Viking Therapeutics Inc (VKTX)

[whytestocks]

News: $VKTX Viking Therapeutics to Present at 2019 Cantor Global Healthcare Conference

SAN DIEGO , Sept. 25, 2019 /PRNewswire/ -- Viking Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced that the company will deliver a corporate pr...

Find out more VKTX - Viking Therapeutics to Present at 2019 Cantor Global Healthcare Conference

[PaPaGriz]

Here's a little article about VKTX. Nice to have a bit of opinion being published.

https://seekingalpha.com/article/4222613-viking-therapeutics-live-hype

[greens12]

Looking forward to getting the Phase 2b vk2809 started, it should lift the stock .

VKTX

[roadkilll]

Impressed with the 5mg data and really hoping for a 2.5mg arm in coming trial

Comparison of Madrigal's drug and Viking is even more encouraging

Madrigal's ß SELECTIVE AGONIST FOR NASH
Molecular Weight: 435.22 and dosage of 100mg

Viking"s ß SELECTIVE AGONIST FOR NASH
Molecular Weight : 514.98 and dosage of 5mg

Viking's VK2809 more ß selective and can be used at a lower dose? And, nobody is ruling out a 2.5mg dose. The lower the dose the fewer off target hits you get and better odds of a more effective safer drug. Madrigal's MGL-3196 (resmetirom) had very impressive biopsy based phased 2 trial showing till then unprecedented liver fat reduction and fibrosis reduction, just not nearly as good as Vikings VK2809.

Looks like MDGL and VKTX are going to be winners for investors, 2H19 is going to be interesting

[roadkilll]

Appreciate the CC post
Looks like a lot analyst interest is picking up as Viking nears some important FDA feedback.

[DMOST]

Viking Therapeutics Inc (VKTX) Q2 2019 Earnings Call Transcript

Viking Therapeutics Inc (NASDAQ: VKTX)
Q2 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

More VKTX analysis

Transcript powered by AlphaStreet

This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability.

This article was originally published on Fool.com
https://finance.yahoo.com/news/where-viking-therapeutics-1-204257603.html

GO VKTX

"PEACE"

[roadkilll]

7/15/2019 22,751,462 shares short
Continues to drop. What happens to these shorts if Phase II trials are announced with a 2.5mg arm? An effective drug at 20mg with a go forward side effect profile. A very broad range of dosages allows for a lot of interesting things to be tried.
Madrigal is ahead in trials with a best class of NASH drugs in a phase 3 trail, but may be having a problem looking over it's shoulder with Vikings best in class.

GLTA, the catalysts to move this stock are getting near

[DMOST]

VKTX: Awaiting Feedback from FDA regarding pre-IND submission; Phase 2b trial in NASH expected to initiate 2H19…

Business Update

Phase 2b Trial for VK2809 to Initiate 2H19

Viking Therapeutics, Inc. (VKTX) is currently preparing for the initiation of a Phase 2b clinical trial of VK2809, the company’s thyroid beta receptor (TRß) agonist, for the treatment of nonalcoholic steatohepatitis (NASH). The company has submitted a pre-IND briefing package to the FDA and is currently awaiting written feedback. The pre-IND submission was completely voluntary; the company undertook in an effort to gauge the agency’s thoughts regarding the upcoming Phase 2b trial and any potential areas that may require more attention in the IND. The Phase 2a trial (performed under an IND filed with the Division of Metabolic and Endocrinology Products) had restrictive inclusion criteria, thus it was in the company’s best interest to gauge whether the Division of Gastroenterology and Inborn Error Products (where the IND for the Phase 2b trial will be filed) had any potential concerns about patient inclusion or other aspects of the company’s plan for the trial.

We anticipate that Viking will receive feedback regarding the pre-IND submission in the next couple of weeks. Assuming the FDA has no major issues regarding the company’s current thinking on the study design, the IND will be submitted as quickly as possible. Following submission of the IND, the FDA then has 30 days to respond with any concerns, otherwise the company will be free to initiate the trial. It is at this time we anticipate learning the details of the trial regarding number of patients, dosing, treatment length, etc.

Viking cannot finalize details of the trial until after hearing back from the FDA, however we believe that the trial will include biopsy-confirmed NASH patients with F2 and F3 fibrosis (with potentially a small number of F1 fibrosis patients). Based upon the efficacy of the 5 mg dose in the Phase 2a trial, we anticipate at least one dose below 5 mg being tested. When examining data from the 14-day Phase 1 trial, in which doses from 0.25 mg to 40 mg were tested, signs of efficacy were not apparent below the 1 mg dose, thus we don’t anticipate the company going below that dose.

We continue to anticipate the trial initiating in the second half of 2019 and based on the length for competitors Phase 2b trials we estimate topline data will be available in the first half of 2021, although the fourth quarter of 2020 is not out of the question. Regarding the pace of enrollment, the company is aware that it could present a potential problem given the number of trials ongoing in NASH and is doing everything possible to mitigate potential competitive issues. In comparison to the Phase 2a trial, management anticipates enrollment proceeding more smoothly.

Data Presentation at EASL Showcases VK2809 Superior Attributes

Following the data presentation at EASL (see our previous report for a full discussion), we view VK2809 as a potential ‘best-in-class’ treatment for NASH based on its efficacy, potency, and safety.

? The mean relative liver fat reduction in the 5 mg cohort was -53.8% (P=0.0001), which compared quite favorably to the cohorts receiving 10 mg every other day (-56.5%, P=0.0018) and 10 mg every day (-59.7%, P=0.0004). In addition, all nine patients in the 5 mg cohort experienced ≥ 30% reduction in liver fat and 77.8% were ‘super-responders’, defined as experiencing ≥ 50% reduction in liver fat.

? The results seen with the 5 mg cohort are superior to both of the cohorts in Madrigal Pharmaceuticals’ (MDGL) Phase 2b trial, as shown in the table below. For those who may argue that the patient populations are too dissimilar to offer a valid comparison, we believe that the very similar placebo responses seen in both outcomes in the table below indicate that the two populations are in fact quite similar. In addition, we have yet to see data on the proportion of MGL-3196 ‘super responders’, or data from patients who received and stayed on the 80 mg starting dose of MGL-3196, or data from patients receiving either the up- or down-titrated doses of MGL-3196. Rather, the only MGL-3196 data that have been presented have been pooled results from patients receiving “high exposure” to the drug, without further explanation with respect to dose level or corresponding statistical relevance.


