– Reporting its financial results and continued progress across short-acting psychedelics portfolio – Executive team and IP position strengthened
LONDON, June 09, 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 fiscal year ended February 28, 2022. 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.
Cash on hand as of February 28, 2022 of $40.7 million
Cash used in operating activities of $16.2 million for the 12 months ended February 28, 2022.
Operating expenses for the 12 months ended February 28, 2022 were $18.1 million.
Business Highlights (including post-period events)
Ultra Short-acting Psychedelic Program: SPL026
The Company’s lead program, SPL026 intravenous (“IV”) N,N-dimethyltryptamine (“DMT”) assisted psychotherapy in major depressive disorder (“MDD”), is in the Phase IIa part of the Phase I/IIa clinical trial, with completion of patient dosing expected in coming months.
Drug interaction patient study expected to commence in H2 2022, assessing the impact of selective serotonin reuptake inhibitors (“SSRIs”) on the safety, tolerability, pharmacokinetics and pharmacodynamics of SPL026 with psychotherapy.
Preparation is continuing for the international multi-site Phase IIb clinical trial, with further scientific advice requested from the United States Food and Drug Administration (the “FDA”), the UK Medicines and Healthcare products Regulatory Agency (the “MHRA”) and the European Medicines Agency (the “EMA”). A centralized Contract Research Organization to support the execution of the study has been selected.
Short-acting Psychedelic Programs
SPL026 IM preclinical program has been completed. Phase I study is currently planned for H2 2022 to compare the treatment profile of intramuscular (“IM”) and IV modes of administration.
SPL028, the Company’s deuterated DMT-assisted psychotherapy program was initiated with positive preclinical data of IM and IV formulations of SPL028. A Phase I clinical trial is planned for H2 2022.
Continued to build upon its existing patent portfolio to a total of six granted patents (including two new Composition of Matter patents) and 74 patent applications pending across the Company’s psychedelic and non-psychedelic portfolio.
Strengthening of Executive Team
Appointment of Dr. Alastair Riddell as Chief Operating Officer and Ms. Marie Layzell as Chief Manufacturing and Development Officer to support the growing pipeline of molecules as they progress into and through clinical trials.
Peter Rands, Chief Executive Officer of Small Pharma, said:
“With depression cases on the rise globally and current antidepressants failing so many, there is a growing sense of urgency to develop entirely novel treatment approaches. This is the reason why the Company is taking a radically different approach to mental health treatment, but one that can be embedded into the current clinical setting. Short-acting psychedelics such as DMT may offer a practical and convenient treatment for patients, clinicians and health systems, and importantly one that has the potential to scale. As we advance our short-acting and ultra-short acting psychedelic programs, and with efficacy data for our lead DMT program on the horizon, it is an exciting time for the whole class of short-acting psychedelics.”
The board of directors of the Company has granted options to purchase up to an aggregate of 6,300,000 common shares in the capital of the Company (the “Common Shares”) to certain directors and officers of the Company pursuant to the Company’s stock option plan. Each option is exercisable for one Common Share at a price equal to the greater of (i) $0.16 per Common Share; and (ii) the closing price of the Common Shares on Friday, June 10, 2022, being the first trading day after the release of the Company’s financial results. The options are exercisable for a period of ten years and are subject to certain vesting requirements.
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 robust pipeline of proprietary preclinical assets.
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. Small Pharma is advancing a pipeline of DMT-based therapies and is leading the most advanced clinical trial in commercial development for DMT-assisted psychotherapy in Major Depressive Disorder.
For further information contact:
Peter Rands Chief Executive Officer
Tel: +44 (0)20 7112 9118
Media Relations Contacts:
USA: McKenna Miller
KCSA Strategic Communications
Tel: +1 (949) 949-6585
Investor Relations Contacts:
Tel: +1 (646)-889-1200
KCSA Strategic Communications
Tel: +1 (212) 682-6300
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; 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 drug interaction patient study assessing the impact of SSRIs; the Company’s plans, expectations, timelines and possible outcomes of the further Phase I study of SPL026 comparing IM versus IV modes of administration and Phase I clinical trial for the SPL028 deuterated DMT-assisted program; the expected roles of Mr. Riddell and Ms. Layzell as the Company progresses through clinical trials; the ability for short-acting psychedelics to provide mental health treatments and be scalable for patients; 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 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.