|
Cognition Therapeutics, Inc. (CGTX): Business Model Canvas [Dec-2025 Updated] |
Fully Editable: Tailor To Your Needs In Excel Or Sheets
Professional Design: Trusted, Industry-Standard Templates
Investor-Approved Valuation Models
MAC/PC Compatible, Fully Unlocked
No Expertise Is Needed; Easy To Follow
Cognition Therapeutics, Inc. (CGTX) Bundle
You're looking to cut through the noise and see exactly how Cognition Therapeutics, Inc. is structured to tackle Alzheimer's, and honestly, it boils down to a focused, capital-dependent biotech model. As a former head analyst, I see a clear picture: they are betting big on Zervimesine (CT1812) protecting synapses, currently driving a Phase 2 'START' study, all while managing a runway supported by about $39.8 million in cash plus another $36.3 million in obligated NIA grant funds as of Q3 2025. Their primary cost is R&D, running at $3.8 million in Q3, which they supplemented with a $30 million equity raise that same quarter. This canvas maps out every key partnership, from the NIA to the ACTC, and shows exactly where the value-and the risk-lies before they hit a potential registrational Phase 3. It's a classic pre-commercial blueprint, so see the full nine blocks below to understand their game plan.
Cognition Therapeutics, Inc. (CGTX) - Canvas Business Model: Key Partnerships
You're looking at the external relationships Cognition Therapeutics, Inc. (CGTX) relies on to push zervimesine through clinical development, which is the core of their value creation. For a clinical-stage biotech, these aren't just vendors; they are co-investors and essential operational links. Honestly, their reliance on non-dilutive funding sources like government grants is a major feature of their current financial structure.
National Institute on Aging (NIA) for grant funding
The National Institute on Aging (NIA), a division of the National Institutes of Health (NIH), is a critical, non-dilutive funding partner for Cognition Therapeutics, Inc. (CGTX). This relationship directly supports the expensive clinical trial work for zervimesine. As of the third quarter of 2025, the company reported that the total obligated grant funds remaining from the NIA stood at $36.3 million. This contrasts with earlier figures; for instance, as of Q2 2025, $41.9 million in obligated grant funds remained, and prior to that, as of March 31, 2025, $47.0 million was outstanding. The Phase 2 SHINE Study, which informed later regulatory discussions, was previously supported by NIA grants totaling approximately $30 million.
Alzheimer's Clinical Trials Consortium (ACTC) for the Phase 2 START study
The collaboration with the Alzheimer's Clinical Trials Consortium (ACTC) is central to advancing zervimesine in early Alzheimer's disease. The Phase 2 START study (NCT05531656) is being conducted in partnership with ACTC colleagues. This trial is heavily supported by non-dilutive funding, specifically carrying $81 million in grant support from the NIA. As of the third quarter of 2025, Cognition Therapeutics, Inc. (CGTX) announced that enrollment in the Phase 2 'START' study had surpassed 75%. This is up from the milestone reported in Q2 2025, when enrollment passed 50%.
Here's a quick look at the key metrics tied to this partnership:
| Metric | Value as of Late 2025 | Context |
|---|---|---|
| NIA Grant Support for START Study | $81 million | Direct funding for the Phase 2 Alzheimer's trial. |
| START Study Enrollment (Latest) | 75% surpassed | Milestone achieved as of September 30, 2025. |
| START Study Enrollment (Earlier) | 50% surpassed | Milestone achieved as of June 30, 2025. |
Contract Research Organizations (CROs) for global trial execution
While specific financial figures for individual Contract Research Organizations (CROs) aren't typically disclosed as a line item in public filings, Cognition Therapeutics, Inc. (CGTX) relies on these external organizations to execute its global clinical trials. The successful completion of enrollment milestones, such as the 75% mark in the START study, is a direct testament to the operational capacity managed through these CRO relationships. These partnerships handle the site management, patient monitoring, and data collection necessary for studies like the ongoing Phase 2 work and the planned Phase 3 registrational studies.
