Q3 2021 Achieve Life Sciences Inc Earnings Call
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Ladies and gentlemen, and welcome to the achieve life Sciences third quarter 2021 earnings conference call. At this time, all participants are in a listen only mode.
Later, we will conduct a question and answer session and instructions will follow at that time, if anyone should require assistance. During the conference. Please press star zero on your Touchtone telephone and as a reminder, this conference call is being recorded I would now like to turn the call conference over tiers, you for today Ms Jami Xenith ma'am.
Please go ahead.
Thank you Larry and thanks, everyone for joining us on the call today from <unk>, We have John <unk>, Chief Executive Officer, Dr. Cindy Jacobs, President and Chief Medical Officer, Gerry One principal accounting Officer, Rick Stewart Executive Chairman of the board of Directors and Dr. Anthony Clarke, Chief Scientific Officer, I would like to remind everyone.
One that todays conference call contains forward looking statements based on current expectations. These statements are only predictions and actual results may vary materially from those projected please refer to achieve documents filed with the SEC concerning factors that could affect the company copies of which are available on our website I will now turn the call over to John Thank you Jamie on <unk>.
Call will provide an update on the site is clinically and development program, including our ongoing Orca to study the great progress we are making on our upcoming clinical trials and provide an overview of our Q3 financial results.
Let's begin with Orca to our current phase III trial evaluating <unk> in 810 adult cigarette smokers at 17 clinical trial sites in the United States.
<unk> was initiated in October of 2020, and is evaluating the efficacy and safety of three milligrams cider cynically dosed three times daily over a period of six and 12 weeks versus matched placebo.
We reached a key milestone of completing our target enrollment in June of this year. All randomized subjects were assigned to one of three arms to receive either 12 weeks of placebo 12 weeks of cider cynically or six weeks of cider cynically, followed by six weeks of placebo.
All subjects are then followed monthly out to 24 weeks.
The Orca two study has two independent primary efficacy endpoints that will evaluate the rate of smoking abstinence cytosine clean during the last four weeks of treatment compared to placebo at the end of both six weeks and 12 weeks of treatment orchids.
<unk> will be successful if either or both of the site is clinically and arms show an efficacy benefit over placebo.
All Orca two subjects have now completed study treatment and are in follow up.
We expect the last patient last visit to occur by end of December 2021, and top line data results to be announced in the first half of 2022.
Achieve will remain blinded until the completion of all study follow up evaluations and until the database has been finalized and locked.
Additionally, planning is well underway for Orca three our proposed phase III clinical trial, which we anticipate to launch by early 2022, Orca III will mirror the Orca two trial and study design safety and efficacy evaluations and statistical criteria.
<unk> III will serve as the second required phase III trial to support the site is clinically and regulatory submission in the U S.
Similar to Orca to approximately 750 subjects are expected to be enrolled into orca, three and ramp randomized to one of three study arms to determine the smoking cessation efficacy and safety profile of <unk> administered for either six or 12 weeks compared to placebo.
To support the initiation of Orca three we've hired three new full time clinical operations employees completed the selection process for the CRO.
<unk> the packaging and study drug supply and are currently undergoing clinical trial site selection.
We look forward to providing you with additional updates in the coming months as we progress towards Orca three initiation.
We are also making excellent progress on our plans for expansion into nicotine E cigarette or vaping cessation.
We announced just a few days ago that the FDA has completed their review and acceptance of our IND application to investigate cytosine a clean as a cessation treatment for nicotine E cigarette users.
As previously discussed we have secured non dilutive grant funding from the NIH to offset costs related to the phase III <unk> trial, which will enroll approximately 150 adult nicotine E cigarette users in the U S.
The grant is awarded in two phases with the initial amount of 320000 used to complete regulatory and clinical operational activities such as protocol protocol Finalization clinical trial site identification and the submission of a new idea for basic cessation to FDA.
Upon completion of these milestones as assessed by NIH achieve expects to receive the next stage of Grant award of approximately $2 5 million in early 2022, which will enable execution of the Orca one study.
The funding is subject to author authorization by the NIH under the grant process and is expected to cover approximately 50% of the total orca one trial costs.
