Q4 2023 Cognition Therapeutics Inc Earnings Call

Operator: Hello, everyone, and welcome to Cognition Therapeutics' fourth quarter 2023 earnings call. Please note that this call is being recorded. I'd now like to hand over to our first speaker for today, Mike Meyer. Please go ahead.

Hello, everyone and welcome to cognition Therapeutics fourth quarter 'twenty to 'twenty three earnings call. Please note that this call is being recorded I would now like to handle very child refresh speaker for today, Mike Moira. Please go ahead.

Unknown Executive: Thank you, operator, and good morning, everyone. Welcome to the Cognition Therapeutics fourth quarter and year-end 2023 results conference call. With me today are Lisa Ricciardi, President and Chief Executive Officer, John Doyle, Chief Financial Officer, and Dr. Tony Caggiano, Chief Medical Officer. This morning, the company issued a press release detailing its 2023 fourth quarter and year-end results.

Mike Moira: Thank you operator, and good morning, everyone welcome to the cognizant Therapeutics fourth quarter and year end 2023 results Conference call with me today are Lisa Richard <unk>, President and Chief Executive Officer, John Doyle, Chief Financial Officer.

Mike Moira: Doctor, Tony Casciano, Chief Medical Officer.

Mike Moira: Morning, The company issued a press release detailing its 2023 fourth quarter and year end results. We encourage everyone to read this morning's press release as well as commissions annual report on Form 10-K.

Unknown Executive: We encourage everyone to read this morning's press release, as well as Cognition's annual report on Form 10-K, which is now filed with the SEC and available on our website. In addition, this conference call is being webcast on the company's website and will be archived for 30 days. Please note that certain information discussed on the call today is covered under the Safe Harbor Provisions of the Private Securities Litigation Reform Act. We caution listeners that during the call, management will be making further, actual results could differ materially from those stated or implied by these forward-looking statements due to the risks and uncertainties associated with the company's business.

Mike Moira: Which is now filed with the SEC and available on our website. In addition, this conference call is being webcast through the company's website and will be archived for 30 days.

Mike Moira: Please note that certain information discussed on the call today is covered under the Safe Harbor provisions of the private Securities Litigation Reform Act, we caution listeners that during the call management will be making forward looking statements actual results could differ materially from those stated or implied by these forward looking statements due to the risks and uncertainties associated with the company's business. These forward looking statements are quantum.

Unknown Executive: These forward-looking statements are qualified by the cautionary statements contained in Cognition's press release and SEC filings, including its annual report on Form 10-K and previous, This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast. Cognition undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With that, I would now like to turn the call over to Lisa Ricciardi. Mike, thank you. Good morning, everyone.

Mike Moira: Side by the cautionary statements contained in this press release.

<unk> SEC filings, including its annual report on Form 10-K previous in previous filings. This conference call contains time sensitive information that is accurate only as of the date of this live broadcast Commission undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this conference call with that I would now like to turn the call over to Lisa for sharp.

Lisa Ricciardi: Hi, Thank you good morning, everyone welcome to cognition Therapeutics earnings conference call covering our 2023 results and highlights from recent weeks on today's call John Doyle and I will share prepared remarks on the company's progress and then we'll be joined by Dr. Tony <unk>, Our Chief Medical Officer, and head of R&D to take your.

Lisa Ricciardi: Welcome to Cognition Therapeutics' Earnings Conference Call covering our 2023 results and highlights from recent weeks. On today's call, John Doyle and I will share prepared remarks on the company's progress, and then we'll be joined by Dr. Tony Caggiano, our Chief Medical Officer and Head of R&D, to take your questions. Our drug candidate, our leading drug candidate, is currently in the clinic being tested for Alzheimer's disease and dementia with Lewy bodies, also referred to as DLB. For Alzheimer's disease, we are studying both early-stage patients and patients with mild to moderate disease. We're also studying CT1812 and geographic atrophy, second to dry, age-related AMD, or dry AMD, as it is known. Modulating the sigma 2 receptor complex with a brain penetrant small molecule drug candidate is a unique approach differentiated from other companies developing treatments for both neurodegenerative and ophthalmological diseases.

Lisa Richard: <unk>.

Lisa Richard: Pardon you shouldn't focus is the development of innovative orally available drug candidates targeting age related is degenerative diseases of the central nervous system and retina, our current clinical programs build on our expertise in the Sigma two receptor, which regulate cellular function disrupted by neuro degenerative disease.

Lisa Richard: Jesus our drug candidate our leading drug candidate is currently in the clinic being tested for Alzheimers disease and dementia with Lewy bodies also referred to as D. L. B.

Lisa Richard: <unk> disease, we're studying both early stage patients and patients with mild to moderate disease. We're also studying CK 18, 12 in geographic atrophy second to dry age related AMD or dry AMD as it is no.

