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George Tziras to succeed Peter Rands as Small Pharma Chief Executive Officer

George Tziras to succeed Peter Rands as Small Pharma Chief Executive Officer

– Building on strong foundations to take Small Pharma through development to commercial success

– Peter Rands to take on role as Chief Innovation & Intellectual Property Officer

LONDON, July 18, 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, is pleased to announce that the Company’s board of directors (the “Board”) has appointed Mr. George Tziras as Chief Executive Officer of the Company (“CEO”), effective as of July 20, 2022. Mr. Peter Rands, founder and current CEO, will take on the role of Chief Innovation & Intellectual Property Officer of the Company (“CIIPO”). Mr. Rands will be relocating to the United States as part of a planned succession to better position the business for the later stages of clinical development and establishing the Company’s footprint in the United States. Mr. Rands will continue to serve on the Board following the transition.

Lyne Fortin, Chair of the Board, said: “With key data expected from our lead candidate, SPL026, and the anticipated launch of new clinical trials later this year, we have focused on building strength and breadth to our leadership team. George brings decades of international capital markets expertise and relationships, and critically he brings a sharp focus on corporate strategy to take the business forward at this pivotal stage of the Company’s growth. I would also like to take this opportunity to thank Peter. Small Pharma is the organization it is today due to his vision, entrepreneurship and ambition to find innovative therapeutic solutions for under-served mental health patients. With the recent addition of Dr. Alastair Riddell as COO, and Peter focused on innovation and intellectual property, we have a strong team to support George as he leads Small Pharma in building its reputation as a world leader in alternative treatments for mental health.”

Peter Rands, current CEO and future CIIPO of Small Pharma, added: “I am delighted to be handing the reins of the Company to my colleague, George. The best biotech companies must always have the right person at the top to take them through each stage of development. I am proud of what we have achieved in building the foundations of Small Pharma and now is the right time for George, with his deep understanding of markets, deal structure and business expertise to lead the Company into our critical next phase of evolution. For me, my new role is taking me back to where my heart is: innovation and the protection of it. I look forward enormously to supporting George in this job as we continue to shape the future of mental health treatment.”

George Tziras, current Chief Business Officer (“CBO”) and future CEO of Small Pharma, commented: “I am looking forward to taking on this role and the new challenges it will bring. Small Pharma is a great company with a bright future, which has the potential to deliver new alternative therapies that could change the lives of patients. Peter has done a brilliant job. I am excited to be leading the Company into the next stage of growth.”

Mr. Tziras initially joined Small Pharma in 2015 as a director of Small Pharma Ltd, the Company’s main operating subsidiary, before also being appointed to the role of CBO and director of the Company in 2021. George has been pivotal in building the Company’s reputation across the capital markets, leading to the successful fundraising of CDN$63 million in 2021, and its transformation from a private to a public company.  His role has been responsible for business development and strategy, investor relations and overseeing corporate activities.

Prior to joining Small Pharma full-time, George was an Executive Director at Goldman Sachs. George has over 15 years’ experience in investment banking and international capital markets, having worked at a number of global financial institutions including Credit Suisse, Nomura, Lehman Brothers and CIBC. Over the course of his career, he has executed a broad range of transactions including debt and equity financings; mergers, disposals and acquisitions; and private equity buyouts and debt restructurings, all across a number of industries, including healthcare.

Mr. Tziras holds a BA degree in Economics and Management from the University of Oxford and a MA degree in International Relations from the Johns Hopkins School of Advanced International Studies. 

Option Grant

In relation to Mr. Tziras’ appointment as CEO of Small Pharma, the Board has granted him options to purchase up to an aggregate of 1,000,000 common shares in the capital of the Company (the “Common Shares”) 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) $0.105 per Common Share; and (ii) the closing price of the Common Shares on July 18, 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.   

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 N,N-dimethyltryptamine (“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 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.

