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Viking Therapeutics Inc (VKTX 0.22%)
Q2Â 2019 Earnings Call
Aug. 01, 2019, 4:30 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Welcome to the Viking Therapeutics 2019 Second Quarter Financial Results Conference Call. [Operator Instructions]
I would now like to turn the conference over to Viking's Manager of Investor Relations, Stephanie Diaz. Please go ahead, Stephanie.
Stephanie Diaz -- President and Chief Executive Officer
Hello, and thank you all for participating in today's call. Joining me today is Brian Lian, Viking's President and CEO; and Michael Morneau, Vice President of Finance and Administration.
Before we begin, I'd like to caution that comments made during this conference call today, August 1st, 2019, will contain forward-looking statements within the meaning of the Securities Act of 1933, concerning the current beliefs of the Company, which involve a number of assumptions, risks and uncertainties. Actual results could differ from these statements and the Company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the Company's filings with the SEC concerning these and other matters.
I'll now turn the call over to Brian Lian for his initial comments.
Brian Lian -- Chief Executive Officer
Thanks, Stephanie, and thanks to everyone listening on the webcast or by phone. Today, we'll provide an overview of our second quarter financial results, as well as an update on recent progress and developments related to our pipeline programs and operations.
The second quarter of 2019 was exceptionally active at Viking. While it may have appeared relatively quiet from the outside, I can assure you that this was a time of great progress inside the Company. Early in the quarter, we presented a late-breaking poster at the EASL Conference in Vienna, highlighting new data from our Phase 2 trial of VK2809. These results demonstrated that VK2809, when dosed as low as 5 milligrams per day, produced efficacy that was similar to that observed at the higher 10 milligram doses reported previously. These new data provides further support for our belief that VK2809 possesses best-in-class characteristics and we are excited to further evaluate this agent for the potential treatment of non-alcoholic steatohepatitis or NASH.
We worked diligently during the quarter to prepare for our planned IND filing with the FDA, which will outline our upcoming Phase 2b clinical trial in patients with biopsy-confirmed NASH. I will provide additional detail on our second quarter development activities in a few minutes, but first, we'd like to review our second quarter financial results.
I'll now turn the call over to Mike Morneau, Viking's Vice President of Finance and administration to discuss our financial results. Mike?
Michael Morneau -- Vice President of Finance and Administration
Thanks, Brian. In conjunction with my comments, I'd like to recommend that participants refer to Viking's 10-Q filing with the Securities and Exchange Commission, which we expect to file later today for additional details. I'll now go over the financial results for the second quarter and six months ended June 30th, 2019.
Our research and development expenses for the three months ended June 30th, 2019, were $7.3 million compared to $5.2 million for the same period in 2018. The increase was primarily due to increased manufacturing expenses related to our drug candidates, preclinical study efforts, salaries and benefits, use of third-party consultants and stock-based compensation, partially offset by a decrease in clinical study expenses.
Our general and administrative expenses for the three months ended June 30th, 2019, were $2.2 million compared to $1.7 million for the same period in 2018. The increase was primarily due to increased stock-based compensation expense, salaries and benefits, use of third-party consultants and professional fees.
For the three months ended June 30th, 2019, Viking reported a net loss of $7.7 million, or $0.11 per share, compared to a net loss of $6.7 million or $0.13 per share in the corresponding period in 2018. The increase in the net loss for the three months ended June 30th, 2019, was primarily due to the increases in research and development and general and administrative expenses noted previously, partially offset by an increase in interest income.
The decrease in net loss per share for the three months ended June 30th, 2019, is primarily due to the additional shares outstanding at June 30th, 2019, versus those outstanding at June 30th, 2018, given the additional shares issued by the Company since June 2018, primarily through a public equity offering.
Our research and development expenses for the six months ended June 30th, 2019, were $11.8 million compared to $8.3 million for the same period in 2018. The increase was primarily due to increased manufacturing expenses related to our drug candidates, preclinical study efforts, salaries and benefits, use of third-party consultants and stock-based compensation expense, partially offset by a decrease in clinical study expenses.