View Exhibit I

? Safety and adverse event data showed that there were no serious treatment-emergent adverse events (TEAEs) and that a greater percentage of VK2809-treated patients completed the study compared to those receiving placebo. There were similar proportions of VK2809- and placebo-treated patients experiencing cardiovascular (CV)-related AEs and no changes to CV toxicity markers (troponin, CK-MB, NT-proBNP) were reported, thus further supporting the cardio safety of VK2809. Lastly, treatment with VK2809 resulted in statistically significant decreases in LDL cholesterol, triglycerides, and the atherogenic proteins apolipoprotein B and lipoprotein A. We believe this may be particularly relevant in a NASH population as the most common cause of death for patients with NAFLD is cardiovascular disease (Azzam et al., 2015).

VK0214 IND Anticipated in 1H20

VK0214 is being developed for the treatment of X-linked adrenoleukodystrophy (X-ALD), an orphan neurodegenerative disease that affects approximately 8,000 individuals in the U.S. and 12,000 in Europe. In contrast to VK2809, VK0214 is a TRß agonist that is activated by carboxyesterases that are ubiquitously expressed in the body. The drug also has a different pharmacokinetic and pharmacodynamic profile than VK2809, thus potentially making the drug more suitable for a disease such as X-ALD, which is more diffuse than NASH.

X-ALD is caused by a mutation(s) in the ABCD1 gene, which encodes the adrenoleukodystrophy protein (ALDP). ALDP is responsible for transporting very long chain fatty acids (VLCFAs) into peroxisomes for degradation, thus without proper ALDP function the VLCFAs accumulate to toxic levels. The theory behind using VK0214 to treat X-ALD is that it increases the expression of ALDR (encoded by the ABCD2 gene), which is also a VLCFA transporter, thus compensating for the loss of ALDP. The following graph shows that VK0214 induces the expression of the Abcd2 gene in mice.


View Exhibit II

The company previously reported positive in vivo results from a study involving the Abcd1 knock-out (KO) mouse model, which while not displaying the inflammatory characteristics of the more severe forms of X-ALD, does recapitulate a phenotype similar to those with adrenomyeloneuropathy (AMN), the less severe form of X-ALD. As shown in the following figure, Abcd1-/- mice have elevated levels of VLCFAs compared to wildtype mice.


View Exhibit III

Treatment with VK0214 resulted in a dramatic decrease in VLCFA levels in plasma only six weeks after initiating treatment, and this decline held relatively steady through the entire 25-week treatment period.


View Exhibit IV

Perhaps most importantly, tissue levels of VLCFAs were shown to be lower in mice treated with VK0214 compared to mice treated with vehicle control. The following figure shows there was a statistically significant decrease in the level of C26:0 in both the liver and spinal cord. In addition, in the brain there was a statistically significant decrease in C20:0 and an 11% decrease in C26:0 that trended toward significance (P=0.07).


View Exhibit V

IND-enabling studies are currently ongoing for VK0214, and we anticipate an IND being filed such that a proof-of-concept study can be initiated in the first half of 2020.

Financial Update

On August 1, 2019, Viking announced financial results for the second quarter of 2019. As expected, the company did not report any revenues in the second quarter of 2019. The company reported a net loss of $7.7 million, or $0.11 per share, for the second quarter of 2019 compared to a net loss of $6.7 million, or $0.13 per share, for the second quarter of 2018. R&D expenses for the second quarter of 2019 were $7.3 million compared to $5.2 million for the same period of 2018. The increase was primarily due to increased manufacturing expenses, pre-clinical studies, third-party consultants, and stock-based compensation. G&A expenses in the second quarter of 2019 were $2.2 million compared to $1.7 million for the second quarter of 2018. The increase was primarily due to increased stock-based compensation, salaries, and the use of third-party consultants.

As of June 30, 2019, Viking had approximately $292.6 million in cash, cash equivalents, and short-term investments. As of July 31, 2019, Viking had approximately 72.2 million shares of common stock and when factoring in stock options, warrants, and restricted stock the company has a fully diluted share count of approximately 81.4 million shares.

Conclusion

We’re glad to hear that everything remains on track for filing the IND for VK2809 and initiating the Phase 2b clinical trial in the second half of 2019. Investors should not expect any type of announcement regarding the IND or trial initiation until the study is cleared to get underway, thus for the time being “no news is good news”. We believe the company is well prepared to get the study started and to execute it as efficiently as possible and while data will likely not be available until the first half of 2021, the potential for partnerships for VK2809, VK5211, and/or VK0214 continues. Our current valuation is $24.
https://finance.yahoo.com/news/vktx-awaiting-feedback-fda-regarding-153000052.html

..If things hold to annual pattern(s). We should be seeing some up-tick in share pricing going into the middle of Aug? But past performance is no guarantee a of future movement equivalency.

GO VKTX

"PEACE"

[BreakOnThrough]

Totally agree with both the how long this dry spell has been and how necessary it is for Brian to step up his game. I can’t believe we hit $7 again today. So frustrating to see that. I just keep thinking about how positive the results have been and WB’s quote “the stock market is a device for transferring money from the inpatient to the patient”. I’m being patient but bloody hell this is getting old!

[greens12]

vk5211 has huge potential , the great data they have from the P2 trial will be enough to find at least a couple IND's. I'm trying to stay Patient awaiting some news it has been a long dry spell for a long time and Brian needs to step up his game and give shareholders a big PR.

VKTX

[BreakOnThrough]

I haven’t been optimist, (in the short term in the long term I’m still all in), about anything with this stock for a while now but I am about IND news. Curious what others are thinking about it? Do you think we’ll finally see some actual change here?

[greens12]

Nice bounce today, should see 9.00 soon. Waiting for that vk5211 news on IND or partnership.

VKTX

[BreakOnThrough]

You’ve got that right!!

[smallbio]

A partnership announcement for Vk5211 would be nice.

[BreakOnThrough]

Thoughts on ringing the bell tomorrow..?
Curious What others are thinking about it. In my mind it seems like a weird thing to do if they’re not going to follow it up with some kind of news or action. I know we’ve been promised a “midsummer” announcement but Brian’s announcements tend to be pretty underwhelming. Won’t it show a weak face publicly if after the bell ringing nothing happens?

