Company advances ongoing clinical trials with Phase I completed and dosing initiated in Phase IIa trial for lead product candidate, SPL026, a DMT-assisted therapy for the treatment of Major Depressive Disorder
Fast-track Innovation Passport Designation awarded by the MHRA for SPL026
Successful upgrade to the OTCQB® and DTC eligibility
LONDON, Nov. 01, 2021 (GLOBE NEWSWIRE) — 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 second quarter results for the three and six months ended August 31, 2021. A full copy of the results can be found under the Company’s profile on SEDAR at www.sedar.com. Unless otherwise indicated, all currency references are in Canadian dollars.
Recent Operational Highlights (including post-period events):
- Continued progress in Phase I/IIa clinical trial for lead product candidate, SPL026, a DMT-assisted therapy for the treatment of Major Depressive Disorder (“MDD”)
- Successful completion of Phase I
- Initiation of Phase IIa, including the dosing of the first patients
- Topline data readout of Phase IIa anticipated in H1 2022
- Phase IIb anticipated to commence in H2 2022
- Grant of the fast-track Innovation Passport Designation by the U.K. Medicines and Healthcare products Regulatory Agency (the “MHRA”) for SPL026 under its Innovative Licensing and Access Pathway (the “ILAP”)
- Expanded patent portfolio to three granted patents and 41 patent applications pending
- Appointment of Lyne Fortin as non-executive independent chair of the board of directors of the Company
- Expanded the operational team to 14 employees, including Head of Intellectual Property
- Successful upgrade from the OTC’s Pink® Open Market (the “OTC Pink”) to the OTCQB® Venture Market (the “OTCQB”), receipt of Depository Trust Company (“DTC”) eligibility to support trading on the OTCQB
- Inclusion in inaugural launch of AdvisorShares® Psychedelics ETF (“PSIL”)
- Cash on hand as of August 31, 2021, is $50.3 million, which provides sufficient funds to progress clinical development plans including the completion of SPL026’s proof-of-concept clinical trial and pre-clinical development of pipeline candidates towards first-in-human clinical trials.
- Cash used in operating activities of $7.6 million was reported for six months and $3.2 million for three months ended August 31, 2021, respectively.
- Operating expenses for the six months ended August 31, 2021 increased to $8.0 million, compared to $1.9 million during the same period in 2020. This reflects the increased R&D costs related to the acceleration and progression of the Company’s clinical development plans, increased headcount to execute on the Company’s strategic plans and increased public and investor relations activities to broaden corporate awareness. H1 also included one-off costs related to the reverse takeover transaction and listing on the TSX Venture Exchange (the “TSXV”).
Peter Rands, Chief Executive Officer of Small Pharma, said: “We continue to advance our pipeline to fast track the development of new therapies for patients affected by depressive disorders. Our Phase I/IIa clinical trial continues to move forward following the successful results from our Phase I trial, where our lead product candidate SPL026 was deemed safe and well-tolerated in individuals with no previous experience with psychedelics. With the Phase IIa trial of the SPL026 program now dosing MDD patients, this is an exciting time for the Company as we aim to demonstrate the effectiveness of our DMT-assisted therapy portfolio. We anticipate reporting topline results in the first half of next year.”
Mr. Rands continued: “The fast-track ILAP designation granted by the MHRA has the potential to enable a quicker and more efficient development pathway for SPL026 in the U.K., with the opportunity for accelerated access to a novel treatment for patients with MDD. Additionally, we have expanded and matured our patent portfolio and endeavoured to broaden our investor reach through an upgrade to the OTCQB. To support these multiple initiatives, we have expanded our team and will continue to grow as necessary. We also welcomed Lyne Fortin as Chair of the Board. Her in-depth experience will continue to be invaluable as we strive to reach key value inflection points in the coming year.”
