Small Pharma Reports Fiscal First Quarter 2024 Highlights

• Cash on hand as of May 31, 2023 was approximately $13.2 million.
• Cash used in operating activities was $5.8 million for the three months ended May 31, 2023.
  • Two of the Company’s Phase I studies recently completed dosing. These exploratory studies are aimed at informing the development path of the Company’s key clinical programs.
  • The Company recently conducted an operational restructuring. This is expected to deliver a reduction in cash burn for upcoming quarters, which is anticipated to provide a cash runway extension until at least Q4 2024.
• Operating expenses for the three months ended May 31, 2023 were $5.7 million.

• Intravenous (“IV”) SPL026 drug interaction study: The last patient has been dosed in the Company’s Phase Ib drug interaction study assessing the potential interaction between selective serotonin reuptake inhibitors (“SSRIs”) and SPL026 in patients with Major Depressive Disorder (“MDD”). This 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/Intramuscular (“IM”) SPL026 Phase I: Results from this study, which compared the safety, tolerability, PK and PD profiles of IV and IM SPL026 administration in 14 healthy volunteers 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 met the target treatment length, demonstrating the potential for IM administration as a convenient route for patients and physicians.
• 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 currently dosing in an ongoing Phase I study in healthy volunteers. It is a randomized, blinded, placebo-controlled, dose-escalating study evaluating the safety, tolerability, PK and PD of both IV and IM administration of SPL028.
• Preliminary findings from the first two cohorts of the study demonstrate that IV SPL028 elicits a psychedelic experience of <1 hour and is well-tolerated. Topline data is expected in Q4 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 for SPL028 in 2024. Accordingly, the Company’s protocol for the SPL028 Phase I program includes the option of initiating a Phase Ib patient study evaluating the efficacy and safety 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.
• 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 26 patents granted and 95 patent applications pending across the Company’s four key areas of patent protection. These include: Composition of Matter, covering novel drug substances; Medical Use, covering therapeutic compositions and medical uses thereof; Drug Product, covering pharmaceutical formulations; and Synthetic Route, covering the novel and efficient synthesis of high purity drug substance at scale.

• The team presented clinical and preclinical data on SPL026 and SPL028 at a number of key scientific and industry events including the 34th CINP World Congress of Neuropsychopharmacology in Montreal, Canada; the Psychedelic Science 2023 conference in Denver; and the British Association for Psychopharmacology 2023 Summer Meeting.
• The Company hosted a virtual roundtable discussion with key opinion leaders in psychiatry in March 2023. Dr. Carol Routledge was joined by Jerry Rosenbaum, MD, Professor of Psychiatry at Harvard Medical School, and David Erritzoe, MD, PhD, Imperial College London to discuss the potential of short-duration psychedelics as a treatment for depression and other mental health conditions. A replay of the roundtable discussion can be accessed here.

“Our exploratory SPL026 and SPL028 Phase I studies, which are aimed at expanding patient access to DMT-based treatments, are almost complete. This will enable us to make a data-driven decision on the optimal development path for our clinical programs. We were very pleased that the results from the IV/IM study indicate the potential for IM as a convenient alternative route of treatment administration with a favorable safety profile. We also look forward to sharing the results of the SPL026-SSRI drug interaction study soon, which could further expand access to DMT-based treatments in the future given the large population of patients who currently take SSRI medication.”

George Tziras, CEO of Small Pharma

About Small Pharma

Small Pharma is a biotechnology company progressing a pipeline of short-duration psychedelic-assisted therapies for the treatment of mental health conditions. Small Pharma has a portfolio of clinical-stage DMT-based assets, SPL026 and SPL028. The Company was granted an Innovation Passport designation for SPL026 from the U.K. Medicines and Healthcare products Regulatory Agency (the “MHRA”) and has a pipeline of proprietary preclinical assets.