Our general and administrative expenses for the six months ended June 30th, 2019, were $4.5 million compared to $3.5 million for the same period in 2018. The increase was primarily due to increased stock-based compensation expense, salaries and benefits, use of third-party consultants, insurance expense and professional fees.
For the six months ended June 30th, 2019, Viking reported a net loss of $12.6 million, or $0.18 per share, compared to a net loss of $10.2 million, or $0.21 per share, in the corresponding period in 2018. The increase in net loss for the six months ended June 30th, 2019, was primarily due to the increase in research and development expenses and general and administrative expenses noted previously, partially offset by an increase in income related to the decrease in the fair value of the debt conversion feature liability, as well as an increase in interest income.
The decrease in net loss per share for the six months ended June 30th, 2019, is primarily driven by the additional shares outstanding at June 30th, 2019, versus those outstanding at June 30th, 2018, given the additional shares issued by the Company since June 30, 2018, primarily through a public equity offering.
Turning to the balance sheet, at June 30th, 2019, we had cash, cash equivalents and investments totaling $292.6 million. As of July 30th, 2019, Viking had 72,210,630 shares of common stock outstanding.
This concludes my financial review, and I'll now turn the call back over to Brian.
Brian Lian -- Chief Executive Officer
Thanks, Mike. During the second quarter, we continued working diligently to prepare for our upcoming Phase 2b study of VK2809 in non-alcoholic steatohepatitis. As a reminder, VK2809 is an orally available small molecule agonist of the thyroid hormone receptor that possesses selectivity for liver tissue as well as the beta receptor subtype, suggesting promising therapeutic potential in a range of lipid disorders, including NASH.
In September of last year, we announced positive results from our Phase 2 trial of VK2809 in patients with hypercholesterolemia and fatty liver disease. The trial achieved both its primary and secondary endpoints, demonstrating potent reductions in liver fat content and improvements in plasma lipid measures. These results were presented last November during the oral late-breaker session at the Annual Meeting of the American Association for the Study of Liver Diseases, or AASLD. Additionally, updated results were presented this past April in a late-breaking poster at the Annual Meeting of the European Association for the study of the Liver or EASL.
The Phase 2 trial randomized patients to receive VK2809 doses of 5 milligrams daily, 10 milligrams daily, 10 milligrams every other day or placebo for 12 weeks. The trial's primary endpoint evaluated the effect of VK2809 on LDL cholesterol after 12 weeks of dosing compared to placebo. The key secondary endpoint evaluated change in liver fat as assessed by MRI proton density fat fraction or MRI-PDFF.
As we've reported at both the AASLD and EASL conferences, with respect to the trial's primary endpoint, VK2809 treated patients achieved statistically significant reductions in LDL compared with placebo treated patients. In addition, VK2809-treated patients experienced statistically significant improvements in other lipids, including triglycerides and the atherogenic proteins, apolipoprotein B and lipoprotein A.
With respect to the key secondary endpoint, VK2809 treated patients experienced significant reductions in liver fat as assessed by MRI-PDFF. The magnitude of this response remains unmatched among oral agents in development today. Specifically, patients receiving VK2809 dosed at 5 milligrams daily for 12 weeks, experienced a median relative reduction in liver fat content of approximately 54% from baseline. Patients receiving VK2809 doses of 10 milligrams every other day experienced a median relative reduction in liver fat content of approximately 57% from baseline and patients receiving VK2809 doses of 10 milligrams daily experienced a median relative liver fat reduction of approximately 60% from baseline. Across all VK2809 cohorts, the median relative reduction in liver fat was approximately 57%. By comparison, patients receiving placebo experienced a median relative reduction in liver fat of approximately 9%.
The trial also included the responder analysis, which was intended to assess whether the observed reduction in liver fat may predict broader clinical benefit. Patients were characterized as responders if they experienced a greater than or equal to 30% reduction in liver fat content. This threshold is of interest as multiple studies have demonstrated that liver fat reduction of 30% or more correlates with increased odds of improved overall histology.
