Small Pharma, much to its name, has been quietly establishing itself in the psychedelic medicine space. The UK-based company listed on the TSXV in May of last year under the awesome ticker symbol “DMT”, and has since been making steady progress.
And there doesn’t seem to be anything particularly small about their work or company profile. With over $40 million in the bank and an advanced Phase 2 DMT trial underway, the firm, despite its status as a newcomer, has built an impressively strong early position.
So we thought it’d be a good idea to take a look at their recent financials and business highlights. See the full press release below and stay tuned for more in-depth coverage.
Interested in more on Small Pharma? Check out Psychedelic Groundbreakers: Small Pharma and New DMT Player as Small Pharma Lists on the TSXV
Small Pharma Reports Fiscal Third Quarter 2021 Highlights
Significant progress made across the clinical portfolio with lead candidate advancing through trials
Source: Small Pharma Inc.
LONDON, Jan. 31, 2022 (GLOBE NEWSWIRE) — 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.
Business Highlights (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.
Financial Highlights
- 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.
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 (<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.
For further information contact:
Small Pharma Inc.
Peter Rands
Chief Executive Officer
Email: ir@smallpharma.co.uk
Tel: +44 (0)2071 129118
Media Relations Contact
McKenna Miller
KCSA Strategic Communications
Email: smallpharmapr@kcsa.com
Tel: +1 (949) 949-6585
Investor Relations Contacts
Eric Ribner
LifeSci Advisors, LLC
Email: eric@lifesciadvisors.com
Tim Regan/ Adam Holdsworth
KCSA Strategic Communications
Email: smallpharmair@kcsa.com
