Small Pharma Inc. Stock Price, News & Analysis

Small Pharma Inc. has successfully completed enrollment for its Phase IIa clinical trial of the intravenous formulation of SPL026 (DMT) combined with psychotherapy for treating Major Depressive Disorder (MDD). This milestone follows the trial's primary endpoint dosing completion and will lead to a follow-up of patients over 12 weeks. The company anticipates topline results soon, which will influence plans for a larger Phase IIb trial. The treatment aims to explore rapid antidepressant effects and the durability of these effects.

Small Pharma has announced an automatic share purchase plan (ASPP) with Eight Capital to facilitate share buybacks amid its normal course issuer bid (NCIB) approved by the TSXV. Effective September 13, 2022, the ASPP allows repurchases during regulatory restrictions. The NCIB began on August 19, 2022, permitting the buyback of up to 5 million shares for cancellation until August 18, 2023. The company focuses on psychiatric therapies using DMT, highlighting its potential for rapid antidepressant effects in treating mental health conditions.

Small Pharma Inc. (TSXV: DMT, OTCQB: DMTTF) will present at investor conferences this September, featuring CEO George Tziras and Chief Medical Officer Dr. Carol Routledge. The upcoming events include:

• H.C. Wainwright 24th Annual Global Investment Conference: Sept 12-14, 2022, virtual fireside chat.
• Jefferies Innovation in Mental Health Summit: Sept 22, 2022, in-person fireside chat in New York City.

Small Pharma focuses on developing DMT-assisted therapies for mental health, emphasizing short-acting psychedelics.

Small Pharma, a biotechnology company focused on psychedelic-assisted therapies, has received approval from the TSX Venture Exchange for a normal course issuer bid (NCIB) to repurchase up to 5 million common shares, equating to 1.55% of its issued shares. The NCIB will commence on August 19, 2022, and is projected to conclude on August 18, 2023, unless the maximum number of shares is bought sooner. This initiative aims to enhance shareholder value, reflecting the company’s belief that its current share price does not represent its true value.

Small Pharma Inc. has received regulatory approval to initiate a clinical trial in the U.K. evaluating the interaction between SSRIs and its lead DMT candidate, SPL026, in patients with Major Depressive Disorder. This study aims to assess safety, tolerability, and pharmacokinetics in up to 24 participants, particularly those currently taking ineffective SSRIs. The trial is expected to commence in Q3 2022, with dosing completion in H1 2023. Positive outcomes could increase patient recruitment and accessibility to DMT-assisted psychotherapy, aligning with the company's patient-centric strategy.

Small Pharma has been granted a Canadian patent (no. 3104072) protecting the Composition of Matter for certain deuterated analogues of N,N-dimethyltryptamine (DMT), including its candidate SPL028. This marks a significant milestone as it enhances the company’s intellectual property portfolio, which now includes nine granted patents and over 70 pending applications. With a focus on psychedelic-assisted therapies for mental health, Small Pharma aims to enter clinical trials with SPL028 soon. The U.S. patent for novel DMT formulations is expected to be granted on August 9, 2022.

Small Pharma Inc. has received a patent issuance notification from the U.S. Patent and Trademark Office for its injectable DMT formulations under patent no. 11,406,619. This patent, effective August 9, 2022, will protect their two lead products, SPL026 and SPL028, until August 2041. The company’s CEO highlighted this as a pivotal moment in their strategy, coinciding with ongoing clinical trials for these therapies aimed at treating Major Depressive Disorder. Small Pharma’s portfolio now includes nine granted patents and over 70 pending applications.

Small Pharma has appointed George Tziras as the new CEO, effective July 20, 2022. Peter Rands, the founder and previous CEO, transitions to Chief Innovation & Intellectual Property Officer while remaining on the Board. Tziras has extensive experience in capital markets and is expected to lead the company through critical clinical developments. The company’s lead candidate, SPL026, is anticipated to provide key data soon. An option grant of 1,000,000 shares was also announced for Tziras, with a 10-year exercise period.

Small Pharma Inc. (TSXV: DMT; OTCQB: DMTTF) reported its financial results for the quarter ending May 31, 2022, with cash on hand of $32 million, despite a $2.3 million unrealized loss from currency fluctuations. The company incurred $6.3 million in operating cash outflows with $5.8 million in operating expenses. It is actively progressing its Phase I/IIa clinical trial of SPL026 in Major Depressive Disorder, with patient dosing completion expected soon. Additionally, two new patents were granted in July 2022, strengthening its intellectual property portfolio.