In this study, all patients treated with VK2809 dosed at 5 milligrams daily experienced at least a 30% reduction in liver fat content. Approximately 77% of patients receiving VK2809 dosed at 10 milligrams every other day, demonstrated at least a 30% reduction in liver fat content and among patients treated with VK2809 doses of 10 milligrams per day, approximately 91% experienced at least a 30% reduction in liver fat. The responder rate across all of the VK2809 cohorts in this study was approximately 88%. By comparison, approximately 17% of patients receiving placebo demonstrated a response.
VK2809 also demonstrated an encouraging safety and tolerability profile in this study. No serious adverse events were reported among patients receiving VK2809 or placebo, and the overall numbers of adverse events were relatively evenly distributed across treatment arms. Given the promising potency and safety demonstrated in this study, we believe VK2809 is positioned as one of the most promising compounds in development today for the potential treatment of NASH.
VK2809's unique potential to improve liver health, while also providing global cardiovascular benefits through reductions in systemic lipids is a key differentiating factor when compared to many other agents currently in development for this setting.
As we have previously discussed, later this year, we plan to initiate a Phase 2b study of VK2809 in patients with biopsy confirmed NASH. To that end, we recently submitted a pre-IND briefing package to the FDA in anticipation of filing an IND to initiate the study. As a reminder, our existing IND, under which our 12-week Phase 2 study was conducted is filed with the FDA's Division of Metabolism and Endocrinology Products, which is where many lipid targeting agents are reviewed. Our planned IND will be filed with the FDA's Division of Gastroenterology and Inborn Errors Products, the division in which NASH drugs are typically reviewed. While the details of our planned Phase 2b study will be informed by our FDA interactions, we currently anticipate that the trial will target patients with F2 and F3 fibrosis, as well as a limited number with F1 fibrosis. We expect to evaluate more than one dose of VK2809 for up to 12 months.
In preparation for this study, we've been hard at work putting the resources in place to allow us to begin enrolling patients as soon as possible after we are clear to proceed. We look forward to providing further information about the study as we move closer to initiation.
I'll now provide an update on our VK0214 program. VK0214 is being evaluated as a potential treatment for X-linked adrenoleukodystrophy, or X-ALD. X-ALD is a devastating disease caused by a defect in a peroxisomal transporter called ABCD1. Defects in this transporter can result in an accumulation of very long chain fatty acids in plasma and tissue.
These elevations are believed to contribute to the severe cerebral and motor neuron toxicities that are characteristic of the disease. The thyroid beta receptor is an important potential target for therapeutic intervention in X-ALD as it is a known regulator of very long chain fatty acid metabolism.
Like VK2809, VK0214 is an orally available, small molecule thyroid receptor agonist that possesses selectivity for the beta receptor subtype. To-date, results from in-vitro and in-vivo studies of VK0214 have been encouraging. These data had demonstrated that administration of VK0214 results in a significant reduction of very long chain fatty acids in both plasma and tissue, potentially leading to a therapeutic benefit.
We are currently conducting the IND-enabling work for this program and plan to initiate a proof-of-concept study in humans early next year. We are excited to be advancing this program into the clinic and believe that VK0214 may represent the first potential pharmacologic agent for this debilitating disease.
Moving to corporate matters, we continue to maintain a strong balance sheet. As Mike indicated, we completed the second quarter with over $290 million in cash and equivalents. Our net burn in the quarter was approximately $6 million, which is consistent with our historical burn of $1.5 million to $2 million per month.
While we expect expenses to increase with the initiation of new clinical studies, we believe our current cash balance is sufficient to allow completion of multiple clinical inflection points, including our planned Phase 2b study of VK2809 in biopsy-confirmed NASH, as well as proof-of-concept studies with VK0214 in X-ALD.
Despite this runway, we remain keenly focused on managing our financial resources and controlling our development spend. To this end, concurrent with the filing of our quarterly Form 10-Q this evening, we will also be filing an at-the-market, or ATM prospectus, with the SEC. To be clear, we do not anticipate a need for additional capital in the near term, nor do we plan to utilize the facility at this point, rather, we're filing the documents as a matter of good housekeeping in line with many other companies at our stage of development.