U.S. Food and Drug Administration (FDA) for regulatory pathway alignment
Engagement with the U.S. Food and Drug Administration (FDA) is a crucial, non-financial partnership that dictates the path to market. Cognition Therapeutics, Inc. (CGTX) recently completed a productive End-of-Phase 2 meeting with the FDA to review results from the Phase 2 SHINE study and discuss registrational plans for zervimesine in Alzheimer's disease. As of the third quarter of 2025, the company reported achieving alignment with the FDA on a registration path for zervimesine in Alzheimer's disease. This alignment covers key design elements for the planned Phase 3 studies, including the use of the iADRS composite as an efficacy endpoint and enrichment for patients with lower plasma p-tau217 levels.
Potential strategic pharmaceutical partners for late-stage development
Cognition Therapeutics, Inc. (CGTX) maintains an active business development program aimed at securing strategic pharmaceutical partners to help fund and execute late-stage development, particularly for Phase 3 trials. The company stated that key clinical and regulatory milestones-such as the FDA alignment and the expected FDA decision on breakthrough designation for DLB in Q3 2025-are intended to be valuable to potential partners. Following a $30 million registered direct offering in September 2025 to support Phase 3 preparations, the need for a partner remains a strategic goal to share the financial burden of pivotal trials. The company is evaluating its options to support the development of zervimesine across its indications.
Key partnership-related financial and strategic points include:
- The company is exploring partnerships to secure non-dilutive funding for clinical development efforts.
- A $30 million registered direct offering was completed in Q3 2025 to support the next stage of development, which may precede or occur alongside a major partnership.
- The company has no long-term debt, which provides flexibility when negotiating potential co-development or commercialization deals.
- The CEO noted that expected milestones will be valuable to potential partners as they evaluate development support options.
Cognition Therapeutics, Inc. (CGTX) - Canvas Business Model: Key Activities
You're looking at the core engine driving Cognition Therapeutics, Inc. right now-the things they absolutely must execute on to move Zervimesine forward. It's all about clinical milestones and keeping the lights on via smart financing.
Executing the Phase 2 'START' study for early Alzheimer's disease
The Phase 2 'START' Study, assessing the safety and activity of zervimesine (CT1812) in early Alzheimer's disease, hit a major operational mark. Cognition Therapeutics announced reaching target enrollment of 540 participants in this randomized, placebo-controlled study as of November 13, 2025. This was a significant operational push, as enrollment surpassed 75% as early as September 3, 2025. The study is being conducted in collaboration with the Alzheimer's Clinical Trials Consortium (ACTC). The expected timeline for topline results depends on all participants completing 18 months of treatment. Interestingly, about 15% of the randomized participants were already on stable background therapy with an approved monoclonal antibody, like Leqembi or Kisunla.
Key metrics for the START study activity include:
- Target Enrollment Reached: 540 participants.
- NIA Grant Support: $81 million.
- Primary Efficacy Measures: CDR-SB and ADAS-Cog rating scales.
- Expected Topline Readout: Post 18 months of participant treatment.
Advancing Zervimesine (CT1812) to a registrational Phase 3 program
The most critical recent activity was securing the regulatory roadmap for the next stage. Cognition Therapeutics achieved alignment with the U.S. Food and Drug Administration (FDA) on a registrational path for zervimesine in Alzheimer's disease following an end-of-Phase 2 meeting in July 2025. The proposed Phase 3 program is lean, calling for two randomized 1:1 six-month studies, with participants receiving 100 mg of oral zervimesine daily or placebo. Efficacy will be measured using the iADRS composite scale. This strategy is heavily informed by Phase 2 data, where the lower plasma p-tau217 subgroup showed a 95% slowing of cognitive decline on the ADAS-Cog11 scale versus placebo.
For the Dementia with Lewy Bodies (DLB) indication, where the company holds FDA Breakthrough Therapy Designation, Phase 2 SHIMMER study results showed significant functional improvements:
| Endpoint Category | Observed Improvement vs. Placebo |
| Behavioral Outcomes | 86 percent better |
| Activities of Daily Living | 52 percent improvement |
| Cognitive Fluctuations | 91 percent reduction |
| Motor Function | 62 percent better |
The company is also actively evaluating its strategy across DLB and Alzheimer's Disease.
Managing regulatory filings and meetings (FDA, planned EMA)
Regulatory management centers on solidifying the global plan for Zervimesine. Following the FDA agreement in July 2025, the next step is seeking international alignment. Cognition Therapeutics is planning a scientific advice meeting with the European Medicines Agency (EMA) in February 2026 to harmonize the global registrational strategy. The company also has the benefit of FDA Breakthrough Therapy Designation for its DLB program.
