Small Pharma Reports First Fiscal Quarter 2021 Highlights

Successful completion of listing on TSX Venture Exchange

$58 million financing enables potential rapid advancement of Small Pharma’s patent portfolio

LONDON, United Kingdom, July 30, 2021 (GLOBE NEWSWIRE) — Small Pharma Inc. (TSXV: DMT) (the “Company” or “Small Pharma”), a neuropharmaceutical company focused on psychedelic-assisted N,N-dimethyltryptamine (“DMT”) therapies, has today published its first quarter results for the three months ended May 31, 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 to Canadian dollars.

Operational Highlights (including post-period events):

• Strong progress in Phase I/IIa clinical trial for lead product, SPL026, DMT-assisted therapy for the treatment of depression
  • Completion of fourth cohort in the Phase I component of the study
  • Acceleration of Phase IIa with addition of second clinical trial site
  • Topline data readout of Phase IIa anticipated H1 2022
• Preparation underway for Phase IIb DMT-assisted therapy clinical trial, anticipated to commence in H2 2022
  • Launch of psychotherapy training program ahead of Phase II clinical trials
  • Positive discussions with UK Medicines and Healthcare products Regulatory Agency (“MHRA”) on Phase IIb clinical trial design
• Advancement of other pipeline candidates towards clinical studies including:
  • SPL028, prolonged duration DMT
    • Anticipate completion of pre-clinical studies by year end
    • Start of Phase I/IIa anticipated to commence H1 2022
• Grant of UK patent covering composition of matter protection on a range of novel tryptamines

Financial Highlights:

• Completion of the Company’s “go-public” transaction, by way of a reverse takeover of Unilock Capital Corp. (the “Reverse Takeover”), on the TSX Venture Exchange (the “TSXV”) under the ticker symbol “DMT”
• Successful financing of $58 million
• Loss for the period of $5.2 million (May 31, 2020: $0.4 million), an increase due primarily to commencement of clinical trials
• Operating expenses increased to $3.2 million (May 31, 2020: $0.4 million) reflecting the increased R&D costs, advertising and promotion costs, together with professional fees, salaries and wages
• $52.8 million cash as of May 31, 2021

Peter Rands, Chief Executive Officer of Small Pharma, said: “We have made considerable progress leading the first DMT clinical trial under regulatory approval. Major progress across our portfolio of DMT-assisted therapies during the quarter includes the initiation of our Phase I/IIa clinical trial for the treatment of depression, preparation of the Phase IIb clinical trial, including positive discussions with MHRA on trial design. This work has been supported by our successful $58 million financing and subsequent listing on the TSXV. The continued support of our investors and a stable financial base is expected to assist us with our objective of rapidly progressing and building out our patent portfolio in the coming year, creating a strong foundation for advancing DMT-based therapies for mental health conditions.”

Overview

Psychedelics have been shown to have therapeutic benefits in disorders such as depression, anxiety, substance abuse and post-traumatic stress disorder. These so-called “internalizing disorders” are characterized by debilitating flows of recurring negative thoughts. Clinical research suggests that DMT will disrupt the neuronal pathways underlying these negative thought processes and, by doing so, may facilitate the clinical benefits of therapy given in combination with DMT. DMT-assisted therapy targets the root cause of depression and other “internalizing” conditions and has the potential to provide a treatment with rapid onset and a long duration of antidepressant effect following treatment.

In March 2021, Small Pharma successfully raised $58 million from new and existing securityholders, leading to the completion of the Reverse Takeover and listing on the TSXV in May 2021. With a robust financial base, the Company has initiated a number of steps to accelerate development of its patent portfolio.

Strong progress in Phase I/IIa clinical trial for lead product, SPL026, for the treatment of depression

Small Pharma has initiated a blinded, two-part Phase I/IIa clinical trial. Phase I of the study aims to demonstrate the safety, tolerability, pharmacokinetics and pharmacodynamics of different dose levels of SPL026, a DMT fumarate, in psychedelic-naïve subjects when compared to placebo. Phase IIa, the patient proof of concept, will assess the efficacy, safety and tolerability of one versus two doses of SPL026 versus a placebo in combination with psychotherapy, in patients with major depressive disorder. Efficacy will be assessed using the Montgomery-Asberg Depression Rating scale to measure the severity of depressive episodes.