Lisa Richard: Relating to the Cigna two receptor complex with a brain penetrant small molecule drug candidate is a unique approach differentiated from other companies developing treatments in both narrowed degenerative and ophthalmology diseases.

Lisa Ricciardi: Now, an update on our trial. Our SHINE study is a Phase II clinical trial of CT1812 that has completed enrollment of 153 patients with mild to moderate Alzheimer's disease. Patients were randomized one-to-one-to-one to receive placebo or oral doses of 100 or 300 milligrams of drug. We expect top-line data mid-24 after the last patient has completed six months of treatment, and we anticipate presenting our more detailed findings at the Alzheimer's Association International Conference, or AAIC, meeting later in the summer. Now, the question at the forefront of everyone's mind, of course, is what would we consider to be a success in SHINE?

Lisa Richard: Now an update on our trials.

Lisa Richard: Our Shine study is a phase two clinical trial of CK 18, 12 that completed enrollment of 153 patients with mild to moderate Alzheimers disease patients were randomized one to one to one to receive placebo or oral doses 100, or 300 milligrams of drug we expect.

Lisa Richard: <unk> line data mid 24 after the last patient patient has completed six months treatment and we anticipate presenting our more detailed findings at the Alzheimers Association International conference or a AIC meeting later in the summer.

Lisa Richard: Question at the forefront of everyone's mind of course is what would we consider to be a success in Cheyenne.

Lisa Ricciardi: As an objective measure, we consider the results from the most recently approved disease-modifying antibody intravenous infusion therapy, Lecanumab, in which treated participants showed a 1.4 point difference in ADIS-CoG 14 over 18 months. Now, we have exceeded this in our preliminary analysis of the first 24 patients in SHINE, where we saw a three point difference in the slowing of cognitive decline compared to placebo on the ATIS-Cog 11 Results similar to our preliminary analysis of the initial 24 patients would represent a clinically meaningful outcome. Endpoints in SHINE include safety, changes in cognitive and functional scores, including the ADIS-CoG-11, the Neurosite Test Battery, the ADCS, and activities of daily living. In addition, we would look to corroborate CT1812 biological activity and its brain penetrant target engagement through the analysis of biomarkers.

Lisa Richard: As an objective measure we consider the results from the most recently approved disease modifying antibody intravenous infusion therapy, Mccanna, mab and which treated participants at a one four point difference in Adas Cog 14 over 18 months.

Lisa Richard: We exceeded this and our preliminary analysis of the first 24 patients in Cheyenne.

Lisa Richard: Are we saw a three point difference in the slowing of cognitive decline compared to placebo on the Adas Cog 11, just that for six months.

Lisa Richard: Results similar to our preliminary analysis of the initial 24 patients would represent a clinically meaningful outcome.

Lisa Richard: Endpoints in China include safety changes in cognitive and functional scores, including the Adas Cog 11, the neuro site kits battery the adcs activities of daily living. In addition, we would look to corroborate <unk>, 18th 12 biological activity and its brain penetrant target engaged.

Lisa Richard: Through the analysis of Biomarkers.

Lisa Ricciardi: Before moving on, I would like to acknowledge the support of our study participants and their caregivers, our clinical trial investigators, CRO partners, and collaborators at the NIH National Institute of Aging. We look forward to seeing the full study results later this year. Now let me turn to our SHMR study, a Phase II U.S.-based trial of CT1812 in mild-to-moderate dementia with Lewy bodies, or DLB. An estimated 1.4 million people are affected by DLB, making the disease the second most common form of dementia. There are no currently approved treatment options, and few drugs are being studied for this condition.

Speaker Change: Before moving on I would like to acknowledge the support of our study participants and their caregivers, our clinical trial investigators CRM partners and.

Speaker Change: Collaborators at the NIH National Institute of aging, we look forward to seeing the full study results later this year.

Speaker Change: Now, let me turn to our Schumer study a phase two U S. Based trial of <unk> 12 in mild to moderate dementia with lewy bodies or D. L. B.

Speaker Change: Estimated one 4 million people are affected by D. L b, making the disease. The second most common form of dementia. There are no currently approved treatment options and few drugs are being studied for this condition.

Lisa Ricciardi: Now, we know from the literature that more than half of DLB patients are estimated to have both amyloid beta and alpha-synuclein oligomers in their brains. CT1812 has been shown to protect neurons from the toxicity of both amyloid beta and alpha-synuclein pathogenic proteins, and thus it has the potential to treat this sizable population of DLB patients with copathology. The SHIMMER trial is also supported by non-dilutive funding from the NIA, and it's being led by Dr. Jim Galvin, our primary investigator at the University of Miami School of Medicine, as well as the Lewy Body Dementia Association, or LBDA, whose centers of excellence are among the sites enrolling patients. We aim to complete enrollment and present top-line data in the second half of the year. Again, we extend our thanks to patients, caregivers, our clinical trial investigators, our CRO partners, and the NIH, NIA. The prior trials I've discussed are being run in a mild to moderate patient population. Our START trial is a 540 patient phase two study of CT1812 in adults with early Alzheimer's disease.

