Q4 2019 Earnings Call
Ladies and gentlemen, please stand by your achieve conference call will begin momentarily again.
Please standby your conference where began in two minutes. Thank you.
[music].
Good morning, ladies and gentlemen, and welcome to the achieved life Sciences fourth quarter and yearend 2019 earnings conference call. At this time all participants are in I listen only mode. Later, we will conduct a question and answer session.
Instructions will follow at that time.
If anyone should require assistance during the conference. Please press Star then zero on your Touchtone telephone.
As a reminder, this conference is being recorded I would now like to turn your the conference over to your host Ms. Jamie's Dana's Spicer executive Vice President of achieve thank you.
Thank you Sandy and thanks, everyone for joining us.
On the call today from achieve we have Rick Stewart, Chief Executive Officer Doctors, many Jacob Chief Medical Officer, Dr., Anthony Clark, Chief Scientific Officer, and Jon Benet, <unk>, Chief financial and operating officer before we begin I'd like to remind everyone that todays conference call contains forward looking statements based on current expectation. These statements are only front.
Actions and actual results may vary materially from those projected please refer to achieve documents filed with the FCC concerning factors that could affect the company copies of which are available on our website I will now turn the call over to Rick.
Thank you Jamie.
I'll start by focusing on the major success is for the Saudis clinically in development program during 2019 before examining some of the near term value drivers.
Mostly the positive outcome from the old her one phase Twob trial in 254 patients provided clear clinical evidence that the side you see Mclean three milligram three times daily dose was the optimal dose administration.
A 54% quit rates at the end of treatment was a real when differentiating so actually cynically him with a superior side effect profile to other prescriptions smoking cessation drugs.
And also providing a signal a potentially better efficacy. The currently approved smoking cessation products, we will talk more about these later.
Secondly, the phase to be results allow constructive interactions with the FDA to obtain final agreements on the protocol design for our two phase three clinical trials.
We anticipate to initiate the first trial in midyear subject to the availability of capital.
Thirdly achieved his maintain momentum on the outstanding Nonclinical studies required for NDA filing such as the carcinogenicity and chronic toxicology studies.
Fourthly commercialization activities commenced with a detailed assessment of the market opportunity, where champix the market leader generated over $1.1 billion in global revenues in 2019.
Globally, there are more than 1.1 billion smokers with over 34 million smokers in the U.S., but.
Approximately 480 deaths occur annually in the us from smoking related diseases.
Glazing into 1300 smoking debts daily.
Without doubt it is a huge market opportunity with chantix only treating roughly 4% of all use smokers.
Fiddling, we're in discussions with key opinion leaders about the design of a phase two trial using side you cynically into treat vapors and E cigarette users who are addicted to nicotine.
Vaping, an E cigarettes are harm reduction through smokers, where there are currently no treatment options for papers and E cigarette users who want to stop there reliance on nicotine.
It is estimated that are approximately 11 million vapors an E cigarette users in the U.S. the loan and the proportion wants to stock, but find it difficult because of nicotine addiction.
The 2019 controversy over severe lung illness in some vapors has only exacerbated the situation.
We have engaged with free mind, the consultancy, which identifies non dilutive funding sources to assist in raising financing for this trial.
Achieve will potentially be the first mover to pursue an indication in E cigarette uses and vapors wanting to control or stop nicotine addiction.
And finally achieved successfully raised additional capital to fund the continued progress on the Nonclinical and clinical program.
On today's call, we will focus on three near term value drivers.
Firstly, an overview of the new or two one slightly cynically analyses presented this week at the society for research on nicotine tobacco Orest RMT annual meeting.
Then I will provide an update on future trials, including the outcome of our FDIC discussions and plans for phase three as well as an exploration of cited cynically in for E cigarette users and Vegas.
And finally, John will review the financial results from the fourth quarter and year end 2019.
An overview of new analyses with presented to the as our into R&D conference by Dr., Mitch nights of L.A. clinical trials yesterday.
