Q2 2021 Cassava Sciences Inc Earnings Call
Greetings and welcome to the cost of the Sciences report of the second quarter 2021financial results. At this time all participants are in a listen only mode of question and answer session will follow the formal presentation.
Operator: Greetings and welcome to the Kosovo Sciences report on the second quarter 2021 financial results. At this time, all participants are in a listen-only mode. The question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press Star Zero on your telephone keypad. As a reminder, this conference is being recorded. I'd now like to turn the conference over to your host, Eric Schoom. Please go ahead. Good morning, and I thank all of you for joining us today.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad. As a reminder of this conference is being recorded I'd now like the turn the call for summer for your host Eric Schoen. Please go ahead Sir.
Good morning, and thank all of you for joining today's call. My name is Eric Schoen I'm, the Chief Financial Officer of Cassava Sciences.
Eric Scho: Good morning, and thank all of you for joining today's call. My name is Eric Scho, and I'm the chief financial officer of Casabah Sciences.
I'd like to remind you that any statements made during this call by management other than statements of historical fact will be considered forward looking and as such will be subject to risks and uncertainties that could materially affect the company's expected results. These forward looking statements include without limitation of the various risks described in the company's annual report on form 10.
Eric Scho: I'd like to remind you that any statements made during this call by management, other than statements of historical fact, will be considered forward-looking, and such forward-looking statements will be subject to risks and uncertainties that could materially affect the company's expected results. These forward-looking statements include, without limitation, the various risks described in the company's annual report on Form 10K for the year ended December 31, 2020. You are cautioned not to place undue reliance on forward-looking statements made during this conference call.
For the year ended December 31.2020.
You are cautioned not to place undue reliance on forward looking statements made during this conference call importantly.
Importantly, this conference call also contains time sensitive information that is accurate only as of the date of the live call August 3rd 2021 except as required by law. The company undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the time of this call.
Eric Scho: Importantly, this conference call also contains time-sensitive information that is accurate only as of the date of the live call, August 3, 2021. Except as required by law, the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the time of this call. Go ahead, go ahead. Would you like to present the financial overview? I sure will. On the cash front, we ended the June quarter with $278.3 million in cash. We believe this amount of cash can fund our Phase 3 program in Alzheimer's disease.
Remi.
Oh go ahead go ahead of you want to present the financial overview.
I sure will.
On the cash front, we ended the June quarter with $278.3 million in cash.
We believe this amount of cash can fund our phase III program in Alzheimer's disease.
The company has no debt.
Eric Scho: The company has no debt.
Net cash used in operations during the 6 months ended June 30th 2021 was $7.4 million net of reimbursements received from the National Institutes of Health Grant Awards.
Eric Scho: Net cash used in operations during the six months ended June 30, 2021, was 7.4 million net of reimbursements received from the National Institutes of Health Grant Award. Net cash use for operations for full year 2021 is in line with previous guidance. We still expect net cash use will be approximately 20 to 25 million for full year 2021 before giving effect for potential one-time uses or sources of cash.
Net cash used for operations for full year 2021 is in line with previous guidance. We still expect net cash used will be approximately $20 million to $25 million for full year 2021 before giving effect for potential 1 time uses or sources of cash.
In our operations net cat E Dash youth is driven by higher head count and personnel expenses.
Eric Scho: In our operations, Netcat-use is driven by higher headcount and personnel expenses, manufacturing costs around large-scale drug supply, professional service expenses related to clinical programs, and operating costs such as insurance, office space, and IT-related expenses. Also, we anticipate our cash use will increase materially in 2022 and beyond as the company grows. And, of course, activities related to our Phase 3 program will greatly contribute to the increase in operating expenses. The net loss for the second quarter ended June 30th, 2021, was 5.1 million or 13 cents per share compared to a net loss of 1.1 million or 5 cents per share for the same period in 2020.
Manufacturing costs around the large scale of drug supply.
Professional service expenses related to clinical programs and operating costs, such as insurance office space and I T related expenses.
Also we anticipate our cash use will increase materially in 2022 and beyond as the company growth.
And of course activities related to our phase III program will greatly contribute to the increase in operating expenses.
Net loss for the second quarter ended June 30th 2021 was $5.1 million for 13 cents per share compared to a net loss of $1.1 million or 5 cents per share for the same period in 2020.
Research and development expenses were $3.9 million compared to the point 6 million for the same period in 2020.
Eric Scho: Research and development expenses were 3.9 million compared to 0.6 million for the same period in 2020. This increase was due primarily to costs related to the manufacture of clinical trial supplies in anticipation of launching a phase three clinical program in Alzheimer's disease, costs of an ongoing open-label study as well as increased personnel. General and administrative expenses were 1.2 million compared to 0.8 million for the same period in 2020. This increase was due primarily to the annual shareholder meeting and insurance costs compared to the prior year.
This increase was due primarily the costs related to manufacture of clinical trial supplies in a tissue anticipation of launching a phase III clinical program in Alzheimer's disease cost of an ongoing open label study as well as increased personnel expenses.
General and administrative expenses were $1.2 million compared to <unk> 8 million for the same period in 2020.
This increase was due primarily to higher annual shareholder meeting and insurance costs compared to the prior year.
