Cingulate Inc.
CING evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for CING—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · CING
Cingulate Inc. is a clinical-stage biopharmaceutical company developing CTx-1301, a once-daily, multi-dose tablet for ADHD using its proprietary Precision Timed Release (PTR) platform, with a Phase 3 topline readout expected in early 2027.
Key risk: Clinical trial failure
BioSniper Score
Based on 3 of 6 signals
Limited data coverage
Financial data as of Jun 30, 2026.
Tracking 2 clinical trials · 1 catalyst for Cingulate Inc..
Cingulate Inc. is a clinical-stage biopharmaceutical company developing CTx-1301, a once-daily, multi-dose tablet for ADHD using its proprietary Precision Timed Release (PTR) platform, with a Phase 3 topline readout expected in early 2027.
- Lead candidate CTx-1301 is a once-daily, multi-dose ADHD tablet using the proprietary PTR platform with an Erosion Barrier Layer for timed drug release [sec_mda · as of 2026-08-13].
- Cash and cash equivalents were $28.4 million as of June 30, 2026, expected to fund operations into mid-2027, including CMC work and regulatory activities for CTx-1301 [sec_mda · as of 2026-08-13].
- Net loss for the quarter ended June 30, 2026 was $5.9 million; shareholders' equity was $2.5 million and total debt was $5.1 million as of that date [sec].
- A Phase 3 topline data readout for CTx-1301 in attention-deficit/hyperactivity disorder is expected on February 1, 2027 [catalyst].
What works
- The PTR platform's Erosion Barrier Layer may enable true once-daily, multi-dose tablets with a potentially superior side effect profile, addressing an unmet need in ADHD treatment [sec_mda · as of 2026-08-13].
- Cash runway into mid-2027 covers completion of requested CMC work and regulatory submission for CTx-1301, reducing near-term financing risk for the lead program [sec_mda · as of 2026-08-13].
- The company has already submitted an NDA for CTx-1301 (September 2025), triggering a milestone payment, indicating progress toward potential approval [sec_mda · as of 2025-11-13].
What to weigh
- Cingulate has a history of operating losses and expects to continue incurring substantial losses as it develops CTx-1301 and prepares for potential commercialization [sec_mda · as of 2025-11-13].
- The company will need additional capital to advance programs beyond CTx-1301, and its ability to generate revenue depends entirely on successful development, regulatory approval, and commercialization of its product candidates [sec_mda · as of 2026-08-13].
- Manufacturing costs for CTx-1301 process validation batches are estimated at approximately $7.0 million, representing a significant cash outlay for a single program [sec_mda · as of 2025-11-13].
From the filings
Quoted directly from source documents.
Cash runway into mid-2027
“As of June 30, 2026, we had cash and cash equivalents of $28.4 million, which we believe will be sufficient to fund our operations into mid 2027, including costs associated with completing the requested CMC work and seeking regulatory approval for CTx-1301 and the build-out of internal and external support for the commercial launch of CTx-1301, if approved.”
SEC MD&A · August 13, 2026
PTR platform mechanism
“Our PTR platform incorporates a proprietary Erosion Barrier Layer designed to allow for the release of drug substance at specific, pre-defined time intervals, unlocking the potential for once-daily, multi-dose tablets.”
SEC MD&A · August 13, 2026
NDA submission milestone
“The second milestone payment of $250,000 was paid in September 2025 upon submission of the NDA.”
SEC MD&A · November 13, 2025
Manufacturing cost estimate
“We entered into agreements with Societal, our CMO, for both the manufacturing of process validation batches of our lead asset, CTx-1301, including active pharmaceutical ingredients and materials. with a total estimated cost of approximately $7.0 million.”
SEC MD&A · November 13, 2025
Catalyst timeline
- 2027-02-01 · Phase3_Topline · attention-deficit — Phase 3 Topline: A Phase 3, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled, Parallel Efficacy and Safety Study of CTx-1301 in Adult Subjects with Attention-Deficit/Hyperactivity Disorder — Topline efficacy and safety data from the pivotal Phase 3 trial will determine whether CTx-1301 meets its primary endpoints and supports regulatory filing.
Risks & what to watch (4)›
Key risks
- Clinical trial failure — Phase 3 topline results for CTx-1301 are expected in early 2027; negative or mixed data could impair the program's viability [catalyst].
- Regulatory approval uncertainty — Even with NDA submission, FDA approval is not guaranteed; the company has no approved products and no revenue [sec_mda · as of 2026-08-13].
- Cash runway dependency — Cash of $28.4M as of June 30, 2026 funds only into mid-2027; failure to secure additional capital could halt operations [sec_mda · as of 2026-08-13].
- Single product focus — All resources are concentrated on CTx-1301; any setback for this candidate would severely impact the company [sec_mda · as of 2026-08-13].
What to watch
- Phase 3 topline data for CTx-1301 expected February 1, 2027 [catalyst].
- FDA regulatory decision on CTx-1301 NDA; timing not yet specified [sec_mda · as of 2025-11-13].
- Cash burn rate and any new financing or partnership deals to extend runway beyond mid-2027 [sec_mda · as of 2026-08-13].
- Progress on CMC process validation batches and commercial manufacturing scale-up [sec_mda · as of 2026-08-13].
Sources: SEC MD&A · Generated August 28, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 3 of 6 signals · derived from public data
No clinical pipeline tracked — this score reflects financial & catalyst signals only.
14.7 months
D/E 0.41 · 0% dilution
No tracked pipeline phase
No tracked pipeline candidates
1 upcoming, next in ~155d
No insider transactions in the last 180 days
Runway
Catalysts
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
23
Total value held
$7.6M
| Holder | Shares | Value |
|---|---|---|
| vanguard capital management llc | 617,934 | $3.8M |
| geode capital management, llc | 101,373 | $630K |
| marshall wace, llp | 92,934 | $577K |
| jane street group, llc | 90,867 | $564K |
| xtx topco ltd | 53,503 | $332K |
| bcv asset management inc. | 51,200 | $318K |
| vanguard fiduciary trust co | 50,074 | $311K |
| renaissance technologies llc | 31,888 | $198K |
| state street corp | 27,588 | $171K |
| blackrock, inc. | 23,269 | $145K |
Showing top 10 of 23 institutional holders of Cingulate Inc.. Open the full 13F history after sign-in.
Short Interest
as of May 20, 2026- % of float
- 14.9%
- Days to cover
- 3.3
- Shares short
- 1,495,654
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
CING short interestGovernance
Frequently asked questions
What is the AI investment thesis for Cingulate Inc.?
Cingulate Inc. is a clinical-stage biopharmaceutical company developing CTx-1301, a once-daily, multi-dose tablet for ADHD using its proprietary Precision Timed Release (PTR) platform, with a Phase 3 topline readout expected in early 2027.
What is Cingulate Inc.'s next catalyst?
Cingulate Inc.'s next tracked catalyst is a Phase3_Topline event — "Phase 3 Topline: A Phase 3, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled, Parallel Efficacy and Safet" — expected February 1, 2027.
Who is the CEO of Cingulate Inc.?
Dr. Shane J. Schaffer Pharm.D. is the chief executive officer of Cingulate Inc. (CING).
Where is Cingulate Inc. headquartered?
Cingulate Inc. (CING) is headquartered in Kansas City, KS, United States.
What therapeutic areas does Cingulate Inc. focus on?
Cingulate Inc. develops therapies across Oncology, Neurology.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.