Q2 2024 Cognition Therapeutics Inc Earnings Call
Operator: Hello, and thank you for standing by. At this time, we would like to welcome you to the Cognition Therapeutics Second Quarter 2024 Linux Call.
Hello, and thank you for standing by. At this time, we would like to welcome you to the Cognition Therapeutics second quarter 2024 earnings call.
Operator: A 24-Hour Earnings Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press the star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again.
Operator: All the lines are in place, and we need to prevent any background noise. After the speakers are marked, there will be a question and answer session. If you would like to ask a question during this time, simply press star, followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. I would now like to turn the conference over to Tom Johnson. Please go ahead.
Speaker Change: All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number 1 on your telephone keypad. If you would like to withdraw your question, press star 1 again.
I would now like to turn the conference over to Tom Johnson. Please go ahead.
Tom Johnson: Thank you, operator, and good morning, everyone. Welcome to the Cognition Therapeutics second quarter 2024 results conference call. With me today are Lisa Ricciardi, President and Chief Executive Officer, John Doyle, Chief Financial Officer, and Anthony Caggiano, Chief Medical Officer. This morning, the company issued a press release detailing its financial results for the second quarter and first half of the 2024 fiscal year. We encourage everyone to read this morning's press release, as well as Cognition's quarterly report on Form 10-Q, annual report on Form 10-K, and periodic reports on Form 8-K, which are now filed with the SEC and available on our website.
Unknown Executive: Welcome to the Cognition Therapeutics second quarter 2024 results conference call. With me today are Lisa Ricciardi, President and Chief Executive Officer, John Doyle, Chief Financial Officer, and Anthony Caggiano, Chief Medical Officer. In addition, this conference call is being webcast through the company's website and will be archived for 30 days. Please note that certain information discussed on the call today is covered by the safe harbor provisions of the Private Securities Litigation Reform Act
Tom Johnson: thank you operator in good morning everyone
Speaker Change: Welcome to the Cognition Therapeutics second quarter of 2024 results conference call. With me today are Lisa Ricciardi, President and Chief Executive Officer, John Doyle, Chief Financial Officer, Anthony Caggiano, Chief Medical Officer.
Speaker Change: this morning the company issued to press lease detailing its financial results for the second quarter and first half of the two thousand and twentyfour fiscal year
Speaker Change: We encourage everyone to read this morning's press release, as well as Cognition's quarterly report on Form 10-Q , annual report on Form 10-K , and periodic reports on Form 8-K, which are 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.
Tom Johnson: In addition, this conference call is being webcast through the company's website and will be archived for 30 days. Please note that certain information discussed on the call today is covered by the safe harbor provisions of the Private Securities Litigation Reform Act. Requestional listeners that during this call of management, I will be making forward-looking statements. However, actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business.
Tom Johnson: These forward-looking statements are qualified by cautionary statements contained in the Cognition Press Release and SEC filings, including its quarterly report on Film Room 10-Q and previous filings. This conference call contains time-sensitive information, which is accurate only on 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 said, I would like to hand the call over to Lisa Ricciardi. Lisa?
Speaker Change: please note that certain informationdissed on the calls todayate iscovered by the safe harborprovisions of the private securities litigation reform act we caution listeners that during this call management will be making forward-looking statements
Speaker Change: Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business.
Speaker Change: these forward-looking statements are qualified by cautionary statements contained in the cognition press release and sec filings including its quaral report on urman on q and previous filings
Speaker Change: This conference call contains time-sensitive information which is accurate only of the date of this live broadcast.
Speaker Change: 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 like to hand the call over to Lisa Ricciardi. Lisa?
Unknown Executive: Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by cautionary statements contained in the Cognition Press Release and SEC filings, including its quarterly report on Firmware 10Q and previous filings. 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 like to hand the call over to Lisa Ricciardi. Lisa?
Lisa Ricciardi: Thank you, Tom, and good morning everyone. We appreciate your participation in Cognition Therapeutics' Financial Results Conference call. Today, our CFO, John Doyle, and I will share prepared remarks on the company's progress and financial performance over the first half of the year, after which we'll take your questions.
Lisa Ricciardi: Thank you, Tom. And good morning, everyone. We appreciate your participation in Cognition Therapeutics Financial Results Conference Call.
Lisa Ricciardi: Today, our CFO , John Doyle, and I will share prepared remarks on the company's progress and financial performance over the first half of the year, after which we'll take your questions. For Q&A, we'll be joined by our Chief Medical Officer and Head of R&D, Dr. Tony Caggiano.
Lisa Ricciardi: For Q&A, we'll be joined by our Chief Medical Officer and Head of R&D, Dr. Tony Caggiano. At Cognition Therapeutics, our focus is on the development of innovative, orally available drug candidates targeting age-related degenerative conditions of the CNS and retina. Clinical programs include multiple phase two trials for both early and mild to moderate Alzheimer's disease. We are also studying CT1812 in dementia with Lewy bodies and geographic atrophy secondary to dry AMD. Now, during today's call, my formal remarks will be on the completed SHINE trial and then on our next study to read out the SHIMMER trial. Let's begin with Shine.
Lisa Ricciardi: At Cognition Therapeutics, our focus is on the development of innovative, orally available drug candidates targeting age-related degenerative conditions of the CNS and retina. The trial enrolled a total of 153 adults with mild to moderate Alzheimer's disease. Participants were randomized to receive either placebo or oral doses of 100 or 300 milligrams of CT1812, and there were 51 participants in each arm of the study. Functional Improvement Scales were included, as were biomarker analyses.
Lisa Ricciardi: At Cognition Therapeutics, our focus is on the development of innovative, orally available drug candidates targeting age-related degenerative conditions of the CNS and retina.
Speaker Change: Our clinical programs include multiple phase 2 trials for both early and mild to moderate Alzheimer's disease. We are also studying CT 1812 in dementia with Lewy bodies and geographic atrophy secondary to dry AMD.
Lisa Ricciardi: Our SHINE study was a Phase II clinical trial proof of concept study of CT1812 in mild to moderate Alzheimer's disease. This was our first proof of concept study. The trial enrolled a total of 153 adults with mild to moderate Alzheimer's disease. Participants were randomized to receive either placebo or oral doses of 100 or 300 milligrams of CT1812, and there were 51 participants in each arm of the study. Our primary purpose was to assess safety and followability after six months of daily dosing.