Last I want to be clear on 1 point.
Eric Scho: Last, I want to be clear on one point. We believe Kasava Sciences is headed for a period of hyper growth over the next few quarters and the next few years. But at the same time, we do not anticipate raising funds from the capital market.
We believe cassava sciences is headed for a period of hyper growth over the next few quarters and next few years.
At the same time, we do not anticipate raising funds from the capital markets.
On that note I will turn the microphone over to our president and CEO Remi Barbier for a preview of the company's growth strategy.
Eric Scho: On that note, I will turn the microphone over to our president and CEO, Remy Barbee, for a preview of the company's growth strategy. Thank you, Eric, for presenting this financial overview. Please note that with the company's growth, we expect to hold these conference calls more often than we have historically. I will now share my comments regarding three topics, recent clinical data, growth strategy, and also some personal observations around what happened late last week.
Thank you Eric for presenting the financial overview.
Please note that with the company's growth we expect the hold these conference calls more often than we have historically.
I will now share of my comments regarding 3 topics recent clinical data growth strategy and also some personal observation around what happened late last week.
So first let's talk about recent clinical data for the Smiths Lam, our drug for Alzheimer's disease.
I think of as everyone knows where drug developers drug developing is a true developed excuse me is a humbling activity. It's humbling because although we're excited about drug activity our highest priority is safety.
Eric Scho: So first, let's talk about recent clinical data for Symiflam, our drug for Alzheimer's disease. I think, as everyone knows, we're drug developers. Drug development is, excuse me, a humbling activity. It's humbling because although we're excited about drug activity, our highest priority is safety. Specifically, our job is to safeguard the well-being of patients who have agreed to take our investigational drug.
Specifically, our job is the safeguard the well being of patients who have agreed to take our investigational drug.
As Dr. The Burns mentioned in her talk late last week at a a I see the.
The purpose of our open label study is to evaluate drug safety and Tolerability.
Now as I understand 1 of the main critiques the against US is that last week's open data open label data set did not provide clear evidence of efficacy well, yes. We can all agree that open label data is not proof of efficacy.
Remy Barbee: As Dr. Burns mentioned in her talk late last week at AAC, the purpose of our open label study is to evaluate drug safety and tolerability. Now, as I understand it, one of the main critiques against us is that last week's open label data set did not provide clear evidence of efficacy. Well, yes, we can all agree that open-label data is not proof of efficacy. However, unequivocal proof of efficacy requires a phase three program. That's coming up. That's our next attraction.
Unequivocal proof of efficacy requires a phase III program.
That's coming up that's our next the attraction.
But until then can we learn something useful about treatment effects in an open label study. We believe the answer is yes, we can.
Keep in mind that Alzheimers R&D has been in a 20 year drought for 20 years, nothing safe useful or effective has come out of the anyone's glad to treat people with Alzheimers Alzheimers research has been the desert of dry holes given the historical record it's high time to incur.
Remy Barbee: But until then, can we learn something useful about treatment effects in an open-label study? We believe the answer is yes, we can. Keep in mind that Alzheimer's R&D has been in a 20-year drought. For 20 years, nothing safe, useful, or effective has come out of anyone's lab to treat people with Alzheimer's. Alzheimer's research has been a desert of dry holes. Given this historical record, it's high time to encourage new approaches to treat Alzheimer's disease. As I see it, the data for Smithlam right now are green shoots. Why would anyone bash green shoots simply because they haven't yet reached the height of a tree?
The new approaches to treat all the time of his disease.
And I see the data for submit Slim right now is green shoots why would anyone Bash green shoots simply because these haven't yet reached the height of the treat my opinion, that's an unreasonable reaction to encouraging open label data.
Now it is fair to ask why are we conducting an open label study to begin with well. The first this is the standard method of demonstrating drug safety.
Second we believe that it's an experimental drug for Alzheimer's shows no treatment benefit in a well designed open label study then there is no chance that drug will succeed in the randomized controlled trial.
Of course, the opposite is not true encouraging treatment effects. The open label study is not evidence of drug efficacy, nor cannon excuse me, nor can encouraging treatment effects predict clinical success.
Remy Barbee: In my opinion, that's an unreasonable reaction to encouraging open-label data. Now, it is fair to ask, why are we conducting an open-label study to begin with? Well, first, this is a standard method of demonstrating drug safety. Second, we believe that if an experimental drug for Alzheimer's shows no treatment benefit in a well-designed open-label study, then there is no chance that the drug will succeed in a randomized control trial. Of course, the opposite is not true.
And the phase III program.
So for US an open label study is an exercise in risk management, we think it's prudent to do a study whose results can help inform and manage the inherent risks and uncertainties of a large expensive phase III clinical testing program. It's the safe thing to do and it's the right thing to do.
And by the way almost every drug candidate must go through an open label study. We just chose to do it prior to spending of $100 million of share of shareholder value.
On a phase III program.
I also believe last week's data are 1 of the kind of.
Remy Barbee: Encouraging treatment effects in an open-label study is not evidence of drug efficacy, nor can encouraging treatment effects predict clinical success in the phase three program. So for us, an open-label study is an exercise in risk management. We think it's prudent to do a study whose results can help inform and manage the inherent risks and uncertainties of a large, expensive phase three clinical testing program. It's the safe thing to do, and it's the right thing to do.