We expect to initiate the Orca one study in the second quarter of 2022.
Recent data indicate there are more than 11 million adult users of nicotine in cigarettes in the United States alone.
While E cigarettes have historically been viewed as less harmful than combustible cigarettes, Theyre long term safety remains controversial.
Since these products can also sustain addiction. Many vapors are now seeking to quit nicotine completely and research conducted by achieved roughly 73% of E. Cigarette users expressed a desire to quit within 12 months.
Of those with a more urgent interest in quitting more than half indicated they would be interested in a new prescription cessation therapy <unk>.
Currently there are no treatment, specifically indicated to help E. Cigarette users quick so we see this as an unmet commercial opportunity.
If our development efforts proved to be successful cited cynically may offer a new sensation option for this growing population of E cigarette users who seek to quit nicotine for good.
Finally in the third quarter, we had two sided clinically and data presentation at the society for research on nicotine and tobacco annual European meeting.
The first dataset evaluated the time to sustained abstinence with <unk> compared to placebo in our phase II Orca one trial.
This new analysis determined that smokers treated in the study with <unk> showed an earlier onset of sustained abstinence compared with placebo.
This cohort it took smokers who are successful liquidity a median of seven days to achieve smoking abstinence compared to 18 days for placebo.
We have seen this early onset of activity in earlier studies, including in our repeat dose PK PD study, where we saw a greater than 75% reduction in cigarettes consumed within the first 48 hours of initiating treatment.
Data were also presented from additional Orca, one subgroup analysis evaluated outcomes in smokers, who previously failed treatment with Chantix.
<unk> received three milligrams cited cynically three times daily demonstrated a week for abstinence rate of 51, 3% compared with 15, 8% for placebo treated subjects.
The <unk> three times, a day regimen appeared to be more effective for smokers, who had previously failed to quit on Varenicline then the titration regimen.
We believe both the speed of cessation and cited cynically as efficacy and <unk> pretreated smokers bodes well for the phase III development program and for the commercial prospects of the product.
That concludes the overview of our recent highlights now I'd like to turn the call over to Gerry to discuss our financial results.
Thanks, John.
I'd like to provide an update on our cash balance as of September 32021, and then review our third quarter financials.
As of September 30, the company's cash cash equivalents short term investments and restricted cash was $33 4 million compared to $35 9 million as of December 31, 2020.
We believe our current cash balance is sufficient to provide runway into 2023.
This includes our anticipated cost for the Orca two and it could be one trials, but does not include the cost of other planned clinical trials such as of August three.
Turning to our statement of operations the company incurred a net loss of $6 7 million for the quarter ended September 32021, as compared to a net loss of $3 8 million for the same period in 2020.
Net loss for the nine months ended September 32021 increased to $26 million compared to $10 million in the nine months ended September 32020.
Operating expenses continued to be elevated in the third quarter as we fully enrolled in our <unk> phase III trial we.
We expect our quarterly operating expenses to decline in the fourth quarter in line with completion of the <unk> trial and in advance of the initiation of the <unk> III and <unk>, one study, which are anticipated in the first half of 2022.
That concludes a summary of our financial results.
Now I'll turn the call back over to John.
Thank you Jerry.
It has been an incredible year, so far for achieve as we continue to deliver on our milestones and objectives. Our orca two phase III trial of <unk> in the U S has completed enrollment subjects have finished treatment and we are focused on execution and monitoring to ensure data results are announced as soon as possible in the first half of 2022.
And significant progress is being made on plans for both orca, three and or could be one specifically in regard to clinical operation activities that are crucial for those studies to begin.
We believe <unk> has the potential to make a significant impact and lives of smokers and E cigarette users who want to live healthier lives and we appreciate your continued support as we work towards reaching that goal.
Thank you again for joining US today, we will now open the line for questions.
Thank you and ladies and gentlemen to ask a question at this time simply press Star then the number one on your telephone keypad. If your question has been answered or you wish to remove yourself from the queue. Please press the pound key one moment. Please for our first question.
Yes.
And your first question comes from the line of Michael Hall from Lake Street Capital. Your line is open.
Great. Good afternoon. This is Michael Ho, calling in for Thomas Flaten.
