Q3 2023 Achieve Life Sciences Inc Earnings Call
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Greetings welcome to achieve life Sciences third quarter earnings conference call and webcast.
At this time, all participants are in listen only mode.
A question and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero from your telephone keypad.
Please note this conference is being recorded.
At this time I'll turn the conference over to Nicole Jones with Investor Relations.
You may now begin.
Thank you operator, and thank you to everyone for joining the call today today from achieved we have John benefits Chief Executive Officer, Dr. Cindy Jacobs, President and Chief Medical Officer, and Jerry One principal accounting officer.
<unk> management will be available for Q&A after the prepared remarks.
I'd like to remind everyone 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 available on our website and filed with the SEC concerning factors that could affect the company I'll now turn the call over to John.
Thank you Nicole and thanks, everyone for joining us today to review, our third quarter highlights and the overall status of the site, it's been a clean program.
Over the last quarter as well as throughout the entire year significant progress has been made in establishing the foundation for the first novel nicotine dependence treatment in almost two decades.
So far this year with a small inefficient team of only 22 full time employees.
<unk> accomplished many significant milestones.
<unk> the announcement of positive results from our second phase III side, its been a clean trial for smoking cessation.
Published results from our first phase III trial in Jama.
Reported a statistically significant efficacy benefit and the phase two orca one trial, the first ever randomized controlled trial for E cigarettes cessation.
We've completed three additional clinical studies of over 100 subjects required for NDA submission.
Made significant progress on the compilation of the NDA held numerous interactions and conducted three formal meetings with the agency to prepare for filing and approval in the U S. Including most recently a pre NDA discussion that occurred at the end of October.
And increased outreach and further discussions with potential commercial organizations on the site is clinically in U S and global marketing opportunity.
We believe pending FDA approval by the Senate clean holds promise for providing a fresh start to the millions grappling with quitting smoking and vaping.
There remain over 1 billion cigarette smokers around the globe.
In the United States alone over 28 million adult smoke combustible cigarettes, and 11 million adults vape nicotine.
The market potential for side its been a clean is substantial.
And its potential impact on global public health is unparalleled.
We have strong confidence inside the stena cleans effectiveness and assisting individuals who are motivated to quit smoking.
Our phase III clinical trial results demonstrate a significant advantage with smokers treated with cytosorb into clean being up to eight times more likely to successfully quit smoking compared compared to those receiving placebo.
Notably cider Scenically and stands out from existing treatments due to its excellent tolerability with the most common adverse events affecting fewer than 10% of trial participants.
We proceed to perceive a distinct opportunity beside a thinner clean to reinvigorate the nicotine addiction market and make a profound impact on public health.
By introducing this new treatment option, we anticipate a higher number of individuals' will be encouraged to embark on a new quit attempts.
With a product that is well tolerated, we anticipate a high level of compliance and adherence to treatment.
By enhancing their chances of successfully quitting.
Our competence inside its been a clean is reinforced by leaders in the smoking cessation community, who have consistently shown their willingness to collaborate express interest in new research and assist us in disseminating these crucial findings.
Our engagements with this influential community.
They have expressed that the Gulf for a new therapy should be to double the likelihood of a successful quit compared to behavioral support alone.
Cited scenically and vastly exceeds the threshold with subjects in our Orca studies treated with cytosorb into clean having odds of quitting improve by upwards of six to eight times.
This quarter, our research of the optimized dosing and administration of site, it's been a clean and U S. Subjects was published in the highly esteemed medical Journal Jama.
This recognition has made a significant impact garnering thousands of online views and being featured in more than 40 media outlets.
More during this quarter Dr. Nancy regarding.
Orca primary investigator and professor of Medicine at Harvard Medical School, and the director of the Tobacco Research and treatment Center at Massachusetts General Hospital <unk>.
<unk> for the first time data results from the phase two or can be one trial or side. It's been a claim for E cigarettes. The station at the society for research on nicotine and tobacco annual European meeting.
Or could be one evaluated the safety and efficacy of cider scenically and treatment for 12 weeks compared to placebo in 160, adults who use nicotine E cigarettes.
Datacenter clean treated subjects experienced statistically significant cessation rate of approximately 32% compared to 15% in the placebo arm or 2.6 times higher odds of quitting vaping.
I've seen across our development program cited Scenically and was very well tolerated and no treatment related serious adverse events were reported.
Our endeavors to combat the vaping epidemic have been met with strong support from government agencies, clinicians and prospective commercial partners highlighting the pressing unmet need in this area.