For further information contact: 

Small Pharma

Peter Rands Chief Executive Officer

Email: ir@smallpharma.co.uk  

Tel: +44 (0)20 7112 9118

Media Relations Contacts:

USA: McKenna Miller

KCSA Strategic Communications

Email: smallpharmapr@kcsa.com

Tel: +1 (949) 949-6585

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

Rest of World:

Jaber Mohamed

Email: smallpharma@mhpc.com

Tel: +44 (0)7720 326 487

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 release of key data from the Company’s SPL 026 Phase IIa clinical trials; the timeline for the anticipated launch of additional clinical trials; the Company’s ability to deliver novel treatments and build its reputation as a world leader in alternative treatments for mental health; 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 TSX Venture Exchange (“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.

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Small Pharma Reports Fiscal First Quarter 2023 Highlights

Small Pharma Reports Fiscal First Quarter 2023 Highlights

– Progress continues apace with multiple trials expected to enter clinic later this year

– First US patent granted

LONDON, July 15 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, has today published its financial results for the quarter ended May 31, 2022. 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 in Canadian dollars.  

Financial Highlights 

  • Cash on hand as of May 31, 2022 was $32.0 million. Cash is net of an unrealized loss of $2.3 million arising from foreign exchanges incurred due to a strengthening of the Canadian dollar against the British pound sterling (“GBP”) during the quarter; however, as most of the Company’s operating costs are incurred in GBP, the loss has little impact on the underlying cash burn of the Company.
  • Cash used in operating activities was $6.3 million for the three months ended May 31, 2022.
  • Operating expenses for the three months ended May 31, 2022 were $5.8 million.
Business Highlights (including post-period events)

Ultra Short-acting Psychedelic Program

  • Progress continues in the Phase I/IIa clinical trial of the Company’s lead program, SPL026 intravenous (“IV”) N,N-dimethyltryptamine (“DMT”) assisted psychotherapy for Major Depressive Disorder (“MDD”). Phase IIa patient dosing is expected to complete in the coming months. Updates on trial completion and topline data timing are anticipated throughout H2 2022.
  • Drug interaction Phase Ib study in MDD patients CTA submission complete; study expected to commence in H2 2022.
    • Assessment of safety, tolerability, pharmacokinetics and pharmacodynamics of DMT-assisted psychotherapy when administered with serotonin reuptake inhibitors (“SSRIs”), .
  • Preparation is ongoing for the Phase IIb international multi-site clinical trial.

Short-acting Psychedelic Programs

  • Phase I study evaluating SPL026 intramuscular (“IM”) is planned for H2 2022 to compare the treatment profile of IM and IV modes of administration.
  • Phase I study evaluating SPL028 deuterated DMT-assisted psychotherapy is planned for H2 2022.

Corporate Activity

  • Strong IP Portfolio with 8 granted patents and 75 patent applications pending across the Company’s psychedelic and non-psychedelic portfolio.
    • Two new patent grants in July 2022:
      • One patent received is a US patent that strengthens the company’s portfolio surrounding certain salt forms of 2R,6R-hydroxynorketamine (“6-HNK”), including SPL801B.
      • Second patent received is a European patent providing protection for high concentration oral dosage forms of 6-HNK salts, including SPL801B.
    • Continued participation in key investor events such as the PSYCH Symposium London, Jefferies Healthcare Conference and HC Wainwright Mental Health Conference.

Peter Rands, Chief Executive Officer of Small Pharma, said:

The remainder of 2022 is expected to be a busy one for our team as we approach the latter stages of the SPL026 Phase IIa clinical trial and prepare to progress a number of new planned trials into the clinic. Although across the world, our industry is facing challenging markets right now, we believe that Small Pharma remains in a strong position with our world-class team, robust pipeline and strong cash position as we strive to change the therapeutic paradigm for these much underserved patients with the option of better mental health treatments.”

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 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.

For further information contact: 

Small Pharma

Peter Rands Chief Executive Officer

Email: ir@smallpharma.co.uk  

Tel: +44 (0)20 7112 9118

Media Relations Contacts:

USA: McKenna Miller

KCSA Strategic Communications

Email: smallpharmapr@kcsa.com

Tel: +1 (949) 949-6585

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

Rest of World:

Jaber Mohamed

Email: smallpharma@mhpc.com

Tel: +44 (0)7720 326 487

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 IV, including the expected timeline for completion of patient dosing, trial progress and the release of the Phase IIa data; the expected timeline for commencing a drug interaction patient study assessing the impact of SSRIs; 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 comparing IM versus IV modes of administration as well as the Company’s Phase I study of SPL028 deuterated DMT-assisted psychotherapy; the Company’s ability to pursue novel treatments to provide better mental health treatments; 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 U.K. Medicines and Healthcare Products Regulatory Agency (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 TSX Venture Exchange (“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.

