Last patient dosed in Phase IIa trial for lead product candidate, SPL026 with supportive therapy for the treatment of Major Depressive Disorder

Completion of 12-week follow up anticipated by year end with data shortly thereafter

SSRI drug interaction study initiated

MHRA approval for new SPL026 trial

LONDON, Oct. 14, 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 three and six months ended August 31, 2022. A full copy of the financial 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 (including post-period events):

• 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.

Operational Highlights (including post-period events):

Ultra Short-Acting Psychedelic Program

• 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.
  

Short-Acting Psychedelic Programs

• 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.

Corporate Activity

• 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.

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

About Small Pharma

Small Pharma is a biotechnology company progressing a pipeline of short-acting psychedelic assisted therapies for the treatment of mental health conditions. The Company’s current focus is on exploring new therapeutic approaches for depression. Small Pharma’s lead candidate, SPL026, is a proprietary synthetic formulation of DMT. The Company is advancing a clinical program of intravenous SPL026 with supportive therapy for the treatment of MDD, which was granted an Innovation Passport designation from the MHRA. In addition, Small Pharma has a pipeline of proprietary preclinical assets in development.

For further information contact:

Small Pharma Inc.
George Tziras, Chief Executive Officer
Email: ir@smallpharma.co.uk
Tel: +1 (646) 751-4363

Investor Relations:
Eric Ribner
LifeSci Advisors
Email: eric@lifesciadvisors.com
Tel: +1 (646) 889-1200

Media Relations:
Jaber Mohamed
MHP Communications
Email: smallpharma@mhpc.com
Tel: +44 (0)7720 326 847

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 expected timeline for patient follow-up and readout of data for the Company’s Phase IIa clinical trial; the anticipated commencement of the Company’s Phase IIb trial of SPL026; the Company’s SSRI drug interaction study with SPL026; the Company’s Phase I study evaluating SPL026 IM; the Company’s Phase I study evaluating SPL028 deuterated DMT with supportive therapy; the protections afforded by European patent no. 3902541 and the Company’s ability to progress short-acting 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 COVID-19; 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.