Ongoing drug discovery and preclinical pipeline development
While Zervimesine is the focus, the company maintains a pipeline targeting other severe conditions. Cognition Therapeutics is developing small-molecule therapeutics for neurodegenerative and retinal diseases. The lead candidate, CT1812, is an oral sigma-2 receptor antagonist. Preclinical and earlier-stage programs target synucleinopathies and dry age-related macular degeneration (AMD). The company concluded its Phase 2 study for dry AMD, which showed a 28.6% reduction in geographic atrophy (GA) lesion growth in Q2 2025. The organization is relatively lean, reporting 25 full-time employees.
Securing non-dilutive grant funding and equity financing
Financial activity in late 2025 was dominated by a significant equity raise to secure the runway for Phase 3 preparations. As of September 30, 2025, Cognition Therapeutics reported approximately $39.8 million in cash, cash equivalents, and restricted cash equivalents. This followed the closing of a $30 million registered direct offering in September 2025, which involved selling 14,700,000 shares at $2.05 per share. This financing, combined with grant funds, extends the estimated cash runway into the second quarter of 2027.
The company continues to benefit from non-dilutive funding, with total obligated grant funds remaining from the National Institute of Aging (NIA) at $36.3 million as of September 30, 2025. The operational costs reflect the winding down of Phase 2 trials:
| Q3 2025 Financial Metric (USD) | Amount |
| Net Loss | $4.93 million |
| Diluted Loss Per Share | $(0.06) |
| Research and Development Expenses | $3.8 million |
| General and Administrative Expenses | $2.6 million |
| Revenue | $0.000 (Forecast for Q4 2025) |
The Q3 2025 net loss of $4.93 million was narrower than the prior year's $9.94 million loss.
Cognition Therapeutics, Inc. (CGTX) - Canvas Business Model: Key Resources
You're looking at the core assets Cognition Therapeutics, Inc. (CGTX) is relying on to push its pipeline forward, especially as they transition toward late-stage studies. Honestly, for a clinical-stage biotech, these resources are everything.
Zervimesine (CT1812) and Intellectual Property
The primary tangible asset is Zervimesine (CT1812), which the USAN Council has officially adopted as the United States Adopted Name for the compound. This is an investigational, oral, once-daily small molecule drug candidate. Its mechanism centers on targeting the sigma-2 receptor (S2R), a key area of intellectual property (IP) for Cognition Therapeutics, Inc. This IP is crucial because the drug is designed to displace toxic protein oligomers that have attached to neurons, aiming to restore normal cellular function in CNS diseases. The company is banking on this mechanism across multiple indications.
The IP protection around the S2R targeting mechanism is what underpins the exclusivity and potential future revenue streams. It's the moat around their lead asset.
Financial and Grant Capital
Financially, Cognition Therapeutics, Inc. is currently supported by a mix of cash reserves and non-dilutive government funding. Following a financing event, the balance sheet looks more secure heading into the next phase of development. Here's the quick math on their liquidity as of the end of the third quarter of 2025.
| Financial Metric | Amount as of Q3 2025 |
| Cash and Equivalents | $39.8 million |
| Remaining Obligated NIA Grant Funds | $36.3 million |
| Total Cash Resources (Cash + Grants) | $76.1 million |
What this estimate hides is the burn rate required to fund the planned Phase 3 preparations, but management guided that this capital extends operations into the second quarter of 2027. Still, securing a partnership remains a high-priority action item to de-risk the Phase 3 programs.
Clinical Data from Completed Phase 2 Trials
The clinical data from the completed Phase 2 trials, SHINE for Alzheimer's disease (AD) and SHIMMER for Dementia with Lewy Bodies (DLB), serve as critical validation points for the asset. These results are the foundation for the FDA alignment on a registrational path for AD. If onboarding new sites takes longer than expected, the timeline for leveraging this data for partnership talks could slip, defintely.
Key statistical highlights from these trials include:
- SHINE Trial (AD): Participants with lower plasma p-tau217 levels experienced a 95% slowing of cognitive decline (ADAS-Cog11) at six months versus placebo.
- SHINE Trial (AD): The study enrolled 153 adults with mild-to-moderate Alzheimer's disease.
- SHIMMER Trial (DLB): Met its primary endpoint of safety and tolerability; DLB affects approximately 1.4 million Americans.