This lines are now available on the achieve website.
Dr. Knives was the principal investigator for the over one phase Twob trial I was also an investigator for multiple chantix trials.
As I said earlier the over one study evaluated 254 smokers.
Eight clinical trial locations in the U.S and smoke is receiving three milligrams three times daily habit 20 point, both treatment period experienced impressive quit outcomes.
Smokers in this 90 cynically demonstrated a 54% abstinence rate at week five four.
Compared to 16% to placebo at a 30% full week continuous abstinence rate compared to 8% cope receiver.
These statistically significant results, obviously indicate that a treatment effect was observed in smokers, who were treated with site is in a clean.
The new analyses presented this week explore two important items, whether or not factors such as demographics smoking habits. Prior credit terms or clinical trial location have an impact on cited cynically in treatment effect.
Further biochemical verification or scientific proof that smokers, who said they quit actually dead.
We conducted these additional analyses so that we typically assured that Sergey cynically is effective regardless of demographics for smoking history and to further confirmed by our additional biochemical verification, citing cynically its effectiveness as an eight smoking cessation.
The analysis of external factors or effect modify our analysis results indicate that scientists silky. So certainly benefit was consistently observed across over a wide variety of criteria, meaning such a silicon help smokers quit regardless of demographics.
Such as Pedro agenda, regardless of how many years or pack today that smoked Ham Italians I tried to equate previously and importantly, regardless of what prior treatments. They have utilized in prior quit attempts, including Chantix zibond or nicotine replacement therapy.
Additionally, these data also confirm that treatment benefit was not influenced by clinical site location.
It's important to note the participants in the off the one trial represented a heavy smoking population with a long duration and extensive product quit attends.
The average smoking history of subjects with 32.1 years smoking an average of 18 cigarettes per day.
Additional sub additionally subjects.
Had an average of 4.5 credit terms without a prescription or over the counter therapies.
Despite these compounding factors such as cynically in demonstrated consistently impressive quit rates.
Moving onto the analysis of the biochemical verification of smoker reported quitting.
Both expanded carbon monoxide, or CEO and serum code mean abide chemical products from cigarette smoking that were measured for objective biochemical outcomes in the order one trial.
These two measures Seo in particular, the gold standard in smoking cessation trials to Biochemically confirms smoking cessation. They are accepted by the FDA and they use the standards for currently approved smoking ban smoking cessation therapeutics.
In the three milligram three times daily arm, the self reported 74% reduction in cigarette smoke.
Was matched by a similar 80% reduction in CEO. This was the highest level and see a reduction in the study and provided objecting verification of the 74% reduction and the number of cigarette smoke.
In contrast.
The placebo group had a self reported 62% reduction in cigarette smoke.
But there was a mismatch with only a 38% decline and see it CEO.
This indicated either a significant under reporting of the actual numbers cigarette smoke or smoke is overcompensated by deep inhalation cigarette smoke and holding smoke and their lungs lungs for longer.
In addition to the CEO efficacy measurement the new analyses also demonstrated sizes. So the cynically in biochemical efficacy by measuring serum codename.
Consistent with the C O analyses all subjects in the cytosine.
Treated arms have a statistically significant reduction NCM codenamed levels by the end of study treatment, whereas the placebo group did not.
These new data points provide additional additional significance. So the order one trial results slightly cynically in was successful in a population of heavy smokers with alone smoking history. We've made a number of private credit sense. This is regardless of age gender race or geographic.
Location of the trial sites.
Also slightly silicon showed significant reduction in the excess X handled CEO and in serum codenamed levels in comparison to placebo treated patients there was a benefit to all side specifically in treating smokers not just confirmed quitters. This is important because it provides.
Hi, its evidence that the better outcome could potentially being achieved if the treatment had been longer than 25 days.
Turning to future plans and an update on the phase three clinical trial program.
