Full Press Release Details
Inc. Reports First Quarter 2023 Financial Results and Provides Clinical and Business Update
$3 Million of Financing
PTR Manufacturing Processes Successfully Transferred to Societal CDMO
Commercialization Agreement for Lead ADHD Candidate CTx-1301
CITY, Kan., May 10, 2023 (GLOBE NEWSWIRE) - Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary
Precision Timed Release (PTR ) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical
products, today provided financial results for the three months ended March 31, 2023, as well as a clinical and business update. Among
other highlights, the Company announced it has obtained an additional $3 million of debt financing, successfully completed the transfer
of its proprietary PTR manufacturing processes to Societal CDMO, Inc. (Societal) and entered into a joint commercialization agreement
with Indegene to provide commercial support for CTx-1301 upon approval from the U.S. Food and Drug Administration (FDA).
are excited to have reached several important milestones," said Cingulate Chairman & CEO Shane J. Schaffer. "Cingulate
has now answered the question as to how it will commercialize CTx-1301 by entering into a joint commercialization agreement with Indegene
that substantially reduces the risks and expenses associated with traditional commercialization, and earlier this month, we announced
the successful transfer of Cingulate's proprietary PTR manufacturing processes to Societal CDMO in Gainesville, Georgia, keeping
our Phase 3 timelines on schedule."
Schaffer continued, "we are pleased to announce that we've received additional non-dilutive financing from long-standing
Cingulate investor and board member Peter J. Werth. Capital will always be critical to Cingulate's long-term success, and as we
look forward to multiple Phase 3 milestones later this summer, we thank Peter for this additional financing and his steadfast support
for Cingulate's pipeline, vision, and overall mission."
Family Investment Associates Provides $3 Million of Debt Financing
received an additional $3.0 million of debt financing from Werth Family Investment Associates LLC (WFIA). The $5.0 million promissory
note, dated August 9, 2022, in favor of WFIA was amended and restated to increase the principal amount to $8.0 million with no changes
to the other terms of the note. The note is unsecured with interest accruing at 15% per annum. Outstanding principal and all accrued
and unpaid interest is due and payable on August 8, 2025 unless accelerated due to an event of default, and WFIA has the right during
the first five business days of each calendar quarter to demand payment of all outstanding principal and interest 120 days following
notice to Cingulate. WFIA owns 975,165 shares of our common stock and Peter J. Werth, a member of the Company's Board of Directors
and the manager of WFIA, owns 21,849 shares of our common stock.
Completes Transfer of Proprietary PTR Manufacturing Processes to Societal CDMO
April 2023, Cingulate successfully completed the transfer of its proprietary PTR manufacturing processes for its lead candidate,
CTx-1301 (dexmethylphenidate), to Societal, a contract development and manufacturing organization (CDMO) dedicated to solving complex
formulation and manufacturing challenges primarily in small molecule therapeutic development. Societal is producing a scalable supply
of CTx-1301 for Cingulate's ongoing and upcoming Phase 3 trials in the manufacturing suite within Societal's Gainesville,
Georgia facility that is outfitted with equipment supplied by Cingulate.
Indegene Announce Joint Commercialization Agreement for Lead ADHD Candidate CTx-1301
March 2023, Cingulate announced a joint commercialization agreement with Indegene, a comprehensive life sciences commercialization company,
to provide commercial support for Cingulate's lead candidate CTx-1301 (dexmethylphenidate), a novel, investigational treatment
being developed as a true, once-daily stimulant medication for attention deficit/hyperactivity disorder (ADHD).
agreement spans cross-functional services through an omnichannel marketing approach uniquely designed to successfully manage pre-commercial
support during Cingulate's Phase 3 clinical trials and to effectively commercialize CTx-1301 nationwide following potential FDA
initiated a Phase 3 adult dose-optimization study in December 2022 to assess onset and duration of efficacy and safety in adults with
ADHD, first cohort has been completed and the second cohort is near completion. Results are expected in the third quarter of 2023.
Phase 3 fixed-dose pediatric and adolescent safety and efficacy study is expected to commence in mid-2023; results are expected in the
first quarter of 2024.
addition, Cingulate is planning to initiate a Phase 3 pediatric and adolescent dose-optimization classroom study in the third quarter
of 2023 to assess onset and duration and efficacy and safety in patients with ADHD. Results are expected in the first quarter of 2024.
order to meet the pharmacology requirement for the CTx-1301 New Drug Application (NDA) submission, Cingulate completed a food effect
study in October of 2022, which demonstrated that CTx-1301 can be taken with or without food.
positive clinical results from the Phase 3 trials, Cingulate plans to submit the NDA for CTx-1301 in mid-2024 under the Section 505(b)(2)
entered into an At The Market Offering Agreement (ATM Agreement) with H.C. Wainwright & Co., LLC, as sales agent (Wainwright), in
January 2023, pursuant to which Cingulate may offer and sell, from time to time through Wainwright, shares of its common stock for aggregate
proceeds of up to $4.97 million (upon the terms and subject to the conditions and limitations set forth in the ATM Agreement).
