Small Pharma Reports Fiscal Second Quarter 2023 Highlights

• Cash on hand as of August 31, 2022, was $27.1 million. Cash is net of an unrealized loss of $3.4 million arising from foreign exchanges incurred due to a strengthening of the Canadian dollar against the British pound sterling (“GBP”) during the second quarter; however, as most of the Company’s operating costs are incurred in GBP, the loss has little impact on the underlying cash burn of the Company.
• Cash used in operating activities was $6.0 million for the three months ended August 31, 2022.
• Operating expenses for the three months ended August 31, 2022 were $7.5 million.
• Normal course issuer bid initiated allowing the repurchase by the Company of up to five million common shares in the capital of the Company, representing 1.55% of the issued and outstanding common shares, over a 12-month period.

• Dosing has been completed in the Phase IIa clinical trial of SPL026 intravenous (“IV”) N,N-dimethyltryptamine (“DMT”) with supportive therapy for Major Depressive Disorder (“MDD”), with no drug-related serious adverse events reported to date. The trial requires patient follow-up for 12 weeks following their second dose, which is on track to be completed by the end of 2022. Data is anticipated shortly thereafter.
• Preparation continues for the SPL026 Phase IIb international multi-site clinical trial following further discussions with the European Medicines Agency (the “EMA”) and United States Food and Drug Administration (the “FDA”).
• Selective serotonin reuptake inhibitor (“SSRI”) drug interaction Phase Ib study in MDD patients has been initiated following approval from the U.K. Medicines and Healthcare Products Regulatory Agency (“MHRA”). This study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SPL026 with supportive therapy when administered with SSRIs.

• Clinical Trial Application (“CTA”) approval received from MHRA for Phase I study evaluating SPL026 intramuscular (“IM”) to compare the treatment profile of IM and IV modes of administration.
• CTA submission complete for Phase I study evaluating SPL028 deuterated DMT with supportive therapy.

• Building of management team with George Tziras appointed as Chief Executive Officer and Dr. Alastair Riddell brought in as Chief Operating Officer. Peter Rands took on the role as Chief Innovation & Intellectual Property Officer and Marie Layzell appointed as Chief Manufacturing and Development Officer.
• Intellectual Property (“IP”) portfolio further strengthened with grant of 3 new patents, increasing the total to 11 granted patents and 72 patent applications pending across the Company’s psychedelic and non-psychedelic portfolio.
  • First United States patent grant within the Company’s psychedelic portfolio under patent no. 11,406,619 provides protection for novel injectable formulations of DMT and deuterium-substituted DMT, including the active ingredients in SPL026 and SPL028. The patent also protects novel injectable formulations of other known psychedelic compounds, including 5-methoxy-DMT and psilocybin.
  • Canadian patent no. 3104072 protects Composition of Matter of certain deuterated analogues of DMT, including the active ingredient in SPL028. It sits alongside the Company’s existing U.K. and European granted patents for SPL028, strengthening its protection in key international markets.
  • European patent no. 3902541 protects the use of a small group of deuterated compounds of DMT in therapy, effectively covering all therapeutic uses of the specified compounds. The patent will provide expanded protection for the Company’s pipeline of deuterated compounds.
• The Company’s Director of Research & Development, Dr. Ellen James, will present the SPL026 Phase I trial data at the European College of Neuropsychopharmacology conference in Vienna on Sunday, October 16, 2022.

“Over the summer months our team has made significant progress across our pipeline of short-acting psychedelic-assisted therapies, with a focus on progressing new trials into the clinic and expanding our IP portfolio, including a key U.S. patent grant. We continue to expand our SPL026 clinical program with the initiation of a SSRI drug interaction study and regulatory approval for a further Phase I trial. We are also approaching a key milestone: the completion of our SPL026 Phase IIa clinical trial in patients with MDD. Dosing is now complete and we eagerly await the results to learn more about the potential efficacy of short-acting psychedelics in treating MDD.”

George Tziras, Chief Executive Officer of Small Pharma