In the fourth quarter 2019, we held discussions with the FDA to finalize our phase three clinical trial protocol and overall development program for cited cynically.
The three key items were agreed with FDA Firstly, a most importantly, the FDA agreed with the overall phase three trial design utilizing the simplified sninety cynically in dosing of three milligrams administered three times daily.
And with an extended treatment period of six and 12 weeks no changes were required for the proposed primary and secondary analyses.
The FDA agreed to that evaluating our longer treatment period was appropriate which as I outlined just now could lead to even better efficacy outcomes.
Secondly, the FDA also agreed that the use of the newly developed single three milligrams slightly cynically in tablet in the phase three program was acceptable.
Thirdly, the FDA agreed that the city single 30 milligram high doses sizes cynically in in a maximum tolerated dose trial was sufficient.
As a reminder, this was a standard safety study the study required for the end da to ensure no serious side effects. If so actually cynically in is taken beyond the recommended dose.
The fact that we did not reach any serious or severe adverse effects at 10 times. The three milligram recommended dose reinforces the safety profile, we have seen cited cynically in historically.
To be clear, we have no intentions of testing dose is higher than three milligrams in our phase three trials over.
Overall, we're extremely pleased with the outcome of our discussions and with our collaboration with the FDA review teams.
We are confident that the phase three trial designs are well poised to address three key factors.
Number one the evaluation of the higher three milligram dose of status in the clean given only three times daily which was the best performing cohort in the Orca one trial number two the simplification of the dosing schedule, leading to ease of use the smokers and number three the extension of the treatment duration.
In two six and 12 weeks expected yield better more durable efficacy results.
The extension of the dosing period to six weeks in the phase three trials could have significant benefits.
It will allow us to measure the primary endpoint of four weeks continuous abstinence, while patients are still receiving cited cynically in treatment.
This was not possible with a 25 day treatment period in the OCA one trial.
As documented in the literature measuring efficacy while patients are on treatment typically results in higher freight rates. This approach is consistent with historic Chantix phase three clinical trials.
Significant as it is now ongoing to prepare for the upcoming phase three trials. The interim chronic toxicology report is under review and expected to be submitted to the FDA in April.
Clinical trial medication has been manufactured and packaged our contract research organization has been selected and clinical site selection is underway.
Shifting towards other opportunities in nicotine addiction achieves proposed phase two clinical study to evaluate the potential for scientists cynically in as a nicotine addiction and cessation treatments are vapors in east cigarettes users has received significant attention.
The number of E. Cigarette uses continues to grow and as reported in the Annals of internal medicine. In 2018 has reached nearly 11 million users in the us alone.
Which nearly half are under the age of 35.
While E cigarettes and rates have historically been viewed as safer than combustible cigarettes. These products must sustain nicotine addiction and their long term safety remains unproven, we believe snack cynically in could help address this emerging issue.
We have initiated an agreement with free mind, an organization that assist life science companies with non dilutive financing opportunities that key focus is to help us identify sources of funding for future cited cynically invading trials.
In parallel we've launched a market research program, including an initial study of 500 subjects to evaluate vaping, an E cigarette user demographics behaviors and perceptions on addiction and quitting the outcome is expected to inform clinical development activities commercial.
Assumptions and patient selection for future clinical trials.
Ill now turn the call over to John for review of the fourth quarter financial results.
Thanks, Rick.
I would like to provide an update on our cash balances as of December 30, Onest 2019, and also our operating expenses for the fourth quarter of 2019.
As of December 30, Onest 2019, the company's cash cash equivalents unrestricted cash or 16.7 million compared to 14.7 million as of December 31 2018.
Our year end cash balance reflects the proceeds from our December financing, which provided incremental cash net of transaction costs of approximately 12.3 million.
Turning to our statement of operations the company incurred a net loss of 3.2 million for the quarter ended December 30, Onest 2019.
As compared to a net loss of $3.6 million for the same quarter of 2018.
Total operating expenses in the fourth quarter 2019 decreased by approximately half a million over the fourth quarter of 2018.
