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Cingulate Inc., a pre‑revenue biopharmaceutical company focused on ADHD and anxiety therapies, reported a net loss of $5.9 million for the quarter and $15.2 million for the six months ended June 30 2026, larger than the prior‑year periods. Operating cash outflow was $12.8 million in the first half.
Cash and cash equivalents increased to $28.4 million from $11.0 million at year‑end 2025, driven by a $12.0 million private placement, at‑the‑market issuances and equity sales under a Lincoln Park purchase agreement. Total liabilities fell to $9.6 million, primarily as a prior Streeterville note was extinguished and the Avondale note was partially repaid or exchanged into equity.
The FDA issued a Complete Response Letter for lead ADHD candidate CTx‑1301, requesting additional CMC information but not raising clinical safety or efficacy concerns. Management is working with its CDMO to support NDA resubmission. The company discloses substantial doubt about its ability to continue as a going concern despite current liquidity, and expects to seek additional capital. A new U.S. patent issued in June 2026 protects CTx‑1301 through December 2042.
Cingulate Inc. reported second quarter 2026 results and detailed progress on its lead ADHD candidate CTx-1301 and commercialization plans. Cash and cash equivalents were $28.4 million as of June 30 2026, up from $11.0 million at year-end 2025, driven by a $12.0 million private placement and $19.0 million raised via an at-the-market program and a purchase agreement, partially offset by $12.8 million of operating cash use. Working capital rose to $21.6 million, and the company believes this cash will fund operations into mid-2027.
R&D expenses fell to $1.5 million for the quarter, down 44.9% year over year, while SG&A expenses increased to $3.9 million, up 101.5%, reflecting commercial readiness investments. Net loss was $5.9 million for the quarter and $15.2 million for the first half of 2026. Total stockholders’ equity increased to $23.5 million.
Regulatory efforts continue after an FDA Complete Response Letter on June 1 2026 requesting additional CMC information for the CTx-1301 NDA, with no new clinical safety or efficacy concerns cited. Cingulate plans to resubmit the NDA as promptly as practicable, has secured a new U.S. patent protecting CTx-1301 through December 2042, and expanded launch infrastructure through agreements with Prasco, Indegene, and IQVIA.
Cingulate Inc. announced a leadership and organizational change. On July 17, 2026, the Board of Directors determined to eliminate the position of Chief Legal Officer. As a result, Nilay Patel will no longer serve as an officer of the company, effective August 3, 2026, defined as the Separation Date.
His termination will be treated as a termination without cause under his existing employment agreement with the company. Cingulate stated that it does not intend to hire a replacement for the Chief Legal Officer role, indicating that the responsibilities will be addressed without reinstating this executive position.
Cingulate Inc. reported that Chief Executive Officer and director Shane J. Schaffer received two grants of stock options on July 16, 2026. One grant covers 197,650 options and a second covers 97,350 options, each exercisable for common stock at an exercise price of $4.43 per share and expiring on July 16, 2036. The options vest 25% on March 31, 2027, with the remainder vesting in substantially equal monthly installments over the following 36 months. For the 97,350-option grant, even vested options only become exercisable if Cingulate’s NDA for CTx-1301 is approved by the FDA during 2027; if that NDA is not approved during 2027, this option grant, including any vested portion, terminates.
Cingulate Inc. reported that director Lawrence Bryan Jay received a grant of 20,000 Stock Options on 2026-07-16. The options cover 20,000 shares of Common Stock at an exercise price of $4.43 per share, expire on 2036-07-16, and vest on the earlier of the one-year anniversary of grant or the 2027 annual meeting of stockholders. Following this award, Jay holds 20,000 derivative securities directly.
Cingulate Inc. granted stock options to EVP and Chief Medical Officer Matthew Brams on July 16, 2026. He received options to purchase 53,600 and 26,400 shares of common stock at an exercise price of $4.43 per share, expiring on July 16, 2036.
Both option grants vest 25% on March 31, 2027, with the remainder vesting in substantially equal monthly installments over 36 months. The 26,400-share option becomes exercisable only if the issuer’s NDA for CTx-1301 is approved by the FDA during 2027, otherwise the entire option terminates.
Cingulate Inc. director Thomas Jeffrey Hargroves received a grant of 20,000 stock options for Common Stock at an exercise price of $4.43 per share. The options vest on the earlier of the one-year anniversary of the grant date and the date of Cingulate’s 2027 annual meeting of stockholders, and expire on 2036-07-16. Following this grant, he holds 20,000 stock options directly. The grant was not reported under a Rule 10b5-1 trading plan.
Cingulate EVP and CFO Jennifer L. Callahan received two grants totaling 60,000 stock options on July 16, 2026, each with an exercise price of $4.4300 per share and expiring July 16, 2036.
For both grants, 25% vests on March 31, 2027, with the remainder vesting in substantially equal monthly installments over the following 36 months. For 19,800 options, vested options become exercisable only if the NDA for CTx-1301 is approved by the FDA during 2027; if that approval is not obtained in 2027, this grant, including any vested portion, terminates.
Cingulate Inc. director Peter J. Werth received a grant of stock options for 20,000 shares of common stock on July 16, 2026. The options have an exercise price of $4.43 per share and expire on July 16, 2036. They vest on the earlier of the one-year anniversary of the grant date or the date of Cingulate Inc.'s 2027 annual meeting of stockholders, leaving Werth with 20,000 stock options held directly.
Cingulate Inc. EVP and CSO Raul R. Silva received two stock option grants on July 16, 2026. One covers 53,600 shares and the other 26,400 shares of common stock at an exercise price of $4.4300 per share, expiring July 16, 2036. Both vest 25% on March 31, 2027 and then in substantially equal monthly installments over 36 months. The second grant becomes exercisable only if the issuer’s NDA for CTx-1301 is approved by the FDA during 2027; otherwise that option, including any vested portion, terminates.