Lisa Ricciardi: Now, during today's call, my formal remarks will be on the completed SHINE trial and then on our next study to read out the SHIMMER trial.
Lisa Ricciardi: We also evaluated multiple cognitive endpoints, including the Avis Cog 11, Avis Cog 13, Cognitive Composite, and the MMSE. Functional Improvement Scales were included as were biomarker analysis. In this study, participants who were treated with CT1812 for six months showed a consistent trend in slowing cognitive decline compared to placebo across all cognitive measures. The aid is Cog 11 and 13, Cognitive Composite, and MMSE.
Lisa Ricciardi: Let's begin with SHINE. Our SHINE study was a phase 2 clinical trial proof of concept study of CT 1812 in mild to moderate Alzheimer's disease. This was our first proof of concept study.
Lisa Ricciardi: On the most commonly used measures, the ADIS-CoG 11 and 13 skills, CT 1812 treated participants showed a 39% slowing of cognitive decline after six months. To put Shine results into context, the recently approved monoclonal antibodies demonstrated 25 to 30 percent slowing in an early patient population over 18 months. We were very encouraged by the 39% slowing in six months with a once daily pill.
Speaker Change: the trial enrolled total of one hundred and fifty three results with miles moderate alztimimer's disease
Lisa Ricciardi: Now, furthermore, on the ADIS-CoG 11 and MMS-E scales at day 98, the midpoint of the study, in the combined 100 and 300 milligram dose groups, P values of less than 0.05 were observed. Putting the full SHINe data readouts in context in the completed trial, participants on placebo in the intent-to-treat analysis worsened by 2.7 points, as measured by ADIS-Co In the pooled 100 and 300 milligram dose group, there was a reduction of 1.66 points, or 39% slower loss of cognition than in the placebo group.
Lisa Ricciardi: Participants were randomized to receive either placebo or oral doses of 100 or 300 milligrams of CT1812, and there were 51 participants in each arm of the study.
Lisa Ricciardi: Said another way, CT 1812 rescued about 40% of the cognitive decline that participants could have experienced. In this trial, we used the functional measures of the ADCS-ADL, or Activities of Daily Living, and the ADCS-CGIC, the Clinical Global Impression of Change.
Lisa Ricciardi: Our primary purpose was to assess safety and solubility after six months of daily dosing. We also evaluated multiple cognitive endpoints including the ADIS-CoG-11, ADIS-CoG-13, cognitive composite, and the MMSE.
Speaker Change: functional improvement scales were infliced as were biomarker analysis
Lisa Ricciardi: CT1812 demonstrated a slowing of loss of function towards the latter part of the trial. However, with 150 people enrolled, or approximately 50 people per arm, the SHINE trial did not achieve statistical significance on the ADIS-COG-11 scale. However, this is the important part.
Lisa Ricciardi: In this study, participants were treated with CT1812 for six months.
Speaker Change: should a consistent trend in slowing cognitive decline compared to foreceboo across all cognitive measures the a is co eleven and thirteen cognitive composite at mc
Lisa Ricciardi: On the most commonly used measures, the ADIS COG 11 and 13 skills, CT 1812 treated participants showed a 39% slowing of cognitive decline after six months. In this trial, we used the functional measures of the ADCS-ADL, or Activities of Daily Living, and the ADCS-CGIC, the Clinical Global Impression of Change. CT1812 demonstrated a slowing of loss of function towards the latter part of the trial. With regard to safety, CT1812 demonstrated a favorable safety and tolerability profile, with most treatment adverse events being mild or moderate. The AEs were consistent with previous clinical experience. There was one case of asymptomatic Area H, and no cases of Area E. We believe that this is evidence that CT1812 acts as a synaptoprotective agent.
Speaker Change: on the most commonly used measures the idisiccoago leven and thirteenth skills c eight twelve treated participants showed a thirty nine percent slowing a cognitive decline after six months
Speaker Change: To put SHINE results into context, the recently approved monoclonal antibodies demonstrated 25 to 30 percent slowing in an early patient population over 18 months.
Speaker Change: We were very encouraged by the 39% slowing in six months with a once-daily pill.
Speaker Change: Now, furthermore, on the ADIS-CoG 11 and MMSE scales at day 98, the midpoint of the study, in the combined 100 and 300 milligram dose group, p-values of less than 0.05 were observed.
Speaker Change: Putting the full SHINe data readouts in context in the completed trial, participants on placebo in the intent-to-treat analysis worsened by 2.7 points as measured by ADIS-CoG 11.
Speaker Change: In the pooled 100 and 300 mg dose group, there was a reduction of 1.66 points, or 39% slower loss of cognition than in the placebo group.
Speaker Change: Said another way, CT 1812 rescued about 40% of the cognitive decline that participants could have experienced.
Speaker Change: In this trial, we used the functional measures of the ADCS ADL, or Activities of Daily Living, and the ADCS CIGIC, the Clinical Global Impression of Change.
Speaker Change: CT1812 demonstrated a slowing of loss of function towards the latter part of the trial.
Speaker Change: With 150 people enrolled, or approximately 50 people per arm, the SHINE trial did not achieve statistical significance on the ADIS-COG-11 scale.
Lisa Ricciardi: The multiple measures we assessed show a consistency across time and dose that is positive. It is this consistency that motivates us to look ahead to longer and larger trials. With regard to safety, CT1812 demonstrated a favorable safety and tolerability profile, with most treatment adverse events being mild or moderate. The AEs were consistent with previous clinical experience. There was one case of asymptomatic Area H and no cases of Aria E. At the 300 milligram dose, nine participants experienced treatment emergent LFT increases greater than three times the upper limit of normal, but these resolved after cessation of the drug without evidence of serious liver injury. Importantly, there were no LFT elevations observed at the 100 milligram dose. This data is all publicly available on our website.
Speaker Change: However, this is the important part.