As highlighted previously.
Operating expenses decreased in the second half of 2019, as we finalized our orca one trial.
We expect our quarterly operating expenses to remain low in advance of initiating the phase three development cited cynically.
That concludes the summary of our fourth quarter financial results I would now like to turn the call back over to Rick.
Thank you John.
Finally, I want to talk about achieves commercialization plan.
Our goal is to maximize the value of direct revenues to achieve and to its shareholders.
There is an obvious global partnering opportunity, which in the case of Chantix in 2019 represented roughly $1.1 billion in revenues the us opportunity alone represents over 80% of the world markets, while nearly $900 million.
We assess the global smoking cessation market in a similar way with an overwhelming majority of revenue potential coming from the U.S market on roughly 20% from the rest of the world.
Our expectation is excited cynically in will be cost effective with potentially better efficacy and a superior side effect profile than currently available prescription smoking cessation drugs.
In terms of future commercialization, we believe there are multiple categories of potential target prescribers, including smoking cessation clinicians specialists in other diseases, such as oncology cardiovascular and respiratory.
And primary care physicians.
Increased access to smoking cessation medications and counseling continues to expand for example, a number of states have permitted the prescribing smoking cessation therapies by pharmacists and retail pharmacies in the US are now implementing behavioral counseling and risk prescribing in stores.
The approach to each of these stake holders is changing rapidly with improved access by digital technology and reduction in reliance on large scale traditional sales forces for the primary care channel.
Achieved commercial strategy reflects this changing environment ultimately, we expect achieves commercial approach to be a combination of digital marketing and highly targeted personal promotional efforts. Our recent discussions with potential use and international partners reflect this dynamic.
So in summary achieve is now phase three ready with a drug that has already treated over 21 million patients to date in central Eastern Europe.
With over 2000 patients into large scale investigator led phase III trials, both of which were published in the New England Journal of Medicine, and the comprehensive clinical development program.
So I just integrating will address the market with 34 million smokers in the U.S and over 1.1 billion globally.
Thank you again again for joining the call operator. Please please open the line for questions.
Ladies and gentlemen, if you have a question at this time. Please press Star then the number one on your touchdown telephone. If your question has been answered or you wish to remove yourself from the Q. Please press the pound key.
Your first question comes from Michael Higgins from Landon at Landenburg Thalmann.
Morning, guys Oreo.
Very well, thank you, Michael giving well.
Good.
Couple of questions for if I could.
I think gives us a bit more feedback on your discussions with.
With government on groups on potential evading study and some three cities that for us on the potential study design number of patients.
Right, what you're looking to get out of that study. Thanks.
Okay. Thanks, Cindy do want to answer that one.
Yes, actually where Jeff finalizing that proud of car with our key opinion leader.
I think at fair to say that its kind, we had double blind randomized study.
The evaluation for safety will look very similar to our phase three studies and smokers.
The efficacy components will be similar as well as far as looking at not only vaping athenanet.
Or vaping sustain cessation for four weeks, but weekly monitoring as far as.
I mean and vaping over a 12 week period.
Yep.
Okay. That's very helpful Osteo as well I assume yes, we are looking NCR because this study right now at looking at vapors only so we are monitoring for any vapor that might go back to smoking as far as CEO level.
Okay.
It would it elsewhere that six and 12 week period like Orca too.
Our subject to be at 12 weeks, but you look we're looking at it at the six week has an independent endpoints as well as the 12 weeks.
Okay. That's interesting okay. Thanks.
Then question on Arora, we're hoping to see some results the spring I understand the principal investigator relates to hold those for a four conference is impossible to get some top line results out the sprint.
Yeah, I think thats going to be a tough one.
You might remember Michael This is conducted in New Zealand.
In a principally mowery population.
And I think there are some processes that need to be gone through.
When the patient population down there. So our expectation is it's going to be coming out in the fall.
Okay.
