Small Pharma Reports Fiscal First Quarter 2023 Highlights

Progress continues apace with multiple trials expected to enter clinic later this year

First US patent granted

LONDON, July 15, 2022 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a biotechnology company focused on short-acting psychedelic-assisted therapies for mental health conditions, has today published its financial results for the quarter ended May 31, 2022. A full copy of the results can be found under the Company’s profile on SEDAR at www.sedar.com. Unless otherwise indicated, all currency references are in Canadian dollars. 

Financial Highlights 

• Cash on hand as of May 31, 2022 was $32.0 million. Cash is net of an unrealized loss of $2.3 million arising from foreign exchanges incurred due to a strengthening of the Canadian dollar against the British pound sterling (“GBP”) during the 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 $6.3 million for the three months ended May 31, 2022.
• Operating expenses for the three months ended May 31, 2022 were $5.8 million.
  

Business Highlights (including post-period events)

Ultra Short-acting Psychedelic Program

• Progress continues in the Phase I/IIa clinical trial of the Company’s lead program, SPL026 intravenous (“IV”) N,N-dimethyltryptamine (“DMT”) assisted psychotherapy for Major Depressive Disorder (“MDD”). Phase IIa patient dosing is expected to complete in the coming months. Updates on trial completion and topline data timing are anticipated throughout H2 2022.
• Drug interaction Phase Ib study in MDD patients CTA submission complete; study expected to commence in H2 2022.
  • Assessment of safety, tolerability, pharmacokinetics and pharmacodynamics of DMT-assisted psychotherapy when administered with serotonin reuptake inhibitors (“SSRIs”).
• Preparation is ongoing for the Phase IIb international multi-site clinical trial.

Short-acting Psychedelic Programs

• Phase I study evaluating SPL026 intramuscular (“IM”) is planned for H2 2022 to compare the treatment profile of IM and IV modes of administration.
• Phase I study evaluating SPL028 deuterated DMT-assisted psychotherapy is planned for H2 2022.

Corporate Activity

• Strong IP Portfolio with 8 granted patents and 75 patent applications pending across the Company’s psychedelic and non-psychedelic portfolio.
  • Two new patent grants in July 2022:
    • One patent received is a US patent that strengthens the company’s portfolio surrounding certain salt forms of 2R,6R-hydroxynorketamine (“6-HNK”), including SPL801B.
    • Second patent received is a European patent providing protection for high concentration oral dosage forms of 6-HNK salts, including SPL801B.
• Continued participation in key investor events such as the PSYCH Symposium London, Jefferies Healthcare Conference and HC Wainwright Mental Health Conference.