10-Q · May 14, 2026
Cingulate's Q1 2026 results reflect a worsening net loss of $9.3 million compared to $3.9 million in Q1 2025, with no revenue reported. Operating expenses have surged significantly, particularly in general and…
Earnings analysis · 10-Q
Filed August 13, 2026 · Our reading of the company's report
The latest report
The supplied 10-Q excerpt does not disclose revenue, gross or operating margin, EPS, cash flow, balance-sheet amounts, or segment results, so quarterly operating trends cannot be quantified. Regulatory and manufacturing…
The supplied 10-Q excerpt does not disclose revenue, gross or operating margin, EPS, cash flow, balance-sheet amounts, or segment results, so quarterly operating trends cannot be quantified. Regulatory and manufacturing risks intensified after the June 2026 CRL for CTx-1301 and the February 2026 Form 483 containing 3 observations at the CDMO facility. Equity-for-debt issuances included 215,225 shares through July 7, 2026 and another 71,827 shares on August 10, 2026, indicating continued reliance on financing and dilution.
Our analysis across the last few reports.
Our model's reading of each filing, not the share price or the market's reaction. Annual and quarterly reports each occupy one position.
Management concluded that disclosure controls were effective as of June 30, 2026, and reported no changes during the quarter that materially affected internal control over financial reporting.
From May 11 through July 7, 2026, the company issued 215,225 shares to lenders in exchange for portions of debt, including 38,343 shares at $5.22, 55,928 at $4.47, and 53,030 at $3.96.
The company issued an additional 71,827 shares at $5.01 to a lender on August 10, 2026, after quarter-end, further reducing debt through equity settlement.
Cingulate received an FDA Complete Response Letter in June 2026 for its CTx-1301 NDA, citing CMC information requests and other non-clinical issues. The company stated that it plans to resubmit, but approval may be delayed, limited, or not obtained.
The FDA conducted a pre-approval inspection of the CTx-1301 CDMO facility in February 2026 and issued a Form 483 containing 3 observations—2 facility-related and 1 specific to CTx-1301. A future re-inspection could identify additional deficiencies.
All stages of the company's manufacturing process are currently completed by a single CDMO, and the filing states that Cingulate has no qualified alternative sources. Transferring production could require significant time and expense and create additional regulatory risk.
The supplied 10-Q excerpt does not provide quantitative revenue, EPS, operating cash flow, or other financial guidance. No segment or income-statement data was included.
Cingulate's Q1 2026 results reflect a worsening net loss of $9.3 million compared to $3.9 million in Q1 2025, with no revenue reported. Operating expenses have surged significantly, particularly in general and…
Cingulate is a clinical-stage biopharmaceutical company focused on its PTR timed‑release platform with lead ADHD candidate CTx-1301 (NDA submitted July 31, 2025 and accepted Sept 29, 2025). The filing reiterates a May…
Cingulate reported a Q3 2025 net loss of $(7,341,062) (EPS $(1.35)), compared with $(4,125,643) (EPS $(2.34)) in Q3 2024 and an EPS deterioration vs. the prior quarter (Q2 2025 EPS $(1.09) to $(1.35)). Cash declined to…
Cingulate remains a pre-revenue biopharma with no reported revenue and a Q2 2025 net loss of $4,788,735 (vs. $3,209,677 in Q2 2024). Cash declined to $8,900,183 as of June 30, 2025 and management states there is…
This is our reading of a public filing, not the filing itself. Analysis can contain errors; check the source document for full context.