Now we know from the literature that more than half of D. L. B patients are estimated to have voice, both amyloid beta and alpha nucleon oligomers and their brain T. T. 18, 12 has been shown to protect neurons from the toxicity of both amyloid beta and Alpha nucleon pathogenic proteins and thus it has the.

Speaker Change: Tension to treat this sizable population of D. L b patients with co pest biology.

Speaker Change: Shimmer trial was also supported by non dilutive funding from the NIH and its being led by Dr. Jim Galvin, Our primary investigator at the University of Miami School of Medicine, as well as the Lewy body Dementia Association or Ob D. A to centers of excellence are among the sites enrolling patients.

Speaker Change: We aim to complete enrollment and present topline data in the second half of the year again, we extend our thanks to patients caregivers, our clinical trial investigators, our CRO partners and the NIH and I E.

Speaker Change: The prior trials I've discussed are being run in a mild to moderate patient population. Our start trial is a 540 patient phase II study of <unk> 12 in adults with early Alzheimers disease.

Lisa Ricciardi: In collaboration with the Alzheimer's Clinical Trials Consortium, or the ACTC, the START trial is measuring the efficacy and tolerability of CT1812 in subjects with mild cognitive impairment or early disease who have elevated amyloid beta. We received grant support totaling $81 million for this trial from the NIA, and we are very pleased to join forces and collaborate with the ACTC. In 2023, we initiated site activations, and the START trial is now actively recruiting from centers of excellence within the ACTC network. We and our collaborators on this study made the decision to allow participants on stable background therapy with Leucanumab to enroll in START. We believe this decision will provide real-world evidence of CT1812 in combination therapy. I will now turn to our opportunity for CT1812 in ophthalmic conditions, specifically dry AMD and geographic atrophy. Dry AMD is estimated to account for up to 90% of the population with age-related macular degeneration. The advanced form of the disease, known as geographic atrophy, can lead to progressive and permanent vision loss, and an estimated 1 million people in the U.S. have geographic atrophy.

Speaker Change: In collaboration with the Alzheimer's clinical trials consortium or the AC T. C start trial is measuring the efficacy and tolerability of <unk> 12 in subjects with mild cognitive impairment or early disease, who have elevated amyloid beta we received rent support totaling 81 million for this.

Speaker Change: Trial from the NIH and we are very pleased to join forces and collaborate with the AC T. C. In 2023, we initiated site Activations in the start trial is now actively recruiting from centers of excellence within the AC DC network, we and our collaborators on this study made the decision to allow participants.

Speaker Change: On stable background therapy, with what candy map to enroll and start.

Speaker Change: We believe this decision will provide real world evidence of <unk> 12 in combination therapy.

Speaker Change: I will now turn to our opportunity for CK 18, 12 in ophthalmic conditions, specifically dry AMD and geographic atrophy.

Speaker Change: He is estimated to account for up to 90% of the population with age related macular degeneration.

Speaker Change: Vance form of the disease known as geographic atrophy can lead to progressive and permanent vision loss and an estimated 1 million people in the U S of geographic atrophy. So looking at this opportunity we have evidence from genome wide studies from preclinical studies from clinical biomarker data as well.

Lisa Ricciardi: Now, looking at this opportunity, we have evidence from genome-wide studies, from preclinical studies, from clinical biomarker data, as well as from results from our Alzheimer's studies that demonstrate treatment with CT1812 may have a beneficial impact on the proteins implicated in dry AMD. The MAGNIFY study is a randomized, placebo-controlled, phase 2 trial expected to enroll approximately 240 people who have been diagnosed with dry AMD with measurable geographic at Over the treatment period, change in GA lesion size, as well as other measures of safety and efficacy, will be assessed to determine if CT1812 can slow macular degeneration.

Speaker Change: As for the results of our Alzheimers studies that demonstrate the treatment with <unk> 18, 12 may have a beneficial impact on the proteins implicated in dry AMD.

Speaker Change: The Magnify study is a randomized placebo controlled phase II trial expected to enroll approximately 240 people who have been diagnosed with dry AMD with jet measurable geographic atrophy over the treatment period change in G. A lesion size as well as other measures of safety and efficacy will be assessed.

Speaker Change: To determine if <unk> 12 can slow macular degeneration. In addition, we have added measures of visual change to assess the impact of our drug on vision. We believe the level of interest investigators and participants have shown in the magnify trial indicate that an effective oral treatment.