Or it could be one was the first randomized placebo controlled trial to achieve success in demonstrating the efficacy of the treatment for addressing this type of nicotine dependence.
These results are highlighted as there are currently no approved treatments tailored specifically for vaping sensation.
The overall E cigarette market continues to expand rapidly with the most recent prevalence rate in the U S, indicating a 20% annual increase of adult users.
Well E cigarettes can serve as a helpful tool for some transitioning away from combustible cigarettes, the long term effects remain unknown and.
Many individuals' aspire to quit nicotine altogether, which is precisely where cited scenically and can step in.
We are assessing our clinical development strategy to pursue an on label indication for E cigarettes decision and plan on holding an end of phase two meeting with FDA in 2024 to discuss the requirements for approval.
As there are no treatments approved for E. Cigarettes decision. This is a recognized area of high unmet need and we will position it as such during our discussions with the FDA.
Our goal is to expand the label side its been a clean it for specific promotions, where E cigarette cessation, even though many health care providers may consider side its been a clean a viable option for treating various forms of nicotine dependence.
As you may recall or could be one was partially financed via non dilutive grant funding from Cnida an NIH we.
We believe there may also be non dilutive funding opportunities available to support a future basing study.
Our aspirations are changing public health hinge on the regulatory filings and successful approval of side its been a clean.
To that end, we have been focused on continuing to work needed to support an NDA filing targeted in the first half of 2024.
We are pleased to share that we have completed all of the in clinic treatment portions of three NDA, enabling clinical trials that have been running over the course of this year <unk>.
Specifically these trials have been run to evaluate Qt interval prolongation.
Steady state pharmacokinetics, and smokers and pharmacokinetic parameters in subjects with renal impairment.
We expect final study reports from these trials to be available in early 2024.
Additionally, last week, we held a pre NDA meeting with the FDA.
The FDA encourages this pre submission engagement to solicit comments and clarification from the agency on the acceptability of key data, including information that might become available for submission during NDA review this.
This initial discussion with constructive an agreement was reached on many of the submission requirements dialer.
Dialogue with the FDA is ongoing and because of this we aren't able to provide additional details at this time.
We will be in a position to provide an overview once discussions are finalized.
The output of the pre NDA discussion is critical to clarifying the final regulatory path of cider Scenically and in the U S and will set the stage for how this product will progress through future market approvals around the globe.
Additionally, these data points are important to furthering the discussions we are having with potential commercial organizations.
Or could be one in orca three have been released and Orca. Two was published in Jama, we have seen significant additional commercial interest in the site of Scenically and program.
As we've stated previously we continue to believe that this asset in the hands of a larger organization will maximize the full commercial opportunity.
So what are we looking for exactly our ideal partner would have global capabilities with an established footprint and strong commercial capabilities and resources to maximize the global health impact Besides scenically and offers.
Given the substantial U S market opportunity strong U S sales and marketing capabilities are an important attribute that we are seeking in our selection process.
We are pleased with the dialogue and engagement with potential commercialization partners and are focused on continuing to move this process forward expeditiously.
At this time I will hand, the call over to Jerry to review, our financial highlights and results.
Thanks, John I will be providing an update on our cash position as of September 30 of 2023.
Reviewing our operating expenses for the third quarter of 2023.
As of September 32023.
The company's cash cash equivalents short term investments and restricted cash were $20 million compared to $24 8 million as of December 31 2022.
We believe our current cash balance is sufficient to provide us runway into the second half of 2024.
With respect to our statement of operations net loss decreased to $7 1 million for the quarter ended September 32023.
$15 1 million for the same quarter of 2022.
Net loss for the nine months ended September 32023.
Decreased to $24 3 million compared to $31 1 million for the same period of 2022.
In line with expectations operating expenses continued to decrease for the third quarter of 2023 with the completion and wind down of both the Orca three phase III trial and it.
It could be one phase II trial.
We expect our quarterly operating expenses to remain lower in the fourth quarter as compared to the first half of 2023.
The decrease in costs will be partially offset by an associated increase in NDA supporting activities, including the finalization of three NDA supportive clinical trials and other NDA preparation activities.
That concludes my financial remarks, and I will now turn the call back over to John.
Thanks, Gerry as I stated at the beginning of the call 2023 has been a remarkable year for achieved and the cider Scenically and development program.
In the near term, we have three key priorities, where we will focus our efforts.
First.
Finalize discussions with preferred strategic commercial organizations.
Second complete preparations to finalize the NDA submission.
And third define the regulatory pathway for cytosine, a clean label expansion in E cigarettes decision.