My first question is what are you hearing from the community about the <unk> recall and it was.
Retail impacting patient settle.
Yes. Thanks for the question, Michael we've obviously been tracking.
What's been going on with Chantix.
Fact that earlier this summer they withdrew a handful of lots from the market because they found nitrile domains, which has the potential carcinogen.
The drug product that was just I think three or four weeks ago that they announced a full withdrawal of the remaining lots that were on the market. So we know that it is currently not available but.
But what we also saw this summer was the first generic that was approved by FDA for par pharmaceuticals.
It does look like that is now available on the market. So while pfizer's product with Chantix is no longer there. We think there is still accessibility is starting to come online with with the generics being launched.
Okay that was very helpful. And then what was it elected to start <unk> one in the second quarter of 2002 is there any chance you can start sooner.
Let me turn that over to Cindy to discuss the order could be one initiation in the second quarter of next year, it's really more for the timing for us to get back to NIH and cleared the milestones for what is the phase one funding and then to go into the phase II funding.
They actually have 75 days as their estimated review time, so just by default by the end of this quarter, we'll have.
What we view our milestones completed we will have gone through a phase one.
Money.
If we get that submitted by the end of this year, we're probably looking in February and March to get them. The second phase III funding and then that's why we asked the <unk> to really as a realistic start Christmas is the government. So it's still an estimate.
Thank you very much and congratulations on a quarter that's all for me.
Thanks, Michael.
And your next question comes from the line of Francois Biswas Oppenheimer. Your line is open.
Hi, Thanks for taking the question. This is Dan on behalf of Frank Please.
Just a following up on some of those questions.
Starting with the question about generics.
Dates in terms of the.
Ongoing issues.
Net loss you mean as it relates to the generics that are now coming into the market for Chantix.
Yes, Thanks, Dan Good question so.
So the FDA did put out.
Some updates on this.
Earlier this fall.
I did indicate the nitrosomine levels not only in Chantix, where they were exceeding the limits, but also for par pharmaceuticals as well as an app attacks generic from Canada, showing that those levels were in line. So we know the generics are within spec.
We haven't seen any update from Pfizer in terms of anticipated.
Resolution of this issue so.
We'll continue to monitor as we go forward, but currently there is no estimated time for gentex being back on the market.
Okay, Thanks, and as a second question.
In terms of the milestones for the <unk> one.
Any color you can add on how far along you are in achieving those milestones as the protocol finalized.
Anything on that.
Yes actually the protocol is finalized it was included in with the IMD.
To FDA as part of the review so they have cleared us for that protocol.
Okay. Thanks.
Thanks for taking the questions.
Yes, Thanks, Dan.
Yes.
And once again, if you would like to ask a question simply press Star then the number one on your Touchtone telephone.
Your next question comes from the line of John Bender Wilson from Baxter. Your line is open.
Hey, good afternoon, John Gerry Cindi, good to hear your voices again.
I wanted to extend the question related to the generics and.
And the Chantix going out of the market does that does that change the dynamics for negotiations you guys might have.
With some of the players out there.
Who might pick up cytosine decline eventually or is it too soon I guess to start to start talking to others about.
About eventual commercialization.
Yes, I think overall, thanks, John good to good to connect I think on the generics issue I think overall, it's a net positive for US I mean, I think in one sense, we always knew we would be launching into a <unk>.
<unk> varenicline market, but I think having the.
The main branded product withdrawn from the market.
Net positive for us it's just another mark on what has been a somewhat dislike product over the years from the box warning to the high rates of nausea, and vomiting in abnormal dreams and just the poor tolerability and now the fact that they found a potential carcinogen in it. So I think does help our prosper.
<unk> long term and create some additional interest in what we're doing.
I think as it specifically relates to any ongoing dialogues I think.
<unk> two and the phase III data is probably going to be more important than at least what we're seeing in the market today with the generics.
Okay very good.
And congratulations on the vaping steady clearance.
Anyone else working there.
There are a bunch of other companies out there that have a foot in the in the space and I'm wondering if anyone else is trying to pursue that market as well.
But you've seen yes, yes. Good question John you at the moment, we're not aware of anyone else.
