Achieve Life Sciences, Inc. (NASDAQ:ACHV) Q3 2022 Earnings Call Transcript

Cindy Jacobs: Well, we are collecting the amount of nicotine in their vaping. There’s so many different vaping devices. So we will have that information to do correlations to see if there is any difference right now. The only stratification factor is whether they at one time were smokers. They couldn’t be smokers obviously and vaping, but we do have history as far as their previous nicotine consumption, whether they were smokers, they’ve always been vapors. Those kind of demographics we will have to be able to then look at the efficacy data in comparison with those demographics.

John Vandermosten: Okay. And last question is just on what the cash burn might be over the next 12 months, now that you’ve completed the two — completed enrollment for the two final trials that you’re working on?

John Bencich: Sure. Yes. On the cash burn side of things, as Jerry mentioned earlier on the call, we would expect the burn to remain elevated here in the fourth quarter of this year, just given the heavy lift still with ORCA-3 as well as ORCA-V1. And then as we get into 2023, we would expect that to start to come down, as those studies wrap up through the middle of the year.

John Vandermosten: Got it. All right. Thank you, Tom. Appreciate it.

Operator: And our next question comes from Jim Molloy from Alliance Global Partners. Go ahead.

Jim Molloy: Hey, John. Thanks for taking my questions. I was wondering if you could talk a little bit about how would you characterize sort of the partnership environment here as you’re getting closer to the finish line. Has the dynamic changed at all? And then what really do you think — I know, it’s hard to tell with partnerships. What do you think triggers the partnership? Does someone pull the trigger in advance after the data, FDA approval? How do you guys see that playing out in your end?

John Bencich: Yes. Thanks for the question, Jim. On the partnership side, we’ll say, we’ve seen some kind of increased momentum on the other side of the ORCA-2 results. So that has been encouraging to see more folks come to the table. I think, in terms of a trigger. It’s always hard to know. You got to put yourself in the other shoes in terms of what’s going to get them over the hurdle to go ahead and move forward with a term sheet. But we had and continue to believe that ORCA-3, as well as ORCA-V1 is going to be an important metric in moving those discussions along. ORCA-3, obviously, sets the stage for the final product profile of this product in terms of the smoking cessation indication. And I think ORCA-V1 from a potential market expansion opportunity into a category that frankly, doesn’t exist today.

So we have heard strong receptivity in terms of having the ability to move forward in the vaping category as well. So I think it’s a combination of things but we do see the milestones that we’ll expect to see in the second quarter of next year being important to those discussions.

Jim Molloy: Excellent. I think in the past, you’ve discussed attempting to synthetically create the API versus the current tree grow. Any updates on where that is? I think that’s something that eventually will come along or the synthesis just not worth the effort given the fact you can get it all on from maturity.

John Bencich: Yes. Good question. So, on the synthetic side, this is an area that we’ve looked into over the past several years in terms of looking for alternative ways to produce this outside of getting more plants in the ground. So far that’s proven elusive just given what nature produces. It’s not something that’s easily replicated in vitro. So, it’s something we’ll continue to look into. It’s not something that we’re actively exploring or researching currently but we do continue to look for other ways to solve for that. But so far, it looks like we’ll continue to focus on natural sourcing for the foreseeable future.