Psychedelics have been shown to have therapeutic benefits in disorders such as depression, anxiety, substance abuse and post-traumatic stress disorder. These so-called “internalizing disorders” are characterized by debilitating flows of recurring negative thoughts. Clinical research suggests that DMT has the potential to disrupt the neuronal pathways underlying these negative thought processes and, by doing so, may facilitate the clinical benefits of therapy given in combination with DMT. DMT-assisted therapy aims at targeting the root causes of depression and other “internalizing disorders” and has the potential to provide a treatment with rapid onset and long-lasting antidepressant effects following treatment. DMT is differentiated by offering the potential for a treatment protocol of psychedelic-assisted therapy that is scalable and clinically economical due to its short dosing duration lasting under 30 minutes.
The Company has continued to make good progress across its business segments during the period. While the Phase I/IIa clinical trials remain the key focus, there have been advances across a wide range of work streams. Small Pharma’s strategic priorities include building awareness of DMT-assisted therapies across both the healthcare and investor communities.
Advancement of lead product candidate, SPL026, for the treatment of MDD
Rapid progress of Phase I/IIa clinical trial of SPL026
In June 2021, the Company secured a second U.K. clinical study site, MAC Clinical Research, to accelerate progress in the world’s first regulated clinical trial for DMT-assisted therapy to treat MDD. The Company subsequently completed Phase I of SPL026, which was administered in combination with supportive psychotherapy, in September 2021. The dose-escalating, placebo-controlled Phase I study in 32 healthy volunteers with no previous experience with psychedelics, demonstrated a favorable safety and tolerability profile. The dataset generated from Phase I has enabled the Company to select a dose of SPL026, which elicits a breakthrough psychedelic experience and is safe and well-tolerated, to administer to patients in Phase IIa.
The Company has progressed to the Phase IIa part of the Phase I/IIa clinical trial. In October 2021, the first of 42 patients with MDD was dosed in the blinded, randomized, placebo-controlled, proof-of-concept Phase IIa study of SPL026 in combination with psychotherapy. Phase IIa, which is being conducted at two U.K. clinical trial sites (Hammersmith Medicines Research and MAC Clinical Research) will assess the efficacy of one versus two doses of SPL026 in patients with MDD, while furthering the Company’s safety and tolerability dataset. Efficacy will be assessed using the Montgomery-Asberg Depression Rating scale to measure the severity of depressive episodes before and after treatment. Topline results of Phase IIa are anticipated in the first half of 2022.
Fast-track Innovation Passport designation granted by the MHRA
In October 2021, the MHRA granted an Innovation Passport Designation for SPL026. This designation provides access to the ILAP, which accelerates time to market and facilitates patient access to emerging and novel treatments. The ILAP provides a single integrated platform for sustained collaborative working among the MHRA, its partners and the medicine developer, which potentially allows for enhanced coordination and monitoring of important product development activities culminating in market authorization. Under the ILAP, Small Pharma will have access to a toolkit to support all stages of the design, development and approvals process, as well as identify key areas for future engagement.
Ongoing Phase IIb clinical trial preparation
The Company continues with preparations for its subsequent international multi-site Phase IIb clinical trial for SPL026 in combination with supportive psychotherapy, anticipated to commence in H2 2022. To date, the Company has had positive discussions with the MHRA on the preliminary protocol design for its Phase IIb clinical trial. The Company is also seeking scientific advice from the United States Food and Drug Administration on its Phase IIb clinical trial design.
Grant of European patent strengthens the Company portfolio
In October 2021, Small Pharma received a European patent providing certain protections for oral dosage forms of a range of 2R,6R-hydroxynorketamine (“6-HNK”) based compounds, including the Company’s preclinical candidate SPL801B, for the treatment of depressive disorders. The European patent office has determined the patentability of the novel dosage forms of 6-HNK, an active ketamine metabolite, and provides protection for a solid oral dosage form of SPL801B for administration in combination with a serotonin modulator, for use in the treatment of depressive disorders. Early preclinical studies of SPL801B have shown signs of potential antidepressant effects without the psychoactive effects typically associated with ketamine.
The Company continues to build a robust IP portfolio with three patents now granted and 41 patent applications pending across its psychedelic and non-psychedelic portfolio.