I believe this is the first report of significant cognitive improvement at 9 months debt also tracks with profound the improvements in biomarkers in patients with Alzheimer's.
And this the excuse me Smith's lane improved cognition scores biomarkers mental and mental health with a clean safety profile and easy administration.
But in my opinion, what is truly impressive about Smiths Lam is the continued improvement on the same dose and a disease with inevitable decline.
We think this is unprecedented and all of the flankers.
Remy Barbee: And by the way, almost every drug candidate must go through an open-label study. We just chose to do it prior to spending $100 million of shareholder value on a phase three program. I also believe last week's data are one of a kind. I believe this is the first report of significant cognitive improvement at nine months that also tracks with profound improvements in biomarkers in patients with Alzheimer's. Smyphalim improved cognition scores, biomarkers, and mental and physical health, with a clean safety profile and easy administration.
Even if just half of the our open label data replicate in phase III clinical testing, we think Smith's lane can become an important drug in clinical medicine not to mention the biggest blockbuster in pharmaceutical history.
This is why we're encouraged by the data.
So let me be clear.
We are both humbled and energized by last week's clinical data humbled, because we see encouraging treatment effects in people with Alzheimer's.
Energized because we believe the data we will replicate in phase III.
As a reminder, we will conduct the Preplanned interim analysis of the open label study of 12 months, we look forward to presenting the 12 month data sometime this fall.
Now lets turn for the second area of discussion our strategy for corporate growth.
Given last week's data, we think Smith's lane represents an enormous clinical and market opportunity.
Remy Barbee: But in my opinion, what is truly impressive about Smith Lamb is a continued improvement on the same dose and a disease with inevitable decline. We think this is unprecedented in all, Even if just half of our open-label data replicates in phase three clinical testing, we think Simithlam can become an important drug in clinical medicine, not to mention the biggest blockbuster in pharmaceuticals. This is why we're encouraged by the data. So let me be clear.
Given the potential upside, it's clear that we need to grow the company strategically and tactically on.
On the tactical front, we may need to double the size of the company every year for a number of years.
As our CFO pointed out earlier, we have financial resources to conduct a phase III clinical program with some Islamic in Alzheimer's disease, we have over $275 million of cash in the bank and no debt.
We think this balance sheet couldn't get us to the other side of phase III data and Alzheimer's disease.
In addition.
Over the next few weeks or months, we expect to make a public announcement regarding of defense that we think will result in significant multi year capital inflows into cassava Sciences.
Remy Barbee: We're both humbled and energized by last week's clinical data. Humbled because we see encouraging treatment effects in people with Alzheimer's, and energized because we believe the data will replicate in phase three. As a reminder, we will conduct a pre-plan interim analysis of the open-label study at 12 months. We look forward to presenting the 12-month data sometime this fall.
For the last 2 weeks clinical dataset.
Wall Street critics may the busy bashing, the green shoots, but other parties with the world of scientific and clinical experience and Alzheimers disease might love to participate in the development of our drug candidate.
The expected capital inflows will be non dilutive and non debt.
Remy Barbee: Now let's turn to the second area of discussion, our strategy for corporate growth. Given last week's data, we think Smith Lamb represents an enormous clinical and market opportunity. Given the potential upside, it's clear that we need to grow the company strategically and tactically. On the tactical front, we may need to double the size of the company every year for a number of years. As our CFO pointed out earlier, we have financial resources to conduct a phase three clinical program with semifflin and Alzheimer's disease. We have over $275 million of cash in the bank and no debt.
Obvious reasons, we cannot provide for the guidance around the potential event until it it occurs and is made public.
So far with the clinical data and because of all the sciences growth strategy.
I would like to close with some personal observations around what happened late last week.
By now everyone knows that last week, we announced the comprehensive dataset at a a R E.
Before the data was made public until certain wall Street firms don't hundreds of millions of dollars of our stock on the open market again this occurred before our data was announced for.
I mean, this doesn't feel like normal market volatility or profit take feels more like it was a well coordinated well timed market strategy. The force down the price of our stock last Thursday, and Friday I don't have the expertise to say whether this was market.
The manipulation, but it sure felt to me like price manipulation.
Remy Barbee: We think this balance sheet can get us to the other side of phase three data and Alzheimer's disease. In addition, over the next few weeks or months, we expect to make a public announcement regarding an event that we think will result in significant multi-year capital inflows into Kasava Science. Remember last week's clinical data set? Wall Street critics may be busy bashing the green shoots, but other parties with a world of scientific and clinical experience in Alzheimer's disease might love to participate in the development of our drug candidates. The expected capital inflows will be non-dilutive and non-dead. For obvious reasons, we cannot provide further guidance around this potential event until it occurs and is made public.
But also the steroids and he has helped some of our critics take below the belts for it.
Example of 1 of the critics of our work as a fellow in England, who.
Essentially called our entire dataset rubbish.
The next day it was disclosed at the Hello, as the highly paid consulted for Biogen.
Coincidence or not you decide.
Last week was also on the example of appalling chauvinist behavior towards women scientists.
Dr. Lindsey Burns of site senior Vice President because of all the sciences.
He presented for US last week at a a R E.