[greens12]

CEO Meeting with the FDA mid summer for IND .

[DMOST]

VKTX...Nada, Zilch, Noot short term. Long term? Phrase 3 study results TBA.
https://finance.yahoo.com/quote/VKTX/?p=VKTX

But there is always a chance a buyer may announce further interest?

GO VKTX

"PEACE"

[PaPaGriz]

Is anything on the docket for VKTX anytime soon? Seems like there hasn't been a significant PR in quite a while.

[DMOST]

How Viking Therapeutics Is Positioned

Viking Therapeutics (VKTX) stock closed at $7.98 on June 12, 2.70% higher than its previous close, 14.49% above its 52-week low of $6.97, and 66.75% below its 52-week high of $24. The company had a market capitalization of $565.38 million. The stock has mainly gained on news of NASH (nonalcoholic steatohepatitis) drug competitor CymaBay Therapeutics reporting discouraging Phase 2b results for its investigational PPARd (peroxisome proliferator-activated receptor delta) agonist, seladelpar.
VK2809 growth prospects

Viking is exploring the use of its investigational small molecule thyroid hormone receptor agonist, VK2809, in NASH. Last September, the company reported positive top-line results for the drug in a Phase 2 trial in terms of improved liver fat and plasma lipid levels. At the International Liver Congress in April, the company presented new data on VK2809’s possible cardiovascular benefits.

Viking plans to file an investigational new drug application to commence a Phase 2b trial evaluating VK2809 in biopsy-confirmed NASH patients. The study is set to explore the effects of several dose strengths of the drug in NASH patients with F2 and F3 fibrosis.

Analysts expect Viking to report revenue of $21.90 million in fiscal 2021. At the end of the first quarter, the company had cash, cash equivalents, and marketable securities worth $298.7 million.
https://marketrealist.com/2019/06/how-viking-therapeutics-is-positioned/?utm_source=yahoo&utm_medium=feed&yptr=yahoo

GO VKTX

"PEACE"

[DMOST]

What Analysts Recommend for CBAY and VKTX

This year, CymaBay Therapeutics (CBAY) has fallen 21.60% and Viking Therapeutics (VKTX) has risen 4.31%. While both clinical-stage companies focus on advancing their NASH (nonalcoholic steatohepatitis) R&D (research and development) programs, Viking seems to be ahead, considering its successful Phase 2 trials. However, Viking’s valuation is higher than CymaBay’s, especially after the latter crashed by ~45% on June 11. Whereas Viking’s PB (price-to-book) and PC (price-to-cash) ratios are 1.94x and 1.89x, respectively, CymaBay’s PB and PC ratios are 1.48x and 1.59x.

NASH’s global addressable market opportunity has been estimated to be $35 billion. In this backdrop, we’ll assess CymaBay’s and Viking’s pros and cons to evaluate which may be a better pick in the long run.

Analysts’ recommendations and target prices

Most analysts recommend “buy” for CymaBay and Viking. They reduced their target price for CymaBay stock from $21.70 in March and April to $21.64 in May and then to $16 in June, which implies a 159.32% upside based on its June 12 closing price. Their highest and lowest estimates are $26 and $8. Of the 11 analysts covering CymaBay, four recommend “strong buy,” six recommend “buy,” and one recommends “hold.”

Analysts have gradually increased their target price for Viking stock, from $26.94 in March to $27 in April, and then to $27.13 in May and June, which implies a 239.97% upside based on its June 12 closing price. Their highest and lowest estimates are $41 and $16. Of the nine analysts covering Viking, three recommend “strong buy,” and six recommend “buy.”
https://marketrealist.com/2019/06/what-analysts-recommend-for-cbay-and-vktx/

GO VKTX

"PEACE"

[Murph32]

So much for your bones I suppose. Came up well short with that offering, certainly won't be the last time. lol

[greens12]

Still holding strong, I'm here for the short squeeze or buyout.

VKTX

[DMOST]

GO VKTX

"PEACE"

[DMOST]

Have Insiders Been Buying Viking Therapeutics, Inc. (NASDAQ:VKTX) Shares?

Want to participate in a short research study? Help shape the future of investing tools and you could win a $250 gift card!

We often see insiders buying up shares in companies that perform well over the long term. On the other hand, we'd be remiss not to mention that insider sales have been known to precede tough periods for a business. So shareholders might well want to know whether insiders have been buying or selling shares in Viking Therapeutics, Inc. (NASDAQ:VKTX).
Do Insider Transactions Matter?

It is perfectly legal for company insiders, including board members, to buy and sell stock in a company. However, most countries require that the company discloses such transactions to the market.

We would never suggest that investors should base their decisions solely on what the directors of a company have been doing. But it is perfectly logical to keep tabs on what insiders are doing. For example, a Harvard University study found that 'insider purchases earn abnormal returns of more than 6% per year.'

View our latest analysis for Viking Therapeutics
Viking Therapeutics Insider Transactions Over The Last Year

In the last twelve months, the biggest single purchase by an insider was when Chairman Lawson MacArtney bought US$250k worth of shares at a price of US$5.22 per share. Even though the purchase was made at a significantly lower price than the recent price (US$7.97), we still think insider buying is a positive. While it does suggest insiders consider the stock undervalued at lower prices, this transaction doesn't tell us much about what they think of current prices.

Over the last year, we can see that insiders have bought 95465 shares worth US$540k. But they sold 21551 for US$199k. Overall, Viking Therapeutics insiders were net buyers last year. You can see a visual depiction of insider transactions (by individuals) over the last 12 months, below. If you click on the chart, you can see all the individual transactions, including the share price, individual, and the date!
NasdaqCM:VKTX Recent Insider Trading, May 14th 2019
NasdaqCM:VKTX Recent Insider Trading, May 14th 2019

Viking Therapeutics is not the only stock insiders are buying. So take a peek at this free list of growing companies with insider buying.
Does Viking Therapeutics Boast High Insider Ownership?

For a common shareholder, it is worth checking how many shares are held by company insiders. Usually, the higher the insider ownership, the more likely it is that insiders will be incentivised to build the company for the long term. Insiders own 2.6% of Viking Therapeutics shares, worth about US$16m. This level of insider ownership is good but just short of being particularly stand-out. It certainly does suggest a reasonable degree of alignment.
What Might The Insider Transactions At Viking Therapeutics Tell Us?