- SHIMMER Trial (DLB): Treated arms showed an 82% slowing in the Neuropsychiatric Inventory (NPI).
- SHIMMER Trial (DLB): Demonstrated a 91% slowing in fluctuations in attention.
Finance: draft 13-week cash view by Friday.
Cognition Therapeutics, Inc. (CGTX) - Canvas Business Model: Value Propositions
You're looking at the core promise Cognition Therapeutics, Inc. (CGTX) is making to patients and the market with its lead asset, zervimesine (CT1812). This isn't about abstract potential; it's about concrete delivery and measurable biological impact as of late 2025.
The primary value proposition centers on zervimesine being an investigational, oral, once-daily pill for serious neurodegenerative disorders like Alzheimer's disease (AD) and Dementia with Lewy Bodies (DLB). This oral dosing is a significant differentiator in a space often reliant on infusions or less convenient regimens.
The mechanism is novel because it aims to protect synapses by interrupting the toxic effects of misfolded proteins. Specifically, zervimesine has been shown to interrupt the toxic effects of A$\beta$ and $\alpha$-synuclein, which are implicated in both AD and DLB pathology. The drug operates through interaction with the sigma-2 receptor, a mechanism functionally distinct from many other approaches currently in development for these diseases.
For Alzheimer's disease, the value proposition is sharpened by a predictive biomarker strategy. Cognition Therapeutics has data suggesting that the drug's benefit is most pronounced in patients with lower baseline levels of the protein p-tau217, which is measurable via a simple blood test. This enrichment strategy is key for future registrational trials, as it targets patients most likely to show a robust treatment effect.
Here is a snapshot of the key clinical performance metrics supporting this value proposition:
| Indication/Study | Patient Subgroup | Endpoint/Measure | Observed Effect vs. Placebo |
| Alzheimer's Disease (Phase 2 SHINE) | Overall Population | Slowing of Cognitive Decline | 38% |
| Alzheimer's Disease (Phase 2 SHINE) | Lower Plasma p-tau217 Levels | Slowing of Cognitive Decline (ADAS-Cog11) | 95% |
| Dementia with Lewy Bodies (Phase 2 SHIMMER) | Overall DLB Patients (6 months) | Improvement on Neuropsychiatric Inventory (NPI-12) | Average of 86% better |
| Dry Age-Related Macular Degeneration (Phase 2) | Overall Population (18 months) | Reduction of Geographic Atrophy (GA) Lesion Growth | 28.6% |
The company is actively advancing the DLB indication, having initiated an Expanded Access Program (EAP) for patients with DLB. Furthermore, as of the third quarter of 2025, Cognition Therapeutics was anticipating an FDA decision on breakthrough designation for zervimesine in DLB in the third quarter 2025.
To support this pipeline momentum, Cognition Therapeutics completed a $30 million registered direct offering in the third quarter of 2025. Financially, as of September 30, 2025, the company reported cash, cash equivalents, and restricted cash of approximately $39.8 million, supplemented by $36.3 million in remaining obligated grant funds from the National Institute on Aging. This position allowed the company to estimate sufficient cash to fund operations into the second quarter of 2027.
The AD program is also progressing with a large trial. The Phase 2 START Study, testing zervimesine in mild cognitive impairment (MCI) or early AD, surpassed 75% enrollment as of September 2025, enrolling approximately 540 individuals.
You should track the following key elements:
- The FDA's decision on breakthrough designation for DLB, which was expected in Q3 2025.
- The expected readout timeline for the Phase 2 START study, which involves an 18-month treatment period.
- The company's cash burn rate, given the net loss for Q3 2025 was $4.9 million.
- The alignment achieved with the FDA on a registrational path for AD, which may require two six-month Phase 3 studies.
Cognition Therapeutics, Inc. (CGTX) - Canvas Business Model: Customer Relationships
You're looking at the relationships Cognition Therapeutics, Inc. (CGTX) builds with the key groups that drive its clinical and financial success. For a clinical-stage biotech, these aren't just customers; they are partners in development and validation.
Close collaboration with clinical investigators and academic sites
The execution of clinical trials relies heavily on strong ties with the medical community. Cognition Therapeutics, Inc. works closely with established consortia and specific investigators to run its studies on zervimesine (CT1812).