Lisa Ricciardi: In addition, we have added measures of visual change to assess the impact of our drug on vision. We believe the level of interest investigators and participants have shown in the MAGNIFY trial indicates that an effective oral treatment option will be well received. And as more treatment options become available, we believe ophthalmologists will move towards combination therapies. Might our drug be synergistic with complement approaches?

Speaker Change: Option will be well received.

Speaker Change: And it's more treatment options become available we believe ophthalmologists will move toward combination therapies might our drug be synergistic with complement approaches this is to be determined.

Lisa Ricciardi: This is to be determined. Beyond our clinical trial work, our scientific and medical teams have been active in 2023. Cognition scientists published two manuscripts and made 11 presentations at medical and scientific congresses this past year. The scientific evidence generated by our team has continued to support our clinical development efforts, providing insights into proteins and biological processes impacted by ZT1812 in Alzheimer's, Parkinson's disease, and dry AMD.

Speaker Change: Beyond our clinical trial work, our scientific and medical teams have been active in 2023 cognition scientists published two manuscripts and made 11 presentations at medical and scientific Congresses. This past year.

<unk> evidence generated by our team has continued to support our clinical development efforts, providing insights into proteins and biological processes impacted by <unk> 12 in Alzheimers parkinsons disease and dry AMD.

John Brendan Doyle: In closing, I'm proud of the progress we have made in advancing CT1812 toward important value-driving milestones for 2024. We believe that CT1812 can be an important part of the developing paradigm for dementia treatment, and we are unwavering in our commitment to developing new therapies for neurodegenerative diseases. With that, I turn the call over to John Doyle to review our financial results. Thank you, Lisa. During 2023, we continue to execute with financial stewardship. We officially managed our resources and leveraged our grant funding and our at-the-market offering facility with Cantor Fitzgerald and B. Riley Securities to support our clinical program. Recently, we concluded a new $11.5 million underwritten public offering that is expected to provide funding for our existing clinical trials and bolster our balance sheet by extending our cash runway through May 2025.

Speaker Change: In closing I'm proud of the progress we have made in advancing Cta 18, 12 toward important value driving milestones for 2024, we believe the C. T 18, 12 can be an important part of the developing paradox for dementia treatment and we are unwavering in our commitment to developing new therapies for neuro.

Speaker Change: <unk> neuro degenerative diseases with that I turn the call to John Doyle to review our financial results. Thank you Lisa.

During 2023, we continue to execute with financial stewardship, we officially manages our resources and leverage our grant funding and our at the market offering facility with Cantor Fitzgerald and B Riley securities to support our clinical programs.

John Brendan Doyle: Recently, we concluded a new 11, and a half million underwritten public offering that is expected to provide funding for our existing clinical trials and bolster our balance sheet by extending our cash runway through may 2025, with that context, let US now proceed to the financials for the fiscal year 2023 research and development expenses were $37.

John Brendan Doyle: With that in mind, let us now proceed to the financials for the fiscal year 2023. Research and development expenses were $37.2 million for the year ended December 31, 2023, compared to $30.3 million for 2022. The increase was primarily related to higher costs associated with Phase II trial activities with contract research organizations, personnel, and preclinical research, partially offset by decreased manufacturing costs. General and administrative expenses were $13.5 million for the year ended December 31, 2023, compared to $13.2 million for 2022. The increase was primarily related to higher employee compensation and benefits, driven by increased headcount and equity-based compensation, partially offset by decreased director and officer liability insurance and other expenses.

John Brendan Doyle: $2 million for the year ended December 31, 2023, compared to $30 3 million for 2022. The increase was primarily related to higher costs associated with phase III trial activities with contract research organizations personnel and preclinical research, partially offset by decreased manufacturing costs.

John Brendan Doyle: General and administrative expenses were $13 5 million for the year ended December 31, 2023, compared to $13 2 million for 2022. The increase was primarily related to higher employee compensation and benefits driven by increased head count and equity based compensation, partially offset by decreased director and officer liability ensure.

John Brendan Doyle: <unk> and other expenses the company reported a net loss of $25 8 million or <unk> 86 per basic and diluted share for the year ended December 31, 2023, compared to a net loss of $21 4 million or <unk> 91 per basic and diluted share for 2022.

Unknown Executive: The company reported a net loss of $25.8 million, or $0.86 per basic and diluted share, for the year ended December 31, 2023, compared to a net loss of $21.4 million, or $0.91 per basic and diluted share, for 2022. Cash and cash equivalents as of December 31, 2023 were approximately $29.9 million, and total grant funds remaining from the NIA were $67.5 million. I will now turn the call back over to the operator who can open the call to questions. Operator. We are now opening the floor to Q&A. If you'd like to ask a question, please press star number one on your telephone keypad. Our first question comes from Charles Duncan from Cantor Fitzgerald. Your line is now open.

