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Small Pharma Shares Business Update Ahead of Annual Financial Results | ||
By: GlobeNewswire - 25 May 2022 | Back to overview list |
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- Appointment of Alastair Riddell as COO 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 EP 3 844 147, Composition of Matter patent 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 Phase IIa clinical trial dosing expected to be completed in coming months Phase IIb clinical trial preparation continues Drug interaction study in patients with MDD expected to commence in H2 2022 UK “Fast-track” Designation Short-acting Psychedelic Programs SPL026 IM Phase I study planned for 2022 SPL028, deuterated DMT-assisted psychotherapy, Phase I clinical trial planned for 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. Investor Relations Contacts: Kristi Papanikolaw Media Relations Contacts: Rest of World 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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