The Phase 2 START study, evaluating zervimesine in early Alzheimer's disease, is being conducted in partnership with colleagues at the Alzheimer's Clinical Trials Consortium (ACTC). As of September 3, 2025, this study had surpassed 75% enrollment of its target of about 540 participants. Full enrollment was announced by November 13, 2025.
For the Phase 2 SHIMMER study in dementia with Lewy bodies (DLB), the enrollment breakdown showed significant engagement:
| Study Arm | Number of Participants Randomized |
| Zervimesine Treatment Arms (100 mg or 300 mg daily) | 88 |
| Placebo Arm | 42 |
| Total Enrolled (SHIMMER) | 130 |
Key investigators involved in these programs include Dr. James E. Galvin of the University of Miami Miller School of Medicine and Dr. Lawrence S. Honig of Columbia University Irving Medical Center.
High-touch engagement with regulatory bodies (FDA, EMA)
Engagement with the U.S. Food and Drug Administration (FDA) is critical for defining the path to market. Cognition Therapeutics, Inc. has secured key agreements that shape its near-term development strategy.
The company achieved alignment with the FDA on a registrational path in Alzheimer's disease following a productive end-of-Phase 2 meeting on July 9, 2025. This agreement suggests that two six-month Phase 3 studies, with participants randomized 1:1 to receive either 100 mg of oral zervimesine or placebo daily, may be sufficient to support a New Drug Application (NDA) filing.
For the DLB indication, the company is pursuing similar input. The FDA has accepted a request for a Type C meeting, scheduled for the second half of January 2026, to discuss the proposed Phase 3 program design for zervimesine in DLB patients.
The high-touch regulatory interaction extends globally, as Cognition Therapeutics, Inc. is planning a scientific advice meeting with the European Medicines Agency (EMA) in February 2026 to align its global Alzheimer's disease registrational plans.
Expanded Access Program (EAP) for DLB patients
The Expanded Access Program (EAP), designated COG1202, provides access to zervimesine for eligible patients with mild-to-moderate DLB outside of a formal trial setting. This program demonstrates a commitment to patients with high unmet need.
The program reached full enrollment as of December 3, 2025, completing enrollment in just three months. The EAP was made possible through a generous philanthropic donation from the family of a former Phase 2 SHIMMER participant.
- Treatment regimen: 100 mg of oral zervimesine daily for up to one year.
- Initial plan targeted approximately 30 patients.
- The program onboarded three clinical sites as of Q2 2025, with the first of eight total sites being Banner Sun Health Research Institute in Arizona.
Investor relations and capital market communications
Maintaining strong relationships with capital providers is essential for funding the late-stage clinical development required for a registrational program. Cognition Therapeutics, Inc. actively engaged the capital markets in 2025.
On September 2, 2025, the Company closed a $30 million registered direct offering, which involved the sale of 14,700,000 shares of common stock to institutional investors. This capital infusion provided significant runway extension.
Key financial and investor metrics as of late 2025:
| Metric | Value/Date |
| Market Capitalization (as of Dec 3, 2025) | $142 million |
| Cash, Cash Equivalents, Restricted Cash (as of Sep 30, 2025) | Approx. $39.8 million |
| Estimated Cash Runway (as of Sep 30, 2025) | Into the second quarter of 2027 |
| Total Obligated Grant Funds Remaining (as of Sep 30, 2025) | $36.3 million (from NIA) |
Investor engagement included participation in the 37th Annual Piper Sandler Healthcare Conference from December 2-4, 2025.
Cognition Therapeutics, Inc. (CGTX) - Canvas Business Model: Channels
You're looking at how Cognition Therapeutics, Inc. (CGTX) gets its science and its potential product, zervimesine (CT1812), out to the world-from the lab bench to the potential patient and the institutional investor. This is all about execution and communication channels for a clinical-stage company.
Global network of clinical trial sites and research institutions
The core of the channel strategy revolves around clinical execution. You can't get to an NDA without running high-quality trials, and that requires a network. The Phase 2 START Study, which is testing zervimesine in mild cognitive impairment (MCI) or early Alzheimer's disease, is a prime example of this channel in action.
