-500R and Humalog Mix 75/25 prandial/basal insulin.

Both of the marketed comparative formulations are used as combination insulin therapy because of both prandial and basal requirements in one injection. While both formulations have adequate basal control, the prandial control significantly granted relative to existing analog prandial insulins.

The Phase 1 clinical data unambiguously demonstrated that BIOD-531 has a dramatically more rapid absorption and onset of action when compared to both Humulin R U-500 and Humalog Mix 75/25 as well as the duration of action adequate for basal insulin coverage. We are extremely pleased with these results and believe that this pharmacokinetic and pharmacodynamic profile of BIOD-531 coupled with its high concentration and corresponding low volumes of injection could represent a novel therapeutic that could be of benefit to many patients with Type 2 diabetes who are on insulin therapy.

Our long-term goal is to demonstrate that BIOD-531’s unique time action profile along with its high concentration is better suited than currently available products to address the needs of one, severely insulin resistant patients with Type 2 diabetes who require a concentrated insulin to cover daily insulin needs which exceeds 200 units a day. And two, patients with Type 2 diabetes will have more typical insulin daily requirements of under 200 units per day but use premix prandial/basal insulin in place of a more complex insulin regimen requiring separate doses of prandial and basal insulin.

The use of concentrated insulin to treat Type 2 diabetes patient with severe insulin resistance continues to increase at a great rate than the overall market with an annual revenue projection for 2014 of approximately $400 million. Eli Lilly's Humulin R U-500 is the only concentrated insulin product currently available to these patients.

Humulin R U-500 duration of action is long enough to provide basal coverage. However, it’s onset of action is delayed relative to equivalent doses of U-100 rapid-acting into an analog and thus does not provide optimum meal time insulin coverage.

The pharmacokinetic and pharmacodynamic results seen in our completed Phase 1 study indicates that BIOD-531 may provide superior prandial coverage compared to Humulin R U-500 while providing adequate basal control and comparable benefits of lower injection volume. Insulin premixes provide basal and prandial bolus therapy with fewer injections per day.

Currently Eli Lilly and Novo Nordisk market human insulin or rapid-acting insulin analog such as NovoLog or Humalog premixed with intermediate-acting basal neutral protamine insulins in a variety of ratios. In the U.S., analog-based premixes sell approximately $1.5 billion annually. While the premixes offer prandial and basal coverage with one injection, the prandial coverage is sub-optimal.

Again the pharmacokinetic and pharmacodynamic results seen in our Phase 1 study indicates that BIOD-531 may provide superior prandial coverage compared to the premixes while providing adequate basal control. Additionally, the concentrated nature of BIOD-531 will provide an additional benefit of lower injection volume.

With these markets in mind, we have rapidly advanced BIOD-531 into two Phase 2 meal study in Type 2 diabetic patients which have quantified the expected advantage in postprandial glucose excursions after a standardized meal. Both trials are single-blinded, four-way crossover study designed to evaluate postprandial glucose responses to standardize meal challenges using either BIOD-531 Humulin R U-500 or Humalog Mix 75/25.

On separate date, subjects will be treated with BIOD-531 before the meal, BIOD-531 after the meal, Humulin R U-500 before the meal or Humalog Mix 75/25 before the meal. In Study 3-152, we will enroll 12 subjects with Type 2 diabetes who used between 50 to 200 units of insulin per day, a target population that currently uses premix insulin.

In Study 3-151, we will enroll 12 subjects with Type 2 diabetes who use greater than 200 units of insulin per day, a target population that uses Humulin R U-500. We anticipate completing these trials and announcing top line results in the fourth calendar quarter of 2014.

Key questions on BIOD-531 program relates to the regulatory requirement for product approval. We have already submitted questions to the FDA to assist us in defining the toxicology requirements and the clinical development program including pivotal study that may define the path to NDA submission. We expect feedback from the FDA by the third calendar quarter of 2014 and look forward to updating you on our plans for late-stage development with exciting products in our next earnings call.