Speaker Change: Cash and cash equivalents as of December 31, 2023 were approximately $29 9 million and total grant funds remaining from the Nia were $67 $5 million I will now turn the call back over to the operator, who can open the call to questions operator.

Speaker Change: And we are now opening the floor for Q&A, if you'd like to ask a question. Please press star and number one on your telephone keypad. Our first question comes from Charles Duncan from Cantor Fitzgerald. Your line is now open.

Unknown Executive: Hey, good morning, Lisa and team. Congratulations on the progress. It could be a transformational year.

Charles Cliff Duncan: Hey, good morning, Lisa and team congratulations on the progress could be a transformational year. Thanks for taking our question I had a couple of questions regarding shine.

Unknown Executive: Thanks for taking our question. I had a couple of questions regarding SHINE. And then, yeah, on the program for 18-12, I guess you mentioned a point change that would be clinically meaningful, and I agree with you. However, I would argue that actually a lower point change may also be clinically meaningful, given that you have an oral compound and given that you are seeing that in a very short time relative to the antibodies. And so, I guess I would ask you about, you know, smaller changes being impactful and possibly even if they're seen in a more mild patient population. And then, can you update us on the completer rate for SHUN? Morning, Chas.

Charles Cliff Duncan: Yeah on the on the program for 18 12, I guess, you mentioned a point change that would be clinically meaningful and I agree with you. However, I would argue that actually a lower point change.

Speaker Change: It may also be clinically meaningful given that you'll have an oral compound and given that you are seeing that in a very short time relative to the antibodies and so I guess I would ask you about a.

Speaker Change: Smaller change being impactful.

Speaker Change: And possibly even if it is seen in a more mild patient population and then can you update us on the completer rate for Schein.

Speaker Change: Good morning, <unk> good to talk to you I'm going to turn your question over to Tony and I Spoiler alert I will not update you on the clear rate per shine. When the study is fully completed will provide more information.

Unknown Executive: Good to talk to you. I'm going to turn your question over to Tony and, spoiler alert: I will not update you on the completion rate for Shine. When the study is fully completed, we'll provide more information. Yeah. So it's a good question, and we agree with you, Chas.

Anthony O. Caggiano: So good question and we agree with you Chaz.

Anthony O. Caggiano: There is a lot of meaning in changes that are less than the three points that folks talk about a lot. Indeed, if you look at the Leucanomab data, as Lisa mentioned, there was a 1.44 point change over 18 months. And at six months, they had about a half a point change.

There is a lot of meaning and changes that are left.

Anthony O. Caggiano: The three points that folks talk about a lot. Indeed, if you look at the Cana map data as Lisa mentioned.

144 point.

Anthony O. Caggiano: Change over 18 months and at six months that had.

Anthony O. Caggiano: About a half a point change.

Anthony O. Caggiano: And this is really the current benchmark for what could be seen in disease-modifying therapy. Now, we're optimistic that we'll have very good results based on our preliminary results, which we've reported previously. But indeed, there is success and great success short of that benchmark. We have several secondary measures, which you know how those follow if the preponderance of those secondary measures follows directionally with the primary. Obviously, that would strengthen changes that are more modest. That's very helpful, Tony. And then I think about the mechanism.

Anthony O. Caggiano: And this is really the current benchmark for what what could be seen in the disease modifying therapy.

Anthony O. Caggiano: We're optimistic that we'll have very good results based on our preliminary results, which we reported previously.

Anthony O. Caggiano: But indeed, there is there is success and great success short of that benchmark.

Anthony O. Caggiano: We have several secondary measures, which the how those follow if the preponderance of those secondary measures follow directionally with the primary obviously that would strengths and changes that are more modest.

Speaker Change: That's very helpful. Tony and then.

Speaker Change: Thinking about the mechanism is there.

Lisa Ricciardi: As a Sigma 2 ligand, it would seem to me that the drug may have even greater activity or signal-to-noise in more mild patient populations. I'm so excited to see the START trial progress. I guess I'm wondering when you could anticipate an update from that trial. I know that you're not fully engaged in conducting it, but wouldn't it be great to see activity in an even earlier stage patient with Alzheimer's? Chas, this is Lisa.

Speaker Change: Sigma to like and it would seem to me that.

Speaker Change: Doug may have even greater activity or signal to noise.

Speaker Change: More mild patient population and so excited to see the start trial progress I guess I'm wondering why you could anticipate an update I'll go to that trial I know that youre not fully.

Speaker Change: Engaged in and conducting it but wouldn't it be great to see activity in an even earlier stage patients with Alzheimer's. Thanks.