Dr. Byrne who's the scholar of scientists brilliant researcher and author of numerous scientific manuscript and adventure on several patents.
The executive not he mentioned the Olympic medalist in the World champion. She educated at Harvard and University of Cambridge with Eaton Technical credentials, how is it possible that her personal character was attack last week.
Remy Barbee: So far, we've discussed clinical data and Casabas Science's growth strategy. I would like to close with some personal observations on what happened late last week. By now, everyone knows that last week we announced a comprehensive data set at AAC. Before this data was made public, I'm told, certain Wall Street firms dumped hundreds of millions of dollars of our stock on the open market. Again, this occurred before our data was announced. To me, this doesn't feel like normal market volatility or profit taking.
For work was the write it as quote worthy of an undergraduate student by the Biogen consultant.
Patronizing as debt.
The burdens was the only speaker, who was the little for presenting data for yourself instead of hiring of Kols to do so in fact every presentation on her session was made by companies represent the kids.
For marital status was turning into a topic of discussion.
He was called out by the first name by critics. She never met while at the same critics referred to other professionals as doctors zone, so or professors zone. So it.
It was insinuated that she was presenting data because of her marital status for the <unk>.
Remy Barbee: It feels more like it was a well-coordinated, well-timed market strategy to force down the price of our stock last Thursday and Friday. I don't have the expertise to say whether this was market manipulation, but it sure felt to me like it was.
Record she is what.
Isn't he led our Alzheimers program since its inception over 10 years ago.
Many companies presented biomarker data last week Dr.
Dr. Burnes presented a panel of CSF biomarkers of improvements that also trap with improvement in cognition, which is an important scientific findings.
Remy Barbee: What also disturbs me is how some of our critics hit below the bill. For example, one of the critics of our work is a fellow in England who essentially called our entire dataset rubbish. The next day, it was disclosed that this fellow is a highly paid consultant for biogic. Coincidence or not, you decide.
And yet 1 analyst singled out for biomarker data and dismissed its importance by claiming alzheimers patients can change their own CSF biomarkers by changing lifestyles.
In other words, just the analysts of the thing he has all of the timers. It's your own fault go change your own your lifestyle. This is outrageous people with Alzheimer's go through unspeakable suffering and loss of the dignity as disease progresses.
Remy Barbee: Last week was also an example of appalling chauvinistic behavior towards women's rights. Dr. Lindsay Burns is Senior Vice President in the Casaviscience. He presented for us last week at AAIC. Dr. Burns is a scholar, a scientist, a brilliant researcher, an author of numerous scientific manuscripts, an inventor on several patents, and an effective executive, not to mention an Olympic medalist and world champion. She was educated at Harvard and the University of Cambridge.
The last thing patients need to here as the Wall Street person, saying, it's their fault for getting sick.
As I see it last week was not so much a debate about data data interpretation.
It was an attack on gender personal background, even the entire Alzheimer's community the very people who.
The deserve to know about promising drugs in the pipeline.
And rhetorically how is it in 2021 women scientists they heavier expectations when it comes to the quality of their work their parents and whether they should be allowed to per cent.
Remy Barbee: With these impeccable credentials, how is it possible that her personal character was attacked? Her work was derided as, quote, worthy of an undergraduate student by the Viagen consultant. How patronizing! Dr. Burns was the only speaker who was belittled for presenting data herself instead of hiring a KOL to do so. In fact, every presentation in her session was made by a company representative, and her marital status was turned into a topic of discussion. She was called out by her first name by critics she's never met, while the same critics refer to other professionals as Doctor so-and-so or Professor so-and-so.
Okay.
How is it that in 2021 employees tolerate and even reward gender discrimination and chauvinism towards patients with disease.
I am appalled by these disease Criticising, a person's gender marital status personal history or disease is never acceptable.
We cannot undo what has been done but.
We should all be outrage.
Painful to see this happening in 2020.1.
But the see this happening in the highly educated people.
Beyond the pale.
As the science community, we are better than that.
In closing this call, let me say that could solve of sites as well finance we are growing we're not raised money.
We believe in it.
Your muscle of drug for Alzheimer's disease shows no treatment benefit in a well designed open label study and there is no chance that drug of will succeed in a randomized controlled trial.
Remy Barbee: It was insinuated that she was presenting data because of her marital status. For the record, she has led our Alzheimer's program since its inception over 10 years ago. Many companies presented biomarker data last week. Dr. Burns presented a panel of CSF biomarker improvements that also tied to improvement in cognitive function, which is an important scientific finding. And yet, one analyst singled out her by-market data and dismissed its importance by claiming Alzheimer's patients can change their own CSF biomarkers by changing lifestyles. In other words, this analyst is saying, if you have Alzheimer's, it's your own fault. Go change your own, your lifestyle.
That insight coupled with the responsibility to demonstrate safety.
<unk>, our open label strategies.
We're about to initiate a phase III program enrollment in the ongoing cognition maintenance study is going well.
And we expect to announce 12 months data on safety and cognition sometime this fall.
Regarding corporate growth, we expect to make a major announcement in the weeks or months ahead, it's an exciting time for cassava sciences.
With that let's turn it over for Q&A I am told I was told by the operator of that we have over 500 people on this call, which means we will need to set time limits on this Q&A session. Thank you.