In addition, as part of the Small Business Innovation Research or SBIR program that’s being funded by the National Institutes of Health, we have conducted preclinical study to evaluate BIOD-531 for use in insulin pumps. This work may lead to evaluation of the BIOD-531 in experimental artificial pancreas or closed loop systems.

Finally, we are pleased to report that two late-breaking poster presentation of BIOD-531 have been accepted for the 74th Scientific Session of the American Diabetic Association or ADA Meeting in San Francisco, California, June 13 to June 17, 2014. The first is related to our recently completed Phase 1 clinical trial while the second presents pre-clinical data on the relative PK and PD profiles of BIOD-531 which is Humalog or U-500 R in an insulin pump.

Let me now turn to our glucagon program which is focused on developing a portfolio rescue products of diabetes patient experiencing severe hypoglycemia or very low concentrations of blood glucose. Currently marketed glucagons products are complicated and difficult to use which has considerably impeded their acceptance and use.

Our goal is to introduce devices that both convert and expand this poorly served existing market. We continue to make steady progress in developing our two unique proprietary devices and companion formulation to accomplish this goal. Our most advanced programs for which we expect to submit an NDA in late 2015 is a device that we refer to as the Glucagon Emergency Management or GEM, GEM product.

The GEM is a customized version of a dual chamber auto reconstitution syringe manufactured by Unilife Corporation that we are developing for use as a rescue treatment for severe hypoglycemia. The GEM device is specifically designed to address and expand an underserved market currently wrestling with cumbersome kits that are especially difficult to use and operate during an emergency.

In the past quarter, we have continued progress on GEM, including completion of the dosing portion of the ongoing GLP toxicology study in rats. We anticipate the completion of the study, including pathology assessments and reports by the third calendar quarter. This is a final requirement before filing our IND in order to initiate clinical development.

In parallel, we plan on conducting at least two human factor studies this year and test and document the advantages of the GEM device versus an existing rescue kit. We also recently signed a long-term commercial manufacturing agreement with Emergent BioSolutions for the fill and finish of Biodel's GEM device.

This agreement along with the previously announced licensed and supply agreement for the GEM device with Unilife and the bulk glucagon supply agreement with Bachem, essentially completed the supply chain arrangements necessary to manufacture the registration lots required for NDA submission and scale up of the firm’s final commercial product. We are working with Unilife and Emergent in the technology’s transfer process to facilitate the manufacture of the GEM product.

We are pleased to have had an abstract accepted by the ADA for publication at the upcoming 2014 meeting, which compares the PK and PD profiles in dogs of our auto-reconstitution glucagon formulation to the marketed products.

In summary, with regards to the GEM program, we remain on track for an IND filing in the third calendar quarter of 2014, production of the registration lots and initiation of the clinical trials in the fourth calendar quarter of 2014 and an NDA submission in late 2015.

The second component of our glucagon program is the Uniject device, which is being developed as a follow-on product to complement the GEM product. As we announced late last year, we entered into a long-term supply agreement with Becton, Dickinson, one of the world’s leading suppliers and innovators for injection and infusion-based drug delivery.

This agreement granted us worldwide exclusive rights to the novel and proprietary Uniject disposable device for the delivery of liquid glucagon to treat severe hypoglycemia. The Uniject device is a very small portable, all-in-one prefilled drug delivery system for intramuscular and subcutaneous injections.

Uniject's low unit cost will allow us to develop liquid glucagon filled multipacks that enabled users to remove a single device from long-term refrigerated storage every four months to be carried as a go-anywhere ultra-portable defense against the threat of severe hypoglycemia. This multipack approach remarkably lowers the hurdle of room temperature stability, duration from two years down to four months and eliminates needs to refill a prescription immediately after using one of the devices.

Uniject’s ultra-portability and simplicity may be particularly compelling to active people with diabetes as well as parents and caregivers of children with diabetes. Having obtained exclusive access to the Uniject’s platform from Becton, Dickinson, we reinitiated our program late last year to develop stable liquid glucagon formulation.

