Numinus Wellness Inc. Submits New Drug Application for PTSD Treatment with MDMA

2024-01-17

Numinus Wellness Inc., a leading company in the field of psychedelic-assisted therapy, held its Q1 2024 Earnings Call Transcript on January 15, 2024. The conference call was attended by Craig MacPhail (IR), Payton Nyquvest (Founder & CEO), Nikhil Handa (CFO), Reid Robinson (Chief Clinical Officer), and Paul Thielking (Chief Science Officer).

During the call, the Q1 2024 earnings results for Numinus Wellness Inc. were discussed. The company exceeded expectations with an EPS of -$0.01, while the revenue for the quarter fell short of expectations by $396.45K, amounting to $4.43M.

A significant highlight of the call was the announcement that MAP, a subsidiary of Numinus, had submitted a new drug application to the FDA for the treatment of PTSD with MDMA. The Phase III trial for this treatment demonstrated promising results, with over 70% of participants no longer meeting the criteria for PTSD after undergoing three dosing sessions with therapy.

In terms of financials, Numinus reported operating expenses of $6.3 million for the quarter, representing a decrease from the previous quarter. The company's net loss also narrowed to $4.4 million or $0.02 per share, compared to the prior quarter and the same period last year.

Numinus is strategically positioned to benefit from the advanced stages of drug development and the increasing demand for comprehensive clinical research on psychedelic compounds. As these drugs gain approval, they will need to be administered and monitored in treatment clinics following FDA-approved methodologies. This is expected to create a significant demand for trained psychedelic therapy practitioners.

The Numinus network has experienced a substantial increase in interest, particularly with the progress of MAPS' approval process. The network has a wealth of experience and expertise in serving as clinical trial sites for various studies and providing treatments in real-world settings through Canada's special access program. The network's primary focus is on delivering exceptional patient care and ensuring a positive client experience, with a balance between full-time and part-time practitioners.

To ensure safety and efficacy in therapy, Numinus has implemented a training pathway to prepare practitioners for the upcoming clinical setting. The company is committed to providing the best learning experience and instilling confidence in practitioners. Additionally, they offer support to practitioners who aspire to establish their own clinics or are currently in clinical settings that lack the necessary infrastructure for delivering MDMA-assisted therapy.

Looking ahead, Numinus has promising opportunities in both MDMA and psilocybin-assisted therapy. The company has already treated individuals with psilocybin-assisted therapy through the special access program and has served as a clinical trial site for drug developers like Compass. Numinus is focused on commercialization and has established the infrastructure required for conducting clinical trials.

In conclusion, Numinus Wellness Inc. is making significant strides in the field of psychedelic-assisted therapy. With promising results from clinical trials and a strong emphasis on training and patient care, the company is well positioned to capitalize on the growing demand for these innovative treatments.