Okay.
Thank you and at this time, we will be conducting a question and answer session. If you would like to ask a question. Please press star 1 on your telephone keypad the confirmation tone the confirmation.
Remy Barbee: This is outrageous. People with Alzheimer's go through unspeakable suffering and loss of dignity as the disease progresses. The last thing patients need to hear is a Wall Street person saying it's their fault for getting it. As I see it, last week was not so much a debate about data or data interpretation. It was an attack on gender, personal background, and even the entire Alzheimer's community.
The confirmation tone will indicate your line is in the question queue. You May Press Star 2 if you would like to remove your question from the queue for participants using speaker equipment and may be necessary to pick up your handset before pressing the star key 1 moment, while we poll for questions.
And we'll go first to.
My mum, Tony with B Riley Securities.
Good luck good morning team, thanks for taking our questions and congrats on the progress and data the last week and Unfortunately, some of the response of since then but especially the kudos to Lindsay for the presentation of Dr.
Remy Barbee: The very people who deserve to know about promising drugs in the pipeline. And rhetorically, how is it that in 2021, women scientists faced heavier expectations when it comes to the quality of their work, their appearance, and whether they should be allowed to present? How is it that in 2021, employees tolerate and even reward gender discrimination and chauvinism towards patients with disease? I am appalled by these diseases; criticizing a person's gender, marital status, personal history, or disease is never accepted.
Dr <unk> excuse me.
So maybe a couple of quick questions for me is as.
Let me you touched on there might be a few investors waiting for the placebo controlled data set and that makes your God mission maintains mendelian study extremely important.
Could you maybe just go in more detail on rational and design of the study and and and maybe you know what what the drug studies like this have shown in the past and and if you can be a little more specific on timeline and and how that study is progressing that would be helpful.
Remy Barbee: We cannot undo what has been done, but I think we should all be outraged. It is painful to see this happening in 2021; to see this happening among highly educated people is beyond the pale. As a science community, we are better than this. In closing this call, let me say that Consolvis Sciences is well financed. We are growing. We're not raising money.
And I have the follow ups.
Sure Great first question. The question is I as I hear it.
Is please expand it down around the cognition maintenance study.
So most studies asked the question what happens to of patient when the patient is given a drug.
With the cognition maintenance study, we're doing the opposite.
We're saying here are a 100.100, plus patients who have been taking the.
Remy Barbee: We believe that if an experimental drug for Alzheimer's disease shows no treatment benefit in a well-designed open-label study, then there is no chance that the drug will succeed in a randomized control trial. That insight, coupled with a responsibility to demonstrate safety, drives our open-label strategy. We're about to initiate a phase three program. Enrollment in the ongoing cognition maintenance study is going well, and we expect to announce 12-month data on safety and cognition sometime this fall. Regarding corporate growth, we expect to make a major announcement in the weeks or months ahead. It's an exciting time for Kasava Science.
And this land an open label basis.
What happens when those patients are enrolled in a randomized controlled trial half the patients continue on their normal doses and the slim and half the patients are on <unk> are given placebo.
It's a fascinating question and it's really the flip side of a phase III program.
I'm not going to say, it's the conventional type of study, but I think given the patient population. It is important to ask the question and also given that it's the CNS drug it's important to ask the question what happens when patients are taken off drug.
Clearly, we don't have an answer yet because we don't have the data.
But we think it can provide attitude.
Operator: With that, let's turn it over for the Q&A. I'm told, I was told by the operator, that we have over 500 people on this call, which means we'll need to set time limits for this Q&A session. Thank you. Thank you. And at this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1.
Information regarding not just the safety, obviously of a Smith's lane, but more importantly, some early evidence of efficacy or treatment benefits.
In terms of timelines.
We've had a very high conversion rate from open label studies patients who concluded the open label portion of the study enrolled.
Operator: Thank you. And at this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line has ended the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. One moment while we pull for questions, and we'll go first to Myak Monsetani with B Riley Securities.
I won't say the conversion rate is somewhere around 60.70 per cent.
It's not 100% sub patients.
Simply don't want to be enrolled in a randomized controlled trial.
But given.
Given the enrolled the conversion rate I would expect us to have data.
On the cog maintenance cognition study, perhaps sometime say.
Say middle of next year.
Great. Thanks, Thanks for that and the.
Then on the 12 month data that you have coming up.
Specifically, maybe focusing on biomarkers the.
Myak Monsetani: Good morning team. Thanks for taking our questions and congratulations on the progress and data last week. And, unfortunately, some of the responses since then, but, you know, special kudos to Lindsay for the presentation. Or Dr. Burns, excuse me.
The which which ones you know at that time theaters in Europe, and then add more.
The meaningfully to focus on and Ah.
Are you going to essentially have the similar updated like you had a D. A C and potentially a medical conference.
Remy Barbee: So maybe a couple of quick questions for me. As Remy touched on, you know, there might be a few investors waiting for the placebo control data set. And that, you know, makes your cognition, maintain, and study, you know, extremely important. And could you maybe just go in more detail on the rationale and design of the study and maybe, you know, what withdrawal studies like this have shown in the past? And if you can be a little more specific on the timeline and how that study is progressing, that would be great. And I have a follow-up.