Utilizing the technology, we then licensed from major therapeutics in 2012, we have made solid progress, improving the stability of glucagon formulation and are now testing several formulations in animal models. We also continue to develop stable, comfortable liquid glucagon formulations funded by an FDA grant that could further extend the market and address other applications such as the development of an artificial pancreas.

Now let me shift gears and touch on our ultra-rapid acting prandial insulin portfolio. As a reminder, our strategy with regards to the ultra-rapid acting prandial insulin products which require large development resources and commercial infrastructure is to develop the candidates through proof-of-concept and engage in partnering discussions. Our later stage program is our earlier aspart based ultra-rapid acting insulin candidate, BIOD-123.

As we reported in September 2013, BIOD-123 achieved a primary efficacy endpoint of non-inferiority in change from baseline HbA1c relative to Humalog in our 18-week Phase 2 clinical trial. We have recently received feedback from the FDA regarding pivotal trial requirements for BIOD-123. The FDA provided feedback from the design of proposed clinical studies necessary to secure approval for the product, with labeling describing its accelerated onset of actions.

The FDA also provided useful feedback on details of the pivotal Phase 3 programs, including lack of the requirements for a cardiovascular outcome trial. This feedback will greatly assist us with our ongoing conversations with potential corporate partners. Based on this information, we plan on moving BIOD-123 forward, when we finalize a partnership deal with a large pharmaceutical company with adequate resources to commercialize a prandial insulin incentive for both Type 1 and Type 2 patients.

Rounding on our four ADA presentations, we are also pleased to have been invited to give an oral presentation on the Phase 2 BIOD-123 results at the upcoming ADA Scientific Sessions. Let me finish by updating you on our analog-based ultra-rapid acting, insulin programs which offers opportunities independent of the RHI-based program.

We have previously presented data showing at our prototype Humalog-based formulation, BIOD-250, has a significantly more rapid rate of absorption, faster decline from peak concentration and injection site tolerability comparable to Humalog.

Utilizing lispro, the active pharmaceutical ingredient or an API in Humalog, we have identified what we believe are vital commercial candidates, with the appropriate stability and PK/PD profiles to move into the clinic. As with BIOD-123, we are discussing these candidates with companies, which have adequate resources to commercialize a prandial insulin and turn it for both Type 1 and Type 2 patients.

So we are also in active discussions with a number of manufacturers to source [DMP] (ph) supplies of lispro to enable clinical developments. In order to expand the utility of our ultra-rapid acting technology beyond RHI in lispro, we recently signed a research supply and technology development agreement with HEC Pharma for ultra-rapid acting insulin aspart, the API and NovoLog.

Under the agreement, HEC will supply insulin aspart, which Biodel will use to formulate aspart based ultra-rapid acting insulin formulations. Biodel has granted HEC an option to enter into negotiations for an exclusive license to develop and market in China any resulting product candidates. Biodel maintains rights with the product candidates in worldwide markets.

In summary, we are pleased to have achieved multiple important milestones in all of our key programs over the last quarter. I look forward to reporting on key milestones in 2014, such as the BIOD-531 Phase 2 data and the initiation of the GEM clinical study as we execute upon the strategy.

Now, I will turn the call over to Gerard for a review of our second quarter fiscal year 2014 financial results.

Gerard Michel

Thank you, Errol. Biodel reported a net loss for the three months ended March 31, 2014 of $6.2 million or $0.29 per share of common stock, compared to a net loss of $5.2 million or $0.37 per share of common stock for the same period in the prior year.

R&D expenses were $4.3 million for the three months ended March 31, 2014, compared to $3 million for the same period in the prior year. This increase is primarily due to expenses associated with the development of our GEM product candidate.

General and administrative expenses were $1.7 million for the three months ended March 31, 2014, compared to $2.2 million for the same period in the prior year.