Speaker Change: the multiple measures we assess show a consistency across time and dose that is positive it is this consistency that motivates us to look ahead to longer and larger trials
Speaker Change: With regard to safety, CT1812 demonstrated a favorable safety and tolerability profile, with most treatment adverse events being mild or moderate.
Speaker Change: The AEs were consistent with previous clinical experience. There was one case of asymptomatic Area H and no cases of Area E.
Speaker Change: at the three hundred milligram dose nine participants experienced treatment emergent lftt increases greater than three times the upper limit of normal thesees resolved after cessation of drug without evidence of serious liver injuries
Speaker Change: importantly there were no t elevation observed in one hundred milillly brain do
Lisa Ricciardi: We are continuing to analyze the Exploratory CSF Biomarker Program data. The study showed a significant change in neurofilament light, or NFL, and this is a marker of neurodegenerative disease. This occurred at the 300 milligram dose.
Speaker Change: This data is all publicly available on our website.
Speaker Change: We are continuing to analyze the exploratory CSF biomarker program data. The study showed significant change in neurofilament light, or NFL, and this is a marker of neurodegenerative disease. This occurred at the 300 milligram dose.
Lisa Ricciardi: We believe that this is evidence that CT1812 acts as a synaptoprotective agent. Other CFF biomarkers assessed included Neurobrannan, Synaptotagmin, SNAP25, P-tau, Total Tau, and G-tau. We'll share more in the future as we continue analyzing biomarker data from this trial.
Speaker Change: we believe that this is evidence ct eighteen and twelve accessas a syanaso protective agent
Lisa Ricciardi: Other CFF biomarkers assessed include Inurobrannan, Synaptotagmin, SNAP25, T-tau, Total Tau, and G-tau. We'll share more in the future as we continue analyzing biomarker data from this trial. We met our key objective of assessing safety.
Speaker Change: Other CSS biomarkers assessed include Inurobrannan, Synaptotagmin, SNAP25, P-tau, Total Tau, and G-tau. We'll share more in the future as we continue analyzing biomarker data from this trial.
Lisa Ricciardi: We believe these findings provide evidence that amyloid oligomer antagonism, a new and distinct mechanism for therapeutic intervention, may have a role as a monotherapy or a drug in treat use in combination with other drugs for the treatment of AD and other conditions. We met our key objectives of assessing safety, tolerability, and Cognitive and Functional Changes. We learned that the 100 milligram dose showed good efficacy and had no incidence of elevated liver enzymes or discontinuations due to adverse events. There were no new safety signals in the Shine trial.
Speaker Change: taken in total we believe these findings provide evidence that the emalloid a ligamer and tagonism
Speaker Change: A new and distinct mechanism for therapeutic intervention may have a role as a monotherapy or a drug used in combination with approved drugs for the treatment of AD and other dementia.
Lisa Ricciardi: Tolerability and Cognitive and Functional Changes. We learned that the 100 milligram dose showed good efficacy and had no incidence of elevated liver enzymes or discontinuations due to adverse reactions. We have a strong and consistent trend demonstrating potential efficacy in slowing cognitive decline in patients with mild to moderate disease. We believe the magnitude of the effect is consistent with other drugs recently developed and approved. We believe the biomarker data supports the true slowing of neurodegeneration.
Speaker Change: we met our key objectives of assessing safety
Speaker Change: Tolerability and Cognitive and Functional Changes. We learned that the 100 milligram dose showed good efficacy and had no incidence of elevated liver enzymes or discontinuations due to AEs.
Lisa Ricciardi: We have a strong and consistent trend demonstrating potential efficacy at slowing cognitive decline in patients with mild to moderate disease. We believe the magnitude of the effect is consistent with other drugs recently developed and approved. We believe the biomarker data supports the true slowing of neurodegeneration. While in Philadelphia last week at the AAIC conference, we had the opportunity to speak with multiple physicians and PIs from the SHINE trial. They were very supportive of the trial results and, particularly, the consistency of cognitive changes across the scales.
Speaker Change: there were no new safety signals in the shine trial
Speaker Change: We have a strong and consistent trend demonstrating potential efficacy at slowing cognitive decline in patients with mild to moderate disease.
Speaker Change: We believe the magnitude of effect is consistent with other drugs recently developed and approved. We believe the biomarker data supports the true slowing of neurodegeneration.
Lisa Ricciardi: While in Philadelphia last week at the AAIC conference, we had the opportunity to speak with multiple physicians and PIs from the SHINE trial. They were very supportive of the trial results and particularly the consistency of cognitive changes across the scales. They valued the new safety information and profile of the 100 mg dose group. We also know that pharma groups, having wonnowed CNS programs over the years, are now looking to add important CNS drugs to their portfolios. We have completed enrollment, and we expect to report top-line results by year end. Now, a word about our other two trials.
Speaker Change: while in philadelphia last week at the ai conference we had the opportunity to speak with multiple phpositiions of p from the shinetrial
Speaker Change: they were very supportive of the trial results and particularly the consistency of cognitive changes across the scales they value the new safety information and profile of the one hundred milligram those were
Lisa Ricciardi: They valued the new safety information and profile of the 100 mg dose group. Consistent with feedback from various investors, RPIs are interested in the next steps in terms of a new trial, duration, dose, patient population, endpoint, and trial side. We also know that pharma groups, having wonnowed CNS programs over the years, are now looking to add important CNS drugs to their portfolios. For many, Alzheimer's disease is a top target. We continue to look. We are looking forward to continuing our dialogue with these companies.
Speaker Change: consistent with feedback from various investors rpi is are interested in the next steps in terms of a new trial duration dose patient population end points and trial size
Speaker Change: We also know that pharma groups, having winnowed CNS programs over the years, are now looking to add to their portfolios important CNS drugs.
Speaker Change: formany alzheimer's disease as a top target we continue to look we are looking forward to continuing our dialogue with these companies
Lisa Ricciardi: Our next step is to convene a panel of leading neurologists to review our data, test the findings, and discuss their thinking on next steps in CT1812 drug development. I would like now to turn to the SHMR study, which is our next data readout. This phase two trial with CT1812 enrolled 130 people with mild to moderate dementia with Lewy bodies or DLB. As a reminder, there are an estimated 1.5 million people in the U.S. affected by DLB, and this disease is the second most common form of dementia. These patients are characterized by dementia, mobility issues, visual and sensory hallucinations, and significant GI issues. There are no currently approved treatment options.