We maintain our confidence in cytosine it cleans ability to change the face of public health and we appreciate your support as we work diligently to bring forward this important treatment.
At this time I'd now like to turn the call over to the operator for questions.
Thank you well now be conducting a question and answer session.
I'm going to ask a question today. Please press star one on your telephone keypad than a confirmation tone will indicate your line is in the question queue.
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One moment, please while we poll for questions.
Thank you. Our first question is from the line of Thomas Flaten with Lake Street. Please proceed with your question.
Yeah, Hey, guys I appreciate you taking the questions.
John with respect to the timing of the NDA submission given that the data from the three supportive studies will be out in the first quarter is second quarter, most likely I know youre guiding to first half but.
Just some thoughts on mall.
Yeah. That's helpful. Thanks for the question there so yes.
Even as the discussions are ongoing with the agency as we can.
Includes a pre NDA meeting and we look to get final agreement.
At the other end.
We're not able to refine anything further on that.
Future update as we kind of Jetblue that final process of dialogue with the agency.
And coming out of that October meeting what was there anything surprising any incremental studies that they've requested or was it was a pretty straightforward.
So I think in terms of the output you know I think as we mentioned the discussion was constructive we did get agreement on many of the items that we were looking for.
The other pieces that we're looking to get finalized.
Written documents.
And so.
We will be able to provide a further update on that as we.
Get through those final discussions.
And then just one final question for me could you give us maybe a little assistance in mapping up spending between today and the.
And the submission.
Yes.
Yeah. So I think if you look at the third quarter in terms of kind of the decrease in burn that we saw from the first half of this year.
Expect that will continue through the fourth quarter of this year as well.
So we will see that decline Kerry carryforward, if youre looking at kind of projecting that ahead.
A good way to think about it at the moment.
Excellent I appreciate you taking the questions. Thank you.
Yes, Thanks Thomas.
Our next question is from the line of Michael Higgins with Ladenburg Thalmann. Please proceed with your questions.
Thanks, Operator, Hi, John Hi, guys. Congrats on the continued to progress according to your own expenses.
Notable here in Q3 results and thanks for taking some questions here.
If I could ask a bit more and the feedback on your progress with potential commercialization partners wondering how that's coming along and if you believe in discussions with the FDA, we'll be wrapping up.
And first part of 2024 do you expect to have feedback from the NIH regarding dating before you complete those potential commercialization conversations.
Yeah. Thanks for the question so on the vaping indication.
What we've been guiding to is holding an end of phase two meeting next year.
In terms of <unk>.
Further refining on timing on that we can't really provide that at the moment. Our focus will continue to be on the smoking cessation NDA as kind of that that initial priority to make sure that that forward expeditiously.
Is it fair to say the partnering discussions would be separate for cigarette versus anything.
Okay.
On the partnering discussions I think we have seen a fair amount of interest.
Coming from the vaping side of the opportunity, yes bookings decision will continue to be the core of that.
And so I think in terms of the additional opportunity that's going to be the first piece to watch so.
Both are important but I think the smoking given kind of the near term nature of it is going to be.
The majority of it is there.
That's fair thanks.
And then.
Just to clarify for everyone on board here are the gating factors head of the NDA filing obviously you have discussions with the agency. He's got some three studies reading out early next year are those the two primary drivers are obvious discussion with the agency, but anything else. Besides those three that you're waiting on.
Yes.
Those three are obviously critical.
Uh huh.
Having those key components that we knew were going to be needed for the NDA I think as we finalize the pre NDA discussion as we get those final written minutes, we'll be able to clarify.
Further timing on the NDA.
The key piece of this is getting clarity.
Going forward and that feeds back into partnering discussions and making sure that the patch.
<unk> towards approval is fully clarified and that's exactly what we're getting out of it.
Yeah.
Makes sense I appreciate it thanks guys.
Okay.
Thank you.
Our next question is from the line of Francois <unk> with Oppenheimer. Please proceed with your question.
Hi, This is Dan on for Frank Thanks for taking my questions.
Firstly congrats on the Jama publication also the or could be two presentation at a and the V. One presentation that that person Archie can you give us a sense of the kols feedback that you're hearing from these conferences anything in particular in terms of Pakistani claims features tolerability efficacy that is standing out.
That is coming up any color there.
Yeah. Thanks for the question can I hand, this over to Cindy.
Yeah, well, it Nancy or gaudy actually presenting him and our other kols, they're pretty excited as far as.
Either.
But actually there even more.
Got it.
50 profile, which allows then individuals to stay on treatment.
So it's really a combination of the efficacy and safety profile that they are the most excited.
For smokers and.