Expenses for the three months ended March 31, 2014, included cost of $200,000, compared to $300,000 for the same period in the prior year and stock-based compensation expense related to options and restricted stock units granted to employees and our non-employee directors.

Biodel did not recognize any revenue during the three months ended March 31, 2014, or 2013. At March 31, 2014, Biodel had cash and cash equivalents of $28.7 million and 21.1 million shares of common stock outstanding. We continue to project that our current cash will last until at least the end of the second calendar quarter of 2015.

That concludes our prepared remarks. Now, we’d like the operator to open the call to your questions.

Question-and-Answer Session

Operator

(Operator Instructions) And our first quarter comes from Matt Kaplan of Ladenburg. Your line is now open.

Matt Kaplan - Ladenburg

Hi, guys.

Dr. Errol De Souza

Hey, Matt.

Matt Kaplan - Ladenburg

First, just wanted to touch on the ongoing discussions you mentioned with respect to your ultra-rapid-acting prandial program. Can you give us a sense in terms of where those partnership discussions are and what the opportunity is there?

Dr. Errol De Souza

Matt, thanks for the questions. And as you know from the past, we won’t project when a partnership deal might be consummated. But having said that, I think the interest level is very good and it’s really a bundling approach in terms of our discussions with partners really leverage the portfolio. And just to remind you and the audience, the portfolio of ultra-rapid-acting prandial insulin candidates currently include several formulations, which achieve both the stability profile and the PK/PD profile similar to what we showed in the clinic with 250. Obviously includes the later-stage asset, including BIOD-123 where we not only met the primary endpoint but also showed improvements relative to Humalog in terms of the meal challenge study.

And finally, now, we are adding to that portfolio a program that we’ve just initiated, which would be to develop aspart-based ultra-rapid-acting insulin formulations. So it’s truly a portfolio discussion that we’re having with the different players and the interest level is clearly there.

Matt Kaplan - Ladenburg

I guess now with the visibility that you have from the FDA in terms of the pivotal study requirements, should that assist in your discussions?

Dr. Errol De Souza

I think what it does, Matt, is actually provide clarity, because the obvious question that was always asked related by BIOD-123 was what the pivotal trial look like, what toxicology requirements was there, do you need a cardiovascular outcome trial as the FDA has required for several studies and what our correspondents with the FDA gave us was clarity in terms of the trials.

Alan, would you want to add specifics in terms of the type of feedback that we’ve got from the FDA? There is the trial design for Type 1, Type 2s and some of the other points that we addressed.

Dr. Alan Krasner

Well, yes, we actually -- this is Alan. We submitted to them for consideration full protocols and they gave us detailed feedback, most of which concurred with our plans. So we really have very definite guidance on what -- how big these trials would need to be, how long they would need to last, what sort of expectations they would have, what sort of regulatory expectations might exist in terms of the output of the trial.

Matt Kaplan - Ladenburg

Anything you willing to share with us now or that’s…

Dr. Alan Krasner

No, I mean, I think these trials are in general pretty standard and the trials we are talking about now would look very much like the parallel group, randomized studies that are doing at pivotal trials for most insulin products. We got some definition on how the trial would be divided. So most of these trials, as you know, are six months in treatment duration and we clarified with FDA how long we should titrate the doses versus how long we should leave the doses at relatively stable, and then measure HbA1c. Some analytic features were discussed, some statistical features, but in general, the overview of the trial is very similar to other pivotal trials.

Dr. Errol De Souza

Just to add to what Alan said as an example, I think there was an acknowledgement in terms of the efficacy demonstrated in the Phase 2 and the pivotal study in Type 1 will be smaller than the pivotal study would be in Type 2 patients as an example. They are encouraged to blind the trial as much as possible based on some of the discussions. So we’ve got a lot of feedback, Matt, which is exactly what we’re looking for and it helps us in terms of the discussions that we are currently having.

