Significant progress made across the clinical portfolio with lead candidate advancing through trials
January 31, 2022 – London, United Kingdom – Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a neuropharmaceutical company focused on psychedelic-assisted N,N-dimethyltryptamine (“DMT”) therapies, has today published its third quarter results for the three and nine months ended November 30, 2021. 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.
(including post-period events):
- Continued strong progress in Phase I/IIa clinical trial of lead product candidate SPL026, DMT-assisted therapy, for Major Depressive Disorder (“MDD”), following the successful completion of Phase I in September 2021:
- Full dataset for the Phase I clinical trial expected imminently by the Company for analysis and future publication.
- Phase IIa clinical trial progressing on track for anticipated topline results in H1 2022.
- Positive discussions with the United States Food and Drug Administration paves the way for an international multi-site Phase IIb clinical trial, expected to commence in H2 2022.
- Preclinical portfolio progressing towards clinical trials.
- Following the award of the fast-track Innovation Passport Designation by the U.K. Medicines and Healthcare products Regulatory Agency (the “MHRA”) in October 2021, Small Pharma completed the first step to access the Innovative Licensing and Access Pathway (the “ILAP”) through compilation of the SPL026 Target Development Profile. The ILAP accelerates time to market and facilitates patient access to emerging and novel treatments.
- Continued to build upon its existing patent portfolio to a total of four granted patents (including two new patents granted) and 56 patent applications pending across the Company’s psychedelic and non-psychedelic portfolio.
- The first new patent granted is a European patent which provides protection for solid oral dosage forms of 2R,6R-hydroxynorketamine (“6-HNK”), including its preclinical candidate SPL801B, in combination with a serotonin modulator, for use in the treatment of depressive disorders. The second is an Australian patent that strengthens the Company’s portfolio surrounding crystalline forms of 6-HNK, including SPL801B.
- Strengthened the Board with the appointment of Paul Maier as Independent Director. Mr. Maier joins Small Pharma with over 30 years’ experience in senior executive roles in U.S. public companies across the biopharmaceutical and biotech industry.
- Cash on hand as of November 30, 2021 of $45.6 million.
- Cash used in operating activities of $3.5 million for the three months ended November 30, 2021.
- Operating expenses for the three months ended November 30, 2021 were $4.6 million.
Peter Rands, Chief Executive Officer of Small Pharma, said:
“As we enter 2022, the impact of the pandemic on mental health has reinforced the urgent need to discover and develop novel treatments for under-served patients. With the successful completion of Phase I, and the commencement of the Phase IIa part of our SPL026 clinical trials, progress continues apace across both our clinical portfolio of DMT-assisted therapies and preclinical candidates. We look forward to an exciting and important year ahead with data read-outs, the anticipated commencement of Phase IIb and advancing pre-clinical candidates towards clinical trials.”
About Small Pharma
Small Pharma is a neuropharmaceutical company specialized in IP led development of novel treatments for mental health conditions, with a focus on depression. Small Pharma initiated a clinical program into DMT-assisted therapy in February 2021. This program includes a Phase I/IIa trial on its lead candidate, SPL026, alongside 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 (<30mins), 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 world’s first DMT clinical trial for depression, in collaboration with Imperial College London.
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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 progress in Phase I/IIa clinical trial of SPL026, the anticipated timing for the readout of topline data for the Company’s Phase IIa trial, the Company’s advancement of pre-clinical trials into new clinical trials, including the anticipated commencement and timing of the Company’s Phase IIb trial of SPL026, the Company’s success in launching a clinical program into DMT-assisted therapy, the Company’s ability to develop solutions to effectively address depression through DMT-based therapies, the potential of DMT-assisted therapies to transform the lives of patients suffering with MDD, the ILAP providing potential access to speedier time to market and facilitation of patient access to emerging and novel treatments, and the Company’s development of a robust pipeline of proprietary preclinical assets. 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.
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