And in the fall.
I'm just curious like what increment of lead deal inflammation can be learned about the longer term.
Treatment of treatment with the Muslim for them from a mechanistic standpoint in that dataset.
Yeah very good follow up question, but remember what I said, what I believe is truly impressive about the Netherlands.
Is the continued improvement on the same dose and they disease with inevitable decline.
This has never been seen before in Alzheimers disease.
In plain English what that means is that even if.
Even if the patient is cognition scores maintain where they are the fact that patients are declining.
Remy Barbee: Sure, great first question. The question, as I hear it, is please expand on the cognition maintenance study. So most studies ask the question, what happens to a patient when a patient is given a drug? With the cognition maintenance study, we're doing the opposite.
Signifies that the drug is continuing to exert some beneficial treatment effect.
And that's a very important finding because collectively between the biomarkers.
And the cognition scores.
All of the this to US suggests disease modification.
Remy Barbee: We're saying, here are 100, 100 plus patients who have been taking this lamb on an open label basis. What happens when those patients are enrolled in a randomized controlled trial, half the patients continue on their normal dose of semifiland, and half the patients are given placebo. It's a fascinating question, and it's really the flip side of a phase three program. I'm not going to say it's a conventional type of study, but I think given the patient population, it is important to ask the question, and also given that it's a CNS drug. It's important to ask the question what happens when patients are taken off drugs.
And that has been the name of the game and Alzheimers R&D for many many years.
Okay, great. Thanks for taking my questions.
We'll go next to the Vernon Bernardino with H C Wainwright.
Hi, Erika and Lindsay thanks.
Thanks for taking my question and congrats on the results of.
I was impressed in the hopefully others for 2 who.
The more closer attention I was just wondering and.
And in the presentation.
All of the individual patient changes in Adas Cog, where you have the different colored docs than.
The percentage of patients who prove that 9 months in the patients showed a decline of less than expected.
I'm just wondering if you could comment on the changes if you have the data from the 6 month data that you observed from 6 months to 9 months.
Remy Barbee: Clearly, we don't have an answer yet because we don't have the data, but we think it can provide additive information regarding not just the safety, obviously, of semifiland but, more importantly, some early evidence of efficacy or treatment benefits. In terms of timelines, we've had a very high conversion rate from open-label studies, patients who concluded the open-label portion of the study enrolled. I want to say the conversion rate is somewhere around 60 or 70%.
So the the I'm not sure I understand the the question and all of its details, but the again I believe what Vernon is referring to is on slide 9 of our presentation.
We show.
Individual patient changes the Adas cog.
The the reason that's important is because and studies. The the first thing you want to make sure. If you see of treatment effect. The first thing you want to make sure is that the treatment effects that are observed are not concentrated in the very very small handful of patients.
Clearly that is not the case here.
Remy Barbee: It's not 100%. Some patients simply don't want to be enrolled in a randomized controlled trial. But given the conversion rate, I would expect us to have data on the maintenance cognition study sometime, say the middle of next year.
88% of.
The patients declined less than expected 66 per cent of patients improved at 9 months.
That is not a coincidence to us that is highly suggestive of.
Of beneficial treatment effect.
The the slide on the.
The slide the slide 9 shows the actual improvement by patient.
Remy Barbee: Great, thanks for that color. And then on the 12-month data that you have coming up, you know, specifically maybe focusing on biomarkers there. Which ones, you know, at that time period, in your opinion, are more meaningful to focus on? And are you going to essentially have a similar update like you had at AIC at potentially a medical conference in the fall? Yeah.
Yes, some decline as you would expect too.
But most improved again this is of significant and unique finding in alzheimers.
The did I did I answer specifically your question.
Hum partially.
Also of trying to get at if let's say in the 6 months data.
The 8% or what percentage of patients either improved with the cloud the mcarthur.
Okay. So similar data for 6 months.
Remy Barbee: I'm just curious, like, what incrementally new information can we learn about the longer-term treatment with simophilum from a mechanistic standpoint in that data system?
Okay, I don't have that data right in front of my eyes, but I believe it was a similar similarly, it was a very high percentage of patients who improved at 9 months was at the exact same dots you see on slide 9 I don't I simply don't have the.
Remy Barbee: Yeah, very good follow-up question, but remember what I said. What I believe is truly impressive about Simithalam is the continued improvement on the same dose in a disease with inevitable decline. This has never been seen before in Alzheimer's disease. In plain English, what that means is that even if cognition scores maintain where they are, the fact that patients are declining signifies that the drug is continuing to exert some beneficial treatment effect.
That data in front of me.
What I do know is that the data were well distributed it at 6 months as well so it's probably the case the.
That patients who improve continue to improve.
Well, those who maintain cognition, which by the way is the very important finding by itself.
Also are likely to maintain.
Remy Barbee: And that's a very important finding because, collectively, between the biomarkers and the cognition scores, all of this, to us, suggests disease modification, and that has been the name of the game in Alzheimer's R&D for many, many years.
And as a follow up.
Regarding the baseline Adas cog for this study of admittedly, yes, if it's the open label how does that compare the baseline cockpits you observed in the study of compared to other studies.
How does how do Adas cog scores compare in our study versus other studies.