This study is being run in collaboration with the Alzheimer's Clinical Trials Consortium (ACTC). That consortium is an NIA-funded clinical trial network comprising 35 leading academic sites specializing in Alzheimer's disease trials. It's a powerful channel for recruitment and site management. The ACTC partnership is key, especially since the START Study is supported by an $81 million grant from the National Institute on Aging (NIA) at the National Institutes of Health. The company reached its target enrollment of 540 participants in this Phase 2 study as of November 13, 2025. To be fair, the previous Phase 2 SHINE study was smaller, enrolling 153 adults with mild-to-moderate Alzheimer's disease, but the START enrollment shows scaling in this channel.
Here's a quick look at the scale of their clinical channel activity through late 2025:
| Trial/Program | Target Indication | Enrollment Status (as of late 2025) | Key Collaborator/Network |
|---|---|---|---|
| Phase 2 START Study | Early Alzheimer's Disease (MCI/early AD) | Target enrollment of 540 participants reached (Nov 13, 2025) | Alzheimer's Clinical Trials Consortium (ACTC) |
| Phase 3 Registrational Program | Mild-to-Moderate Alzheimer's Disease | Design agreed upon with FDA; planning two six-month studies | U.S. FDA (via July 2025 EOP2 meeting) |
| Expanded Access Program (EAP) | Dementia with Lewy Bodies (DLB) | Full enrollment reached (Dec 3, 2025) | Various clinical sites/donors |
Regulatory submissions (NDA) to the U.S. FDA and other agencies
The regulatory pathway is the most critical channel for commercialization. Cognition Therapeutics, Inc. has made significant strides here. They completed an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on July 9, 2025, for their Alzheimer's program. The outcome was a clear channel to market: the FDA confirmed that the proposed Phase 3 design could support a New Drug Application (NDA) filing for zervimesine as an Alzheimer's treatment. This framework relies on two six-month Phase 3 trials using enrichment for patients with lower plasma p-tau217 levels. Also, they applied to the FDA for breakthrough designation for zervimesine in DLB, with an expected decision in the third quarter of 2025. For global alignment, they plan an EMA scientific advice meeting in February 2026.
Scientific and medical conferences (e.g., CTAD) for data dissemination
Disseminating data effectively is how Cognition Therapeutics builds credibility with clinicians and researchers, which, in turn, drives investigator interest and patient enrollment. They actively use major medical meetings as a primary channel.
The most recent, and perhaps most important, dissemination event was presenting the Phase 3 registrational plan at the Clinical Trials on Alzheimer's Disease (CTAD) conference on December 1, 2025, in San Diego, CA. Earlier in 2025, results from the Phase 2 SHIMMER study in DLB were presented at the Alzheimer's Association International Congress (AAIC) on July 29th in Toronto, Canada. This conference activity directly fueled enrollment acceleration in the START study, with approximately 50% of the entire study population enrolled during the last six months of 2025.
The key data dissemination channels include:
- Presenting Phase 3 plan at CTAD (December 1, 2025).
- Presenting Phase 2 DLB data at AAIC (July 29, 2025).
- Participation in the 37th Annual Piper Sandler Healthcare Conference (December 2-4, 2025).
- Live presentation by the CEO at the Life Sciences Virtual Investor Conference (March 13, 2025).
Investor roadshows and direct communication with institutional investors
Securing capital is a crucial channel for a clinical-stage company. Cognition Therapeutics, Inc. actively engaged institutional investors throughout 2025. A major event was closing a $30 Million Registered Direct Offering on September 2, 2025, which involved two new fundamental institutional investors, including a preeminent global investment firm. This capital supports the planned Phase 3 development. Furthermore, the President and CEO, Lisa Ricciardi, delivered a live presentation at the Life Sciences Virtual Investor Conference on March 13, 2025, at 9:30 a.m. ET. This direct engagement channel helps manage expectations and secure necessary funding, as evidenced by the $30 million raised in September. Finance: draft 13-week cash view by Friday.
Cognition Therapeutics, Inc. (CGTX) - Canvas Business Model: Customer Segments
You're looking at the specific groups Cognition Therapeutics, Inc. (CGTX) targets with its investigational drug zervimesine, which is key for understanding their near-term commercial focus and investor appeal.
Patients with early Alzheimer's disease (MCI/mild AD)
This segment represents a massive, underserved population where Cognition Therapeutics, Inc. (CGTX) is actively pursuing development with its lead candidate, zervimesine (CT1812). The company's Phase 2 START Study specifically targets this group, aiming for early intervention.
- Estimated 7.2 million Americans aged 65+ living with Alzheimer's dementia as of 2025.