It doesn't really mean much that no insider has traded Viking Therapeutics shares in the last quarter. On a brighter note, the transactions over the last year are encouraging. Overall we don't see anything to make us think Viking Therapeutics insiders are doubting the company, and they do own shares. Of course, the future is what matters most. So if you are interested in Viking Therapeutics, you should check out this free report on analyst forecasts for the company.
https://finance.yahoo.com/news/insiders-buying-viking-therapeutics-inc-150637917.html

GO VKTX

"PEACE"

[sorkin]

Dreaming!

[guyguyguy]

GILD or BMY or PFE will offer to buyout VKTX in the next 30 days.... IMHO. Shorts Shit their pants. Feel it in my bones. Crazy option action, today! Something's up!!

[sorkin]

28.7 million shares short!!

[Sage7243]

Wow! Excellent analysis. I am intrigued.

[Murph32]

That means absolutely nothing for the most part, especially in biotechs.

[sorkin]

VRTX needs another dosing 40mg/day in their trial! And that may be the
Game Changer!

[sorkin]

Largest institutional holder
Fidelity management and research
Sold 2.1 M shares out of 3.89 M holding

[greens12]

All the Analysts covering this stock have Targets above 20.00, and Raymond James has 40.00 PT.

VKTX

[sorkin]

$5

[DMOST]

What Are Analysts Recommending for VKTX and ENTA?
WRITTEN BY Margaret Patrick FEATURED IN Company News, Insights, & Analysis

Stock price movement

On April 12, Viking Therapeutics (VKTX) closed at $9.35, 6.22% lower than its previous closing price, 153.39% higher than its 52-week low of $3.69, and 61.04% below its 52-week high of $24.00. The company’s market capitalization is $653.47 million, and its PB (price-to-book) and PC (price-to-cash) ratios are 2.25x and 2.17x, respectively. Since its last earnings release on March 13, Viking Therapeutics stock has increased by 13.33% from $8.25 on March 13 to $9.35 on April 12.

What Are Analysts Recommending for VKTX and ENTA?

On April 12, Enanta Pharmaceuticals (ENTA) closed at $92.20, 0.47% higher than its previous closing price, 43.87% higher than its 52-week low of $64.08, and 27.84% below its 52-week high of $127.77. The company’s market capitalization is $1.79 billion, and its PE, PS (price-to-sales), PB, and PC ratios are 22.35x, 7.51x, 4.20x, and 5.18x, respectively.

Since its last earnings release on February 6, Enanta Pharmaceuticals stock has increased by 10.00% from $83.80 on February 6 to $92.20 on April 12.

Analysts’ recommendations and target price

Wall Street analysts expect an upside potential of 188.77% for Viking Therapeutics based on the company’s closing price on April 12. Analysts reduced the company’s 12-month consensus target price from $29.79 in February to $26.94 in March but have raised it to $27.00 in April. The current consensus analyst recommendation for the stock is a “buy.”

Of the nine analysts covering Viking Therapeutics, three have rated the company as a “strong buy,” and six have rated it as a “buy.” Wall Street analysts expect an upside potential of 9.00% for Enanta Pharmaceuticals based on the company’s closing price on April 12. Analysts have raised the company’s 12-month consensus target price from $99.50 in February to $100.50 in March and April. The current consensus analyst recommendation for the stock is a “hold.”

Of the seven analysts covering Enanta Pharmaceuticals, two have rated the company as “buy,” and five have rated it as a “hold.”
15Apr

VKTX or ENTA: What to Expect from Revenue Growth in 2019
WRITTEN BY Margaret PatrickFEATURED IN Company News, Insights, & Analysis

Growth drivers

In November 2018, Viking Therapeutics (VKTX) issued a press release announcing positive results from its Phase 2 trial evaluating the efficacy of the 1-mg dose alternate day and the 10-mg dose daily of its investigational liver-selective thyroid receptor beta agonist therapy, VK2809, in patients suffering from NAFLD (non-alcoholic fatty liver disease) and high LDL-C (low-density lipoprotein cholesterol). The trial demonstrated a statistically significant decline in liver fat content as well as in LDL-C at the end of 12 weeks for patients treated with VK2809.

VKTX or ENTA: What to Expect from Revenue Growth in 2019

In April 2019, Viking Therapeutics issued a press release announcing more positive data in terms of reduction in liver fat content and LDL-C from a Phase 2 trial evaluating the efficacy of 5mg daily dosing of VK2809 in NALFD and elevated LDL-C patients.

Viking Therapeutics plans to begin its Phase 2b trial evaluating VK2809 in biopsy-confirmed NASH (non-alcoholic steatohepatitis) patients in the second half of 2019. According to the company’s fourth-quarter earnings conference call, the company expects to enroll patients with F1, F2, and F3 fibrosis in this trial and evaluate more than one dose of VK2809 for 12 months of dosing.

According to the company’s fourth-quarter earnings conference call, the selectivity of the investigational VK2809 therapy for liver tissue can be used to evaluate even lower dosages of the drug in the NASH indication, in future clinical studies.

On March 18, Enanta Pharmaceuticals (ENTA) issued a press release announcing the completion of enrollment in Phase 2 trial ARGON-1 to evaluate investigational FXR (Farnesoid X Receptor) Agonist therapy, EDP-305, in the NASH indication.

Wall Street's projections

Wall Street analysts expect Viking Therapeutics to report no revenues in fiscal 2019 and fiscal 2020. In fiscal 2021 the company is expected to post revenues of $21.90 million.

On the other hand, Wall Street analysts have projected Enanta Pharmaceuticals’ revenues to be $220.13 million, $193.28 million, and $166.89 million for fiscal 2019, fiscal 2020, and fiscal 2021, respectively, which implies a YoY change of 6.54%, -12.20%, and -13.65%, for fiscal 2019, fiscal 2020, and fiscal 2021, respectively.
https://articles.marketrealist.com/2019/04/what-are-analysts-recommending-for-vktx-and-enta/

GO VKTX

"PEACE"

[ClayTrader]

* * $VKTX Video Chart 04-12-2019 * *

Link to Video - click here to watch the technical chart video

[sorkin]

Sell the news and cashin

[sorkin]

Compared to Placebo, Absolute liver fat reduction with 5mg = 8.7% and with 10 mg dose = 10%!