Speaker Change: Chosen whose lease so your point is well taken at this time I believe you know there is no interim planned for start I'll leave that all that Tony and his acte colleagues.

Lisa Ricciardi: Your point is well taken. At this time, I believe, you know, there is no interim plan for starting. I leave that all to Tony and his ACTC colleagues, and consistent with our previous trials, we're not reporting any interim updates on enrollment or things of that nature. So, as for now, we'll continue to provide communication that says it's enrolling. And if there's anything else to communicate, we'll let you know. But we found it's more effective for us to say, when the trial is done, it's done, and not to provide partial progress. Okay, that's fair.

Speaker Change: And consistent with our previous trials were not reporting any interim updates on enrollment our thing of things of that nature. So as for now we will continue to provide communication that says it's enrolling.

And if there anything if there is anything else to communicate well, let you know, but we've found it's more effective for us to say when the trial is done it's done and not to provide partial progress.

Speaker Change: Okay. That's fair last question and sorry to hop back to Shine and that is following the six months treatment period could you remind us what happens with those patients are they given an opportunity to continue on to treatment and if so have any done that.

Unknown Executive: Last question, and sorry to hop back to Shine, and that is following the six-month treatment period. Could you remind us what happens to those patients? Are they given an opportunity to continue on with treatment? And if so, have any done that?

Lisa Ricciardi: We do not have an open label extension at this time. So after six months of treatment, folks are followed for another month for safety, and then the study is completed. Chess, to be honest, we have wanted to do an open label extension, but the economics were prohibitive for a company of our size.

Speaker Change: We do not have an open label extension.

Speaker Change: So after six months of treatment.

Speaker Change: Folks are followed for another month for safety.

Speaker Change: And then the studies completed tends to be honest, we have wanted to do an open label extension, but the economics work prohibitive for a company of our size and so that's something we're considering as we look forward to great question something the team with lighter should be in a position to do.

Unknown Executive: And so that's something we're considering as we look forward. It's a great question, something the team would like to be in a position to do. Yeah, understood. Hopefully, good data will change that. Thanks for taking our questions.

Speaker Change: Yeah understood hopefully good data will change here, thanks for taking our question yeah.

Unknown Executive: Thanks, Jeff. Our next question comes from Jay Olson from Oppenheimer. Your line is now open.

Speaker Change: Thanks, Chad.

Speaker Change: Our next question comes from Jay Olson from open Hymer. Your line is now open.

Unknown Executive: Well, hey, congratulations on the progress and thanks for taking the question. Can you talk about the patient's baseline characteristics in the SHINE study? And also, can you describe how you plan to share the top-line results of the SHINE study? Will that be in a press release or a medical meeting? And then I had a follow-on. Thank you. Yeah, good morning, Jay.

Jay Olson: Oh, Hey, congrats on the progress and thanks for taking the question.

Can you talk about the.

Jay Olson: Patient baseline characteristics and the Shine study and also.

Jay Olson: Can you just describe how you plan to share the top line results.

Jay Olson: Shine study will that be in a press release or a medical meeting and then I had a follow on.

Speaker Change: Yeah. Good morning, Jay good to hear from you Tony and let you take these questions.

Anthony O. Caggiano: Good to hear from you, Tony. I'm going to let you take these questions. Sure. Yeah, we do not have baseline characteristics for this study as yet. It's still blinded, and the data is obviously not yet been locked, cleaned, and analyzed.

Speaker Change: We do not have baseline characteristics.

For this study yet still blinded.

Speaker Change: The data is.

Speaker Change: Not yet been locked cleaned.

Speaker Change: Analyzed.

Anthony O. Caggiano: The plan to read out the data, we'll have a top line read, obviously, soon after we get it. And then the plan is to have the full data set at the AAIC meeting at the end of July this year. Obviously, that's timing dependent upon when we get the data, but that's the current plan. Great, thank you for that. And then, just as a follow-up, can you just talk about the level of interest you've seen from investigators and the progress you're making in site activation for the START study? Yeah, the sites are top sites around the country.

Speaker Change: The plan to read out the data.

We will have a top line read.

Speaker Change: Obviously soon after we get it and then the plan is to.

Speaker Change: Rollout the full dataset at <unk>.

Speaker Change: The AIC meeting at the end of July.

Speaker Change: This year, obviously the timing dependent.

Speaker Change: When we get the data.

Speaker Change: Current plan.

Speaker Change: Great. Thank you for that and then just as.

Speaker Change: A follow up can you just talk about the level of interest you have seen from investigators and the progress youre, making in site activation for this start study.

Speaker Change: Thank you.

Speaker Change: Yeah.