- Approximately 1.9 million of those cases are in the 65 to 74 year age bracket, aligning with the early-stage focus.
- The Phase 2 START Study is targeting 540 participants.
- In a survey, 92% of Americans indicated they would take a treatment that could slow disease progression.
The company also completed Phase 2 studies for mild-to-moderate Alzheimer's disease via the SHINE trial.
Patients with Dementia with Lewy Bodies (DLB)
Cognition Therapeutics, Inc. (CGTX) is also focused on DLB, evidenced by the recent completion of enrollment in an expanded access program for zervimesine in this patient group. This shows a commitment to a distinct neurodegenerative indication.
- The expanded access program enrolled eligible patients to receive 100 mg of oral zervimesine daily for up to one year.
- The company has a scheduled Type C meeting with the FDA in the second half of January to discuss the proposed design for a Phase 3 program in DLB patients.
Clinical investigators and neurologists specializing in neurodegeneration
These professionals are crucial for trial execution, site selection, and ultimately, adoption of the therapy. Cognition Therapeutics, Inc. (CGTX) is actively engaged with key opinion leaders in the field.
Here's a look at the key personnel and funding sources involved in their clinical efforts:
| Role/Affiliation | Involvement/Detail | Associated Study/Program |
|---|---|---|
| Dr. James E. Galvin, MD, MPH | Lead investigator for the multi-center, open-label program. | DLB Expanded Access Program |
| Dr. Lawrence S. Honig | Investigator in the expanded access program. | DLB Expanded Access Program |
| National Institute of Aging (NIA) | Provided grant support for the Phase 2 START study. | Phase 2 START Study (Early AD) |
| Alzheimer's Clinical Trials Consortium | Collaboration partner for the START study. | Phase 2 START Study (Early AD) |
Institutional investors and public equity markets
The public market and institutional holders are the primary source of capital for this clinical-stage biopharma. Recent trading activity shows significant interest, though the company is operating under a tight cash runway.
Here are the key financial and ownership metrics as of late 2025:
| Metric | Value/Amount | Date/Context |
|---|---|---|
| Market Capitalization | About $158.9M | As of December 5, 2025 |
| Institutional Ownership Percentage | 28.9% | As of September 2025 filings |
| Estimated Cash Runway | Into the second quarter of 2026 | As of Q2 2025 results |
| Largest Institutional Holder (Shares) | 6.00Mn shares (BIOS Capital Management, LP) | As of September 30, 2025 |
| Largest Institutional Holder (Percentage) | 8.17% of outstanding stock | BIOS Capital Management, LP |
| Q3 2025 Stake Increase (Vanguard) | 105.6% increase | Vanguard Group Inc. |
| Q3 2025 New Stake Value (Davenport) | $3,631,000 | DAVENPORT & Co LLC |
| Consensus Analyst Price Target (Average) | $3.33 | Twelve-month forecast |
| Analyst Consensus Rating | Moderate Buy | Based on 5 analysts |
You can see institutional buying was strong in Q3 2025, with BlackRock, Inc. adding 891,844 shares, representing a 1160.4% increase in their position for that quarter. Still, the company's cash position as of June 30, 2025, was approximately $11.6 million, supplemented by $41.9 million in remaining NIA grant funds.
Cognition Therapeutics, Inc. (CGTX) - Canvas Business Model: Cost Structure
You're looking at the core expenses for Cognition Therapeutics, Inc. (CGTX) as they push zervimesine through later-stage development. For a clinical-stage biotech, the cost structure is heavily weighted toward the science, not selling products-that's the reality of this business phase.
The primary driver for Cognition Therapeutics, Inc. (CGTX) cost structure is Research and Development (R&D) expenses. This reflects the ongoing investment in clinical trials and preclinical work for their pipeline, especially zervimesine (CT1812).
Here's a quick look at the key operating expenses reported for the third quarter ended September 30, 2025:
| Expense Category | Q3 2025 Amount (in millions) | Q3 2024 Amount (in millions) |
| Research and Development (R&D) | $3.8 | $11.4 |
| General and Administrative (G&A) | $2.6 | $3.1 |
| Total Operating Expenses | $6.38 | $14.46 |
R&D expenses were reported at $3.8 million for Q3 2025. This figure represented a significant year-over-year decrease from $11.4 million in Q3 2024, driven by the completion of the SHINE and SHIMMER clinical trials and associated professional fees.