Is that a big difference from “Placebo”???

[girlfriend]

<This stock will be < $2 in 2-3 years>

You know something Sorky you may be right. ...maybe even 0. Viking may be purchased by then

LOL

[Natureboy1]

Ha ha ha ha! Good one.

[sorkin]

This stock will be < $2 in 2-3 years

Pipeline drug will not see sunlight

[Paullee]

Viking Therapeutics Presents New Data from Phase 2 Study of VK2809 in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Elevated LDL-Cholesterol at The International Liver Congress™ 2019
PR Newswire PR Newswire•April 11, 2019
Patients Receiving 5 mg Daily Doses of VK2809 Demonstrated Statistically Significant Median Reduction in Liver Fat Content of 53.8%

88% of Patients Receiving VK2809 Experienced ≥ 30% Reduction in Liver Fat Content at 12 Weeks, Including all Patients Receiving 5 mg Daily Doses

VK2809 was Safe and Well Tolerated at all Doses Studied; No SAEs Reported in Any Cohort

SAN DIEGO, April 11, 2019 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the presentation of new results from the company's 12-week Phase 2 study of VK2809, its novel liver-selective thyroid receptor beta agonist, in patients with non-alcoholic fatty liver disease (NAFLD) and elevated low-density lipoprotein cholesterol (LDL-C) at the International Liver Congress™ 2019. The study results were presented in the late-breaker poster session of the annual meeting of the European Association for the Study of the Liver (EASL), being held April 10-14 in Vienna, Austria.

Viking Therapeutics (PRNewsfoto/Viking Therapeutics, Inc.)
Viking Therapeutics (PRNewsfoto/Viking Therapeutics, Inc.)
More
Highlights from the late-breaker poster include newly reported data demonstrating that all patients who received 5 mg of VK2809 dosed daily were considered responders, as defined by a relative reduction in liver fat of ≥ 30% at Week 12. Patients in the VK2809 5 mg cohort also experienced a statistically significant median relative reduction in liver fat content of 53.8%. Consistent with the observations from the 10 mg cohorts in this study, VK2809 was shown to be safe and well tolerated when dosed at 5 mg daily, with no serious adverse events reported. Overall, a greater proportion of VK2809-treated patients completed the study compared with patients randomized to placebo.

Data presented at The International Liver Congress 2019 include:

Reduction in LDL-C

The study successfully achieved its primary endpoint, with patients receiving VK2809 demonstrating statistically significant reductions in LDL-C following 12 weeks of treatment. In addition to LDL-C, VK2809-treated patients also demonstrated statistically significant improvements in other lipids, including triglycerides and the atherogenic proteins apolipoprotein B and lipoprotein (a). These improvements suggest potential cardiovascular benefit associated with VK2809 treatment.

Reduction in Liver Fat Content

The study successfully achieved its secondary endpoint, with VK2809-treated patients experiencing statistically significant reductions in liver fat content compared with placebo after 12 weeks of treatment. Newly reported data demonstrated that 100% of patients receiving 5 mg of VK2809 dosed daily were considered responders, experiencing ≥ 30% relative reduction from baseline in liver fat content at Week 12. With new data from the study's 5 mg cohort, the overall responder rate for VK2809-treated patients increased to 88%, compared to approximately 17% for patients randomized to placebo. Furthermore, the study's 'super'-responder rate for VK2809-treated patients increased to 70% when data from the 5 mg cohort are incorporated. 'Super'-responders are those patients who demonstrated ≥ 50% reduction in liver fat content at 12 weeks. Overall, the results from the 5 mg daily dosing cohort are comparable to previously reported results for study patients receiving 10 mg VK2809 dosed every other day or 10 mg VK2809 dosed daily for 12 weeks. Liver fat content was assessed by magnetic resonance imaging, proton density fat fraction (MRI-PDFF).


Placebo



(n=12)



VK2809 5 mg QD

(n=9)



VK2809 10 mg QOD

(n=13)

VK2809 10 mg QD

(n=11)



VK2809

combined

(n=33)

Median relative % change in liver fat by MRI-PDFF

-9.4%

-53.8%

(p=0.0001)

-56.5%

(p=0.0018)

-59.7%

(p=0.0004)

-56.5%

(p<0.0001)

Mean absolute % change in liver fat by MRI-PDFF

-1.1%

-8.7%

(p=0.014)

-8.9%

(p=0.013)

-10.6%

(p=0.0030)

-9.4%

(p=0.0007)

Percentage of patients experiencing ≥ 30% reduction in liver fat

16.7%



100.0%

(p=0.0002)

76.9%

(p=0.0048)

90.9%

(p=0.0006)

87.9%

(p<0.0001)

Percentage of patients experiencing ≥ 50% reduction in liver fat

16.7%



77.8%

(p=0.0092)

61.5%

(p=0.041)

72.7%

(p=0.012)

70.0%

(p=0.014)

Maximum observed reduction

52.8%

77.9%

72.4%

75.6%

77.9%



Safety and Tolerability

VK2809 was shown to be safe and well tolerated at all doses evaluated in this study. No serious adverse events (SAEs) were reported among patients receiving either VK2809 or placebo. The incidence of overall adverse events (AEs) and treatment-emergent adverse events (TEAEs) were relatively evenly distributed between patients receiving VK2809 compared with patients receiving placebo. A greater proportion of VK2809-treated patients completed the study compared with patients receiving placebo and the rate of study discontinuation due to an adverse event was similar for patients receiving either placebo or VK2809.

Mean alanine aminotransferase (ALT) levels among patients receiving VK2809 were reduced relative to those of patients receiving placebo at Week 12. Among patients with elevated ALT at baseline, those receiving VK2809 demonstrated even greater reductions in mean ALT levels relative to placebo at Weeks 12. Mean aspartate aminotransferase (AST) levels among VK2809-treated patients were also reduced relative to placebo at Weeks 12. There were no clinically or numerically meaningful differences in direct bilirubin, indirect bilirubin, alkaline phosphatase, or international normalized ration (INR) between patients treated with VK2809 or placebo.

