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.
  

Peter Rands, Chief Executive Officer of Small Pharma, said: "The remainder of 2022 is expected to be a busy one for our team as we approach the latter stages of the SPL026 Phase IIa clinical trial and prepare to progress a number of new planned trials into the clinic. Although across the world, our industry is facing challenging markets right now, we believe that Small Pharma remains in a strong position with our world-class team, robust pipeline and strong cash position as we strive to change the therapeutic paradigm for these much under-served patients with the option of better mental health treatments."

About Small Pharma

Small Pharma is a biotechnology company progressing a pipeline of short-acting psychedelics with therapy for the treatment of mental health conditions, with a current focus on depression. Small Pharma initiated a clinical program into DMT-assisted psychotherapy in February 2021. This program includes a Phase I/IIa trial on the Company's lead candidate alongside the development of a pipeline of proprietary preclinical assets.

About DMT

DMT is a naturally occurring psychedelic tryptamine found in plants and in the brain of mammals. Scientific evidence suggests DMT offers the potential for rapid-acting and long-lasting antidepressant effects. DMT is differentiated by its short psychedelic experience (< 30 mins), which allows for short treatment sessions and offers the potential for convenient supervised treatments within patient clinics.

For further information contact:

Small Pharma Inc.
Peter Rands
Chief Executive Officer
Email: [email protected]
Tel: +44 (0)20 7112 9118

Investor Relations Contacts:
Eric Ribner
LifeSci Advisors
Email: [email protected]
Tel: +1 (646)-889-1200

Kristi Papanikolaw
KCSA Strategic Communications
Email: [email protected]
Tel: +1 (212) 682-6300

Media Relations Contact:
McKenna Miller
KCSA Strategic Communications
Email: [email protected] 
Tel: +1 (949) 949-6585

Rest of World
Jaber Mohamed
MHP Communications
Email: [email protected]
Tel: 0+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 Company's continued progression of Phase IIa clinical trials of SPL026 IV, including the expected timeline for completion of patient dosing, trial progress and the release of the Phase IIa data; the expected timeline for commencing a drug interaction patient study assessing the impact of SSRIs; the Company's preparation for the international multi-site Phase IIb clinical trial of SPL026; the Company's plans, expectations, timelines and possible outcomes with respect to its anticipated SPL026 study comparing IM versus IV modes of administration as well as the Company's Phase I study of SPL028 deuterated DMT-assisted psychotherapy; the Company's ability to pursue novel treatments to provide better mental health treatments; and the Company's ability to develop solutions to effectively address depression through DMT-based therapies.

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 U.K. Medicines and Healthcare Products Regulatory Agency (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.