Lastly, I'd like to take this opportunity to welcome the newest member of Viking's Board of Directors. We recently announced the appointment of Dr. Kathy Rouan to our Board. Dr. Rouan has nearly 30 years of pharmaceutical industry experience with drug discovery and development expertise across a range of therapeutic areas, including gastroenterology, cardiovascular disease, immunology and oncology. We are pleased to welcome Dr. Rouan to the team.
In conclusion, the second quarter was highlighted by continued progress toward our planned clinical studies with VK2809 and VK0214. The new Phase 2 data presented at EASL validated the potency and safety of VK2809 even at the lowest dose of 5 milligrams per day. These results provide further evidence of VK2809's unique potential to improve liver health while providing broad cardiovascular benefits, distinguishing it from other compounds starting in NASH and NAFLD in general.
Based on these findings, our team worked diligently during the second quarter to prepare for our planned IND filing for the continued clinical development of VK2809. We remain on track to file an IND and initiate a Phase 2b study of VK2809 in biopsy confirmed NASH later this year. In addition to our progress with VK2809, we continue to advance our pre-IND work for VK0214, and expect to initiate a proof-of-concept study for the treatment of X-ALD early next year.
Finally, to support these endeavors, we continue to carefully manage spending and have maintained a strong balance sheet that we believe will see the Company through key milestones, including our planned clinical studies.
This concludes our prepared comments for today. Thanks again for joining us, and I'd now like to open the call for questions. Operator?
Questions and Answers:
Operator
[Operator Instructions] The first question is from Joon Lee of SunTrust. Please go ahead.
Joon Lee -- SunTrust -- Analyst
Hi. Thanks for the questions and congrats on all the progress. To the extent that you're able, can you share any feedback from any discussions you may have had with the FDA regarding your pre-IND submission? And regarding your upcoming Phase 2b NASH study in the second half of '19, are there any trial differences you hope to incorporate so you can differentiate 2809 versus the competitors, any secondary endpoints of particular interest that we should be on the lookout for? Thank you.
Brian Lian -- Chief Executive Officer
Hi, Joon. Thanks for the question. So, no dialogue with the FDA really with respect to the package that was submitted. We do expect that in a relatively near term, but there isn't a lot of back and forth after the submission. You have a date that you'll receive the response at. And regarding the design of the Phase 2 study, I think, it's going to be a design similar to other Phase 2b studies that are out there. We don't have all of the parameters. We may change things based on the FDA feedback, but right now, it's going to look like other Phase 2b studies that have been completed and it's going to conform to the guidance that was published back in December.
Joon Lee -- SunTrust -- Analyst
That was great. Thank you.
Brian Lian -- Chief Executive Officer
Okay. Thanks, Joon.
Operator
The next question is from Steve Seedhouse of Raymond James. Please go ahead.
Steve Seedhouse -- Raymond James -- Analyst
Good afternoon, and thank you. Brian, just on the nature of the interaction with the FDA here, my understanding is when you request a pre-IND meeting, the sponsor can request the meeting by phone, face-to-face or a written response only. So, my question is, what type of meeting did Viking request and if Viking did request written response only upfront, maybe talk about whether that's because you didn't see anything controversial in the data package or just strategically why that would be the direction you decided to go?
Brian Lian -- Chief Executive Officer
Well, it wasn't our decision. We've requested a pre-IND meeting and we received a response that it would be a written response only. We didn't go back and debate or request anything further than that. We were told when the day would be and we were told that it was going to be a written response.
Steve Seedhouse -- Raymond James -- Analyst
Okay. Thank you. And I assume the final clinical study reports for Phase 2a and preclinical data from the six-month animal safety studies for VK2809 were submitted in the pre-IND package. So one question is, are the 12-month non-human primate studies also completed? And second part of that is, do you have any general comments on the results of those studies that you'd be willing to share?
Brian Lian -- Chief Executive Officer
No. We've always said, we're not going to go through the data from the completed GLP tox studies and that's pretty consistent across the industry. What was submitted in the pre-IND briefing package, we are not going to itemize what was submitted there. It typically submits summaries of completed studies, not the several thousand page clinical study reports. In a pre-IND package, the actual study reports go into the IND, but you summarize key findings in the briefing package with appendices that refer to key passages from the study reports.
