Small Pharma's Q1 2024: Revamping Strategy And Potential Fast-Tracked Clinical Trial

UK’s short-acting psychedelics developer Small Pharma DMTTF published its financial results for the fiscal first quarter ended May 31, 2023:

• Cash on hand as of May 31 was approx. $9.9 (CA$13.2) million, an almost 30% quarterly outflow as compared to the $14 million held on Feb. 28, 2023.

• Cash used in operating activities was $4.3 million for the three months ended May 31, 2023 as compared to the $4.8 million used in the same period in 2022. 

• Quarterly operating expenses totaled $4.3 million as compared to $4.4 million during the same period in 2022.

• R&D expenses for the quarter amounted to $1.9 million vs. $1.6 million in the same period in 2022.

• Net loss for the period was $4.3 million, a mild recovery from the prior year’s same period of $4.4 million. Yet in the context of a spike in accumulated deficit: March 1, 2023 showed $41.3 million, a 72.8% increase from the $23.9 million accumulated deficit in March 1, 2022.  

The company has stated it expects its recently-applied operational restructuring will reduce upcoming quarters’ cash burn and allow for a runway extension until at least the fourth quarter of 2024.

Biz And R&D Recap

• DMT asset SPL026 is undergoing several clinical trials, including an ongoing Phase 1b IV drug interaction (SSRIs) study on patients with Major Depressive Disorder (MDD); a completed Phase 1 IV/intramuscular (IM) study showing the latter as a viable administration route for SPL026.

• Proprietary deuterated DMT compound SPL028 is currently dosing in an ongoing Phase 1 IV/IM study, of which topline data is expected in Q4 2023. The novel psychedelic holds a multi-layered IP portfolio, covering composition of matter in several countries.

• Small Pharma anticipates that combined data from SPL026 and SPL028 programs could enable an expedited path for a multi-site Phase 2 study for SPL028 in 2024. Due to this, the SPL028 Phase 1 program’s protocol includes the option of initiating a Phase 1b patient study on the efficacy and safety of injectable SPL028 in depression.

• The IP portfolio has overall grown significantly, with 26 patents granted and 95 applications pending across four key areas of patent protection. 

• Aimed at expanding patient access to DMT-based treatments, the “almost complete” exploratory SPL026 and SPL028 Phase 1 studies would enable the company to better decide on the development path for both clinical programs, stated CEO George Tziras. 

• The team is “very pleased” with the IV/IM study results showing IM’s potential as a “convenient alternative” administration route with a “favorable” safety profile, Tziras says.

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• Lucy Scientific LSDI trades at $1.08, a daily 1.89% increase.

• Photo: Benzinga edit with photo by Zita and canadastock on Shutterstock.