• Multiple clinical milestones achieved including the first proof-of-concept for DMT-based therapies from a blinded placebo-controlled study

• Preliminary findings from SPL028 Phase I clinical trial support target drug profile

• Operational efficiencies underway to deliver meaningful runway extension

LONDON, June 28, 2023 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a biotechnology company focused on short-duration psychedelic-assisted therapies for mental health conditions, has today published its financial results for the fiscal year ended February 28, 2023. A complete copy of the audited consolidated financial statements prepared in accordance with International Financial Reporting Standards and the corresponding management’s discussion and analysis 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 (including post-period events)¹:

• 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.

Recent Business and R&D Highlights (based on a calendar year):

SPL026: N,N-dimethyltryptamine (“DMT”)
Small Pharma has advanced its clinical program of SPL026, with ongoing exploratory studies to evaluate additional formulations and treatment populations.

• 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: Proprietary Second-Generation Deuterated DMT Asset
Small Pharma advanced its second generation short-duration psychedelic asset into the clinic, with preliminary findings to date validating the Company’s target drug profile.

• 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.

Operational Efficiencies
As part of a focus to enhance operational efficiencies, the Company has conducted a strategic review that is expected to generate material cost savings and a reduction in its historical annual cash burn. The Company anticipates this to extend the runway of its current resources to at least Q4 2024, which will enable the Company to achieve key value-based milestones.

Intellectual Property Portfolio Progress

• 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.
    

George Tziras, Chief Executive Officer of Small Pharma, said: “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.”

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.

Note:
⁽¹⁾ All quarterly date references in this press release are based on a calendar year-end.

Contact Information:
Small Pharma Inc. & Investor Relations:
George Tziras, Chief Executive Officer
Email: ir@smallpharma.co.uk
Tel: +44 (0)7720 326 847

Media Relations:
Jenny Maguire, Head of External Affairs
Email: jenny.maguire@smallpharma.co.uk

Cautionary Note Regarding Forward Looking Statements
This press release contains statements that constitute “forward-looking information” (“forward-looking information”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward-looking statements in this news release include statements regarding its SPL026 clinical trials and studies, including anticipated results from such studies and the Company’s decisions related to SPL026’s development path based on study results; statements related to the SPL028 clinical trials and studies, including readout for topline data; the Company’s implementation of operational efficiencies to generate material cost savings and reduce its historical cash burn; the ability for the operational efficiencies to extend the runway of the Company’s current resources to at least Q4 2024; the Company’s achievement of key value-based milestones; the potential for psychedelic-based therapies to offer commercially viable and efficacious treatments for patients; and the Company’s ability to provide short-duration psychedelic-assisted therapies for the treatment of mental health conditions.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting the Company’s business and results of operations; the impact of pandemics or other future disruptions; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

Small Pharma makes no medical, treatment or health benefit claims about its proposed products. The MHRA or other similar regulatory authorities have not evaluated claims regarding DMT-assisted therapies and other next generation psychoactive compounds. The efficacy of such therapies has not been confirmed by MHRA-approved research. There is no assurance that such DMT-assisted therapies and other psychoactive compounds can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Any references to quality, consistency, efficacy and safety of potential therapies do not imply that Small Pharma verified such in clinical trials or that Small Pharma will complete such trials. If Small Pharma cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Small Pharma’s performance and operations. 

The TSX Venture Exchange (“TSXV”) has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.