Steve Seedhouse -- Raymond James -- Analyst
Okay. Last question, any abstracts submitted to AASLD this year? Thanks.
Brian Lian -- Chief Executive Officer
Sure. Thanks. Not yet. We may submit one a little bit later. I know we're past the original deadline, but the late-breaker deadline has not come up yet, so we may submit one for a late-breaker.
Steve Seedhouse -- Raymond James -- Analyst
Just to follow-up, would that be additional data from the Phase 2a study or something else?
Brian Lian -- Chief Executive Officer
Yeah. It would be from the Phase 2a study. Yeah.
Steve Seedhouse -- Raymond James -- Analyst
All right. Thank you.
Brian Lian -- Chief Executive Officer
Thanks, Steve.
Operator
The next question is from Jay Olson of Oppenheimer. Please go ahead.
Jay Olson -- Oppenheimer -- Analyst
Hi. Thanks for taking the questions. I was wondering if you could please comment on the doses that you're considering studying in Phase 2b? And then also, how fast do you think you can enroll that study or will you use the same study sites that you used for Phase 2a?
Brian Lian -- Chief Executive Officer
Hi, Jay. Thanks for the question. So we haven't given the details on the Phase 2b study. What we said is that, there will be some representation from the Phase 2a studies. There will be overlap in some of the doses from the Phase 2a study, as well as lower doses. And as far as the timing, as soon as possible but I think if you look at some of the recent Phase 2b studies that have been completed, that's kind of the timing that we would like to parallel. And so, if you think of four to six quarters from initiation till the initial data readout, that seems like a fairly reasonable estimate. We won't know until we get the study under way. And as far as the clinical sites, we'll probably use a couple from the Phase 2a study, but it's going to be more sites and so, we won't use -- there won't be a lot of overlap there, just a couple.
Jay Olson -- Oppenheimer -- Analyst
Will that be a global study?
Brian Lian -- Chief Executive Officer
No, we will be focused on the US.
Jay Olson -- Oppenheimer -- Analyst
Great. Thanks for taking the questions.
Brian Lian -- Chief Executive Officer
Thanks, Jay.
Operator
The next question is from Joe Pantginis of H.C. Wainwright. Please go ahead.
Joe Pantginis -- H.C. Wainwright -- Analyst
Hey, guys. Good afternoon. Brian, you probably can't say too much to my questions, but I wanted to go off of your prepared comments when you said, how busy you guys have been behind the scenes. So with that said, I wanted to focus on business development, maybe wanted to see if you had any comment about how things might be going for 5211. And do you have any potential early interest or phone calls or what have you for 2809?
Brian Lian -- Chief Executive Officer
Yeah. Great questions, Joe. So, yes, there we had a good bio meeting that was back in June in Philadelphia, a very busy schedule and that was probably split pretty close to 50-50 on 5211 and 2809. And we've always said, with 5211 the registration path seems challenging there, but there are still some, I think, interested parties with that program. Hard to guide to timing there, but I think it's safe to say, it's not stuffed back in a shelf and forgotten about here at the Company. With 2809, yeah, everybody is aware of the compound and has watched the development and continues to watch the development and probably won't give any more color than that on any of the dialogue we've had there.
Joe Pantginis -- H.C. Wainwright -- Analyst
No, of course, I won't ask you when the term sheet is coming, but that's very helpful. Thanks
Brian Lian -- Chief Executive Officer
Thanks, Joe.
Operator
The next question is from David Bautz of Zacks Small-Cap Research. Please go ahead.
David Bautz -- Zacks Small-Cap Research -- Analyst
Hey. Good afternoon. Brian, I'm curious if you would have any reason to believe that there would be a restrictions on enrollment in the Phase 2b trial? And also, do you have any expectation that you're going to be required to conduct a drug-drug interaction study with statin similar to what other NASH companies had to do?
Brian Lian -- Chief Executive Officer
So I think that's kind of a standard course of development and we would certainly expect to complete drug-drug interaction studies through the course of VK2809's development. And as I said to an earlier question, we're not going to itemize what was included in the briefing packet, or what will be included in the IND.