Broadening investor access and corporate presence
As part of the Company’s strategy, Small Pharma has engaged in a range of activities to increase its corporate presence and broaden investor access. This includes participation in leading investor conferences and industry events regarding psychedelics, DMT and mental health.
In September 2021, AdvisorShares® Investments LLC, a leading sponsor of actively managed exchange-traded funds, included Small Pharma in the inaugural launch of PSIL. PSIL invests in the emerging psychedelic drugs sector, offering exposure to biotechnology, pharmaceutical, and life sciences companies leading the way in this nascent industry.
In October 2021, Small Pharma upgraded from the OTC Pink to the OTCQB. The Company also received DTC eligibility to support trading on the OTCQB. The common shares in the capital of the Company continue to trade on the TSXV.
Small Pharma continues to make considerable progress across its portfolio of DMT-assisted therapies with successful advancement in its Phase I/IIa clinical trial for the treatment of MDD and preparation for the Phase IIb clinical trial. In addition, Small Pharma continues to progress preclinical development of its broader DMT portfolio. The continued broadening of its investor support and a stable financial base will allow the Company to rapidly progress and build out its portfolio in the coming year, with the aim of accelerating the development of novel treatments for mental health conditions.
About Small Pharma
Small Pharma is a neuropharmaceutical company specialized in IP led development of novel treatments for mental health conditions, with a focus on depression. Small Pharma initiated a clinical program into DMT-assisted therapy in February 2021. This program includes a Phase I/IIa trial on its lead candidate, SPL026, alongside development of a robust pipeline of proprietary preclinical assets.
DMT is a naturally occurring psychedelic tryptamine found in plants and in the brain of mammals. Scientific evidence suggests DMT offers the potential for rapid-acting and long-lasting antidepressant effects. DMT is differentiated by its short psychedelic experience (<30mins), which allows for short treatment sessions and offers the potential for convenient supervised treatments within patient clinics. Small Pharma is advancing a pipeline of DMT-based therapies and is leading the world’s first DMT clinical trial for depression, in collaboration with Imperial College London.
For further information contact:
Small Pharma Inc.
Chief Executive Officer
Tel: +44 (0)2071 129118
Media Relations Contact
KCSA Strategic Communications
Tel: +1 (949) 949-6585
Investor Relations Contacts
LifeSci Advisors, LLC
Tim Regan/ Adam Holdsworth
KCSA Strategic Communications
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 placebo-controlled, proof-of-concept Phase IIa study of SPL026, the anticipated timing for the readout of topline data for the Company’s Phase IIa trial, the anticipated commencement and timing of the Company’s Phase IIb trial of SPL026, the completion of the Company’s pre-clinical studies and trials and assessment of the efficacy of the trials using the Montgomery-Asberg Depression Rating scale, 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 acceleration of SPL026’s time to market and facilitation of patient access to medicines for emerging and novel treatments, the Company’s access to a toolkit to support all stages of the design, development and approvals process, as well as to identify key areas for future engagement under the ILAP, enhanced coordination and monitoring of important product development activities culminating in market authorization as a result of the ILAP, the Innovation Passport Designation providing potential access to speedier and more efficient development pathways for SPL026, current and future status of the Company’s patent application, rapid advancement and build-out of the Company’s portfolio, the Company’s ability to innovate and develop novel treatment candidates for mental health conditions through ketamine-based candidates, and the Company’s ability to accelerate the development of novel treatment to mental health conditions. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting the Company’s business and results of operations; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.
Small Pharma makes no medical, treatment or health benefit claims about its proposed products. The MHRA or other similar regulatory authorities have not evaluated claims regarding DMT-assisted therapies and other next generation psychoactive compounds. The efficacy of such therapies has not been confirmed by MHRA-approved research. There is no assurance that such DMT-assisted therapies and other psychoactive compounds can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Any references to quality, consistency, efficacy and safety of potential therapies do not imply that Small Pharma verified such in clinical trials or that Small Pharma will complete such trials. If Small Pharma cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Small Pharma’s performance and operations.
This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. Small Pharma’s securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.
The TSXV has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.