Completion of fourth cohort of SPL026 therapy
Small Pharma has successfully completed the administration of SPL026, DMT-assisted therapy to 32 psychedelic-naive healthy subjects in the Phase I component of the trial. The study will provide data to support dose selection for the Phase IIa proof of concept component of the clinical trial, which is on track to commence in Q3 2021.

Acceleration of Phase IIa with addition of second clinical trial site
In June 2021, Small Pharma secured an additional clinical trial site with MAC Clinical Research at Prescott, Liverpool in the UK, increasing the total number of patients in its Phase IIa trial to 42. As a result of this appointment, timelines for the Phase I/IIa clinical trial are expected to accelerate with anticipated top-line results brought forward from the end of 2022 to the first half of 2022.

Preparations underway for Phase II DMT-assisted therapy clinical trials

Launch of psychotherapy training program ahead of Phase II clinical trials
In July 2021, Small Pharma launched its DMT-assisted therapy training program to educate therapists on the process required to support treatment delivery of Small Pharma’s DMT-assisted therapy clinical trials. The initial training program was successfully completed at the University of Oxford and will help set the foundations for the effective delivery of this treatment.

Positive discussions with MHRA on Phase IIb clinical trial protocol
Small Pharma had positive discussions with UK regulators on the preliminary protocol for the Company’s Phase IIb clinical trial, anticipated to commence in the second half of 2022. The MHRA endorsed minimal additional preclinical safety studies based on the additional human exposure data being obtained in the Phase I/IIa clinical trial, which provides an expedited nonclinical path to the start of the Phase IIb study. In addition, the MHRA commented positively regarding the design of the Phase IIb study noting thoroughness of the clinical design including patient population, the inclusion/exclusion criteria and the overall study design.

Advancement of pipeline candidates towards clinical studies
Small Pharma has progressed preclinical studies for its pipeline of novel DMT analogues, including in vivo pharmacokinetic studies and behavioral pharmacology studies and remains on track to select the next candidates to progress towards clinical trials in 2022.

Grant of UK patent
In July 2021, Small Pharma received granted status under patent number GB2585978 for its UK patent application GB2008303.6. The UK patent office has determined the novelty of exploiting the effects of deuterium modification of DMT and additional tryptamines to control the duration of its psychological effects. This patent covers composition of matter protection on a range of novel tryptamines that delivers an extended psychedelic experience for use in protocols for treating depression. Small Pharma is using this technology to create novel DMT analogues, including SPL028, a second generation psychedelic substance that may provide flexibility and expand administration routes. The Company is building a robust IP portfolio with two patents granted and 36 patent applications pending across its psychedelic and non-psychedelic portfolio.

Options Grants
The Company announces that the board of directors of the Company has granted options to purchase up to an aggregate of 1,090,000 common shares to certain directors and officers of the Company pursuant to the Company’s stock option plan. Each option is exercisable for one common share at a price equal to the greater of (i) $0.49 per share; and (ii) the closing price of the common shares on Tuesday, August 3, 2021, 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.

Outlook
Small Pharma has made considerable progress across its patent portfolio of DMT-assisted therapies with the initiation of its Phase I/IIa clinical trial for the treatment of depression and preparation of the Phase IIb clinical trial. This work has been supported by the Company’s successful $58 million financing and subsequent listing on the TSXV. The continued support of Small Pharma’s investors and a stable financial base is enabling the Company to rapidly progress and is expected to accelerate the build out of its patent portfolio in the coming year, creating a strong foundation to advance treatment to address the unmet need in mental health conditions.

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

Investor Relations Contact
Eric Ribner
LifeSci Advisors, LLC
Email: eric@lifesciadvisors.com

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 current and future status of the Company’s patent applications, rapid advancement and build-out of the Company’s patent portfolio, the Company’s success in launching a clinical program into DMT-assisted therapy, acceleration of the development of the Company’s patent portfolio, data to support dose selection for the Phase IIa proof of concept component of the clinical trial of SPL026, the impact of the Company’s training program, the outcome of any discussions with regulators including but not limited to the MHRA, the Company’s development of a robust pipeline of proprietary preclinical assets, the potential of DMT to transform the lives of patients suffering with depression, the Company’s training program and the results thereof, the completion of the Company’s pre-clinical studies and the commencement and results of the Company’s Phase IIa and Phase IIb clinical trials. In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions. 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.

This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. Small Pharma’s securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

The TSXV has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.