Small Pharma Shares Business Update Ahead of Annual Financial Results

LONDON, May 25, 2022 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a biotechnology company focused on short-acting psychedelic-assisted therapies for mental health conditions, provides a business update ahead of its annual financial results for the fiscal year ended February 28, 2022. All references to “$” in this press release refer to Canadian dollars unless otherwise indicated.

Strengthening the Team

Small Pharma has appointed Dr. Alastair Riddell as Chief Operating Officer of the Company. Dr. Riddell joins the management team with over 30 years of international leadership experience in the pharmaceutical, life science and biotech industries. In his roles as CEO of Pharmagene plc, Paradigm Therapeutics and Stem Cell Sciences as well as Chairman of Feedback plc, Dr. Riddell led significant fundraises, including an IPO on the London Stock Exchange and trade sales to Takeda in Japan and Stem Cells, Inc. in the USA. In companies now acquired by Pfizer, J&J and GE Healthcare, Dr. Riddell oversaw all phases of clinical trials of novel anti-inflammatory, anti-infective and oncology products before moving to international sales and marketing. Dr. Riddell was recently Chairman of the South-West Academic Health Science Network, which fosters links between the National Health Service, industry and universities. He is non-executive director of one NASDAQ-listed and two UK biotech companies.

Following Dr. Riddell’s appointment, Marie Layzell, the current COO and Head of CMC, will take on the role of Chief Manufacturing and Development Officer to build out the infrastructure to support Small Pharma’s growing pipeline of products as they progress into and through clinical trials.

Peter Rands, Chief Executive Officer of Small Pharma, said: “2022 is an important year for Small Pharma as we continue to develop our pipeline of short-acting psychedelics, strengthen our patent portfolio, and announce the efficacy data from our Phase IIa clinical trial of DMT-assisted psychotherapy in Major Depressive Disorder due later this year. At this stage of the Company, it is critical that we build a strong executive team with the right expertise to take us through our next phase of growth. Dr. Riddell is a highly respected leader with vast experience across the healthcare industry and we are delighted to welcome him to the team at Small Pharma. As we look to deepen our reputation as a leader in psychedelic-assisted therapies, Dr. Riddell’s understanding of growing, expanding and building successful healthcare businesses will facilitate the continued rapid growth and evolution of Small Pharma.”

Intellectual Property

The Company continues to build a robust IP portfolio with two additional patents granted. These new patents bring the Company’s portfolio to a total of six granted patents and 68 patent applications pending across the Company’s psychedelic and non-psychedelic portfolio.

EP 3 826 632, Composition of Matter patent
This European patent protects Composition of Matter of certain deuterated homologues of N,N-dimethyltryptamine (“DMT”), including the active ingredient in SPL028. This patent sits alongside the Company’s UK patent for SPL028, strengthening its protection in European markets.

EP 3 844 147, Composition of Matter patent
This European patent protects Composition of Matter of certain deuterated homologues of certain tryptamine compounds, including the active ingredients currently being investigated in the SPL029 series. This patent also provides protection for therapeutic applications of these deuterated tryptamines and their use in the development of orally active formulations.

Portfolio Advances with Ultra Short-acting and Short-acting Psychedelic Programs

As Small Pharma’s portfolio continues to advance and expand, the Company has structured its programs into two areas: (i) “Ultra Short-acting” Psychedelic Program targeting a <30-minute psychedelic experience aimed at maximizing the clinical scalability of psychedelic therapies; and (ii) “Short acting” Psychedelic Programs, which incorporates a pipeline targeting a >30-minute short psychedelic experience aimed at optimizing patient convenience and expanding therapeutic potential in depressive disorders and additional indications.

Ultra Short-acting Psychedelic Program

SPL026 intravenous (“IV”) DMT-assisted psychotherapy for the treatment of Major Depressive Disorder (“MDD”) is the Company’s lead program, currently in the Phase IIa part of the Phase I/IIa trial.

Phase I results demonstrate SPL026 to be safe and well tolerated and to elicit a short, psychedelic experience
The full dataset for the Phase I clinical trial demonstrates a clear correlation between the intensity and quality of the psychedelic experience and doses of SPL026, starting at 9 mg and up to 21.5 mg, across all four cohorts. IV administration of SPL026 offers a short-lived, well-tolerated psychedelic experience of ~20 minutes, enabling a dosing session of ~30 minutes. No drug-related serious adverse events and minimal short-lived adverse events were reported.

Phase IIa clinical trial dosing expected to be completed in coming months
The Phase IIa clinical trial is progressing well as the Company enters the latter stages, with a significant number of patients dosed and no safety concerns highlighted to-date. However, slower than anticipated patient recruitment following COVID-19 government restrictions in the UK had some impact on trial timelines. These restrictions have been lifted and as such, patient recruitment has significantly improved. As a result, dosing is expected to complete in the coming months. Updates on trial completion progress and data are anticipated throughout H2 2022.

