Small Pharma Inc. announced a research and development strategy update, aimed at expediting its clinical program of SPL028, the Company's novel deuterated N, N-dimethyltryptamine compound with multi-layered intellectual property protection. SPL028 is currently dosing in an ongoing Phase I study in healthy volunteers. Preliminary findings from the first two cohorts demonstrate that intravenous SPL028 elicits a psychedelic experience of <1 hour and is well-tolerated.

SPL028 is based on the following target value proposition: · Distinct DMT-based therapeutic profile: An extended DMT psychedelic experience of up to ~1 hour may provide efficacy for more patients with depression, and for additional therapeutic indications, compared to native DMT. Additionally, the pharmacokinetic profile of SPL028 may enable optimized dose formulations for different administration routes. · Strong commercial proposition: An anticipated short in-clinic treatment (~<2.5hr dosing with therapy) offering a rapid and durable antidepressant response, as supported by the SPL026 Phase IIa data, enables the potential for a treatment that is delivered episodically on an "as required" basis, rather than via a fixed treatment regimen.

This may maximize convenience for both patients and physicians, as well as provide economic benefits for payers. · Robust IP protection: SPL028 has a multi-layered IP portfolio, including Composition of Matter protection in multiple jurisdictions, and protection surrounding related deuterated compounds. Development of the SPL028 program is informed by data from the Company's clinical trials of SPL026, Small Pharma's native DMT compound.

The Company showed clear proof-of-concept with SPL026 for the treatment of Major Depressive Disorder in a Phase IIa trial. This was the first placebo-controlled study to demonstrate the clinical efficacy of a DMT-based therapy, indicating a rapid and durable antidepressant response in many patients until at least six months. Further, the PK profiling of IV and intramuscular ("IM") SPL026 through the Phase I studies has been critical in informing dose selection for the active Phase I SPL028 study.

Topline data from the SPL028 Phase I healthy volunteer study is anticipated in Fourth Quarter 2023. The Company anticipates that the combined data from the SPL026 and SPL028 programs could enable an expedited path to initiating a multi-jurisdiction, multi-site Phase II study in 2024. Accordingly, the Company's protocol for the SPL028 Phase I program includes the option of initiating a Phase Ib patient study of injectable SPL028 in depression.

Determination of the optimal development route for SPL028, including the target depression patient population, will be reviewed following the conclusion of the ongoing Phase I studies.