Small Pharma's Q2 2023 Financial Results, 'Ultra Short-Acting Psychedelic Program' Underway

Small Pharma Inc. DMTTF, a biotech company developing short-acting psychedelic-assisted therapies for diverse mental health disorders, reported its financial results for the three and six months ended August 31, 2022.

For the period numbers show:

• Total cash of $19.805.288, compared to $29.662.667 in February 28, 2022

• R&D expenses of $1.985.451 for the three months ended August 31, 2022 compared to $1.289.229 for the same period in 2021; and $3.522.154 for the six months ended August 31, 2022 compared to $1.639.778 for the same period in 2021.

• Net loss of $5.440.085 for the three months ended August 31, 2022 compared to $3.306.427 on the same period the prior year; and a $9.688.404 net loss for the six months ended August 31, 2022, compared to the $9.370.384 for the same period in 2021.

The company is progressing a pipeline of short-acting psychedelics currently focused on therapeutic approaches for depression, most noticeably its lead candidate SPL026, a synthetic formulation of DMT, while an additional pipeline of preclinical assets is under development as well. 

For the period ended August 31, 2022, the firm’s operational highlights involve two main initiatives: the ultra short-acting and the short-acting psychedelic programs.

Small Pharma’s clinical program of intravenous (IV) SPL026 with psychotherapy for the treatment of Major Depressive Disorder (MDD) was granted an “Innovation Passport” designation by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 

The Phase IIa clinical trial assessing SPL026 for MDD has completed its dosing stage with no drug-related serious adverse events reported to date. Patient follow-up is set for 12 weeks following the second dose, which will be completed by the end of 2022. 

The company is preparing the SPL026 Phase IIb international multi-site clinical trial following further discussions with the European Medicines Agency (EMA) and the FDA. Meanwhile, Phase Ib trial assessing SPL026 and Selective Serotonin Reuptake Inhibitors (SSRIs)’ drug interaction in MDD patients has begun after approval from the MHRA.

As for the second of the company’s initiatives, the short-acting psychedelic programs, the MHRA has approved the beginning of a Phase I clinical trial comparing the intramuscular (IM) and the intravenous (IV) modes of administration for SPL026. Additionally, Small Pharma has filed a clinical trial application to assess its second lead drug candidate SPL028, a deuterated form of DMT, in a Phase I study.

The company’s IP portfolio got 3 new patents and now has a total 11 with 72 patent applications pending. 

Photo courtesy of Chokniti-Studio and Gorodenkoff on Shutterstock.