Our MSR NT I assume.
Correct.
Okay.
The last one from me and I'll jump back in the Q.
News today of course is covered 19.
We are hearing.
One of the reasons, maybe the theory that men and channels had so much more detrimental impact from the virus that there are smoking rates are much higher than women.
And this is our respiratory disease.
Any evidence that evening may have an effect on one's ability to become severely affected by Cabot 19.
Yes.
I think it's very early days to to be able to call definitively I think.
Theres been a lot of.
Debate around the fact that use the mortality rate of mine in China is somewhat higher than the women's population I think Isabella 70 30.
Split.
I don't think it can be translated more widely yet.
But certainly the mayor of New York on Sunday, I believe was talking about the impact of smoking and vaping on.
The either the the the prevalence of Kobe 19, and though the severity of it Tony you want to talk a little bit about the kind of underlying pathology related to that.
Yes sure.
I mean, the has Oh this is a moving sales.
Literally on a daily basis, new stuff is apparent from researchers, but my understanding is that.
When they look back at what happened with paused.
In China.
It did seem to affect males more prevalent leads and female.
And one of the arguments presented at the time is there's a huge disparity and the number of moca compared with non smokers.
Lets males. Most a lot more would females, though in China, another kind of people looked at it and said what kind of interesting, but I wonder if thats the real reason or was it something else.
What happened since then is that.
We know we now understand that there are two reasons, how these cobot viruses get it.
We are now.
And the area with along that we all like several football field Thats massive that's one by.
The other thing that seems to have happened that we discovered is that.
The eighth to reset this is an angiotensin converting and bind to reset.
It's also expressed them along that it seems to be the proteins that these viruses latch onto.
On the interesting thing here that literally is coming out just in recent days.
Is that it appears that this this this new carpet 19.
Uses a similar mechanism so it seems to bind to the ace two receptor.
And the reason that's important is because nicotine.
Things to caused an increase in the expression of Ace two receptors. They belong in other words smokers and also bankers.
Could also expressed a lot more of this reset the run that maybe lease them.
More prone to the virus taken hold if they and highlight.
And I think this is really important because.
A lot of the press in the last couple of years, it's insane.
It's like a debate than it is too to smoke rope certainly in terms of a lot of the stock splits and smoke that might be true and cigarette smoke, but now we're seeing the if it nicotine that causes. This then papers adjusted much at increased risk of of this virus taking hold us.
Okay.
It's a moving fail, but it's it's looking really answer the first time, nothing but we've seen a real problem that is.
Specific to kind of baking.
Whereas previously every month and basing a safe.
No.
Yeah that makes sense.
Overlap with.
Sars virus.
The 19.
Sorry to viruses are calling it.
Yes, the same receptor binding motif say ace two receptor same critical residues.
Yes so.
And that's also why theyre, bringing a lot of what's working Sars year recorded makena.
I returned more production impact in Q.
The stuff appearing on the daily basis with us. So that's that's my latest understanding.
Referring to break them out so far.
Appreciate that thanks, guys.
You're welcome.
Your next question comes from Vernon Bernardino from H.C. Wainwright.
Hi, guys. Good morning, Thanks for taking my question and that's on the progress and.
Getting closer to the the phase three looking forward to.
Initiation with the Senate Queen.
I'm intrigued by.
Michael's question on on innovating and the doctors answer on Ace two ANNEXA team.
ROE and increase in expression.
But first I'd like to ask as far as the.
Since were K wells on our vapors views on two things.
Do they see that the because one of things about assistance cynically is perhaps.
As as we all know the the studies show that if some patients for example, some subjects in the phase three studies in the past had been on the trial along with their.
Correct.
The achieved.
There could have stopped smoking.
Is there a dynamic that that seem in vapors using the proceeds something like that I know that.
Yes, I look at 12 weeks, but you're also going to be able to look at six and.
Sufficient.
The durability after that but is there anything like that as far as the thinking.