Matt Kaplan - Ladenburg

Very good. Thanks for the added detail. In terms of the 531 program now that you are in the two meal studies -- the Phase 2 meal studies, can you give us a sense in terms of what we should look for in that data when it’s announced the second half of the year?

Dr. Errol De Souza

Alan?

Dr. Alan Krasner

Right. I would hope that 531 based on its PK and PD profile that we’ve demonstrated in the initial plan study, I would hope that we’re able to show unambiguously that the postprandial glucose excursion after a meal is lower with 531 relative to the comparatives, the Humalog Mix and Humalog 500. I think that would be a clear demonstration of proof-of-principal that the more rapid absorption and the more rapid early glucose lowering effect translates into better coverage at mealtime.

Dr. Errol De Souza

The one other thing on the program that I referred to in the call, I mean, for us the key thing is again clarity from the FDA in terms of what is the path to NDA submission. As a reminder, U-500 -- Humulin R U-500 never went through doing pivotal studies. It was grandfathered demand. So we need that clarity. And as soon as we get that clarity and we anticipate getting that in the third quarter since we’ve already filed our questions, we could come back and talk about moving into late-stage clinical trials which really is a game changer for Biodel in terms of a late-stage program. So that coupled with the meal studies gives us some very nice value driving milestones I think in terms of the second half of 2014.

Matt Kaplan - Ladenburg

And you should have that feedback you said in the third quarter from the FDA?

Dr. Errol De Souza

We anticipate, you can never hold. There is no clock ticking on it, but I’ve got to say the FDA has been pretty good in terms of sort of the general quarter and a half in terms of feedback and that’s the basis of our projections anticipating feedback in the third quarter, which is not that far away in terms of giving us clarity what do we need to do in terms of moving into pivotal trials.

Matt Kaplan - Ladenburg

Good. And it sounds like you’re going to have a relatively significant presence at the ADA this year. And thanks for giving us the color in terms of what you expect to present there. Could you give us a sense in terms of related to your glucagon program, what we should focus on at ADA?

Dr. Errol De Souza

At ADA, actually, we were pleased that two of the presentations actually related to 531, both late-breaking, which I think gives us a really good sense of the interest level in 531 that they were selected after all the abstract deadlines had come about. Glucagon, we’re going to present the PK/PD data. It will be published actually just showing bioequivalence to the Lilly product and both of us been somewhat better and then talk about the GEM device.

The other thing that we were very pleased with is Alan will have an overall presentation, podium presentation on the Phase 2 data related to Biodel-123. So we’ve got a full plate with four presentations at the ADA.

Matt Kaplan - Ladenburg

Sounds very good. Congrats on the progress during the quarter.

Dr. Errol De Souza

Great. Thanks so much.

Operator

Thank you. Our next question comes from Marc Stutman of Trimark. Your line is now open.

Marc Stutman - Trimark

Hi, how are you? I just want to clarify a few things on the call. Did I understand correctly that you would not start a Phase 3 BIOD-123 trial until marketing arrangements have been done?

Dr. Errol De Souza

Marc, in line with the strategy that we’ve outlined sort of over the last couple of calls, we’ve got a lot in our plate. And we really need to think about which programs we fund with dollars and cash that we currently have so that we can drive significant milestones to build shareholder value and which programs best develop in the hands of partners that can not only bring the larger financial resources that would be required for a Phase 3 study, for example, with Biodel-122. But equally is important, the commercial infrastructure that is required to compete in this market where you have Novo and Eli Lilly dominating this area.

Marc Stutman - Trimark

Right.

Dr. Errol De Souza

So that’s the reason the decision we’ve made on the ultra-rapid-acting prandial insulin program, that’s BIOD-123. The lispro rate approach is to really move forward with a partner and not on our own.

Operator

The next question comes from Jason Butler of JMP Securities. Your line is now open.