VK2809 demonstrated encouraging cardiovascular safety in this study. The proportion of VK2809-treated patients reporting a CV-related AE was comparable to, though numerically lower than, the proportion of placebo-treated patients reporting a CV-related AE. No changes to cardiovascular toxicity markers such as troponin, CK-MB, or NT-proBNP were observed among VK2809-treated patients compared with placebo. Additionally, no clinically meaningful changes to the thyroid hormone axis were observed among VK2809-treated patients compared with placebo-treated patients. VK2809 was also shown to be well-tolerated in this study, with no differences in gastrointestinal-related adverse events compared with placebo.

Based on these study results, Viking is preparing to initiate a Phase 2b study of VK2809 in patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH), which is anticipated to begin in the second half of 2019.

"The liver fat reductions produced by low-dose VK2809 are impressive and may suggest improvement in histology in longer-term biopsy-based studies. Our research suggests that reducing liver fat by 30% or more increases the likelihood of a potential histologic response in NASH patients. Since more than two-thirds of patients receiving VK2809 demonstrated at least a 50% reduction in liver fat we would expect a potentially higher likelihood of improved liver histology," stated Rohit Loomba, M.D., MHSc, Director, NAFLD Research Center, and Professor of Medicine, University of California at San Diego. "These robust improvements in liver fat content, combined with reductions in plasma lipids such as LDL-C suggest a potential cardioprotective benefit in these patients, which would represent a promising and novel profile."

"We are gratified that VK2809's robust efficacy is maintained at doses as low as 5 mg daily. The results observed at 5 mg are similar to those obtained at higher doses and support our enthusiasm for VK2809's promise as a potential therapy for patients with NASH. The totality of data suggests a differentiated therapeutic profile, with the potential to improve liver health and provide global benefits on systemic lipids such as LDL-C and atherogenic proteins," stated Brian Lian, Ph.D., chief executive officer of Viking. "We are also encouraged by VK2809's preliminary safety and tolerability profile, and in particular that no SAEs have been observed in any study to date. In this Phase 2 study, the number of patients completing treatment, reporting treatment-emergent AEs, and discontinuing due to AEs all appear well-balanced between treatment and placebo cohorts. Importantly, liver and cardiovascular safety are promising, with mean ALT and AST levels reduced relative to placebo and no evidence of changes observed to vital signs or markers of cardiovascular safety. We look forward to initiating our planned Phase 2b study in patients with biopsy-confirmed NASH later this year."

Study Design

The Phase 2 study was a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety and tolerability of VK2809 in patients with elevated LDL-C and NAFLD. Patients were randomized to receive placebo, 5 mg VK2809 dosed daily, 10 mg VK2809 dosed every other day, or 10 mg VK2809 dosed daily for 12 weeks. Completion of enrollment of patients in the 5 mg cohort was deferred until enrollment was complete in the 10 mg QD and 10 mg QOD arms. The trial's primary endpoint assessed the effect of VK2809 treatment on LDL-C after 12 weeks compared to placebo. The secondary endpoint evaluated changes in liver fat content by MRI-PDFF in patients with a valid baseline and post-baseline MRI.

About VK2809

VK2809 is an orally available, tissue and receptor-subtype selective agonist of the thyroid beta receptor (TRß) that possesses selectivity for liver tissue, as well as the beta receptor subtype, suggesting promising therapeutic potential in a range of lipid disorders. The compound successfully achieved primary and secondary endpoints in a Phase 2 study for the treatment of patients with elevated LDL-C and non-alcoholic fatty liver disease (NAFLD). VK2809 belongs to a family of novel prodrugs, which are cleaved in vivo to release potent thyromimetics. Selective activation of the TRß receptor in liver tissue is believed to favorably affect cholesterol and lipoprotein levels via multiple mechanisms, including increasing the expression genes associated with lipid metabolism and clearance.

[DMOST]

Why Viking Therapeutics Stock Perked Up in March

What happened

Shares of the clinical-stage metabolic specialist Viking Therapeutics (NASDAQ: VKTX) gained 13.3% last month, according to data from S&P Global Market Intelligence. The biotech's shares jumped in response to two interrelated catalysts:

On March 27, the company released an abstract for the International Liver Congress Annual Meeting of the European Association for the Study of the Liver showing that its experimental fatty liver disease drug, VK2809, is highly efficacious even at low doses (5 mg). This positive clinical update, in turn, prompted Leerink to more than double its 12-month price target on the stock (from $10 to $21) a few days later.

So what

Viking's shares have been a magnet for short-sellers of late, and for good reason. In brief, the biotech's stock took flight after the company reported positive mid-stage data for VK2809 in patients with nonalcoholic fatty liver disease late last year. But the market's initial reaction to these encouraging trial results may have been overdone -- perhaps wildly so.

The long and short of it is that VK2809 could end up as the third -- or maybe even the fourth -- drug to market for another form of fatty liver disease known as nonalcoholic steatohepatitis (NASH). If so, Viking's NASH candidate will have to post stellar safety and efficacy results in its next set of clinical trials in order to effectively compete in this crowded market.

Now what

Viking plans on advancing VK2809 into a second mid-stage trial specifically for NASH in the second half of 2019. Assuming this next study hits the mark, Viking might be able to get the drug into late-stage development as soon as late 2020.

So while this experimental NASH drug could haul in billions in sales one day, investors arguably shouldn't buy this stock unless they are willing to let VK2809 slowly wend its way through at least two more studies. This process, after all, could take several more years to complete.
https://finance.yahoo.com/news/why-viking-therapeutics-stock-perked-210000096.html

GO VKTX

"PEACE"

[DMOST]

Here's Why Investors Are Betting Against These 2 Biotech Stocks

Shares of Viking Therapeutics (NASDAQ: VKTX) and TherapeuticsMD (NASDAQ: TXMD) packed on some nice gains in 2019, and their success has attracted lots of short-sellers. These intrepid investors come out ahead when stocks fall, which is a lot more dangerous than it sounds.

Prices can only fall to zero, while misguided enthusiasm is unlimited. Being correct doesn't help if that enthusiasm outlives your ability to remain solvent, and most rookie short-sellers are quickly transferred to desks with less responsibility.

You might not agree with their conclusions, but it's usually a good idea to understand why so many fund managers are willing to stick their necks out to bet against biotech stocks that look pretty good on the surface.