Speaker Change: The sites are top sites around the country that CIC PC network, absolutely top side as I always say to investors day of your family member would say these are the places you'd want to go and so there is a lot of enthusiasm.

Lisa Ricciardi: That's the ACTC network, absolutely top sites. I always say to investors, Jay, if your family member was sick, these are the places you'd want to go. And so there is a lot of enthusiasm. I don't have the number of active sites at the top of my head, but we are making progress, and they are keen to have the opportunity to study an oral drug for their early patient population. So, from our perspective, it's positive.

Speaker Change: Don't have it top my head the number of active.

Speaker Change: Active sites, but we are making progress and they are keen to have the opportunity to study an oral drug for their early patient population. So from our perspective, it's positive we're looking to get that study fully enrolled and completed it's a big study and it's a long study.

Lisa Ricciardi: We're looking to, you know, get that study fully enrolled and completed. It's a big study, and it's a long study, but we're making positive progress and met with enthusiasm by the PIs. Great. Thanks so much for taking the questions. Congratulations again on the progress. Thanks, Jay. Our next question comes from Mayank Mamtani from B. Riley Securities. Your line is now open.

Speaker Change: Study.

Speaker Change: But we're making positive progress and met with enthusiasm by the Pis.

Speaker Change: Okay.

Speaker Change: Great. Thanks, so much for taking the questions and congrats again on the progress.

Speaker Change: Thanks Jay.

Speaker Change: Okay.

Speaker Change: Our next question comes from my Mum Danya from B Riley Securities. Your line is now open.

Unknown Executive: Good morning, team. Thanks for taking our questions. I appreciate the comprehensive update. Maybe just quickly on the phase two SHINE study, could you comment on your expectation for the rate of ARIA? And if you do have any understanding of how the split of mild and moderate patients is going to be in the SHINE study? Obviously, in the earlier 24 patient cohort, branching, and breaking out mild and moderate was not possible, but in this larger cohort, that could be a possibility. And then I have a couple of follow-ups. Good morning, Mayank.

Danya: Good morning team, thanks for taking our questions and I appreciate the comprehensive update maybe just quickly on the phase II <unk> study could you comment on your expectation for rate of Eylea.

Danya: You do have any understanding on how the split of mild and moderate patients.

Danya: We're going to be in the in the Shine study.

Danya: Earlier.

Danya: 24 patient cohort.

Danya: Brian just breaking out mild and moderate <unk> plus a little bit in this larger cohort that could be a possibility and then I have a couple of items.

Speaker Change: Good morning, Mike.

Anthony O. Caggiano: I'm going to let Tony take your question. Yeah, so the second part first: we will be doing analysis of how folks' scores are breaking down between mild and moderate or more severe and less severe and how that impacts their change on our outcome measures. And then, remind me of the first question.

Anthony O. Caggiano: Tony take your question.

Anthony O. Caggiano: Yes, so the <unk>.

Taking the second part first we will be doing the analysis.

Anthony O. Caggiano: How folks their scores entering breaking down between mild and moderate or more severe and less severe and how that impacts their change.

Anthony O. Caggiano: Our outcome measures.

Anthony O. Caggiano: And then can you remind me of the <unk>.

Anthony O. Caggiano: Question.

Great.

Speaker Change: So yes, yes, yes, so we don't expect the based on our mechanism of action.

Anthony O. Caggiano: So we don't expect, based on our mechanism of action, that ARIA will be an issue. With antibody therapies pulling amyloid from brain and blood vessels and the rest of the vasculature, you would expect to see those findings. We do not, however, obviously, the full safety picture of our drug will come out as we do complete studies.

<unk> will be an issue.

Speaker Change: With antibody therapies, pulling amyloid from brain and blood vessels.

Speaker Change: The rest of the vasculature.

Speaker Change: You would expect to see those findings we do not however.

Speaker Change: However, obviously the full the full safety picture of our drug will come out as we do.

Speaker Change: Complete studies.

Anthony O. Caggiano: And then in regards to your recent EEG proteomics and even brain volume data, you know, that has been helpful to understand sigma-2 receptor biology. Any specific biomarker data you'd have in the top line for both readouts that is worth paying attention to, if you could point to that, that would be great. Yeah, sure. So we'll be reporting out basically the same biomarkers that we did from the preliminary read. And those are the canonical biomarkers that you would expect to see changes in monomer, synapse proteins, GFAP, NFL, et cetera.

Speaker Change: Understood and then in regards to recent E G four deal mix and even bringing volume data.

Speaker Change: And hopefully you'll understand Sigma one receptor biology, any specific biomarker data you'd have in the top line.

Speaker Change: For both Readouts.

That is worth paying attention to good pointing to that then that would be great.

Speaker Change: Yes, sure so we'll be reporting out.

Speaker Change: Basically the same biomarkers that we did from the preliminary read.

