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CGTX

Cognition Therapeutics, Inc.

CGTX Nasdaq Biological Products, (No Diagnostic Substances) EDGAR ↗
$0.95
+0.02 +1.75%

Key statistics

from XBRL data in SEC filings
Market cap ⓘ
$90.8M
Revenue (TTM) ⓘ
—
Net income (TTM) ⓘ
-$16.8M
EPS (TTM) ⓘ
$-0.16
P/E ratio ⓘ
—
Dividend yield ⓘ
—
Free cash flow ⓘ
-$24.6M
Cash ⓘ
$34.0M
Total assets ⓘ
$38.9M
Gross margin ⓘ
—
52-week range ⓘ
$0.55 – $2.05

AI briefing

from the latest 10-K, 10-Q and 8-K events

Cognition Therapeutics is a clinical-stage biopharmaceutical company developing zervimesine (CT1812), an oral small molecule for age-related degenerative diseases of the CNS, with no approved products.

What they do

The company discovers and develops small molecule therapeutics targeting age-related degenerative diseases of the central nervous system and retina. Its lead candidate, zervimesine (also known as CT1812), is an orally delivered small molecule designed to protect neuronal synapses by preventing binding of oligomers of pathogenic proteins including beta-amyloid and alpha-synuclein. The company has conducted Phase 2 trials in mild-to-moderate Alzheimer's disease (SHINE), dementia with Lewy bodies (SHIMMER), and geographic atrophy secondary to dry AMD (MAGNIFY).

Revenue drivers

  • Grant funding (NIA/NIH) — The company has no product revenue; clinical trials have been funded by approximately $171 million in cumulative grants, primarily from the National Institute on Aging, with $21.6 million of obligated grant funds remaining as of June 30, 2026.
  • Zervimesine in Alzheimer's disease — Lead program. Phase 2 SHINE enrolled 153 adults with mild-to-moderate AD and met safety/tolerability endpoints; Phase 2 START enrolled 545 patients with MCI and early-stage AD, funded by a grant of approximately $81 million.
  • Zervimesine in dementia with Lewy bodies (DLB) — Phase 2 SHIMMER enrolled 130 adults with DLB and met its primary safety/tolerability endpoint; the company plans to advance zervimesine into a late-stage trial in DLB psychosis. SHIMMER was funded by an approximately $29.5 million NIA grant.
  • Expanded access program (DLB) — Open-label COG1202 EAP provides 100 mg daily oral zervimesine for approximately two years to eligible participants; extended through 2027 with funding from a second philanthropic donor. No commercial revenue.

Recent performance

For the second quarter ended June 30, 2026, Cognition reported a net loss of $3.9 million, or $(0.04) per basic and diluted share, compared to a net loss of $6.7 million, or $(0.11) per share, in the same period of 2025. Research and development expenses were $5.1 million versus $11.5 million in the prior-year quarter, driven by lower trial activities with contract research organizations, compensation and professional fees. General and administrative expenses were $2.6 million versus $2.5 million, primarily on higher professional fees. Cash, cash equivalents and restricted cash equivalents were approximately $34.8 million as of June 30, 2026, with total obligated remaining NIA grant funds of $21.6 million.

Strategy

Based on FDA feedback, the company plans to develop zervimesine for DLB psychosis, with a pivotal study randomizing participants to 100 mg once-daily oral zervimesine or placebo for nine months and plans to initiate the Phase 3 study in mid-2027 with an improved tablet composition. For Alzheimer's disease, the FDA concurred with a proposed Phase 3 design of 100 mg daily for at least six months, enriched for patients with lower plasma p-tau217; the company is reviewing EMA scientific advice indicating a preference for a longer trial. The company is also conducting the Phase 2 START study in MCI and early AD, with topline results expected after all participants complete 18 months of treatment. A Notice of Allowance was received for a composition-of-matter patent covering a polymorphic crystalline form of zervimesine, which once issued would extend protection through 2045 before patent-term extension.

Risks

  • No approved products; history of losses — The company has no products approved for commercial sale and has incurred significant net losses since inception in 2007, with an accumulated deficit of $198.6 million as of December 31, 2025 and net losses of $23.5 million (2025) and $34.0 million (2024).
  • Clinical and regulatory uncertainty — Zervimesine's Phase 3 programs in AD and DLB psychosis are not yet initiated, and the company still needs to align with the FDA on DLB psychosis endpoints before timing can be provided.
  • Cash runway and grant dependence — The company estimates cash funds operations into the fourth quarter of 2027, and clinical trials depend heavily on NIA grants, with $21.6 million of obligated grant funds remaining as of June 30, 2026.
  • Reliance on external networks and collaborators — The START trial is conducted with the Alzheimer's Clinical Trial Consortium (ACTC), and the company relies on contract research organizations for trial execution.

Outlook

Management plans to initiate the Phase 3 study in DLB psychosis in mid-2027 with an improved tablet composition, and will provide a timing update after alignment with the FDA on endpoints. Topline results from the Phase 2 START study in MCI and early AD are expected after all participants complete 18 months of treatment. The company estimates it has sufficient cash to fund operations and capital expenditures into the fourth quarter of 2027. The expanded access program in DLB has been extended through 2027 with funding from a second philanthropic donor.

Recent SEC filings

40 most recent
Annual, quarterly & current reports