As far as the enrollment restrictions, we don't believe that we should be held to enrollment restrictions, but it's hard for me to prognosticate what the FDA will come back with, but there is no evidence that we're aware of that would suggest that those restrictions should be applied. The same restrictions from the Phase 2a should be applied to the Phase 2b, but again, very difficult to guess what the FDA will or will not allow.
David Bautz -- Zacks Small-Cap Research -- Analyst
Okay. And what is left to do for 0214 before an IND can be filed?
Brian Lian -- Chief Executive Officer
Well, we've done a lot of formulation work with that compound. The formulation is somewhat and we will be working on the GLP tox studies in the second half of the year.
David Bautz -- Zacks Small-Cap Research -- Analyst
Great. Thanks for taking the questions.
Brian Lian -- Chief Executive Officer
Thanks, David.
Operator
The next question is from Andy Hsieh of William Blair. Please go ahead.
Andy Hsieh -- William Blair -- Analyst
Hi. Thanks for taking my questions and congratulations on all the progress. Just from timing or disclosure perspective, are you planning on communicating with the Street in terms of when the written response from the FDA has occurred? And following that, would you let us know when you finalize the study design before initiating the study, just I want to get a sense of the news flow in the second half?
Brian Lian -- Chief Executive Officer
Yeah. I think the biggest news item will be the initiation of the study with the details on study design. I think that will answer questions that are out there. As far as when we receive a response, that's not going to help anybody decide anything. I mean, we certainly wouldn't disclose any details that we've received from the FDA. And the pre-IND information is not the IND itself and so we won't know really what the FDA thinks until we file the IND with the exact protocol with our recommended patient population and we get a response. So, once we get that response and begin enrolling is when we'll disclose most of those details.
Andy Hsieh -- William Blair -- Analyst
Okay. And it's my understanding that the IND immediately becomes active after 30 days, is that correct? So basically during that period of time no news is good news.
Brian Lian -- Chief Executive Officer
Yeah. What that normally means, you hear something on day 29, but yeah, no news is good news generally, yes. You don't hear anything, you're clear to proceed.
Andy Hsieh -- William Blair -- Analyst
Okay. And lastly, in terms of enrollment, obviously, there's a lot of Phase 2, Phase 3 trials ongoing in NASH, just curious if there's any strategy that you can employ to speed up or to incentivize patients to enroll in your study relative to others?
Brian Lian -- Chief Executive Officer
Yeah. It's a great question. There are a lot of studies out there and both internally and at our CRO, this has been a real high focus area. We think that our understanding from hearing from some of the sites that we will be participating, there's high enthusiasm for this program and we know that sites have been very responsive when queries are sent to them, according to CRO, more than they are typically seeing. And we will be employing, I think, a lot of the learnings that have been collected over the years from the completed studies to hopefully minimize screen failures and select the right patients to enter the screening process. And all of that, we hope will give us a reasonably productive enrollment time line.
Andy Hsieh -- William Blair -- Analyst
Okay. Cool. Thanks for answering all my questions.
Brian Lian -- Chief Executive Officer
Okay. Thanks, Andy.
Operator
The next question is from Yale Jen of Laidlaw. Please go ahead.
Yale Jen -- Laidlaw -- Analyst
Good afternoon, and congrats on the progress and thanks for taking the questions. Just want to be clear that for the IND filing, that you would not anticipate any face-to-face meetings, but just a more regular exchange of mails or phone calls to finalize the process, is that correct?
Brian Lian -- Chief Executive Officer
That's correct, Yale, yes.
Yale Jen -- Laidlaw -- Analyst
And my second question here is that the last presentation, you guys have shown a rather robust outcomes from a very low dose, if I make a part of that. So, the question is that, are you guys still contemplating maybe having some a loading and maintenance, those type of scheme being placed into the Phase 2 study or you think those are other things you should do in a much later time after the Phase 2b?
Brian Lian -- Chief Executive Officer
Yeah. It's a great question, Yale. I think we had originally spoken about that or talked internally at least about that loading dose followed by a low maintenance dose, I think the trial is complex and challenging enough without implementing that sort of regimen as an exploratory arm. You could still do it in a separate study and we'll see how this study goes, but I think that will be something that we could pursue in a separate study subsequent to this study or another time, but it won't be a part of this study.