Phase IIb clinical trial preparation continues
Preparation continues for the international multi-site Phase IIb clinical trial, with further scientific advice requested from the United States Food and Drug Administration and the European Medicines Agency. The Company has also selected a centralized Contract Research Organization to support the execution of the study.

Drug interaction study in patients with MDD expected to commence in H2 2022
This study will assess the impact of selective serotonin reuptake inhibitors (“SSRIs”) on the safety, tolerability, pharmacokinetics and pharmacodynamics of SPL026 with psychotherapy. The aim of the study is to enable a better understanding of the interaction between DMT-assisted psychotherapy and existing antidepressants, opening up the potential to reach the broadest population of patients suffering from MDD. Additionally, this could facilitate patient recruitment in future trials as patients may no longer be required to discontinue current SSRI medication.

UK “Fast-track” Designation
Following the award of the fast-track Innovation Passport Designation by the MHRA in October 2021, Small Pharma has engaged in the Innovative Licensing and Access Pathway. Small Pharma has initiated collaborative discussions regarding the Target Development Profile with key regulatory bodies to identify opportunities to accelerate time to market and patient access to SPL026, DMT-assisted psychotherapy.

Short-acting Psychedelic Programs

SPL026 IM Phase I study planned for 2022
The SPL026 intramuscular (“IM”) preclinical program is complete and a comparative pharmacokinetics Phase I study is planned for 2022. The study will compare the treatment profile of IM versus IV modes of administration of SPL026. IM injection would offer a simple injectable form that could further enhance convenience and accessibility of DMT-assisted psychotherapy for patients and clinicians.

SPL028, deuterated DMT-assisted psychotherapy, Phase I clinical trial planned for H2 2022
The program has been initiated with positive preclinical data of IM and IV formulations of SPL028. In vitro data demonstrated a reduction in clearance rate and significant extension in half-life compared to SPL026. SPL028 offers a similar pharmacological profile to SPL026 in vitro and in vivo, with differentiated pharmacokinetics. Additionally, toxicological profiling demonstrated SPL028 to be safe and well-tolerated in vivo at all doses tested, demonstrating significant safety margins for progressing into first-in-human trials. A Phase I clinical trial is planned to commence in H2 2022.

New Agreement with LifeSci Advisors as Investor Relations Agency

The Company has entered into a new master service agreement with LifeSci Advisors, LLC (“LSA”) to continue to provide investor relations services (the “Services”). The new agreement will commence on June 1, 2022 for a period of three months and shall automatically continue after the end of the initial term for successive one month periods unless either party provides written notice of termination at least 30 days prior to the commencement of a new term. LSA will receive a monthly fee of US$15,000 for the Services. The Company and LSA act at arm’s length and to the knowledge of the Company, LSA does not currently own any securities of Small Pharma. The agreement is on similar terms and conditions to the initial master service agreement between the parties dated June 20, 2021. LSA has agreed to comply with all securities laws and policies of the TSX Venture Exchange (the “TSXV”) in providing the Services. No stock options or other compensation are being granted in connection with the engagement.

Preliminary Financial Results

The Company had cash on hand as of February 28, 2022 of approximately $40.7 million (unaudited) and working capital of approximately $38.5 million (unaudited). The Company’s annual financial results for the fiscal year ended February 28, 2022 will be reported in June 2022.

About Small Pharma

Small Pharma is a biotechnology company progressing a pipeline of short-acting psychedelics with therapy for the treatment of mental health conditions, with a current focus on depression. Small Pharma initiated a clinical program into DMT-assisted psychotherapy in February 2021. This program includes a Phase I/IIa trial on the Company’s lead candidate alongside the 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 (< 30 mins), 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 most advanced clinical trial in commercial development for DMT-assisted psychotherapy in Major Depressive Disorder.

For further information contact:

Small Pharma Inc.
Peter Rands
Chief Executive Officer
Email: ir@smallpharma.co.uk
Tel: +44 (0)20 7112 9118

Investor Relations Contacts:
Eric Ribner
LifeSci Advisors
Email: eric@lifesciadvisors.com
Tel: +1 (646)-889-1200

Kristi Papanikolaw
KCSA Strategic Communications
Email: smallpharmair@kcsa.com
Tel: +1 (212) 682-6300

Media Relations Contacts:
USA
McKenna Miller
KCSA Strategic Communications
Email: smallpharmapr@kcsa.com 
Tel: +1 (949) 949-6585

Rest of World
Donna Curran
Hanover Communications
Email: dcurran@hanovercomms.com 
Tel: +44 (0)20 7400 4480

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 Company’s continued progression of Phase IIa clinical trials of SPL026, the Company’s preparation for the international multi-site Phase IIb clinical trial of SPL026, the Company’s plans, expectations, timelines and possible outcomes with respect to its anticipated SPL026 study assessing the impact of SSRIs, any statements related to the Company’s initiatives to accelerate time to market and patient access to SPL026, DMT-assisted psychotherapy, the Company’s plans, expectations, timelines and possible outcomes of the further Phase I study of SPL026 comparing IM versus IV modes of administration, and the Company’s ability to develop solutions to effectively address depression through DMT-based therapies.

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.

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.