Small Pharma Inc (TSX-V:DMT, OTCQB:DMTTF) has published its third-quarter results for the three months ended November 30, 2021, which showed the firm had cash on hand as of that date of $45.6 million.
The company noted that cash used in operating activities for the three months ended November 30, 2021, was $3.5 million and its operating expenses for the period were $4.6 million.
In a statement, 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," he added.
READ: Small Pharma starts Phase II of DMT-and-psychotherapy treatment for depression
Third Quarter 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 US Food and Drug Administration (FDA) 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 (MHRA) in October 2021, Small Pharma completed the first step to access the Innovative Licensing and Access Pathway (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 its board with the appointment of Paul Maier as Independent Director. Maier joins Small Pharma with over 30 years’ experience in senior executive roles in US public companies across the biopharmaceutical and biotech industry
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 (less than 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.
Contact the author at jon.hopkins@proactiveinvestors.com