General and Administrative (G&A) expenses were $2.6 million for Q3 2025. That was down from $3.1 million in the comparable period of 2024, primarily due to lower stock-based compensation expenses.
Beyond the reported operating expenses, the cost structure necessarily includes other significant, though perhaps less granularly detailed in every release, expenditures essential for a company advancing drug candidates:
- Costs for manufacturing drug supply for clinical trials, ensuring sufficient quantities of zervimesine are available for ongoing and planned studies, including the registrational path programs.
- Regulatory compliance costs, which cover filings, interactions with the U.S. FDA, and adherence to global health authority requirements.
- Intellectual property maintenance costs, which are critical for securing and defending the patents around their novel small molecule therapeutics.
The net loss for the quarter ended September 30, 2025, was $4.9 million, or $(0.06) per basic and diluted share. This loss was significantly narrower than the net loss of $9.9 million, or $(0.25) per share, for Q3 2024, reflecting the lower operating expenses as major trials concluded.
Finance: draft 13-week cash view by Friday.
Cognition Therapeutics, Inc. (CGTX) - Canvas Business Model: Revenue Streams
You're hiring before product-market fit, which means Cognition Therapeutics, Inc.'s revenue streams are entirely non-commercial right now. The business model relies heavily on non-dilutive government funding and dilutive equity raises to keep the lights on while advancing zervimesine (CT1812) through clinical trials. Honestly, this is standard for a clinical-stage biotech, but you need to track the cash burn against these inflows.
The primary, non-dilutive source of operational support comes from the National Institute on Aging (NIA), a division of the National Institutes of Health (NIH). This grant income directly offsets operating expenses, though the draw-down rate can fluctuate.
- Grant income recognized from the National Institute on Aging (NIA/NIH) for the third quarter ended September 30, 2025, was $1.2 million.
- As of September 30, 2025, the total obligated grant funds remaining from the NIA/NIH stood at $36.3 million.
To bridge the gap between grant receipts and the high costs of late-stage clinical development, Cognition Therapeutics, Inc. turned to equity financing. They successfully executed a significant capital raise in the third quarter of 2025.
Here's the quick math on that equity event:
| Financing Event Detail | Amount/Value |
| Gross Proceeds from Registered Direct Offering | Approximately $30 million |
| Shares Sold | 14,700,000 shares of common stock |
| Purchase Price Per Share | $2.05 |
| Closing Date | September 2, 2025 |
This $30 million registered direct offering, which closed in September 2025, was crucial; it extended the company's estimated cash runway into the second quarter of 2027.
The third component of the revenue stream structure involves external partnerships, though these are prospective rather than realized income streams as of late 2025. Cognition Therapeutics, Inc. is actively evaluating options to support the development of zervimesine through strategic collaborations.
- Potential future milestone payments from strategic pharmaceutical licensing deals remain a key component of the long-term financial plan.
- The company is executing studies to support registrational programs, which are expected to be valuable to potential partners.
It is critical to note the current commercial status. Cognition Therapeutics, Inc. is a clinical-stage company; therefore, there is no current commercial product revenue.
- No top-line sales contribution is recognized; the model remains dependent on grants and capital markets.
Disclaimer
All information, articles, and product details provided on this website are for general informational and educational purposes only. We do not claim any ownership over, nor do we intend to infringe upon, any trademarks, copyrights, logos, brand names, or other intellectual property mentioned or depicted on this site. Such intellectual property remains the property of its respective owners, and any references here are made solely for identification or informational purposes, without implying any affiliation, endorsement, or partnership.
We make no representations or warranties, express or implied, regarding the accuracy, completeness, or suitability of any content or products presented. Nothing on this website should be construed as legal, tax, investment, financial, medical, or other professional advice. In addition, no part of this site—including articles or product references—constitutes a solicitation, recommendation, endorsement, advertisement, or offer to buy or sell any securities, franchises, or other financial instruments, particularly in jurisdictions where such activity would be unlawful.
All content is of a general nature and may not address the specific circumstances of any individual or entity. It is not a substitute for professional advice or services. Any actions you take based on the information provided here are strictly at your own risk. You accept full responsibility for any decisions or outcomes arising from your use of this website and agree to release us from any liability in connection with your use of, or reliance upon, the content or products found herein.