CING (+25%)
Heavy Volume.
--->$1.85
BUT... They just sneaked in an earnings report... and I don't know about this:
Cash Position: As of December 31, 2022, Cingulate had $5.4 million in cash and cash equivalents, as compared to $16.5 million in cash and cash equivalents as of December 31, 2021. Based on the Company’s current operating plan, Cingulate expects its cash and cash equivalents will enable the Company to fund its research and development and general and administrative expenditures into the second quarter of 2023. In January 2023, Cingulate entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC, as sales agent (“Wainwright”), pursuant to which we may offer and sell, from time to time through Wainwright, shares of our common stock for aggregate proceeds of up to $2.65 million. To date, Cingulate has not made any sales under the ATM Agreement. In addition, Cingulate is evaluating other alternatives to raise additional capital, including equity and debt financing.
Ok this is officially scary. I've been noticing an unusual amount of Biotechs saying we don't have our cash there..
Case in point>
Case in point #2 apparently
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But this sounds good:
“With the first of two CTx-1301 Phase 3 studies underway and the second planned to begin mid-2023, we’ve made significant progress towards bringing the first true, once-daily stimulant to market that addresses all major unmet needs in ADHD.”
Phase 3 Adult Dose-Optimization Trial on Track for Q3 2023 Results
The Phase 3 CTx-1301-022 (NCT05631626) trial is evaluating the efficacy and safety of CTx-1301 in adults with ADHD in an laboratory classroom setting, which has been used extensively to evaluate the efficacy of ADHD medications. Following initiation in December, the dose optimization phase for the first cohort has commenced.
The trial is being led by Ann C. Childress, MD, practicing psychiatrist and president of the American Professional Society for ADHD and Related Disorders (APSARD). Dr. Childress has conducted over 180 clinical studies and is considered a preeminent global ADHD expert.
“While we have many approved stimulant medications at our disposal as clinicians, my long-standing desire in over 20-years of clinical practice is to utilize a product that provides entire active-day efficacy, providing a quick onset of action and a duration into the early evening. Afternoon booster doses are our current work-around, but these lead to issues with adherence, optimal efficacy, and the potential for abuse and diversion, and may be accompanied with unwanted side effects. Having a product like CTx-1301 would be beneficial to patients and providers, as it is designed to avoid booster doses and address the long-standing unmet needs facing our patients with ADHD,” said Dr. Childress.
Clinical Update
CTx-1301: Cingulate advanced its clinical program for CTx-1301 on the streamlined approval pathway under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. As part of that effort:
Cingulate initiated a CTx-1301 Phase 3 adult dose-optimization study in December 2022 to assess onset and duration of efficacy and safety in adults with ADHD, dose optimization of the first cohort has commenced and results are expected in the third quarter of 2023.
In addition, the CTx-1301 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.
In 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 our without food.
Assuming positive clinical results from the Phase 3 trials, Cingulate plans to submit the NDA for CTx-1301 in the first half of 2024 under the Section 505(b)(2) pathway.
CTx-2103: Cingulate is constructing a clinical program for CTx-2103 on the streamlined approval pathway under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. Based on the pharmacokinetic profile seen in the formulation study which was completed in September 2022, CTx-2103 achieved the desired triple release of buspirone. These positive results provided the critical information required to allow the Company to request a Pre-IND meeting with the FDA to discuss the design of the Company’s clinical and regulatory programs for CTx-2103, which is expected to allow for a potential IND filing in the fourth quarter of 2023.
CTx-1302: A Phase 1/2 bioavailability study in ADHD patients for CTx-1302 (dextroamphetamine), Cingulate’s second asset for the treatment of ADHD, is planned for mid-2024. If results from this study are successful, pivotal Phase 3 clinical trials in all patient segments for CTx-1302 are expected to begin in late 2024 or early 2025.