In the future periods.
So you have a new therapy to help their nicotine dependence.
Great.
And just any updates on the F D. A inspection readiness on the pharma front and also.
Any updates regarding preparations for novartis supply chain getting the registration batches.
Are all of those processes on track.
Yes, thanks for the question there so I.
I think the so pharma and CMC attributes, we're going to continue to be.
Our focus as we move forward through NDA submission as we can.
Indicated historically, we've been working very closely with pharma and their readiness efforts.
<unk> numerous mark FDA inspection.
Got it.
So that.
Work will continue.
As we progress and so pharma continues to be confident that they can.
Be ready for a future inspection, but it will continue to be a high area of focus for us as we proceed.
Thank you thanks for taking my questions.
Thank you.
As a reminder, if you like to ask a question you May press Star one.
Next question is from the line of John answered in Boston with sacks. Please proceed with your questions.
Alright, thank you.
Is there any reason to think that the potential vaping, a phase III trial would be much different from orca three are there any considerations there might be smaller or I know, it's kind of early but I'm just thinking ahead on that.
Yeah.
Yeah. So in terms of overall sizing I think looking back at work at two in orbit three is probably a good proxy in terms of overall sample size you know as we've indicated before our belief is that a single phase III trial is what would be required for approval in this indication but.
Ultimately well they should get guidance from from FDA on that but.
But the ultimate design will still be working on in terms of what that looks like.
But yes, that's sort of size what you should anticipate.
Okay, Great and I was doing some reading on varenicline in there's thoughts that it could be used for other types of addiction, perhaps companion and things like that is that is that something that.
That you might consider as well.
To pursue beyond nicotine addiction.
As Cindy said, we had a lot of interest from our Kols and other investigators.
You're saying that obviously.
Graham.
And so we're supportive and those types of events.
Whilst it kind of looked at the other areas of addiction.
Yes.
I just finished.
And with that then watch and see what we.
It was the company.
And is that something that you talk to with potential buyers at this point.
Mike does get split off and you pursue you pursue that on your own and then lift out the the nicotine addiction part or is that would that kind of all go together do you think I mean again I know, it's early but just I'm wondering kind of how.
The thought would be on that and maybe conversations that you've had.
Yeah, So I think in terms of.
Discussions with commercialization partners I think this is really looking at the totality of this we're not looking at splitting this apart in terms of multiple pieces like as we indicated.
Get it on a larger scale before you know we've had term sheets ex U S from third parties.
Tequila are a lot of interest coming out of Asia.
Our continued belief that this asset belongs in the hands of a single global partner, one that does have strong U S capabilities to maximize.
The opportunity here in the U S.
So that's what we're looking for and we think that really kind of resolves around the entirety of the asset.
Covering it up into specific indications.
Okay.
And then looking at the potential sales force that might work the best for this after approval are there any characteristics that you kind of look forward and I'm sure you have a number of suitors that you're talking to and obviously you know on your side do you want to see something thats attractive there to know who you can target and negotiate hardest with.
What are some of those features that you look for in a sales force that would allow scientists on our claim to kind of layer on easily and you know have them be very effective.
Yeah, I think when we look at this overall.
Indication.
Historically, and where we see it moving forward it will continue to be a primary care or call point.
So from our perspective, having reps on the ground that can that can hit that call point.
No.
This could be an asset that basically plugged and played into an existing sales force out there, we think thats kind of the easiest path forward, but there could be other opportunities. When you look at more specialty companies that have.
Neither our CNS focus or addiction focus so I think there's a number of angles, but.
Strong overlap with the call point is one of the key considerations for us.
Okay, and then any hints on a brand name that you guys might be working on or.
Looking for.
Good question. This is something that we pre cleared with with the agency already and obviously, it's not fully blessed until the.
NDA review.
True through the end.
But that's one of the components, we did pretty clear early just to make sure that we have that are ready to roll.
Great Alright, Thank you gentlemen, thank you sandy.
Yeah.
Thank you at this time I'll turn the floor back to management for closing remarks.
Yes, thanks, operator, and thanks, everyone for joining us today and we appreciate all the continued interest it's been a tremendous year with data coming out of not only our second confirmatory phase III trial, but also the first ever randomized placebo controlled trial in <unk> and.
And publication of our first phase III trial in Jama, So really excited about where the programs today and the interest that we continue to see from commercialization organization, we look forward to driving this forward.
Expeditiously and providing updates as we proceed thanks, everyone again for joining us today.
Thank you. This will conclude today's conference you may disconnect. Your lines at this time. Thank you for your participation Goodbye.