We think at the moment, we're the only one that is pursuing a specific.
Vaping indication.
And so I think that would set us apart in the market.
Obviously, there would be some.
The products on the market today like NRG and others are people are surely trying those to help quit but I think having a product specifically indicated in this market would be would be very powerful for us. So yes. We're excited about getting that going IND was the first step in that but.
But we look forward to initiating that trial next year.
Yes, Thats great news.
The other thing I want to bring up was the FDA recently authorized the first electronic cigarettes.
And RJ Reynolds product does that change the smoking cessation environment at all for them kind of.
Tacitly, saying that.
This is Ed.
A way to stop smoking.
No I mean, I think we've been tracking. This this has been kind of an ongoing development with the fda's oversight over the E cigarette market, but it took the full year to start to respond back on these marketing applications.
I think if anything shifting its likely just the the market dynamics and where we saw a huge number of products be kicked back a number receive marketing denial orders from FDA.
It may be somewhat consolidated at the end of the day, but it's not going away.
The FDA has made it clear they do not like the candy and fruit flavors.
So some of that looks like it's going to be limited.
But at the end of the day I think there is.
Our market for E cigarettes.
It's smoking cessation or otherwise that will be in play as we go forward.
Okay, great. Thank you John.
Thanks, John.
And your next question comes from the line of Jim Molloy from Alliance Global Partners. Your line is open.
Hey, John Thanks for taking my question.
Question on the Orca three trial could you walk through.
Expectations here on sort of a run rate to get that done in topline data.
It's kind of early to look forward, but potential NDA filing.
Yes, hi, Jim Thanks for the question. So orca three as we indicated on the call, we're actually kind of well underway in terms of the preparations for initiating that study.
Early next year is what we're planning on.
I think before we get into the timelines for data and things like that I think it's important that we get to the point, where we're initiating it which will actually kind of set.
The trajectory going forward, but as we indicated this is an important study for FDA in terms of two well controlled trials for approval.
And from our perspective getting that underway sooner is going to shorten the overall timelines to ultimately an NDA submission approval and a launch of this product, which is why we're looking at accelerating that and not waiting for orca two data to initiate that second trial.
And the thinking is as well just sort of similar to the work or two to kind of ride the crest of new year's resolutions, including smoking on helping get initiation is going well.
Yes, yes, absolutely Jim and I think that's something that we've seen over the years has been a great time to be out in the market recruiting subjects and smoking cessation.
Station trials I think being out early next year would be a great place for us to be with the Orca <unk> III study.
Yes.
And maybe on a nuts and bolts of the R&D, Let me touch on earlier in the call I hopped on a little late I apologize.
R&D kind of down a little bit in the quarter can.
Can you talk about sort of the run rate you had.
First half of the year, you talked a little bit about expectations for the rest of the year for G&A and R&D and then should we see dramatic changes in 2022 or kind of in line with about 21 months.
Yes. So in terms of run rate Q3 did decline a little bit we would expect to see that.
Similar level in Q4, so a little bit less than what we saw first half of this year, which is kind of through the middle of the year with Orca, two which was really the.
The largest portion of the burn this year. So when you kind of fast forward to next year.
Component of that.
Once we initiate or Q3.
He will be a similar sized trial to what we're running this year with orca too.
So I think we will see a bit of a roll off in Q4.
And then I think.
A ramp up as we get into the middle of next year as we get into the <unk> III study as well as work would be one as well layering on.
Well, thank you for taking the questions.
Yeah, Thanks, Jim I appreciate it.
And im showing no further questions in the queue at this time I'll hand, the call back to Mr. John <unk> for closing remarks.
Thanks, Larry and thanks, everyone for joining us today.
Honestly huge progress being made this year. We're excited to announce is kind of where we're headed with orca would be one in orchids orca three <unk>.
Next year, so we've got a lot of.
A lot of things in play moving forward as we go and we're looking forward to keeping everyone updated as we roll into Orca two results.
Next year. So thanks, everyone for joining us and we appreciate the continued support.
Thank you ladies and gentlemen. This concludes today's conference call. Thank you for participating you may now disconnect.