Myak Monsetani: Okay, great. Thanks for taking my question.
Yes, I believe I think the baseline here was.
Vernon Bernardino: We'll go next to Vernon Bernardino with H.C. Wainwright.
Minus 15, and then or what do you observe as baseline cog and others.
Vernon Bernardino: Hi Remy, Eric, and Lindsay. Thanks for taking my question and congratulations on the results. I was impressed and hopefully others were too who paid more close attention. I was just wondering, particularly in the presentation of the individual patient changes in ADAS COG where you have the different colored dots indicating the percentage of patients who approved for that nine months and then patients who decline less than expected. I just wonder if you could comment on the changes if you have that data from the six-month data that you observed from six months to nine.
Our our baseline Adas Cog I think he is on slide 6 and it was roughly 16.6, the important thing or let me rephrase. Your question if I may is.
Our of baseline Adas cog scores consistent with patients who have mild to moderate Alzheimer's disease, Yes, we absolutely believe that it is very consistent if anything a 16.6, though is the <unk>.
Turning to get a little bit of on the more moderate side than mild.
The Biogen Phase III studies for example were conducted and more mild what they call early a D, which is somewhere between more than more than M. C I, but less in miles.
So yeah, absolutely. This patient population represents a mild to moderate and especially leaning more towards the moderate our cogs are.
Remy Barbee: So I'm not sure I understand the question in all its details, but the, again, I believe what Vernon is referring to is on slide nine of our AAIC presentation. We show individual patient changes, ADS COGS. The reason that's important is because in studies, the first thing you want to make sure if you see a treatment effect, the first thing you want to make sure is that the treatment effects that are observed are not concentrated in a very, very small handful of patients.
Cognitive impairment.
Perfect that's exactly what I wanted and so so thank you for the insight and additional information.
For me of conference a lot of things thanks for taking my questions and congrats again.
Thank you.
And lastly, we will go to assume it right.
Hi, I would extend my congratulations also again on the very.
It was data really derisked a lot of the 12 month data in the upcoming in the fall.
Touching back again on the slide 9 of curious if you I know the data size, it's still small only 50 patient, but curious if you have for noticed any biomarker correlation between the patients who are showing improvement versus who are not essentially trying to.
Remy Barbee: Clearly, that is not the case here. 88% of patients declined less than expected, and 66% of patients improved at nine months. That is not a coincidence. To us, that is highly suggestive of beneficial treatment effects. The slide on, Slide 9 shows the actual improvement by patient. Yes, some declined, as you would expect to, but most improved. Again, this is a significant and unique finding in Alzheimer's. Did I answer your question?
Look for any predictive.
Biomarker.
If you have noticed something like that.
Yeah.
Yeah, it's the great Ah Ah.
Statistical Tyco's question.
And there is a correlation.
For the first of all of the backup there is a limit to how much you know interpretation and statistical analysis, we can or we really we should be doing on 50 patients.
Vernon Bernardino: Partially, I was also trying to get at if, let's say, in the six-month data, 88% or what percentage of patients either improve the client? Oh, I'm sorry.
But if you go back in and look at the the CSF Biomarkers of disease and in fact, what you do see is that patients, who improved and and the CSF biomarkers of disease, especially with with regards to Tau levels of both pizza Alan Tee Chao.
Remy Barbee: Okay, so similar data for six months? I don't have that data right in front of my eyes, but I believe it was a similar, similarly, a very high percentage of patients who improved at nine months. Was it the exact same dots you see on slide nine?
The same patients seem to be seem to do better on cognition.
Yeah.
Right so on.
Sorry, the final dataset, we'll obviously have that type of information because it's an important correlation and it is certainly a correlation we saw very nicely in our data set with the phase II B, which as you recall was a randomized controlled trial.
Vernon Bernardino: I don't, I simply don't have that data in front of me. What I do know is that the data were well distributed at six months as well. So it's probably the case that patients who improve continue to improve while those who maintain cognition, which, by the way, is a very important finding by itself, also are likely to maintain.
Alright.
If you kind of help us the sound like the biomarker.
The first hotel of total level reduction of the 6 months versus let's say the some of the.
Your peers, how does it compare because of the data is being presented a little differently. So it's would.
Would you say, 18% reduction in force for Tau indicate indicating a clinical.
Vernon Bernardino: And as a follow-up, regarding the Bayfond ADAS COG for this study, and admittedly, yes, if it's an open label, how does that compare to the baseline COG that you observed in the study compared to
The benefit.
A fascinating question and 1 that I think the person.
<unk> has spent the entire careers. The finding you know what is or what might be of a treatment effect on biomarkers.
Vernon Bernardino: How do AIDUS COGS scores compare in our study versus other studies? Yes,
For the short answer is we don't know what we do know with 100% certainty is that if the level of its levels of these biomarkers goes through the roof. If they go in the up direction, you had 100% certainty of cognitive decline.
Vernon Bernardino: Yes, I believe I think the baseline here was, what, minus 15, and then what do you serve as the baseline cog in a wheel?
Remy Barbee: Our baseline ADS COG, I think, is on slide 6, and it was roughly 16.6. The important thing, let me rephrase your question, if I may, is whether baseline ADS COG scores are consistent with patients who have mild to moderate Alzheimer's disease? Yes, we absolutely believe that it is very consistent.