Speaker Change: The canonical Biomarkers that you would expect to see changes in monomer.

Speaker Change: <unk> proteins.

Speaker Change: NFL et cetera, and then as we did previously we'll be doing complete proteomics analyses from the throughput spinal fluid and plasma of these individuals.

Anthony O. Caggiano: And then, as we did previously, we'll be doing complete proteomic analyses from the cerebrospinal fluid and plasma of these individuals to look at more refined measures of target engagement and disease modification. Yeah, so we'll be doing pretty much the same thing we did in the preliminary read as well, it's just expanded based on what we've learned in the intervening time.

Speaker Change: To look at more refined measures of target engagement and disease modification.

Speaker Change: So we will be doing.

Speaker Change: Pretty much the same thing we did in the preliminary read as well as expanded based on what we've learned.

Speaker Change: Intervening time.

Lisa Ricciardi: Great. And then on the Phase 2 Magnified Study, how has the initial investigator feedback been? I know you're doing well with site activation, but just if you are able to comment on study enrollment. And then lastly, on financials, how much of the expected grant funding is baked into your runway guidance so we can aptly model the next four to five quarters of cash flow once again. You're welcome, Mayank. With regard to Magnify, there is tremendous enthusiasm in the clinical research community for the trial, as well as from patients. So there is, you know, positive momentum in that study. And like our other studies, we don't provide guidance on enrollment.

Speaker Change: Great.

And then on the phase two magnify study how has the initial investigator.

Speaker Change: The feedback been.

Speaker Change: Sure.

Speaker Change: Doing well I would say the activation with just a few Alibaba ducommun done study and government and then lastly, the finite on financial Tom will just.

Speaker Change: <unk> ground funding is baked into your runway guidance. So we could accurately model. The next four to five quarters of cash flow.

Again, we're taking our questions.

Speaker Change: Youre welcome Mike with regard to magnify there is tremendous enthusiasm in the clinical research community, where the trial as well as from patients. So there is positive momentum in that study and like our other studies, we don't provide guidance on enrollment.

Lisa Ricciardi: They are a very enthusiastic group of PIs and patients, so we can tell you that much. And on the grants, John? With respect to the grant funding, Mayank, so we expect to complete the SHMR grant fund this year as we wrap up that trial, and then the remaining balance of that will be dedicated to the START trial as we progress through 2024 and 2025. So, Mayank, your question was about the $67 million in the press release we identified. Is that right? And how much of that is based on the runway?

Speaker Change: Our very enthusiastic group of <unk> patients. So we can tell you that much.

Speaker Change: And on the grants John with respect to the grant funding.

Speaker Change: So we expect to complete the Shimmer Grant fund this year as we wrap up that trial and then the remaining balance of that will be dedicated to magna to to start trial as we progressed through 'twenty four and 'twenty five.

Speaker Change: So my answer to your question was about $67 million in the press release, we identified is that right and how much of that is baked into the runway.

John Brendan Doyle: Yeah, as you know, Mayank, the grants are drawn down as the studies are completed, so it's really a function of the progress we make in those studies how quickly that grant funding is absorbed. Got it. That's helpful. Thanks again for taking our questions and looking forward to an exciting next few months for you. Yeah, thank you. We are as well.

Speaker Change: Yes, as you know mindset. The grants are drawn down as the studies are completed so it's really a function of the progress we make in those studies how quickly that grant funding is absorbed.

Speaker Change: Got it that's helpful. Thanks, again for taking my questions and looking forward to an exciting next few months.

Speaker Change: Yeah. Thank you we are as well thank you.

Lisa Ricciardi: Thank you. As of right now, we don't have any raised hands, so I'd now like to hand the microphone back over to the management for their final remarks. Terrific. To conclude, we're looking forward to our continued progress and important phase two data readouts in 2024. We believe our science is sound, and we continue to build evidence supporting CT1812's potential for patients. We're positioned to achieve and deliver on multiple clinical milestones, and we're focused on creating long-term value for our shareholders.

Speaker Change: As of right now we don't have any raised hands. So I'd now like can that go over to the management for their final remarks.

Speaker Change: Terrific to conclude we're looking forward to our continued progress in important phase III data Readouts in 2024, we believe our science is sound and we continue to build evidence supporting <unk> potential for patients we're positioned to achieve and deliver on multiple clinical milestones and we're.

Speaker Change: Based on creating long term value for our shareholders. Thank you for joining us today.

Operator: Thank you for joining us today. This is the end of today's conference call. You may now all disconnect. Thank you. Goodbye.

Speaker Change: I think today's conference call you May now all disconnect have a good day.

Speaker Change: Thank you goodbye.

Speaker Change: Okay.

Speaker Change: Yeah.