Speaker Change: Our next step is to convene a panel of leading neurologists to review our data, test the findings, and discuss their thinking on next steps in CT1812 drug development.
Speaker Change: yes
Speaker Change: like now to turn to the shimmer study which is our next data read out this phaseis two a trial with c t twelve and roll one hundred thirty people with miles to moderate dementia with ili bodies or dlb
Lisa Ricciardi: As a reminder, there are an estimated million and a half people in the U.S. affected by DLB, and this disease is the second most common form of dementia.
Speaker Change: these patients are characterized by dementionia of mobility issues visual and sensory hallucinations and significant gi issues there are no currently approved treatment option
Lisa Ricciardi: From a pathological perspective, more than half of the DLB patients are estimated to both have alpha-synuclein and A-beta oligomers in their brains. We believe that CT1812, with its novel mechanism of action protecting neurons from the toxicity of both pathogenic proteins, has the potential to treat DLB patients. This is a double-blind, randomized, three-arm study. Patients are randomized one-to-one-to-one with 100 or 300 milligrams of CT1812 or placebo. This study is not powered to show significance.
Speaker Change: from a anthological perspective more than half of the dlb patients are estimated to both have outof the new pl and abeatta allyamers in their brain
Lisa Ricciardi: We believe that CT1812, with its novel mechanism of action, protecting neurons from the toxicity of both pathogenic proteins, has the potential to treat DLB patients.
Lisa Ricciardi: This is a double-blind, randomized, three-arm study. Patients are randomized one-to-one-to-one with 100 or 300 milligrams of CT1812 or placebo.
Lisa Ricciardi: It is designed as a proof of concept study to determine the change in the MOCA, if that is the Montreal Cognitive Assessment Scale, after six months of receiving CT1812 or placebo. This trial is supported by Non-Goluted Funding from the NIH, and the trial is being led by Dr. James Galvin from the University of Miami Miller School of Medicine. We have completed enrollment, and we expect to report top-line results by year-end.
Speaker Change: this study is not powered to show significant
Speaker Change: it is designed as a proof of concept study to determine the change in the mokca if that is the montreal cognitive assessment ill after six months of receiving ceight twelve or willbo
Lisa Ricciardi: This trial is supported by non-diluted funding from the NIH and the trial is being led by Dr. James Galvin from the University of Miami Miller School of Medicine. We have completed enrollment and we expect to report top-line results by year-end.
Lisa Ricciardi: We believe the SHMR trial results will add to the understanding of CT1812's potential for treating neurodegenerative disease. As with AD patients in the SHINE trial, we look forward to providing patients and caregivers an effective, convenient option to track the progress of DLB. Now, a word about our other two trials.
Lisa Ricciardi: We believe the SHMR trial results will add to the understanding of CT1812's potential for treating neurodegenerative disease.
Lisa Ricciardi: As with AD patients in the SHINE trial, we look forward to providing patients and caregivers an effective, convenient option to flow the progress of DLB.
Lisa Ricciardi: In brief, our stark, starked trial is actively recruiting participants with early Alzheimer's disease. Participants on stable background therapy with Lecanumab and Demaniab would be allowed to enroll in the trial, and we expect this will allow us to gather real world evidence of CTA-1812's potential as monotherapy and in combination with monotherapy. Monoclonal antibody treatment.
Lisa Ricciardi: In brief, our START trial is actively recruiting participants with early Alzheimer's disease. Participants on stable background therapy with Leucanumab and Dananibab will be allowed to enroll in the trial. And we expect this will allow us to provide real-world evidence of CT1812's potential as monotherapy and in combination with monoclonal antibody treatment. We're also actively enrolling participants in our MAGNIFY study. This is a randomized placebo-controlled Phase 2 study of 240 participants who have dry, age-related macular degeneration and measurable geographic atrophy.
Lisa Ricciardi: Now, a word about our other two trials. In brief,
Lisa Ricciardi: STARCT trial is actively recruiting participants with early Alzheimer's
Lisa Ricciardi: Participants on Stable Background Therapy with Leucanumab and Denanibab will be allowed to enroll in the trial and we expect this will allow us to provide real-world evidence.
Lisa Ricciardi: of c eighteen twelve potential as monotherapy and in combination with monoateral antibody treatment
Lisa Ricciardi: We're also actively enrolling participants in our MAGNIFY study. This is a randomized placebo-controlled Phase 2 study of 240 participants who have dry, age-related macular degeneration and measurable geographic atrophy. Over the treatment period, change in lesion size and best corrected visual acuity will be assessed to determine if CT-1812 can slow vision loss. Thus, during this past year, cognition scientists published multiple manuscripts and made at least nine presentations at medical and scientific conferences.
Lisa Ricciardi: we're also actively enrolling participants in our magnified study this is a randomized procivo control based two study of two hundred and forty participants who have th a related macular degeneration and measurable geographic astropy
Lisa Ricciardi: Over the treatment period, change in lesion size and best corrected visual acuity will be assessed to determine if CT1812 can slow vision loss. In closing, by 2024, we will have made significant progress advancing CT1812, and we believe this drug has the potential to be an important part of the developing paradigm for dementia treatment.
Lisa Ricciardi: Over the treatment period, change in lesion size and best corrected visual acuity will be assessed to determine if CT1812 can slow vision loss.
Lisa Ricciardi: All the publications are available on our website. Importantly, the scientific evidence generated by our team has continued to support our development efforts, providing insights into proteins and biological processes impacted by CT1812 in neurologic and dry and ophthalmological conditions. In closing, in 2024, we have made significant progress advancing CT1812, and we believe this drug has the potential to be an important part of the developing paradigm for dementia treatment. With that, I turn the call over to John Doyle for a review of our results. Thank you.
Speaker Change: now during this past year cognition scientists public multiple manuscripts and made at least nine presentations at medical and scientific congverses all the publications are available on our website
Lisa Ricciardi: importantly the scientific evidence generated by our team has continued to support our development efforts
Lisa Ricciardi: providing insights into proteins and biological processes impacted by CT1812 in neurologic and dry end ophthalmology conditions.