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Small Pharma Reports Highlights for the Fiscal Year Ended February 28, 2022

Small Pharma Reports Highlights for the Fiscal Year Ended February 28, 2022

– Reporting its financial results and continued progress across short-acting psychedelics portfolio – Executive team and IP position strengthened
LONDON, June 09, 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, has today published its financial results for the fiscal year ended February 28, 2022. A complete copy of the audited consolidated financial statements prepared in accordance with International Financial Reporting Standards and the corresponding management’s discussion and analysis can be found under the Company’s profile on SEDAR at www.sedar.com. Unless otherwise indicated, all currency references are in Canadian dollars.

Financial Highlights

Cash on hand as of February 28, 2022 of $40.7 million
Cash used in operating activities of $16.2 million for the 12 months ended February 28, 2022.
Operating expenses for the 12 months ended February 28, 2022 were $18.1 million.
Business Highlights (including post-period events)

Ultra Short-acting Psychedelic Program: SPL026

The Company’s lead program, SPL026 intravenous (“IV”) N,N-dimethyltryptamine (“DMT”) assisted psychotherapy in major depressive disorder (“MDD”), is in the Phase IIa part of the Phase I/IIa clinical trial, with completion of patient dosing expected in coming months.
Drug interaction patient study expected to commence in H2 2022, assessing the impact of selective serotonin reuptake inhibitors (“SSRIs”) on the safety, tolerability, pharmacokinetics and pharmacodynamics of SPL026 with psychotherapy.
Preparation is continuing for the international multi-site Phase IIb clinical trial, with further scientific advice requested from the United States Food and Drug Administration (the “FDA”), the UK Medicines and Healthcare products Regulatory Agency (the “MHRA”) and the European Medicines Agency (the “EMA”). A centralized Contract Research Organization to support the execution of the study has been selected.
Short-acting Psychedelic Programs

SPL026 IM preclinical program has been completed. Phase I study is currently planned for H2 2022 to compare the treatment profile of intramuscular (“IM”) and IV modes of administration.
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 planned for H2 2022.
Intellectual Property

Continued to build upon its existing patent portfolio to a total of six granted patents (including two new Composition of Matter patents) and 74 patent applications pending across the Company’s psychedelic and non-psychedelic portfolio.
Strengthening of Executive Team

Appointment of Dr. Alastair Riddell as Chief Operating Officer and Ms. Marie Layzell as Chief Manufacturing and Development Officer to support the growing pipeline of molecules as they progress into and through clinical trials.
Peter Rands, Chief Executive Officer of Small Pharma, said:

“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. 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. 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.”
Option Grants

The board of directors of the Company has granted options to purchase up to an aggregate of 6,300,000 common shares in the capital of the Company (the “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) $0.16 per Common Share; and (ii) the closing price of the Common 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.

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

Peter Rands Chief Executive Officer

Email: ir@smallpharma.co.uk

Tel: +44 (0)20 7112 9118

Media Relations Contacts:

USA: McKenna Miller

KCSA Strategic Communications

Email: smallpharmapr@kcsa.com

Tel: +1 (949) 949-6585

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

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 IV, including the expected timeline for completion of patient dosing; 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 drug interaction patient study assessing the impact of SSRIs; 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 Phase I clinical trial for the SPL028 deuterated DMT-assisted program; the expected roles of Mr. Riddell and Ms. Layzell as the Company progresses through clinical trials; the ability for short-acting psychedelics to provide mental health treatments and be scalable for patients; 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 TSX Venture Exchange (“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.

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Small Pharma Shares Business Update Ahead of Annual Financial Results

Small Pharma Shares Business Update Ahead of Annual Financial Results

– Appointment of Alastair Riddell as COO

– Two new Composition of Matter patents granted for pipeline projects

– Progress continues across short-acting psychedelics portfolio


May 25, 2022 – London, United Kingdom – 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

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

Media Relations Contacts:

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

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

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.