As of March 26, 2019, 37.6% of TherapeuticsMD shares available for trading, or the company's float, were sold short. Short-sellers essentially borrow and sell shares with the intent of repurchasing them at a lower price. At the stock's average daily trading volume, it would take 26 days to unwind all of the short positions.

TherapeuticsMD stock bounces around a lot because investors still aren't sure about the future of the company's women's health products. In 2018, the Food and Drug Administration (FDA) issued approvals for three of the company's hormonal therapies, Imvexxy for vulvovaginal atrophy associated with menopause, Bijuva for hot flashes, and Annovera, a patient-controlled, surgery-free contraceptive that prevents pregnancy for an entire year.

Before these treatments earned approval, the company earned all its revenue by selling branded and generic versions of prenatal vitamins. With so many new products to sell, it might seem like success for TherapeuticsMD is a foregone conclusion. Unfortunately, vitamin sales have been sliding, and the company's new drug launches haven't gotten off the ground yet.

Annual prenatal vitamin sales peaked at $20.1 million in 2015, and in 2018, they fell 10% compared to the previous year, to just $15 million. TherapeuticsMD relied on vitamin sales for 93% of its revenue last year, which means its new products need to succeed just to keep the top line from sliding.

Sales of Imvexxy, Bijuva, and Annovera reached just $1.1 million last year, despite earning FDA approvals. The company's expanded its sales force to market these products, which drove total operating expenses to $144 million last year.

After losing $132 million in 2018, TherapeuticsMD finished December with just $162 million in cash. If sales of new products don't reach expectations in 2019, the company will have to ask investors for another handout, and the stock's recent $1.2 billion market cap could implode as a result.

Viking Therapeutics: Populations may vary

In 2018, Viking Therapeutics thrilled investors with clinical trial data for VK2809, an experimental tablet that activates a thyroid hormone receptor known to help lower cholesterol, and only that receptor. Specificity is important from a safety perspective because activating a very similar receptor can lead to symptoms of hyperthyroidism.

Viking licensed VK2809 from Ligand Pharmaceuticals thinking it could be a great new cholesterol-lowering therapy for patients who also have liver cells holding on to more lipids than necessary, or non-alcoholic fatty liver disease (NAFLD). During a 45-patient phase 2 study, people given VK2809 had significantly lower cholesterol, and that wasn't the only highlight.

Viking Therapeutics stock soared last year because investigators noticed 90.9% of patients given VK2809 achieved liver fat reductions of 30% or greater compared to just 8.9% of the placebo group. Also, the average reduction was 59.7%, compared to baseline measurements taken 12 weeks earlier.

Around a third of Americans have NAFLD, and an estimated 20 million have progressed to a state of chronic inflammation, or non-alcoholic steatohepatitis (NASH). There aren't any treatments for NASH, and it's quickly becoming the leading reason people need a new liver.

It stands to reason that a treatment capable of lowering liver fat content should also stop inflammation, and Viking plans to begin a study with actual NASH patients in the second half of the year. A whopping 45.1% of Viking's float is sold short because there's a chance the results won't be much more impressive than another new drug candidate that works the same way.

Not long before Viking thrilled the crowd, Madrigal Pharmaceuticals (NASDAQ: MDGL) shares spiked because its thyroid hormone receptor agonist, MGL-3196, helped 60% of NASH patients achieve liver fat reductions of 30% or better compared to 18.4% of the placebo group.

While it looks like Viking's drug wiped the floor with Madrigal's, confident short-sellers are betting VK2809 won't look much better than MGL-3196 in the long run. That's because Madrigal's results come from a much larger study with biopsy-proven NASH patients that are much harder to treat than the 45 NAFLD patients enrolled in Viking's phase 2 trial.

Don't try this at home

Just because plenty of short-sellers are confident that TherapeuticsMD and Viking Therapeutics are on the way down, following them could be disastrous to your portfolio. At the moment, Viking's market cap is a sprightly $751 million and it could rise to several times its value if investors begin believing it can overcome Madrigal's lead on the development timeline.

TherapeuticsMD may be marketing the same hormones that women have been using for decades, but that doesn't mean its products can't produce significant sales. It's tempting to follow the crowd, but you're probably much better off looking for businesses you expect to succeed.
https://finance.yahoo.com/news/apos-why-investors-betting-against-120300307.html

GO VKTX

"PEACE"

[greens12]

It should move up to 13.00 fairly quickly once it breaks the key 200mda, Then grind back up to offering price 18.50 and higher into 20's by mid summer when they start their 2b vk2809 trial.If they get a vk5211 partner before that then it will get there on that news alone in 1 days worth of trading except I just don't want Gaps left behind on the chart so I'm hoping for a smooth grind up. JMHO

VKTX

[Natureboy1]

What’s your timeline for $18 once it breaks $10.80. Judging by chart history, the number of shorts here, the share structure and the analysts pricing this above $24, I’ll bet this one can move fast. That’s what Im hoping for anyway.

[greens12]

Break the 200dma around 10.80 and we should see a nice rally, my target price is 18.50 where they did the secondary stock offering. GLTA

VKTX

[DMOST]

Viking Therapeutics to Present New Data from Phase 2 Study of VK2809 in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD) and Elevated LDL-Cholesterol at The International Liver Congress™ 2019

Late-Breaker Presentation to Highlight Efficacy, Safety and Tolerability Results from 12-Week Phase 2 Trial Including New Data from Study's 5 mg Treatment Arm

SAN DIEGO, April 4, 2019 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced that data from the company's 12-week Phase 2 study of VK2809 in patients with non-alcoholic fatty liver disease (NAFLD) and elevated low-density lipoprotein cholesterol (LDL-C) will be presented at the International Liver Congress™ 2019. The study results will be presented in the late-breaker poster session of the annual meeting of the European Association for the Study of the Liver (EASL), being held April 10-14 in Vienna, Austria.

As previously reported, the Phase 2 study successfully achieved both its primary and secondary endpoints, and demonstrated an encouraging safety and tolerability profile for VK2089, Viking's novel liver-selective thyroid receptor beta agonist. The International Liver Congress presentation will include new data from the trial's low-dose 5 mg cohort treatment arm, which demonstrated statistically significant reductions in liver fat content relative to placebo, as well as statistically significant response rates, defined by the proportion of patients experiencing at least a 30% or 50% relative reduction in liver fat, compared with placebo. Consistent with prior data from the 10 mg cohorts, VK2809 was well tolerated when dosed at 5 mg daily, and no serious adverse events were reported among patients receiving either VK2809 or placebo.