Speaker Change: in closing in two thousand and twenty four we have made significant progress advancing ctt eight and twelve and we believe this drug has the potential to be an important part of the developing paradigm for deimmentia treatment
Lisa Ricciardi: With that, I turn the call over to John Doyle for a review of our results.
John Doyle: For the first half of 2024, we continue to execute with financial stewardship by efficiently managing our resources and leveraging NIH grant funding to support our clinical program. As of June 30, 2024, our cash and cash equivalents were approximately $28.5 million, and total grant funds remaining from the NIA were $57.3 million. The company estimates that it has sufficient cash to fund operations and capital expenditures into the second quarter of 2025. Research and development expenses were $11.6 million for the second quarter and June 30, 2024, compared to $8.5 million for the comparable period in 2023.
Speaker Change: thank you lisa for the first half of two thousand and twenty four we continue to execute a financial stewardship but efficientally managing our resources and leveraging and ia thread funding to support our clinical programs
Speaker Change: as of junethirty two thousand and twenty-four our cash and cash equivalents were approximately twenty- eight point five million dollars
Lisa Ricciardi: and total grant funds remaining from the NIA of $57.3 million.
Lisa Ricciardi: The company estimates that it has sufficient cash to fund operations and capital expenditures into the second quarter of 2025.
John Doyle: This increase was primarily related to higher costs associated with advancing our clinical programs, including phase two trial activities with contract research organizations and personnel costs. General and administrative expenses were $3.1 million for the second quarter and to June 30, 2024, compared to $3.3 million for the comparable period in 2023. The decrease was primarily related to lower professional services. The company reported a net loss of $7 million, or $0.18 per basic and diluted share, for the second quarter and June 30, 2024, compared to a net loss of $4.7 million, or $0.16 per basic and diluted share, for the same period in 2023.
Speaker Change: Research and development expenses were $11.6 million for the second quarter and in June 30, 2024, compared to $8.5 million for the comparable period in 2023.
Lisa Ricciardi: This increase was primarily related to higher costs associated with advancing our clinical programs, including Phase II trial activities with contract research organizations and personnel costs.
Speaker Change: General and administrative expenses were $3.1 million for the second quarter and the June 30, 2024, compared to $3.3 million for the comparable period in 2023. The decrease was primarily related to lower professional services.
Speaker Change: The company reported a net loss of $7 million, or $0.18 per basic and diluted share, for the second quarter end of June 30, 2024, compared to a net loss of $4.7 million, or $0.16 per basic and diluted share, for the same period in 2023.
Operator: I'll now turn the call back over to the operator, who can open the call to questions. Operator? George Nalton,
Speaker Change: I'll now turn the call back over to the operator who can open the call to questions. Operator?
Operator: Bloor's now open to your questions, so to ask a question this time, please press We're going to pause for just a moment to compile the Q&A roster, and the first question comes from Charles Duncan from Canterfield, Chicago.
Speaker Change: do now open for your questions so to ask a question this time please press our one
Speaker Change: We're going to pause for just a moment to compile the Q&A roster.
Operator: The first question comes from Charles Duncan from Canterfield, Seattle.
Speaker Change: first question comes from charles dlcan from cle pjob
Yingling Kim: Hi, this is Yingling Kim on behalf of Charles Duncan. Thank you for taking our questions. So in the SHINE trial, the 100 mcDose did not meaningfully alter the A beta 40 and 42 levels, while the 300 mcDose did. But the changes with the 100 mcDose may perhaps be more pronounced after a year of dosing versus the six months.
Operator: Hi, this is Yingling Kim on for Charles Duncan. Thank you for taking our questions.
Speaker Change: So in the SHINE trial, the 100 MYC dose did not meaningfully alter the A-beta 40 and 42 levels while the 300 MYC did.
Speaker Change: But would the changes with the 100 big dose perhaps be more pronounced after a year of dosing versus the six months? And I have a follow-up.
unknown: And I have a
Anthony Caggiano: Tony, do you want to address that? Thank you, Elaine. Yeah, hi, Elaine.
Anthony Caggiano: Tony, do you want to address that? Thank you, Elaine. Yeah, hi, Elaine.
Anthony Caggiano: You're right, the 100-milligram dose did not significantly alter the A-beta monomers in the same way that the 300-milligram dose had. I think a more relevant biomarker here is the NFL, which is a marker of general neurodegeneration, where we saw a really robust change, both with the 300 and the 100. You know, the monomers, we believe, are part of the basic mechanism of our receptor, rather than a key part of the disease-modifying process that you see here. To further answer your question about longer trials, we do expect that with longer trials, such as 12- or 18-month trials, we would then begin to see more of the downstream biomarkers moving as well.
Anthony Caggiano: You're right, the 100-milligram dose did not significantly alter the A-beta monomers in the same way that the 300-milligram dose had. I think a more relevant biomarker here is the NFL, which is a marker of general neurodegeneration, where we saw a really robust change, both with the 300 and the 100. You know, the monomers, we believe, are part of the basic mechanism of our receptor, rather than a key part of the disease-modifying process that you see here. To further answer your question about longer trials, we do expect that with longer trials, such as 12- or 18-month trials, we would then begin to see more of the downstream biomarkers moving as well.
Anthony Caggiano: Tony, do you want to address that? Thank you, Elaine.
Anthony Caggiano: Yeah, hi Lynn. You're right, the 100 mg dose did not significantly alter the A-beta monomers in the same way that the 300 mg dose had.
Anthony Caggiano: I think a more relevant biomarker here is the NFL, which is a marker of general neurodegeneration.
Speaker Change: where we saw a really robust change both through the three hundred and the one hundred
Anthony Caggiano: the montorers we believe as part of the basic mechanism of our receptor rather than a key part of the disease modifying process that you see here
Anthony Caggiano: To further answer your question around longer trials, we do expect that with longer trials, such as 12 or 18-month trials, we would then begin to see more of the downstream biomarkers moving as well.
Yingling Kim: Got it. Okay, that makes sense. Thank you.
unknown: Got it. Okay, that makes sense. Thank you.