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Small Pharma To Present at the KCSA Psychedelics Virtual Investor Conference on April 28, 2022

Small Pharma To Present at the KCSA Psychedelics Virtual Investor Conference on April 28, 2022

Live Presentation To Take Place at 9:30AM ET / 2:30PM GMT

April 27, 2022 – London, United Kingdom – 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, announces that Peter Rands, Chief Executive Officer, and Dr. Carol Routledge, Chief Medical and Scientific Officer, will present live at the KCSA Psychedelics Virtual Investor Conference at www.virtualinvestorconferences.com.

Details for the live presentation are as follows:    

DATE: April 28, 2022

TIME: 9:30AM ET / 2:30PM GMT

LINK: https://bit.ly/37mU2p6


The live virtual presentation by the Company will be followed by an opportunity for investors to ask the Company questions in real-time. If attendees are not able to join the event live on the day of the conference, an archived webcast will be made available after the event on the Company’s website. 

To schedule a one-on-one meeting with Small Pharma’s management team, please contact KCSA Strategic Communications at SmallPharmaIR@kcsa.com.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 N,N-dimethyltryptamine (“DMT”) assisted psychotherapy in February 2021. This program includes a Phase I/IIa trial on the Company’s lead candidate 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 (< 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

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

Media Relations Contacts:

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

Investor Relations Contacts:

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

Tim Regan/Adam Holdsworth KCSA Strategic Communications Email: tregan@kcsa.com Tel: +1 (347) 487-6788

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

Cautionary Note

Small Pharma makes no medical, treatment or health benefit claims about its proposed products. The UK Medicines and Healthcare products Regulatory Agency (“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 TSX Venture Exchange (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.Company Updates

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Two approaches to treating depression with DMT

Small Pharma Expands Potential of Commercial Portfolio with DMT-based Psychedelic Assets

After finding its DMT formulation to be well-tolerated, Small Pharma (DMT) is launching two new trials this year. 

One will assess how DMT interacts with SSRIs in patients with depression and the other will compare the drug’s effects when administered through muscles versus veins. 

The company has also developed a form of DMT that lasts longer than the typical 30 minute trip, but is still much shorter than a psilocybin or LSD trip.

Biomind Labs (BMND) is taking the opposite approach. The company reduced a DMT trip to just 10-15 minutes by making a formulation that’s inhalable.

Biomind’s formulation will be assessed in a Phase II trial for treatment-resistant depression, which just received approval by the Brazilian Institutional Review Board.

We’re eager to see if the length of the trip makes a difference!

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Biomind Labs Inc.

PDF of article 1

PDF of article 2

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World’s first DMT trial for depression

World’s First clinical trial for DMT-assisted therapy in Major Depressive Disorder Shows Consistent Quality of Psychedelic Response in Phase I

Small Pharma (DMT) successfully completed a phase I trial on the safety of DMT in preparation for a phase II trial on depression. Researchers discovered that:

  • Most of the 24 patients described the experience as pleasurable and not too challenging (even though no one had tried psychedelics before)
  • Although there were 20 adverse events (85% mild, 15% moderate, and 0% severe), no patient regretted participating
  • The trip lasted 20 minutes, and DMT was nearly undetectable in the blood after 60 minutes
  • For three months following the dose, there were no significant negative effects on anxiety or well-being

Phase II results are expected in the first half of this year, which will reveal how one dose compares to two doses in treating depression.

PDF of article

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World’s First clinical trial for DMT-assisted therapy in Major Depressive Disorder Shows Consistent Quality of Psychedelic Response in Phase I

World’s First clinical trial for DMT-assisted therapy in Major Depressive Disorder Shows Consistent Quality of Psychedelic Response in Phase I

In the Phase I clinical trial, participants were administered SPL026 and underwent a 20-minute psychedelic experience

Phase I full dataset demonstrates consistent dose related effects on the intensity and quality of the psychedelic experience

February 22, 2022 – London, United Kingdom – Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a neuropharmaceutical company focused on psychedelic-assisted N,N-dimethyltryptamine (“DMT”) therapies for mental health, is pleased to share the analysis of Phase I data from the combined Phase I/IIa clinical trial of SPL026 with psychotherapy for the treatment of Major Depressive Disorder (“MDD”).

