Small Pharma Reports Financial Results for the Fiscal Year Ended February 28, 2023 and Recent Business Highlights

• Cash on hand as of February 28, 2023 was approximately $18.5 million.
• Cash used in operating activities was $22.2 million for the 12 months ended February 28, 2023.
• Operating expenses for the 12 months ended February 28, 2023 were $24.7 million.
• Company conducts strategic review to implement operational efficiencies, which are expected to generate material cost savings and a reduction in its historical annual cash burn. Anticipated runway extension from current resources to at least Q4 2024.

• IV SPL026 Phase I/IIa: In Q1 2023, the Company announced positive results from its Phase IIa trial investigating the safety, tolerability and efficacy of intravenous (“IV”) SPL026, with supportive therapy, in 34 patients with moderate/severe Major Depressive Disorder (“MDD”). The trial met its key primary and secondary endpoints with SPL026 demonstrating a rapid and durable antidepressant response to at least six months, as measured by the Montgomery-Åsberg Depression Rating Scale (“MADRS”). Further analyses of additional secondary and exploratory endpoints demonstrated clinically relevant improvements in self-reported depression, anxiety and wellbeing.
• IV SPL026 drug interaction study: In Q4 2022, dosing commenced in the Company’s Phase Ib drug interaction study assessing the potential interaction between selective serotonin reuptake inhibitors (“SSRIs”) and SPL026 in patients with MDD. The ongoing open-label study is investigating the safety, tolerability, pharmacokinetics (“PK”), pharmacodynamics (“PD”), as well as exploratory efficacy of SPL026, alone or in combination with SSRIs. Results from the study are expected in Q3 2023.
• IV/IM SPL026 Phase I: In Q1 2023, the first patient was dosed in a Phase I study comparing the safety, tolerability, PK and PD profiles of intramuscular (“IM”) and IV SPL026 administration in up to 14 healthy volunteers. The study is now complete and the results demonstrated that:
  • SPL026, when administered via the IM route, was well tolerated with no safety concerns reported from participants in the trial.
  • The IM drug profile delivered a mean PK half-life of approximately 40 minutes and a mean psychedelic experience duration of approximately 45 minutes.
  • This data demonstrates the potential for IM administration as a convenient route for patients and physicians.
• IV SPL026 Phase IIb: The Company anticipates that upcoming data from its active SPL026 and SPL028 trials will be informative to SPL026’s progress. As such, the SPL026 development path will be determined upon the completion of the active Phase I trials.

• SPL028 is the Company’s deuterated DMT compound targeting an extended DMT psychedelic experience. SPL028 offers a unique short-duration DMT drug profile that could provide optimized dose formulations for different administration routes and offer distinct therapeutic benefits for patients.
• The Company initiated the first-in-human Phase I clinical trial with SPL028 in Q1 2023. The study is a randomized, blinded, placebo-controlled, dose-escalating study evaluating the safety, tolerability, PK and PD of both IV and IM administration of SPL028 in healthy volunteers.
• Preliminary findings from the first two cohorts of the ongoing Phase I study demonstrate that IV SPL028 elicits a mean psychedelic experience of <1 hour and is well-tolerated. Topline data is expected in Q4 2023.
• SPL028 has a multi-layered intellectual property (“IP”) portfolio that has matured significantly in 2023, and includes Composition of Matter protection in multiple jurisdictions and protection surrounding related deuterated compounds.

• Significant progress has been made in advancing the Company’s IP portfolio with 23 patents granted and 98 patent applications pending across the Company’s four key areas of patent protection. Key patent grants secured in the last quarter and post-period include:
  • A United States (“U.S.”) patent granted, protecting the therapeutic composition of a small group of deuterated DMT compounds, with normal lifetime of exclusivity until April 2041. This patent strengthens the protection around the SPL028 clinical candidate.
  • European and U.S. patents granted protecting a manufacturing process for the preparation of synthetic DMT, DMT-related compounds and deuterated DMT analogs, including pipeline candidates SPL026 and SPL028.

“In the past year we have made considerable progress towards our mission of developing novel and accessible treatment options for patients under-served by the existing standard of care in depression. We achieved multiple clinical milestones and, most importantly, demonstrated proof-of-concept for DMT-based therapy. Our firm belief is that short-duration psychedelic-based therapies offer strong potential for commercially viable and efficacious treatments for patients. With key data readouts anticipated in the coming months, we expect to make meaningful progress and are excited about the year ahead.”

George Tziras, Chief Executive Officer of Small Pharma