Small Pharma Reports Fiscal First Quarter 2024 Highlights

• Last patient dosed in SPL026-SSRI drug interaction study with data readout anticipated in Q3 2023

• Potential for an expedited route to an international, multi-site Phase II study with SPL028 in 2024, based on clinical findings across SPL026 and SPL028 programs to date

• SPL026 Phase IIa clinical trial results well-received at several international scientific conferences

• Anticipated cash runway to at least Q4 2024 following recent operational restructuring

LONDON, July 27, 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 first quarter ended May 31, 2023. A complete copy of the results 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):

• 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.
  

Recent Business and R&D Highlights:

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

• 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: Proprietary Second-Generation Deuterated DMT Asset
SPL028 is the Company’s novel deuterated DMT compound targeting an extended DMT psychedelic experience. It offers a unique short-duration DMT drug profile that could provide optimized dose formulations for different administration routes and distinct therapeutic benefits for patients.

• 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.
  

Intellectual Property Portfolio Progress

• 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.
  

Corporate Activity

• 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.

George Tziras, CEO of Small Pharma, said: “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.”

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.

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 the SPL026 clinical trials and studies to evaluate additional formulations and treatment populations, including anticipated results from such studies and the Company’s decisions related to SPL026’s development path for key clinical programs upon completion of the active Phase I trials; the expected timeline for data readout of the IV SPL026 drug interaction study; statements related to the SPL028 clinical trials and studies, including the Company’s decisions related to SPL028’s optimal development route following conclusion of the ongoing Phase I studies; the potential for SPL028 to provide optimized dose formulations for different administration routes and distinct therapeutic benefits for patients; the potential for the Company to pursue an expedited path to initiating a multi-jurisdiction, multi-site Phase II study for SPL028 in 2024 based on combined SPL026 and SPL028 study results; the Company’s expectation to generate material cost savings as a result of an operational restructuring in order 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 potential for IM administration to provide an alternative safe and convenient route of treatment administration; the ability to further expand access to DMT-based treatments in the future; 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.