Jason Butler - JMP Securities

Hi, thanks for taking my question. Just want to follow-up on the rapid acting program and discussions you have with FDA. Could you -- as well as discussing trial design, discuss potential label claims and really get a sense of how you could at least test questions to get items of clinical differentiation into label?

Dr. Errol De Souza

I’ll ask Alan to address that in particular sort of the ultra rapid acting Type of profile.

Dr. Alan Krasner

Yeah. Actually, we have had discussions with FDA on what I think is the key components of the label that you may be getting at. And that is how do we convey in the label to prescribing physicians that this is faster insulin than what’s on the market now in ultra-rapid. And the FDA gave us very specific guidance on a model study type that they’ve actually published that would achieve that. And specifically, it’s a standardized meal challenge study.

And in fact we use the feedback we receive from FDA on a proposed meal challenge study. That was in the context with BIOD-123 but we use that guidance to help us design this ongoing meal study for BIOD-531. It’s a same principle. In these studies, you take patients and you give them the experimental insulin versus the comparator insulin either right before meal or right after a meal.

And in some of these studies sometimes you give it different times with respect to the meal. And you look at the postprandial glucose curves as a result of the various timing of the injection with respect to the meal. And so since -- this actually was very, very specific in useful feedback we received from FDA. We’re actually using that feedback as we speak.

Jason Butler - JMP Securities

That’s great. Thanks. And then just on 531, can you just walk us through again how you think about the hypoglycemia risk in patients who are not severely insulin resistant?

Dr. Errol De Souza

Alan?

Dr. Alan Krasner

Well, that’s an interesting question. I would say that in general even non-severe insulin resistant Type 2 patients are much less prone to hypoglycemia overall than our Type 1 patient. And so I would imagine that there would be no difference in risk, if anything, I might even hope to see a little bit of a benefit. Although that might be hard to achieve because the incidence related hypoglycemia is so low in this patient population. So in order to see a different statistical, you might need a tremendous sample size.

But in general, I would certainly, wouldn’t expect excess hypoglycemia. When you are able to match a dose to a meal, like Type 1s often do, and when you achieve that better prandial coverage, I think that actually allows you to better choose the doses and if anything prevent hypoglycemia. But in general, I wouldn’t imagine that will be a problem for any of the insulin that I’m aware of in the Type 2 population.

Dr. Errol De Souza

This is a product basin where we’re looking at is really leveraging the more rapid absorption with a label advantage, which would be from the meal studies. But then the rest of the pivotal studies that frankly, we have proposed to the FDA and await their guidance would be a standard non-inferiority. And then we would have the advantage of lower volume injection versus the mix population.

And we would be comfortable to the volume injected with a concentrated insulin. But there, we should have real benefits in terms of the onset of action based on its more rapid absorption. So this is a little bit of a different type of a product where hypoglycemia frankly is something we will monitor but we’re not projecting actually in this population any added benefits there.

Dr. Alan Krasner

And I forgot to mention, if I could add, another thing that might correlate with increased hypoglycemia risk is the overall duration of action of an insulin. And in fact, in some cases, you can see stacking of insulin that moves around in the system to run. What we showed in our Phase 1 study was actually a lower overall duration of action compared to Humalog mix or a new R U-500. So, again, I would predict, they might come into play particularly overnight when patients are sleeping. So we might be able to show that’s nocturnal hypoglycemia but again that awaits multi-dose trials.

Jason Butler - JMP Securities

Great. That’s helpful. Thanks for taking the questions and congrats again on the progress.

Dr. Errol De Souza

Thank you, Jason.

Operator

Thank you. That concludes the Q&A portion of call. I’d turn the call back over to Dr. De Souza.

Dr. Errol De Souza

Great. Thank so much for calling in and we’re very pleased with the progress we’ve made over the last quarter on multiple Phase 2 trials. And really look forward to updating you on multiple milestones to come. Thanks so much. Have a great day.

Operator

Ladies and gentlemen, thank you for participating in today’s conference. This does conclude the program. You may all disconnect. Everyone have a great day.

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