Small Pharma Implements Cost-Cutting Strategy To Reduce Cash Burn As Trial Progresses

UK-based biotech firm Small Pharma Inc. DMTTF shared its financial outcomes for the fiscal year ended Feb. 28, plus pipeline updates. 

Highlights:

• Total cash of $13.9 (CA$18.5) million as of Feb. 28, 2023 compared to $30.6 million held on the same date in 2022.

• Yearly R&D expenses totaled $8.5 million as compared to $3.6 in the former fiscal year.

• Yearly net cash used in operating activities totaled $16.7 million compared to FY2022’s $12.2 million, with operating expenses totaling $18.6 million as compared to prior year’s $13.6 million.

• Net loss of $17.2 million (or $0.05 per share) for the twelve months ended Feb. 28, 2023 as compared to $16.7 (or $0.05 per share) in FY2022.

The company stated it has conducted a strategic review toward implementing operational efficiencies expected to generate material cost savings and reduce its “historical” annual cash burn. These changes will likely provide runway extension to at least the last quarter of 2024.

Focus On DMT: A Comprehensive Clinical Pipeline

Small Pharma’s two DMT-related compounds have shown a multilayered progress throughout the year.

DMT fumarate SPL026’s program includes a new exploratory studies’ assessment to evaluate additional formulations and treatment populations.

But most importantly, a Phase 2a trial on safety, tolerability and efficacy of intravenous (IV) SPL026 with supportive therapy showed positive outcomes in patients with moderate to severe Major Depressive Disorder (MDD).

Additionally, a Phase 1b study assessing the potential interaction between SSRIs and SPL026 in patients with MDD is ongoing and results are expected within this year’s third quarter; and a completed Phase 1 study comparing safety, tolerability and PK/PD profiles of intramuscular (IM) and IV SPL026 administration showed IM route’s potential convenience for both patients and physicians.

The company expects upcoming data from all active trials on both compounds will inform on how to further progress SPL026.

Meanwhile, deuterated, short-duration DMT compound SPL028 has entered the clinical stage this year. Phase 1 trial’s preliminary findings validate its target drug profile so far, including a potential optimized dose formulation for different administration routes (IV and IM) and specific therapeutic benefits.

With topline data from the first-in-human study expected within this year’s fourth quarter, SPL028 has a multi-layered IP portfolio involving composition of matter protection in several jurisdictions plus protection on related deuterated compounds.

Photo: Benzinga edit with photo by chrissmith12 and Bru-nO on Pixabay.