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Okay, ladies and gentleman welcome to D achieve life Sciences third quarter 2021 earnings conference call. At this time, all participants are in a listen only mode.
Later, we will conduct a question and answer session and instructions will follow at that time.
If anyone should require assistance during the conference. Please press the stars zero on your Touchtone telephone and as a reminder, this conference call is being recorded I would not like to start a nickel conference over tears stinker today, Miss Jamie's Dennis Ma'am. Please go ahead.
Thank you Lady and thanks, everyone for joining us on the call today from achieve we have John message Chief Executive Officer factor, sending Jacob President and Chief Medical Officer, Jerry One principal accounting Officer, Rick Stewart Executive Chairman of the board of Directors and Doctor Anthony Clark Chief Scientific Officer.
I would like to remind everyone that today's conference call contains forward looking statements based on current expectations. These statements are only predictions an actual results may vary materially from those projected please refer to achieve documents filed with the SEC concerning factors that could affect the company copies of which are available on our website I will now turn the call over to John Thank you.
Jamie on today's call will provide an update on the side of cynically and development program, including our ongoing Orca to study the great progress we are making on our upcoming clinical trials and provide an overview of our Q3 financial results.
Let's begin with orcutt to our current phase III trial evaluating cited cynically and 810 adult cigarette smokers at 17 clinical trial sites in the United States.
<unk> was initiated in October of 2020, and is evaluating the efficacy and safety of three milligrams cider cynically dose three times daily over a period of six and 12 weeks versus match placebo.
We reached the key milestone of completing our target enrollment in June of this year.
All randomized subjects were assigned to one of $3 to receive either 12 weeks of placebo 12 weeks of cider cynically or six weeks decided cynically followed by six weeks of placebo.
All subjects were then followed monthly out to 24 weeks.
The Orca to study has two independent primary efficacy endpoints that will evaluate the rate of smoking asked and as a side of cynically. During the last four weeks of treatment compared to placebo at the end of both six weeks and 12 weeks of treatment or.
<unk> will be successful if either or both of the side of cynically and arms showing efficacy benefit over placebo.
All Orca two subjects have now completed study treatment and are in follow up.
We expect the last patient last visit to occur by end of December 2021, and top line data results to be announced in the first half of 2022.
Achieve will remain blind is until the completion of all study follow up evaluations and until the database has been finalized and locked.
Additionally, planning is well underway for orca, three or proposed phase III clinical trial, which we anticipate good launched by early 2022 orcas.
Orchid three will mirrored the orca to trial and study design safety and efficacy evaluations and statistical criteria.
<unk> will serve as the second required phase III trial to support the cider cynically, the regulatory submission and the U S.
Similar to work at two approximately 750 subjects are expected to be enrolled into orcutt, three and ramp randomized to one of three study arms to determine the smoking cessation efficacy and safety profile of scientists cynically and administered for either six or 12 weeks compared to placebo.
To support the initiation of Orca three we have hired three new full time clinical operations employers completed the selection process for the sorrow finalize the packaging and study drug supply and are currently undergoing clinical trials site selection.
We look forward to providing you with additional updates in the coming months as we progress towards orchid three initiation.
We are also making excellent progress on our plans for expansion into nicotine cigarettes or vaping cessation we.
We announced just a few days ago that the FDA has completed their review and acceptance of our IMD application to investigate cited cynically as a cessation treatment for nicotine e-cigarette users.
As previously discussed we have secured non dilutive grant funding from the NIH to offset costs related to the phase two orchid. The one trial, which will enroll approximately 150 adult nicotine cigarette users and the U S.
The grant is awarded in two phases with the initial amount of 320000 used to complete regulatory and clinical operational activities such as protocol protocol Finalization clinical trial site identification and the submission of a new int forbade big cessation two FTA.
Upon completion of these milestones as assessed by NIH achieve expect to receive the next stage of Grant award of approximately $2.5 million in early 2022, which will enable execution of the Orca V. One study.
The funding is subject to operate authorization by the NIH under the grant process and is expected to cover approximately 50% of the total orca view on trial costs.
We expect to initiate the orchid the one study in the second quarter of 2022.