No 1 will argue with what I just said.
What we don't know is what's the treatment effect is at a 10% reduction is it a 20 per cent reduction we don't no.
Furthermore.
It's an important to hit just 1 or 2 biomarkers or do you need to hit the entire panel of Biomarkers, what we're saying.
Is that given the reduction the profound reductions in CSF biomarkers at 6 months.
Vernon Bernardino: If anything, 16.6 is starting to get a little bit on the more moderate side than mild. The Biogen Phase 3 studies, for example, were conducted in more mild cases, what they call early AD, which is somewhere between more than MCI but less than mild. So, absolutely, this patient population represents a mild to moderate, and especially leaning more towards moderate cognitive impairment. Perfect.
Weak and the early evidence on cognition.
We think the dataset is consistent with disease modifying effects.
To put your question in perspective.
Some companies are developing drugs for entire drug programs.
The reduced in just 1 single biomarker for.
For example, soluble trend too is a very very hot.
The drug target and farms and farmland.
Vernon Bernardino: Perfect, that's exactly what I wanted. And so, thank you for the insight and additional information; for me, it confirms a lot of things. Thanks for answering my questions. And congrats again.
There are companies entire companies that had been set up to reduce levels of trend too.
We reduced levels of trend to buy 65 per cent.
And reduced levels of P Cal and teach out and narrowed the you know and it goes on the non to non so again I think what is unique and very scientifically and clinically very interesting about the dataset is that we go after the entire panel not just 1 biomarker of disease.
Sumit Roy: And lastly, we'll go to Sumit Roy.
Sumit Roy: Hi, how can I extend my congratulations also again on this very robust data really de-risks a lot, the 12-month data in the upcoming fall. Touching back again on slide 9, I'm curious if you, I know the data size is still small, only 50 patients, but curious if you have noticed any biomarker correlation between the patients who are showing improvement versus those who are not, essentially trying to look for any predictive biomarker if you have noticed something like that.
Perfect. Thank you so much and congratulations again for the entire team.
Thank you.
Yeah.
Operator.
I will now turn the call back over to you for any additional or closing remarks.
No no concluding remarks other than again, it's an exciting time for cassava sciences and we thank everyone for participating this morning.
Remy Barbee: Yeah, it's a great statistical type of question, and there is some correlation. First of all, let me back up. There is a limit to how much interpretation and statistical analysis we can, or really should be doing on 50 patients. But if you go back and look at the CSF biomarkers of disease, in fact, what you do see is that patients who improve in, and the CSF biomarkers of disease, especially with regard to tau levels of both PT-Tal, these same patients seem to do better on cognition.
Thank you. This now concludes today's teleconference. You may now disconnect. Your lines at this time. Thank you for your participation.
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Sumit Roy: Right. On
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Remy Barbee: Sorry, the final data set will obviously have that type of information because it's an important correlation. And it is certainly a correlation we saw very nicely in our data set with the Phase 2B, which, as you recall, was a randomized control trial.
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Sumit Roy: Right. If you can help us discern like the biomarker these phospho-tao-tao levels reduction at six months versus, let's say, some of your peers. How does it compare? Because the data is being presented a little differently. So would you say 18% reduction in phospho-tow is indicating a clinical benefit?
Remy Barbee: Fascinating question, and one that I think professors have spent entire careers defining what is or what might be a treatment effect on biomarkers. The short answer is we don't know. What we do know with 100% certainty is that if the levels of these biomarkers go through the roof, if they go in the upward direction, you have 100% certainty of cognitive decline. No one will argue with what I just said.
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Remy Barbee: What we don't know is what the treatment effect is. Is it a 10% reduction? Is it a 20% reduction? We don't know.
Remy Barbee: Furthermore, Is it important to hit just one or two biomarkers, or do you need to hit the entire panel of biomarkers? What we're saying is that given the reduction, the profound reductions in CSF biomarkers at six months, and the early evidence on cognition. We think the data set is consistent with a disease modifying effect. To put your question in perspective, some companies are developing drugs, an entire drug program, around reducing just one single biomark.
Okay.
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Remy Barbee: For example, soluble Trem2 is a very, very hot drug target in pharma and pharma-in-farmuland. There are companies, entire companies, that have been set up to reduce levels of trend two. We reduce levels of trend 2 by 65%, and reduce levels of T-tow and T-tow and nerve, you know, and it goes on and on and on. So, again, I think what is unique and very scientifically and clinically very interesting about the data set is that we go after the entire panel, not just the one biomarker of the Zer.
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Sumit Roy: Perfect. Thank you so much, and congratulations again to the entire team. Thank you.
Sumit Roy: Perfect. Thank you so much, and congratulations again to the entire team. Thank you.
Remy Barbee: I will now turn the call back over to you for any additional or closing remarks.
Remy Barbee: No concluding remarks other than, again, it's an exciting time for Casava Sciences, and we thank everyone for participating this morning. Thank you. This now concludes today's teleconference. You may now disconnect your lines at this time.
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Operator: Thank you. This now concludes today's teleconference. You may now disconnect your lines at this time. Thank you for your participation.
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Operator: Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you.
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