Speaker Change: Got it. Okay, that makes sense. Thank you. And for the follow up, your cash runway is into the second quarter of 2025. How do you plan on lengthening that runway and support later stage trials? And it may be jumping the gun, but maybe up to phase three. How do you plan on doing that?
Speaker Change: Yeah, thank you, Elaine. I mean, there's a lot of things that we need to evaluate. There will be a lot of options available to us, so as we look to extend our runway, we'll certainly take all of those into consideration and move forward as we design the next stage of those trials.
unknown: And for the follow-up, your cash runway is into the second quarter of 2025. How do you plan on lengthening that runway and supporting later stage trials? And it may be jumping the gun, but maybe up to phase three. How do you plan on doing that?
Lisa Ricciardi: Thank you, Elaine. There are a lot of things that we need to evaluate. There will be a lot of options available to us, so as we look to extend our runway, we'll certainly take all of those into consideration and move forward as we design the next stage of those trials.
unknown: Got it. Thank you for taking our questions.
Yingling Kim: Got it. Thank you for taking our question.
unknown: Our next question comes from Ram Selvarajee from HC Waywide.
Raghuram Selvaraju: Our next question comes from Raghuram Selvaraju from HC Waywide.
unknown: Got it. Thank you for taking our question.
Speaker Change: Thanks very much for taking my questions. First of all, somewhat intellectually provocative one, if I may.
Speaker Change: There was some discussion at AAIC in Philadelphia last month about the potential applicability of GLP-1 receptor agonism to the treatment of Alzheimer's disease. Do you think there could be any synergistic activity of CT1812 with GLP-1 receptor agonist specifically in the context of Alzheimer's?
unknown: Thanks very much for taking my questions. First of all, a somewhat intellectually provocative one, if I may, there was some discussion at AAIC in Philadelphia last month about the potential applicability of GLP-1 receptor agonism to the treatment of Alzheimer's. Do you think there could be any synergistic activity of CT1812 with GLP-1 receptor agonists specifically in the context of Alzheimer's?
Raghuram Selvaraju: Thanks very much for taking my questions. First of all, a somewhat intellectually provocative one, if I may, there was some discussion at AAIC in Philadelphia last month about the potential applicability of GLP-1 receptor agonism to the treatment of Alzheimer's. Do you think there could be any synergistic activity of CT1812 with GLP-1 receptor agonists specifically in the context of Alzheimer's?
Anthony Caggiano: That's a very interesting question, Ram. Tony, any thoughts on that? Sure.
Lisa Ricciardi: That's a very interesting question, Ram. Tony, any thoughts on that?
Anthony Caggiano: Sure. Yeah, interesting. I think, obviously, the world is very interested to see how GLP-1s behave in Alzheimer's disease. You know, given the mechanism of our drug is a very basic upstream interaction within the basic pathophysiology of Alzheimer's disease, we think CT1812 has the potential as monotherapy as well as in conjunction with other therapies. We're certainly interested in seeing it with current approved therapies, and if GLP-1 were to be approved for Alzheimer's disease, it would be very interesting to see how it acts together. So perhaps in the future, we'll see that data.
Speaker Change: what's a very interesting question rom tony any thought on that
Speaker Change: assu interest i think obviously the world is very interested to see how the gp ones behave in alzheimer'sdisease
Speaker Change: You know, given the mechanism of our drug is a very basic upstream interaction within the basic pathophysiology of Alzheimer's disease, we think CT1812 has the potential as a monotherapy as well as in conjunction with other therapies.
Tony: We're certainly interested in seeing it with current approved therapies, and if GLP-1 were to be approved for Alzheimer's disease, it would be very interesting to see how it acts together. So, perhaps in the future we'll see that data.
Raghuram Selvaraju: Great, and then just a quick follow-up on the dosage. I was wondering if there were doses intermediate between the 100 and the 300 that you would consider assessing further in clinical development, or if, at this juncture, you've ruled that out. And if you were to study intermediate doses,
Speaker Change: Great, and then just a quick follow-up on the dosage. I was wondering if...
Speaker Change: there were doses intermediate between the 100 and the 300 that you would consider assessing further in clinical development, or if at this juncture you've ruled that out. And if you were to study intermediate doses, which ones do you think are likely to be most appropriate?
Anthony Caggiano: So we do have intermediate doses being studied right now. In our START trial, which is a 540 participant study in early Alzheimer's disease, we have a 200 milligram dose. And in our MAGNIFY trial, which is the study in dry AMD, we also have the 200 milligram dose. And indeed, we introduced those doses a few years ago for this very reason, believing that it might be a very nice sweet spot where we see really good efficacy but fewer adverse effects. So those doses are already in the clinic.
Speaker Change: Yeah, so we do have an immediate dose is being studied right now.
Speaker Change: In our START trial, which is the 540-participant study in early Alzheimer's disease, we have a 200-milligram dose. And in our MAGNIFY trial, which is the study in dry A&E, we also have the 200-milligram dose.
Speaker Change: And indeed, we introduced those doses a few years back for this very reason, believing that it might be a very nice sweet spot.
Tony: where we see really good efficacy but fewer adverse events so those doses are already in the clinics and it's likely that we'll see them againinthe future
Speaker Change: thank you
Maya Pamtani: Our next question comes from Maya Pamtani, from Bidwari.
Lisa Ricciardi: can age
Speaker Change: Our next question comes from Mayank Mamtani from Beadwriting.
Kevin Grove: Hi, can you hear me?
unknown: Yes, Mayank. Good job.
Lisa Ricciardi: Yes, Mayank. It's good to see you.
Kevin Grove: Oh, this is Kevin Grove for Mayank. Thanks for taking our question. So now that we have seen the data from the SHINE trial, just wondering if you can talk about your expectation for your SHIMA trial later this year, and specifically, maybe your expectation for neuroendocrine or other biomarkers such as GFAP that may not be as relevant in different disease groups like Alzheimer's but maybe have different actions in DLP disease. And maybe if you can point to whether you would still expect 300 milligrams to have some liver enzyme signal.
Speaker Change: Hi, can you hear me?