In the dose-escalating, placebo-controlled Phase I study, 32 healthy psychedelic naïve volunteers across four dose cohorts received either SPL026 in combination with psychotherapy (n=24) or placebo (n=8). This analysis provides additional insight into dose-related effects on the primary outcomes of safety and tolerability as well as on pharmacodynamic measures, including the treatment experience and subject well-being.

Dr. Carol Routledge, Chief Medical and Scientific Officer of Small Pharma said:

The analysis of the unblinded data set supports our choice to explore the antidepressant potential of our selected dose of SPL026 in the Phase IIa trial. Given the subjectivity of the psychedelic experience, it was exciting to see a close correlation between levels of drug in the body and pharmacodynamic endpoints. As for the subjects’ experience, most reported that it was pleasurable, not too challenging, and most importantly, nobody expressed any regrets. Additionally, the strong safety profile and rapid clearance of SPL026 from the body provides the potential for a scalable treatment with limited monitoring needs post dosing.”

Key Results

  • No drug-related serious adverse events and minimal short-lived adverse events reported on dosing day.
  • Of 20 drug-related adverse events, all were mild (85%) or moderate (15%) and resolved rapidly and independently.
  • No statistically significant negative effects on anxiety and well-being identified at any point during the three-month follow-up.
  • Data show a clear correlation between quality of psychedelic experience and dosing levels, starting at 9mg and up to 21.5mg, across all four cohorts.
    • Participant-reported scores, using a 0 to 100 scale, on the richness of the psychedelic experience demonstrated increasing values of 48 (9mg), 79, 79, 88 (21.5mg) across the four increasing doses. A dose correlation was seen across most patient-reported scores.
    •  Therapist assessment of the predicted therapeutic benefit of SPL026 demonstrated a positive relationship with dose.
  • In the majority of participants, there was a strong correlation between levels of N,N-dimethyltryptamine (“DMT”) in the body and the quality and intensity of the psychedelic experience.
  • IV administration of SPL026 offers a short-lived, well-tolerated psychedelic experience of ~20 minutes, enabling a dosing session to last only ~30 minutes.
  • Pharmacokinetic sampling supported rapid clearance out of the body, showing near undetectable DMT levels in the blood by 60 minutes at all investigated doses.

The data confirms the selected dose of SPL026 taken forward into Phase IIa most consistently delivers the target treatment profile across subjects through a multi-dimensional assessment including safety, tolerability, pharmacokinetic and pharmacodynamic parameters. The full dataset is anticipated to be published in a peer reviewed journal.

David Erritzoe of Imperial College London, Chief Investigator of the Phase I/IIa study said:

Psychedelic-assisted therapies have the potential to completely change the treatment paradigm of mental health conditions. The additional insights from Small Pharma’s Phase I study show promising results at this stage of the development. The dosing time of 30 minutes, in comparison with up to 6 hours seen with alternative approaches, has the potential to offer a real benefit in terms of treatment regimen for both patients and providers.”

The blinded, randomized, placebo-controlled, proof-of-concept Phase IIa study of SPL026 in combination with psychotherapy in 42 patients with MDD remains on track to deliver topline results in the first half of 2022. This study will assess the efficacy of one dose of SPL026 versus a placebo, and one versus two doses of SPL026 in combination with psychotherapy in patients with MDD while bolstering existing safety and tolerability data. 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

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

Tim Regan
KCSA Strategic Communications
Email: smallpharmair@kcsa.com
Tel: +1 (347) 487-6788

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 progress in Phase I/IIa clinical trial of SPL026, the anticipated timing for the readout of topline data for the Company’s Phase IIa trial, the Company’s advancement of pre-clinical trials into new clinical trials, including the anticipated commencement and timing of the Company’s Phase IIb trial of SPL026, the Company’s success in launching a clinical program into DMT-assisted therapy, the Company’s ability to develop solutions to effectively address depression through DMT-based therapies, the potential of DMT-assisted therapies to transform the lives of patients suffering with MDD, the ILAP providing potential access to speedier time to market and facilitation of patient access to emerging and novel treatments, and the Company’s development of a robust pipeline of proprietary preclinical assets. 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 U.K. Medicines and Healthcare products Regulatory Agency (“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 TSX Venture Exchange (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.