Yale Jen -- Laidlaw -- Analyst
Okay. Great. And thanks and congrats for the progress.
Brian Lian -- Chief Executive Officer
Thanks a lot.
Operator
[Operator Instructions] The next question is from Mayank Mamtani of B. Riley FBR. Please go ahead.
Mayank Mamtani -- B. Riley FBR -- Analyst
Thanks for taking my question and congrats on the progress. Just two for Brian and one for Mike. Brian, could you maybe talk a little bit about the structural differences for 2809 and 0214? I understand, obviously, the target and the pro-drug format, but I think you mentioned formulation was different. And maybe if there's anything you could comment on the effect on CYP3A and/or vinyl ketone derivative as a byproduct for each of them, that would be great? And then I have a follow-up.
Brian Lian -- Chief Executive Officer
Yeah. 0214 is a different structure and the way we normally write these is the polar part is on the right-hand side and the aromatic ring is kind of extended to the left. The structure of 0214 has never been disclosed, but the substitution pattern on those rings is different between the two molecules. So it does have a little bit different profile in-vitro and in-vivo. It's more selective for the beta receptor and the PK parameters are a little bit different. We always run them side-by-side when we do the animal studies in NASH, and it's certainly very effective in NASH as well. Just when you look at the sub-components, it just looks a little bit different. And so we think that, right now, I mean, just pursuing X-ALD is the best course there.
Mayank Mamtani -- B. Riley FBR -- Analyst
That's really helpful insight. Just to follow-up on that then, as you do the work together on either/or and both together, has there been any observation in the last six to nine months that kind of made your plans to be any different than where you started with?
Brian Lian -- Chief Executive Officer
No changes based on data in the last six to nine months.
Mayank Mamtani -- B. Riley FBR -- Analyst
Excellent. And then, last thing, the placebo response on the 5 mg, was there anything different? I know you reported on an absolute basis for all doses, was there anything that you saw that placebo response was different or similar to the earlier arm?
Brian Lian -- Chief Executive Officer
No. I think that arm added two -- that cohort dataset added two more placebo patients. I don't have the numbers right in front of me, and those placebo patients did not have any meaningful impact on the overall placebo data.
Mayank Mamtani -- B. Riley FBR -- Analyst
Okay. Great. And Mike, just one last question, there were four buckets you said in the R&D spend. I mean would you be able to give any color whether the increase from previous six months or three months was driven by any one or two of the buckets there, like manufacturing expense or pre-IND spend or anything else?
Michael Morneau -- Vice President of Finance and Administration
Yeah. It's a combination of the manufacturing spend as well as some of the efforts on the preclinical side in terms of getting some of the preclinical efforts pull together.
Mayank Mamtani -- B. Riley FBR -- Analyst
Okay. Great. Thanks for taking my questions.
Brian Lian -- Chief Executive Officer
Thanks, Mayank.
Operator
The next question is from Scott Henry of ROTH Capital. Please go ahead.
Scott Henry -- ROTH Capital -- Analyst
Thank you and good afternoon. Just a couple of questions. First, on 2809, could you talk about what is the typical turnaround from a pre-IND submission to when you would get written feedback?
Brian Lian -- Chief Executive Officer
It's 30 days.
Scott Henry -- ROTH Capital -- Analyst
Then it's 30 days from that point the IND to the final or is that an overlapping 30 days?
Brian Lian -- Chief Executive Officer
No. You submit a package, you get information from them and then you, at some later date, file an IND or a new 30-day clock starts.
Scott Henry -- ROTH Capital -- Analyst
Okay. And that's what my understanding was, so it's 30 days as well for the pre-IND submission?
Brian Lian -- Chief Executive Officer
That's right.
Scott Henry -- ROTH Capital -- Analyst
Okay. Thank you for that color. And the second question was, if I recall the original target for the IND was mid-summer. It would seem like we're into the fall, given today's comments. Was there anything that pushed that beyond mid-summer or is it still mid-summer? Just any color you could give would be great.