Recent data indicate there are more than 11 million adult users of nicotine in cigarettes in the United States alone.
While he cigarettes have historically been viewed as less harmful than combustible cigarettes, they're long term safety remains controversial.
Since these products can also sustain addiction may vapors are now seeking to quit nicotine completely.
And research conducted by achieve roughly 73% of e-cigarette users expressed a desire to quit within 12 months.
Of those with a more urgent interest in quitting more than half indicated they would be interested in a new prescription cessation therapy.
Currently there are no treatment, specifically indicated to help E cigarette users quit so we see this as an unmet commercial opportunity.
If our development efforts proved to be successful side of cynically may offer a new cessation option for this growing population of these cigarette users who seek to quit nicotine for good.
Finally in the third quarter, we had two sided cynically and data presentation at the society for research on nicotine in tobacco annual European meeting.
The first dataset evaluated the time to sustained abstinence with cider cynically compared to placebo and our phase II <unk> one trial.
This new analysis determined that smokers traded in the study with side of cynically showed an earlier onset of sustained abstinence compared with placebo.
In this cohort it took smokers who are successful at quitting a median of seven days to achieve smoking abstinence compared to 18 days for placebo.
We have seen this early onset of activity in earlier studies, including in our repeat dose PK PD study, where we saw a greater than 75% reduction in cigarettes consumed within the first 48 hours of initiating treatment.
Data were also presented from additional Orca, one subgroup analysis evaluated outcomes and smokers, who previously failed treatment with Chantix.
Smokers, who received three milligrams side of cynically three times daily demonstrated a week for abstinence rate of 51.3% compared with 15.8% for placebo treated subjects.
The site is cynically and three times a day regimen appeared to be more effective for smokers, who had previously failed to quit on varenicline than the titration regimen.
We believe both the speed of cessation and cider cynically and efficacy and <unk> pre treated smokers bodes well for the phase III development program and for the commercial prospects of the product.
That concludes the overview of our recent highlights now I'd like to turn the call over to Jerry to discuss our financial results. Thanks.
Thanks, John.
I'd like to provide an update on our cash balance as of September 30th 2021, and then review our third quarter financials.
As of September 30th the company's cash cash equivalents short term investments and restricted cash with $33 $4 million compared to 35.9 million as of December 31 2020.
We believe our current cash balance is sufficient to provide runway into 2023.
This includes are anticipated cost for the market too and it could be one trials, but does not include the cost of other planned clinical trials such as <unk>.
Turning to our statement of operation the company and current a net loss of six $7 million for the quarter ended September 30th 2021, as compared to a net loss of $3 $8 million for the same period in 2020.
Net loss for the nine months ended September 30th 2021 increased to $26 million compared to $10 million in the nine months ended September 30th 2020.
Operating expenses continued to be elevated in the third quarter as we've fully enrolled in our pocket to phase III trial, we expect our quarterly operating expenses to decline in the fourth quarter in line with completion of the two trial and in advance of the initiation of the <unk>, One study, which anticipated in the first half of 2020.
Two.
That conclude the summary of our financial results I will now turn the call back over to John Thank.
Thank you Jerry.
It has been an incredible year, so far for achieve as we continue to deliver on our milestones and objectives are orca to phase III trial, a side of cynically and in the U. S has completed enrollment subjects have finished treatment and we are focused on execution and monitoring to ensure data results are announced as soon as possible in the first half of 2022.
And significant progress is being made on plans for both orca, three and or could be one specifically in regard to clinical operation activities that are crucial for those studies to begin with.
We believe side of cynically and has the potential to make a significant impact and lives of smokers and these cigarette users who want to live healthier lives and we appreciate your continued support as we work towards reaching that goal.
Thank you again for joining us today will now open the line for questions.
Thank you and ladies and gentlemen to ask you a question at this time simply precious Star then the number one on your telephone keypad, if you're a question asking and sorry are you wish to remove yourself from the queue. These fast depend on key one moment. Please for our first question.
And your first question comes from the lineup Michael Hall from Lake Street Capital. Your line is open.
Good afternoon. This is Michael highest calling in for Thomas Swanson.
My first question is what are you hearing from the community about the Chantix Nicole and is this recall impacting patient subtle.