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Small Pharma Reports Fiscal Third Quarter 2021 Highlights

Small Pharma Reports Fiscal Third Quarter 2021 Highlights

Significant progress made across the clinical portfolio with lead candidate advancing through trials

January 31, 2022 – London, United Kingdom – Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a neuropharmaceutical company focused on psychedelic-assisted N,N-dimethyltryptamine (“DMT”) therapies, has today published its third quarter results for the three and nine months ended November 30, 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 in Canadian dollars.

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 United States Food and Drug Administration 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 (the “MHRA”) in October 2021, Small Pharma completed the first step to access the Innovative Licensing and Access Pathway (the “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 the Board with the appointment of Paul Maier as Independent Director. Mr. Maier joins Small Pharma with over 30 years’ experience in senior executive roles in U.S. public companies across the biopharmaceutical and biotech industry.

Financial Highlights

  • Cash on hand as of November 30, 2021 of $45.6 million.
  • Cash used in operating activities of $3.5 million for the three months ended November 30, 2021.
  • Operating expenses for the three months ended November 30, 2021 were $4.6 million.

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.”

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

Peter Rands
Chief Executive Officer
Email: ir@smallpharma.co.uk

Media Relations Contacts:

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

Investor Relations Contacts:

Eric Ribner
LifeSci Advisors
Email: eric@lifesciadvisors.com

Tim Regan/Adam Holdsworth
KCSA Strategic Communications
Email: smallpharmair@kcsa.com Tel: +1 (347) 487-6788

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 progress in Phase I/IIa clinical trial of SPL026, the anticipated timing for the readout of topline data for the Company’s Phase IIa trial, the Company’s advancement of pre-clinical trials into new clinical trials, including the anticipated commencement and timing of the Company’s Phase IIb trial of SPL026, the Company’s success in launching a clinical program into DMT-assisted therapy, the Company’s ability to develop solutions to effectively address depression through DMT-based therapies, the potential of DMT-assisted therapies to transform the lives of patients suffering with MDD, the ILAP providing potential access to speedier time to market and facilitation of patient access to emerging and novel treatments, and the Company’s development of a robust pipeline of proprietary preclinical assets. 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 TSX Venture Exchange (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.

Posted on

Small Pharma to Participate in the H.C. Wainwright 2nd Annual Psychedelics Virtual Conference on December 6, 2021

Small Pharma to Participate in the H.C. Wainwright 2nd Annual Psychedelics Virtual Conference on December 6, 2021

LONDON, Dec. 01, 2021 (GLOBE NEWSWIRE) — Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a neuropharmaceutical company focused on psychedelic-assisted therapies, announces its participation in the H.C. Wainwright 2nd Annual Psychedelics Conference, which is being held virtually on Monday, December 6, 2021. A webcast presentation hosted by Peter Rands, Small Pharma’s Chief Executive Officer, will be available to view on demand beginning on December 6, 2021 at 7:00 a.m. ET. The webcast will also be made available on the Events and Conferences page of the Company’s website.

Webcast Information:
Presenter: Peter Rands, Chief Executive Officer
Date: Monday, December 6th, 2021
Time: available on demand
Webcast Link: Click Here

Virtual Meeting Availability:
To schedule a one-on-one meeting with the Small Pharma’s management team at the H.C. Wainwright Conference, please contact your appropriate representative directly, or email H.C. Wainwright at lk@hcwco.com.

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 N,N-dimethyltryptamine (“DMT”) assisted therapy in February 2021. This program includes a Phase I/IIa trial on its lead candidate 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 major depressive disorder, 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

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

Investor Relations Contacts
Eric Ribner
LifeSci Advisors
Email: eric@lifesciadvisors.com

Tim Regan/Adam Holdsworth
KCSA Strategic Communications
Email: smallpharmair@kcsa.com
Tel: +1 (347) 487-6788

Cautionary Note
Small Pharma makes no medical, treatment or health benefit claims about its proposed products. The UK Medicines and Healthcare products Regulatory Agency (“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 TSX Venture Exchange (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.