April 2023, Cingulate entered into a purchase agreement with Lincoln Park Capital Fund LLC, pursuant to which Lincoln Park has agreed
to purchase up to an aggregate of $12.0 million of common stock (upon the terms and subject to the conditions and limitations set forth
in the purchase agreement) from time to time and at Cingulate's sole discretion over the 36-month term of the purchase agreement.
Cingulate issued 368,023 shares of common stock to Lincoln Park as consideration for their commitment to purchase its common
is also evaluating additional strategies to obtain funding which may include additional offerings of common stock, issuance of debt,
or other capital sources, including potential collaborations with other companies or other strategic transactions.
| Research & Development (R&D) Expenses: R&D expenses were $2.1 million for the three months ended March 31, 2023, compared to $2.8 million for the same period in 2022. This change was primarily a result of a decrease in manufacturing costs for CTx-1301 during the three month period ended March 31, 2023, as the three month period ended March 31, 2022 included the manufacturing of clinical supply for Phase 3 CTx-1301 clinical trials; whereas the manufacturing activity in the three months ended March 31, 2023 primarily included expenses related to the build out of our manufacturing suite at our CDMO. This decrease in manufacturing expense was slightly offset by an increase in clinical and regulatory costs as we initiated a Phase 3 clinical trial for CTx-1301 in the first quarter of 2023. | ||
| General and Administrative (G&A) Expenses: G&A expenses were $1.7 million for the three months ended March 31, 2023, compared to $2.2 million for the same period in 2022. This change was primarily the result of a decrease in legal and professional fees of $0.3 million and a decrease in insurance costs of $0.3 million. The decrease in professional fees was related to the timing of services performed for our annual audits and the decrease in insurance costs was related to a decline in the annual directors and officers insurance policy premium which was renewed in December of 2022. |
Inc. is a biopharmaceutical company utilizing its proprietary Precision Timed Release (PTR ) drug delivery platform technology
to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from
frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial
focus on the treatment of Attention Deficit/Hyperactivity Disorder (ADHD), Cingulate is identifying and evaluating additional therapeutic
areas where its PTR technology may be employed to develop future product candidates, such as anxiety disorders.
is headquartered in Kansas City, KS. For more information visit Cingulate.com.
press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than
statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including
statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical
studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities
and other statements that are predictive in nature. These statements are generally identified by the use of such words as "may,"
"could," "should," "would," "believe," "anticipate," "forecast,"
"estimate," "expect," "intend," "plan," "continue," "outlook,"
"will," "potential" and similar statements of a future or forward-looking nature. Readers are cautioned that
any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially
from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities
and Exchange Commission (SEC), including the "Risk Factors" section of our Annual Report on Form 10-K filed with the SEC
on March 10, 2023. All forward-looking statements speak only as of the date on which they are made, and we undertake no duty to update
or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required
| March 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Cash, cash equivalents and short-term investments | $ | 1,738,760 | $ | 5,356,276 | ||||
| Total assets | $ | 7,162,957 | $ | 11,405,057 | ||||
| Total liabilities | $ | 7,081,343 | $ | 7,523,035 | ||||
| Accumulated deficit | $ | (73,413,383 | ) | $ | (69,408,496 | ) | ||
| Total stockholders' equity | $ | 81,614 | $ | 3,882,022 |
Statements of Operations
| Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 2,128,616 | $ | 2,762,284 | ||||
| General and administrative | 1,721,379 | 2,247,060 | ||||||
| Operating loss | (3,849,995 | ) | (5,009,344 | ) | ||||
| Interest and other income (expense), net | (154,892 | ) | 5,833 | |||||
| Loss before income taxes | (4,004,887 | ) | (5,003,511 | ) | ||||
| Income tax benefit (expense) | - | - | ||||||
| Net loss | $ | (4,004,887 | ) | $ | (5,003,511 | ) | ||
| Net loss per share of common stock, basic and diluted | $ | (0.35 | ) | $ | (0.44 | ) |
Investor & Public Relations, Cingulate Inc.
Health Public Relations