In a study in our Baker Hughes.
So Nick.
Well I'm not sure my understanding with question, but this study is really looking at.
Individual to our vaping that want to clip vaping sale will be flatting for those individuals who really want to control reduce their nicotine addiction as well as potentially stopping vaping in their controllers nicotine addiction. We're also doing a survey and I don't know, Jamie if you'd like to.
Kind of just overview.
As far as understanding more the population vapors. Obviously there is not to then study is really looking in this regard it vapors for stopping vaping with like something like side the Senate claim.
So we are kind of on the cutting edge here and looking at this population and moving forward, but we're very committed to looking at this as an added or additional indication to our smoking cessation and with an FDA.
Okay got it could backfire.
But then.
When our vapors use.
These devices to try to quit smoking.
How does that compare us to the length of time, it takes versus other smoking cessation products, including Chantix.
I'm not sure that's really not I don't have that information at hand.
Yes.
Anthony mentioned, we're conducting a survey with 500 paper that ongoing at that time, and we're trying to get at some of those answers and because we all have that same question I need the station method that theyre using beeping for already do they actually want to come off of nicotine altogether and what is their willingness to try alternative strategies beyond anything are you.
Congrats to do that so I think.
Part of the survey that we are currently fielding, we'll probably give us some of that insight.
Okay and so the research.
On them.
Early but as far as.
Now what direction as being taken what are some of the near term questions that PRASK needs to be answered as far as the.
Research and nicotine is too and Corona buyers.
That is a tough one.
I think.
I think the numbers are.
To ill defined right now.
The first incidence of Toronto virus, which really identified in November and whilst at the current time, we getting.
Data coming in from China. The real question is how reflective of that.
Is that data or what is going on you know, saying in the UK and the U.S.
There's certainly some degree of evidence that in fact, the smoking and vaping population is perhaps and announcing perhaps more susceptible to corona virus and perhaps is getting more severe symptoms and I think thats worth.
Build up last year was really getting asked on Sunday in his.
The conference call.
These are only perhaps because we simply don't have enough data points, but it certainly given the impaired nature of smokers and to a degree vapors lungs. It is entirely logical that those two would would be.
Actually Evans with more data.
Yes.
Okay, and then last question for get back into queue.
How do the lungs compare.
People who have.
Severe response to a.
Current of ours versus those with the the on the issues of papers.
Who felt ill with bees and.
Approved type of.
Products.
Again, I don't think there's enough data I mean, I think most recently I mean, as Tony said, you know with missing new data on a day to day basis, certainly as recently as yesterday they were identifying that.
X rays potentially a better.
The tool for diagnosing Togut 19 in patients and certainly what you're seeing is.
Yes, the other whether you've seen in the U.S., but this glass. The fact that people are talking about is a clear characteristic and Kobe 19 now again.
What we're looking at the moment.
Publications coming out of principally in China.
In people males. In particular, who are older and has been substantial smokers. This does that actually correlates with the experience in Italy, where again you have an elderly patient population.
Perhaps not as strong smokers. So I think that diagnostic tools that were talking about for ACA with 19 of developing on a special daily basis. So what we expect to see is moving forward.
Starting to get a better understanding of the impact of.
Smokers versus non smokers Vegas based on those but clearly there is a.
Messages coming out from.
Very sources in the U.S. in terms of start to look at those populations as more at risk than non smokers.
And how many.
How many people in our China user baking products, and then I'll get back into queue. Thanks.
Relatively few.
Yeah, if you take a shot.
She is a smoking population of roughly somewhere between 70 and 80% of the Chinese population.
I think you're looking at somewhere in the 15% to 17% actually use vaping devices and principally that jewel users as well.
Okay. Thank you very much pressure you in closing my follow ups.
Okay.
Your next question comes from John Vandermosten from Zacks S E R.
Good morning.
Regarding the a the framework that that's only related to the vaping study right, it's not going to be funds from that relationship are going to be use more broadly.
