Small Pharma Inc (TSX-V:DMT, OTCQB:DMTTF) has published its financial results for the year ended February 28, 2022, showing the biotechnology company had cash on hand of C$40.7 million at the end of the fiscal year.
Small Pharma said during the year, operating expenses totaled C$18.1 million, of which cash used in operating activities made up C$16.2 million.
"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,” Small Pharma CEO Peter Rands said in a statement.
READ: Small Pharma appoints experienced pharma industry leader Dr Alastair Riddell as its chief operating officer; provides corporate update
“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,” he added.
Small Pharma is advancing a pipeline of N,N-dimethyltryptamine (DMT) based therapies and is leading the most advanced clinical trial in commercial development for DMT-assisted psychotherapy in major depressive disorder (MDD).
The company said its lead program, SPL026 intravenous DMT-assisted psychotherapy in MDD, is in the Phase IIa part of the Phase I/IIa clinical trial, with completion of patient dosing expected in the coming months.
A drug interaction patient study is expected to commence in the second half of this year to assess the impact of selective serotonin reuptake inhibitors on the safety, tolerability, pharmacokinetics and pharmacodynamics of SPL026 with psychotherapy, it added.
On its short-acting psychedelic programs, SPL026 IM preclinical program has been completed, Small Pharma said, adding that the Phase I study is currently planned for the second half of the year to compare the treatment profile of intramuscular and IV modes of administration.
As well, 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 also planned for the second half.
“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,” CEO Rands said.
On its intellectual property, Small Pharma said it is continuing to build upon its existing patent portfolio for psychedelic and non-psychedelic to a total of six granted patents, including two new Composition of Matter patents, and 74 patent applications pending.
The company also announced that its board of directors has granted certain directors and officers of the company the option to purchase up to an aggregate of 6,300,000 common shares under its stock option plan.
Each option is exercisable for one common share at a price equal to the greater of C$0.16 per share and the closing price of the 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, it added.
Contact the author at jon.hopkins@proactiveinvestors.com