Speaker Change: yes my ' good morning
unknown: oh this is kevin go for my an thanks we're taking our across so yeah
unknown: so now that we saw the things have from
unknown: Just saying, Kyle, just wondering if...
Speaker Change: You can talk about your expectation for your SHIMA trial later this year, and specifically maybe your expectation for neuroendocrine treatment.
Speaker Change: or other biomarkers that, such as GFAP, that may not be as...
Speaker Change: relevant in different disease groups like Alzheimer's, but maybe have a different actions in like...
Speaker Change: dp disease and maybe if you can point to quit are you still expect three hundred milligram to have some deliver inside ick no
Kevin Grove: So I think there were three questions. Kevin, you broke up in the middle.
unknown: So I think there were three questions. Kevin, you broke up in the middle.
Kevin Grove: One is overall expectations for Shimmer. Second, you were looking for a read on the number of biomarkers. And the last thing you mentioned was the 300 milligram dose. You know, what might be the profile of that dose? I'll turn those three questions over to Tony. Sure, thank you.
Lisa Ricciardi: One is overall expectations for shimmer. Second, you were looking for a read on the number of biomarkers. And the last thing you mentioned was the 300 milligram dose. You know, what might be the profile of that dose? I'll turn those three questions over to Tony.
Lisa Ricciardi: Thanks.
Lisa Ricciardi: So I think there were three questions. Kevin, you broke up in the middle. One is overall expectations for shimmer. Second, you were looking for a read on the number of the biomarkers. And the last thing you mentioned was the 300 milligram dose.
Anthony Caggiano: Sure, yeah, thank you. So, the SHIMMER study is designed very much like the SHINE study was, enrolling a similar number of individuals, you know, as a first proof-of-concept study where we're really looking, again, for safety and tolerability and then for a clear, you know, and consistent trend that we can slow progression of the disease across multiple outcome measures. As we've announced previously, we're looking for a readout, you know, towards the end of this year.
Lisa Ricciardi: What might be the profile of that dose? I'll turn those three questions over to Tony.
Anthony Caggiano: So, the SHMR study is designed very much like the SHINE study was, enrolling a similar number of individuals, you know, as a first proof-of-concept study, where we're really looking, again, for safety and tolerability and then for a clear, you know, and consistent trend that we can slow progression of the disease across multiple outcome measures. As we've announced previously, we're looking for a readout, you As far as the biomarker scale is concerned, I think, as you've implied, the biomarker profile and changes within DLB are not nearly as well studied or predictable as they are currently in Alzheimer's disease.
Speaker Change: Sure, thank you.
Speaker Change: right so the schimmer study is designed very much like the shine study was en enrlling similar number of individuals
Anthony Caggiano: as a first proof-of-concept study where we're really looking, again, for safety and tolerability and then for a clear and consistent trend that we can slow progression of the disease across multiple outcome measures.
Anthony Caggiano: As far as the biomarker scale is concerned, I think, as you've implied, the biomarker profile and changes within DLB are not nearly as well studied or predictable as they are currently in Alzheimer's disease. Having said that, we have a pretty robust program where we're looking at changes in biomarkers from both CSS and blood, looking at canonical biomarkers, as well as, as you've seen in our previous publications, proteomics and phosphoproteomics, looking at changes there.
Anthony Caggiano: As we've announced previously, we're looking for a readout, you know, towards the end of this year. As far as the biomarkers go, I think as you've implied,
Anthony Caggiano: The biomarker profile changes within DLB are not nearly as well studied or predictable as they are currently in Alzheimer's disease.
Anthony Caggiano: Having said that, we have a pretty robust program where we're looking at changes in biomarkers from both CSS and blood, looking at canonical biomarkers, as well as, as you've seen in our previous publications, proteomics and phosphoproteomics, looking at changes there. So, we look forward to seeing those changes. As far as the liver signal goes, we would expect to see the same thing in these individuals. These are folks who are nearly the same age; there's no reason we would expect to see anything different. So obviously, when that data comes out, we'll know that then.
Anthony Caggiano: Having said that, we have a pretty robust program where we're looking at changes in biomarkers from both CSS and blood, looking at canonical biomarkers, as well as, as you've seen in our previous publications, proteomics and phosphoproteomics.
Anthony Caggiano: So, we look forward to seeing those changes. As far as the liver signal goes, we would expect to see the same thing in these individuals. These are folks who are nearly the same age; there's no reason we would expect to see anything different. So obviously, when that data comes out, we'll know that then.
Anthony Caggiano: looking at changes there so we look forward to see those changes as far as we liver signal goes we would expect the same thing in these individuals
Anthony Caggiano: the eer folks who are nearly the same age there's no reason we would expect to see anything different
Anthony Caggiano: so obviously when that data reports out 'll know that then
Operator: Our next question comes from Daniil Gataulin from Tarbin.
Daniel Gataulin: Our next question comes from Daniel Gataulin from Tardin.
Speaker Change: okay thanks you
Speaker Change: Our next question comes from Daniil Gataulin from Tarbin.
Daniel Gataulin: Hey, good morning, guys. Thank you for taking the questions. Yeah, I have a couple first. Yeah, good morning. First, on SHINE, you know, having had a bit of time to look through the data, and now thinking about the next steps, what do you think are the key learnings from SHINE that you should look to incorporate into the next trial, you know, outside of it being larger and longer?
Daniil Gataulin: Hey, good morning, guys. Thank you for taking the question.
Daniil Gataulin: Yeah, I have a couple. Yeah, good morning. First, on SHINE, you know, having had a bit of time to look through the data, and now thinking about the next steps, what do you think are the key learnings from SHINE that you should look to incorporate into the next trial, you know, outside of it being larger and longer?
Speaker Change: yes a couple first
Daniil Gataulin: Yeah, good morning. Yeah, first, on the shine, you know, having had a bit of time to look through the data.
Daniil Gataulin: And now thinking about the next steps, what do you think are the key learnings from Shine that you look to incorporate into the next trial, you know, outside of it being a larger, the longer trial?
Anthony Caggiano: Great question, Tony. Sure.
Daniel Gataulin: Great question, Tony. Sure.