Yes, Andy Yep correct.
Okay, and I assume that they're looking for things like brands from government or private groups is that is that mostly the source that they would help how people yeah.
That's correct.
Okay and then another question on measuring for that vaping trial it.
Carbon monoxide, and Cook mean levels I assume that carbon monoxide is only related to smoking right. I mean, if they were just vaping you wouldn't be able to tech detected from carbon monoxide yeah.
Yes.
And I think well still be monitoring.
For C.L., obviously for any cigarette reverting back to a cigarette smoking or increasing cigarette smoking got it got and then Codename. That's that's tied to nicotine I'm not quite sure that maybe you could just give me a sentence or two on how that's how that fits in with vaping and also with what smoking.
Yes, so kind of cutting is a metabolic product of nicotine for nicotine then goes into current mean another thing. So you can measure cutting mean in CRM or in this case, where you're going to be looking at it and let in Florida and its with a specific lab that connected with Neil Benelux and his research.
Quantitative.
Live a cut mean testing so we can actually measure than changes in current mean level of which would relate to changes in nicotine.
Okay and is the same amount and nicotine I'm wondering if the fair amount of nicotine is different.
In you're trying to measure it between smoking invading because it was smoking its heated up quite a bit more.
Well it is shaping.
Well, I think and the amount of nicotine, whether its and small for or and vaping either company level well be.
A direct measure of how much nicotine the body hat or in the language that nicotine has gone.
I'm not sure that I know exactly he knows the answer to your question Pat.
That's why it's very important to have a quantitative asked say four county, which a lot of these assay that Jeff yes, now they have than a lower limit.
Detecting mean, but that's why we're really looking at a research lab at a quantitative level for cost cutting to look at various the app aspects of changing.
In this study over the 12 week.
Okay, and you said earlier that the FDA, except both carbon monoxide and Codename for.
For the normal studies that will be done for sarecycline and and regular smoking right. So they already recognized that as as a endpoint.
Absolutely.
And just final question.
I it looks like you guys presented yesterday morning at the I think I started to conference any any feedback from from that at all in terms of out into sponsor.
Anything.
In response to the presentation of that data.
Well, if we know that there were individually they're in areas of out there with over 30 individuals there in the meeting around I guess, that's one thing that surprised us it was given.
By a video and auditory with that Dr. Mitch Snider.
Due to the obviously the reduction in travel.
[music].
Okay. Thank you guys JP answers.
Okay.
Your next question comes from Michael Higgins from Landenburg Thalmann.
Morning, guys couple of follow ups, if I could from accelerated dose study the 20 milligram dose.
Were there any notable adverse events, where the inline with what would be expected say nausea abnormal dreams.
Yeah, so at the highest as a 30 milligram we did.
Finally has seen nausea, and vomiting into or out of six individuals, which even though they were a moderate adverse events at flare ft agreed with us that we didnt need to press far there in this patient population and that was the expected adverse events, we just expected.
It out a lot lower levels.
And that Ted 30 milligrams to actually see that.
Three in theater at 27 earlier.
He thought seminars here may be sporadically throughout the trial, but it was the combination of two out of six individuals that not only had no idea, but actually.
Had vomiting that was then the trigger to say okay. This this terraces, then well it being close to if not there to maximum tolerated dose for this patient population certainly did not.
I'll feel the criteria the protocol, which was any one severe adverse event this as moderate but thats, where then.
The data safety monitoring committee ourselves and FDIC agreed to.
Stop the trial site was adequate.
Right understood.
Yeah those are.
Offered.
Studies.
Cushion.
Excellent.
Now we have worker one being reviewed a bit further I was wondering.
There's no question the adverse events.
In the.
In the downtime attrition arm considering the patients are getting so much more drug.
You know if the adverse events that we see in the in the table here from yesterday slide again here.
They are higher dandridge bounce hydration is the happened earlier the study when they were at a higher jokes seem to make sense.