Brian Lian -- Chief Executive Officer
Yeah. No, it is still around the middle of the summer. I'm not going to give a lot of additional color there.
Scott Henry -- ROTH Capital -- Analyst
Okay. Fair enough. Which would certainly imply that you expect all this to happen very soon. Separate question tied in a little bit to the R&D, it did jump up significantly in 2Q. How should we think about Q2 as a reflection of the rest of the year in terms of sequential growth or should it dip until the trial starts or should we think about it maintaining these levels?
Brian Lian -- Chief Executive Officer
On the R&D side, it's going to tick up here in the second half of the year as we ramp up the spend for the Phase 2b study.
Scott Henry -- ROTH Capital -- Analyst
Okay Great. That should do it for me. Thank you for taking the questions.
Brian Lian -- Chief Executive Officer
Yeah. Thanks, Scott. And just to clarify, middle of the summer, the calendar summer is what we were referring to there. So, middle of the calendar summer is when we had previously indicated we expected to hear something from the FDA, but we never have given a specific date there, just to clarify that, though.
Scott Henry -- ROTH Capital -- Analyst
Just as a follow-up then, what exactly is the calendar summer?
Brian Lian -- Chief Executive Officer
If you look at the calendar, it's third week of June to third week of September.
Scott Henry -- ROTH Capital -- Analyst
Okay. Great. That's helpful. Thank you.
Brian Lian -- Chief Executive Officer
Okay.
Operator
The next question comes from Jason McCarthy with Maxim Group. Please go ahead.
Adep -- Maxim Group -- Analyst
Hi. Everyone, it's Adep [Phonetic] on the line for Jason. Just had a couple of quick questions here, so as I understand, you guys are currently focusing on working with the FDA and down the road eventually getting approval, but I was just wondering, once that's taken care of and achieved, do you have any intention of perhaps setting up meetings with the corresponding regulatory authorities in Europe, is this something that you guys are kind of thinking about?
Brian Lian -- Chief Executive Officer
Not right now, I mean, the focus near term is moving into the Phase 2b study and I mean, we will likely queue up some sites in Europe in the event that enrollment is slower than planned in the US, but there won't be any major European regulatory interactions.
Adep -- Maxim Group -- Analyst
Okay. Great. Thanks. And then with respect to VK2809, do you guys plan on primarily using this as a front-line therapy or do you have any intention of evaluating it in the context of using in conjunction with other current standard-of-care therapies?
Brian Lian -- Chief Executive Officer
We think the data and the mechanism suggests that it could be used in either setting. I think, right now, the expectation is that combination therapy will likely provide the greatest benefit, but we think early stage patients could probably benefit from the mechanism and certainly, in combination, we think it could enhance and be complementary to some of the existing mechanisms -- some of the other mechanisms.
Adep -- Maxim Group -- Analyst
Great. That's very helpful. Thanks a lot. Appreciate it.
Brian Lian -- Chief Executive Officer
Okay. Thank you.
Operator
This concludes our question-and-answer session. I would like to turn the conference back over to Stephanie Diaz for closing remarks.
Stephanie Diaz -- President and Chief Executive Officer
Thank you. Thanks again for your participation and continued support of Viking Therapeutics. We look forward to updating you again in the coming months. You can all disconnect. Thank you and have a great afternoon.
Operator
[Operator Closing Remarks]
Duration: 41 minutes
Call participants:
Stephanie Diaz -- President and Chief Executive Officer
Brian Lian -- Chief Executive Officer
Michael Morneau -- Vice President of Finance and Administration
Joon Lee -- SunTrust -- Analyst
Steve Seedhouse -- Raymond James -- Analyst
Jay Olson -- Oppenheimer -- Analyst
Joe Pantginis -- H.C. Wainwright -- Analyst
David Bautz -- Zacks Small-Cap Research -- Analyst
Andy Hsieh -- William Blair -- Analyst
Yale Jen -- Laidlaw -- Analyst
Mayank Mamtani -- B. Riley FBR -- Analyst
Scott Henry -- ROTH Capital -- Analyst
Adep -- Maxim Group -- Analyst
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