Details of the presentation are as follows:

VK2809, a Novel Liver-Directed Thyroid Receptor Beta Agonist, Significantly Reduces Liver Fat with Both Low and High Doses in Patients with Non-Alcoholic Fatty Liver Disease: A Phase 2 Randomized, Placebo-Controlled Trial

Late-Breaker Poster Number: LBP-20
Date/time: Thursday, April 11, 2019, 9:00 a.m. – 5:00 p.m. Local Time (CET)
Session: Late-Breaker Poster – General Hepatology
Location: Poster Area
Presenter: Rohit Loomba, M.D., MHSc, Director, NAFLD Research Center, and Professor of Medicine, University of California at San Diego

Based on the positive results of this Phase 2 trial, Viking is currently preparing to initiate a Phase 2b study of VK2809 in biopsy-confirmed non-alcoholic steatohepatitis (NASH), which is anticipated to begin in the second half of 2019.

About VK2809

VK2809 is an orally available, tissue and receptor-subtype selective agonist of the thyroid beta receptor (TRß) that possesses selectivity for liver tissue, as well as the beta receptor subtype, suggesting promising therapeutic potential in a range of lipid disorders. The compound successfully achieved primary and secondary endpoints in a Phase 2 study for the treatment of patients with elevated LDL-C and non-alcoholic fatty liver disease (NAFLD). VK2809 belongs to a family of novel prodrugs, which are cleaved in vivo to release potent thyromimetics. Selective activation of the TRß receptor in liver tissue is believed to favorably affect cholesterol and lipoprotein levels via multiple mechanisms, including increasing the expression genes associated with lipid metabolism and clearance.

About Viking Therapeutics, Inc.

Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel, orally available, first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders. Viking's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. The company's clinical programs include VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders, including non-alcoholic steatohepatitis (NASH). In a Phase 2 trial for the treatment of non-alcoholic fatty liver disease (NAFLD) and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content compared with patients who received placebo. The company is also developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of X-linked adrenoleukodystrophy (X-ALD).

Viking's other programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator. In a Phase 2 trial in patients recovering from hip fracture, patients who received VK5211 experienced significant improvements in measures of lean body mass compared with patients who received placebo. Other programs also include VK0612, a first-in-class, orally available drug candidate in Phase 2 development for the treatment of type 2 diabetes as well as two earlier-stage programs targeting metabolic diseases and anemia. The company holds exclusive worldwide rights to a portfolio of five therapeutic programs, including those noted above, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.

Follow Viking on Twitter @Viking_VKTX.

Forward-Looking Statements

This press release contains forward-looking statements regarding Viking Therapeutics, Inc., under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including statements about Viking's expectations regarding its development activities, timelines and milestones, as well as the company's goals and plans regarding VK2809 and its prospects. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and adversely and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the success, cost and timing of Viking's product candidate development activities and clinical trials, including those for VK5211 and VK2809; risks that prior clinical and preclinical results may not be replicated; risks regarding regulatory requirements; and other risks that are described in Viking's most recent periodic reports filed with the Securities and Exchange Commission, including Viking's Annual Report on Form 10-K for the year ended December 31, 2017, and subsequent Quarterly Reports on Form 10-Q, including the risk factors set forth in those filings. These forward-looking statements speak only as of the date hereof. Viking disclaims any obligation to update these forward-looking statements except as required by law.

View original content to download multimedia:http://www.prnewswire.com/news-releases/viking-therapeutics-to-present-new-data-from-phase-2-study-of-vk2809-in-patients-with-non-alcoholic-fatty-liver-disease-nafld-and-elevated-ldl-cholesterol-at-the-international-liver-congress-2019-300824335.html
https://finance.yahoo.com/news/viking-therapeutics-present-data-phase-113000115.html

GO VKTX

"PEACE"

[mauiguy2]

Nice run recently. Good to see. I had been really surprised to see the PPS drop so low. It's a good company with a lot of promise. Really glad to see it reverse its downtrend.

[DMOST]

Here's What Pushed Viking Therapeutics Higher on Friday

What happened

Shares of Viking Therapeutics (NASDAQ: VKTX), a clinical-stage biopharmaceutical company, took off after a handful of investment bank analysts had nice things to say about VK2809 in response to updated clinical trial results. Excitement for signs or efficacy at a lower-than-expected dosage has pushed the stock 16.8% higher on Friday.

So what

Roughly one-third of Americans have nonalcoholic fatty liver disease (NAFLD), and the lives of perhaps 20 million members of this group are at risk due to chronic inflammation of their liver, a condition known as nonalcoholic steatohepatitis (NASH).

There aren't any available treatments for NAFLD or NASH, and the first one could be a huge success. Viking released a preview of mid-stage clinical trial results that investigators will present at a medical conference a couple of weeks from now.

The room will probably be packed as they show off data that bodes well for VK2809's safety profile. Specifically, improvements seen with a 5 mg dose appear nearly as good as 10 mg every day, and 10 mg every other day.

The median relative change in liver fat content was 54% for the low dose, and we already knew that the highest dose led to a 60% reduction. Patients in the placebo group had a 9.4% reduction from baseline, which suggests the lower dosage is good enough to do the job.

Now what

Taking less of a drug usually reduces the risk of side effects, so it's good to know Viking can probably use 5 mg daily, instead of the larger doses. Before you get too revved up, though, it's important to point out that there were only 59 patients in this study, and they were divided into four groups.

The primary goal of the mid-stage trial everyone's so excited about wasn't treating NASH patients; it was a study with NAFLD patients who also have too much bad cholesterol floating around. The big goal was to prove a cholesterol-lowering benefit.

There's no telling what will happen when VK2809 is used to treat patients with full-blown NASH, but we do know that it's generally more difficult to elicit a response from a damaged liver than from ones that aren't under attack.
https://finance.yahoo.com/news/apos-pushed-viking-therapeutics-higher-203100486.html

GO VKTX

"PEACE"

[DMOST]

VKTX....Great!

We'll accept the positive moves up anyway we get them. let's see what the week next rings in.

GO VKTX

"PEACE"