Release Date: August 08, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Cognition Therapeutics Inc (CGTX, Financial) reported a 39% slowing of cognitive decline in the SHINE trial for Alzheimer's disease, which is higher than the 25-30% seen with recently approved monoclonal antibodies.
- The SHINE trial demonstrated a favorable safety and tolerability profile for CT1812, with most adverse events being mild or moderate.
- The company has a strong financial position with $28.5 million in cash and cash equivalents and $57.3 million in remaining grant funds from the NIA.
- Cognition Therapeutics Inc (CGTX) is actively pursuing multiple clinical trials, including the SHIMMER trial for dementia with Lewy bodies and the MAGNIFY study for age-related macular degeneration.
- The company is leveraging non-dilutive funding from the NIH to support its clinical programs, demonstrating efficient financial management.
Negative Points
- The SHINE trial did not achieve statistical significance on the ADAS-Cog 11 scale, indicating the need for larger and longer trials.
- Research and development expenses increased to $11.6 million in Q2 2024 from $8.5 million in the same period in 2023, reflecting higher costs associated with advancing clinical programs.
- The company reported a net loss of $7 million for Q2 2024, compared to a net loss of $4.7 million in Q2 2023.
- There were treatment-emergent liver function test increases at the 300-milligram dose in the SHINE trial, although these resolved without serious liver injuries.
- The cash runway is only sufficient to fund operations into the second quarter of 2025, necessitating future funding strategies to support later-stage trials.
Q & A Highlights
Q: In the SHINE trial, the 100 mg dose did not meaningfully alter the Abeta 40 and 42 levels, while the 300 mg did. Could changes with the 100 mg dose be more pronounced after a year of dosing versus six months?
A: Anthony Caggiano, Chief Medical Officer: The 100 mg dose did not significantly alter the Abeta monomers like the 300 mg dose. A more relevant biomarker is NfL, which showed robust change at both doses. We expect longer trials could show more downstream biomarker changes.
Q: Your cash runway is into the second quarter of 2025. How do you plan on lengthening that runway and supporting later-stage trials?
A: John Doyle, Chief Financial Officer: We will evaluate various options to extend our runway and support the next stage of trials.
Q: Could there be any synergistic activity of CT1812 with GLP-1 receptor agonists in Alzheimer's treatment?
A: Anthony Caggiano, Chief Medical Officer: Given our drug's mechanism, CT1812 has potential as a monotherapy and in conjunction with other therapies. If GLP-1 is approved for Alzheimer's, it would be interesting to see how it acts together with CT1812.
Q: Are there intermediate doses between 100 and 300 mg that you would consider assessing further in clinical development?
A: Anthony Caggiano, Chief Medical Officer: We are studying a 200 mg dose in our START and MAGNIFY trials, believing it might offer good efficacy with fewer adverse events.
Q: What are your expectations for the SHIMMER trial, particularly regarding biomarkers and the 300 mg dose's liver enzyme signal?
A: Anthony Caggiano, Chief Medical Officer: SHIMMER is designed like SHINE, focusing on safety and a trend in slowing disease progression. Biomarker profiles in DLB are less predictable, but we have a robust program. We expect similar liver enzyme signals as in SHINE.
Q: What are the key learnings from SHINE that you'll incorporate into the next trial?
A: Anthony Caggiano, Chief Medical Officer: We saw a consistent trend in slowing disease progression, allowing us to power future studies. We've identified a dose range with good efficacy and manageable adverse events.
Q: How have recent Alzheimer's drug approvals affected enrollment rates for CT1812 trials?
A: Anthony Caggiano, Chief Medical Officer: The patient populations differ slightly, so recruitment wasn't significantly impacted. However, increased awareness of available treatments has boosted interest.
Q: What fraction of participants in the START trial do you expect to be on concurrent approved Alzheimer's medications?
A: Anthony Caggiano, Chief Medical Officer: It's still unknown, as the antibodies are newly launched. We are stratifying participants to ensure an even distribution across treatment groups.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