Yeah. Thanks for the question, Michael we've obviously been tracking.
What's been going on with Chantix.
Fact that earlier this summer they withdrew a handful of lots from the market because they found <unk>, which has the potential carcinogen and the drug product. There was just three or four weeks ago that they announced a full withdrawal of the remaining lots that were on the market. So we know that is currently not avail.
Abel.
But we also saw this summer was the first generic.
Was approved by FDA from power Pharmaceuticals and.
And it does look like that is now available on the market. So while visors product with <unk> is no longer there. We think there is still accessibility starting to come online with with the generic is being launched.
Okay that was very helpful.
And then why was it elected to start <unk> one in the second quarter of 2002 is there any chance you can start sooner.
Let me turn that over to Cindy to discuss the or could be one initiation in the second quarter of next year.
Yeah, it's really marks of the timing for us to get back to NIH and cleared the milestones firm what is the same one in funding and then to go into the phase III funding.
They actually have 75 days is there estimated remediate time.
So just by default by the end of this quarter will have what.
What we view our milestones completed we will have gone through a phase one.
Money. So if we get this submitted by the end of this year, we're probably looking at February March take get to Bend. The second phase to funding and then that slightly ask quarter to really is a realistic start Christmas is the government. So it's still an estimate.
Thank you very much congratulations on a quarter that's all for me.
Thanks, Michael.
And your next question comes from the lineup Francois feasible up via Dolphin Heimer. Your line is open.
Hi, Thanks for taking the question does is Dan on behalf of frankly law.
Just a following up on some of those questions.
It started with a question about generics.
Any updates in terms of the.
Ongoing issues.
What <unk> as it relates to the generic that are now coming into the market for Chantix.
Yes, Thanks, Dan Good question.
So the FDA did put out.
Some updates on this.
Earlier, this fall, where they did indicate the nitrosomine levels not only of Chantix, where they were exceeding the limits, but also for par pharmaceuticals, as well as an appetite generic from Canada showing that those levels were in line. So we know the.
Eric's are within spec, but we haven't seen any update from Pfizer in terms of anticipated.
Resolution of this issue so.
We'll continue to monitor as we go forward, but currently there is no estimated time for chantix being back on the market.
Okay. Thanks.
And as a second question.
In terms of the milestones for the <unk> one.
Any color you can add on how far along you are in achieving those milestones protocol finalized.
Anything on that.
Yeah actually the protocol is finalized it was included in with C. I N D.
Two FTA part of the review so they have cleared us for that protocol.
Thanks for taking the questions.
Yep Thanks, Dan.
And once again I'd like to ask a question Cynthia practice Star then the number line on your Touchtone telephone.
Your next question comes from the line of Shang Bender Nelson from Baxter. Your line is open.
Hey, good afternoon, John Jerry Cindy good to hear your voices again.
The extended their question related to generics and and the Chantix thrown out of the market does that does that change the dynamics for negotiations you got you guys might have.
For some of the players out there.
Who might pick up cytosine decline eventually or is it too soon I guess to start to start talking to others about.
About eventual commercialization.
Yeah, I think overall, thanks, John good too good to connect I think on the generics issue I think overall, it's a net positive for US I mean, I think in one sense, we always knew we would be launching into a generic.
Generic varenicline market, but I think having the main branded product withdrawn from the market.
A net positive for us it's just another mark on what has been a somewhat disliked product over the years from the box warning to the high rates of nausea, and vomiting, and abnormal dreams and just the poor tolerability and now the fact that they've found a potential carcinogen in it so I think does help or <unk>.
<unk> long term and create some additional interest in what we're doing.
I think as it specifically relates steady ongoing dialogue as I think.
Or two in the phase III data is probably going to be more important than what we're seeing in the market today with.
The generics.
Okay very good.
And congratulations on the facing steadied Clarence as anyone else working there.
There are a bunch of other companies out there that has a foot in the in the space and I am wondering if anyone else's trying to pursue that market as well.
That you've seen yes, yes. Good question Johnny at the moment, we're not aware of anyone else.
At the moment, we are the only one that is pursuing a specific.
Vaping indicate.