Anthony Caggiano: Sure. Yeah, well, I think the key learnings, again, are that we saw a very, you know, consistent and clear trend across all the cognitive outcome measures that we can slow disease progression. More specifically, we see the magnitude of effect here as well as the variance. This study now allows us to power future studies. Again, having seen a nearly 40% decrease in progression as per the ADES-COG scales, we can now look to the next round of studies, which I anticipate will both be larger and longer, so that we can see these changes.
Anthony Caggiano: Yeah, well, I think the key learnings, again, are that we saw a very consistent and clear trend across all the cognitive outcome measures. Having seen nearly a 40% decrease in progression as per the ADAS-COG scale, we can now look to the next round of studies, which I anticipate will both be larger and longer.
Anthony Caggiano: Great question. Tony? Sure. Yeah, well, I think the key learnings, again, are that we saw a very, you know, consistent and clear trend across all the cognitive outcome measures.
Anthony Caggiano: that we can slow disease progression more specifically we see in the magnitude of effect here as well as the variance so this study now allows us to power future studies
Anthony Caggiano: Again, having seen nearly 40% decrease in progression as per the ADAS-COG scales, we can now look to the next round of studies, which I anticipate will both be larger and longer.
Anthony Caggiano: We've also nicely identified a dose range, right, where we see an effect without troublesome adverse events. Indeed, as Lisa mentioned, there are no discontinuations due to AEs at the 100 milligram dose and no changes in liver enzymes. So we have a very nice place to operate here for future studies.
Anthony Caggiano: so that we can see these changes. We've also likely identified a dose range, right, where we see effect without troublesome adverse events.
Speaker Change: indeeda we mentioned there are no discontinuations due to aeight s and the one hundred baraggrampta and thosete changes in the renenzyes so we have a very nice place to operate here for future studies
Daniel Gataulin: And another question, you know, with the recent approvals in Alzheimer's, how did that affect the enrollment rates for your CT 1812 trials? And related to that, what fraction of participants in the start trial they expect to be on concurrent approved Alzheimer's disease?
Speaker Change: exs on got it and another question you was the rereasoncent approvals in alzheimer's how did that affect the enrollment rates for for your e twelve trials
Speaker Change: And related to that, what fraction of participants in the START trial do they expect to be on concurrent approved Alzheimer's disease medication?
Anthony Caggiano: Yeah, so, um, The inclusion criteria are the patient population for the monoclonal antibodies, and for our SHINE participants, they were somewhat different, a little bit overlapping, but generally different. So I'm not sure it really impacted recruitment. I think overall, you know, having the general population now very aware and interested that there are drugs available for Alzheimer's disease has been a great asset, and people are coming into clinics and are interested and inquiring. So overall, I'd say it was a boost. But again, it's a somewhat different population.
Anthony Caggiano: Yeah, so, um, and for our SHINE participants, they were somewhat different, a little bit overlapping, but generally different. So, I'm not sure it really impacted recruitment. I think overall, you know, having the general population now very aware and interested that there are drugs available for Alzheimer's disease has been a great asset, and people are coming, you know, into clinics and are interested and inquiring. So, overall, I'd say it was a boost. So we'll have a very good look at, you know, safety and tolerability of combined therapy and, depending on how many people are able to randomize, also potentially see if there are additive effects.
unknown: Okay, I got it. Thank you.
unknown: jo
unknown: Yeah, so...
unknown: The
Speaker Change: The inclusion criteria are the patient population for the monoclonal antibodies.
unknown: and for our SHINE participants were somewhat different, a little bit overlapping but generally different. So I'm not sure it really impacted recruitment.
unknown: i think overall
unknown: having the general population now very way are interested that there are drugs available fall simons disease has been a great asset in people are coming into clinics and interested and inquiring so overall i d say it was a boost
Anthony Caggiano: As far as how many individuals will be on approved monoclonal antibodies within our start trial, that's still a little unknown. Obviously, one of the antibodies was launched not long ago, and we'll see how it penetrates the market. The other antibody, just recently, you see the approval, and it's just now launching. We'll see, within that study, we are stratifying all individuals so that we'll have an even number of people on monoclonal antibodies across the different treatment groups. So we'll have a very good look at, you know, safety and tolerability combined, and depending on how many.
unknown: but again it's a somewhat different population.
unknown: As far as how many individuals will be on approved monoclonal antibodies,
Speaker Change: within our START trial.
Speaker Change: that's still a little on known obviously one of the antibody launched not long ago and we'll see how it centtrates the market
unknown: The other antibody just recently received approval and is just now launching. Right, so we'll see and within that study we are stratifying all individuals so that we'll have an even number of people on monoclonal antibodies across the different treatment groups.
unknown: So we'll have a very good look at, you know, safety and tolerability of combined and depending on how many people are able to to randomize also potentially see if there are additive effects.
Daniel Gataulin: Okay, I got it. Thank you.
Operator: There are no further questions at this time, so I'll turn the call back over to Lisa Ricciardi, CEO.
Speaker Change: Okay, got it. Thank you.
unknown: There are no further questions at this time, so I'll turn the call back over to Lisa Ricciardi, CEO .
Lisa Ricciardi: All right, thank you. To conclude, we are focused on advancing our work to find a treatment to improve the lives of those afflicted with neurodegenerative diseases. The science is sound, we are compelled to move forward, and we continue to build evidence about what CT1812 can do for patients. Thank you for joining us today. The meeting is now concluded. You may now disconnect. Dr. Raghuram Selvaraju
unknown: All right, thank you. To conclude...
Speaker Change: we are focused on advancing our work to find a treatment to improve the lives of those afflicted with neurro degenerative cones the science ists sound we are compelled to move forward and we continue to build evidence about what dt eighteen twelve can do for patients thank you for joining us today
Operator: The meeting is now concluded. You may now disconnect.
unknown: I just want to conclude it. We'll be down just for now. Time to Turn Back Time
Operator: The meeting is now concluded. You may now disconnect.
Yingling Kim: And for the follow-up, your cash runway is into the second quarter of 2025. How do you plan on lengthening that runway and supporting later stage trials? And it may be jumping the gun, but maybe up to phase three. How do you plan on doing that?
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