They were they were sporadic, but there was a slight increase as far as.
Earlier, but it was.
Evident at wells and something that we felt fled the significant time onset, but again, if you're only looking at onset of adverse events in like three to six individual so it's really hard to call out any difference in time onset. So we'll have to look at that.
Matt obviously won't have the titration arms in the phase three but looking at time on set for the three milligrams three times a day, we'll have a better chance of really evaluating that in the phase three studies with.
With them in a 100 subjects.
Right.
Thank you Rick you mentioned, some hasn't comments and orca to design I Didnt catch what you had said in the secondary.
Can you give us some feedback as to what the secondary endpoints are looking like.
That's one of the Cindy again.
Well take it.
The secondary endpoints I really looking at longer term follow up at this at the 24 weeks a six month.
For smoking cessation and that's also looking at some comparison of relapse I'm looking at if there is a reduction in overall relapses. If you to if you had six weeks a treatment versus 12 weeks that treatment.
Hi, just okay.
Interesting. Thank you.
Any update for us on the and CCH funded Nonclinical reproductive study has that been completed yet.
Yes. It has we have actually beginning the report can that it will be probably submitted at the similar time if not at the same time as our 13 week.
For chronic toxicity studies Taski in April.
Okay.
Is the started worker to a gating factor being any beeping.
Non dilutive funded.
Uh-huh event is that what we're winning quarter sounds like sites are being activated.
Drug product is being ready if not ready ready.
Give us nothing that's what they're getting faster with the thing.
Rick do you want to take that.
Sure, Let me make sure I understood. The question Michael So that's what my goal is is the vaping study gated by the start of the phase threes is that right.
Is the start of the phase threes.
Aided by funding or funding for the evening study.
No no I mean, this down to the phase raises entirely independent.
You know the.
We are talking with three three mind that vaping study will start when we don't non dilutive financing.
In the meantime, we've got the smoking cessation phase threes, which are currently in the setup phase.
As I said, we're in site selection right now the actual timing of the start of the phase threes is somewhat dependent on the availability of capital, but they are actually independent.
Okay. Thank you then this was one last one here.
Okay, and Jimmy alluded to the some of this with the 500.
Patient survey.
Just trying to get a better handle on the quick rates among those that have slowed for 30 years on our traditional smoking cessation patient.
Versus the papers, there's 11 million or so your neighbors out there versus 34 six.
Cigarette smokers.
But I would quit rates.
Or wanting to equip rather.
Rates similar or different and.
You may not have that there are just trying to get a sense support here. Thank you.
Yeah, I can say from the survey that is one of that questions that were looking to address segment said on the population that were interviewing into dual users.
Never smokers and.
Prior smokers, so people who have quickly I expect that will get different answers from audiences and that's kind of point of as conducting the researchers to determine where they.
Come together, and where there maybe some commonality versus differences and they're quite behavior and they're quite journey marotta really looking to understand as we did and I smoking survey earlier and about 1100 smokers.
What is what is their willingness to try something new that they have an option and really what is their perceive level of addiction and are they looking to quit or are they find just being on vapors or E. Cigarette users for the expected future. So I think those questions will really help us say build out of forecast.
And also understand who we should be bringing into our trials because we obviously want people who are motivated to quit on to be enrolled in the clinical trials otherwise the results are not going to be.
We would hope.
Right and when do you expect to get you survey results and do you need them to define the statistical assumptions in the heating quick study.
Hi, we do not meet the result for anything directed towards the dates to at this time.
And we expect to have them in the next several weeks.
Great.
Appreciate all the feedback and all the questions. Thanks again guys.
Thank you.
There are no further questions at this time I would like to turn the conference back over to Mr. Rick Stewart.
Well I just wanted to thank you all for joining.
Q4, 2019, and full year result conference call and we look forward to talking to you in the near future. Thanks a lot.
Ladies and gentlemen, this does conclude today's conference you may now disconnect and thank you for your participation.
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