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”) inOctober 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 joinsSmall Pharma with over 30 years’ experience in senior executive roles inU.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 endedNovember 30, 2021 . - Operating expenses for the three months ended
November 30, 2021 were$4.6 million .
About
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.
For further information contact:
Chief Executive Officer
Email: ir@smallpharma.co.uk
Tel: +44 (0)2071 129118
Media Relations Contact
Email: smallpharmapr@kcsa.com
Tel: +1 (949) 949-6585
Investor Relations Contacts
Email: eric@lifesciadvisors.com
Email: smallpharmair@kcsa.com
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that constitute “forward-looking information” (“forward-looking information”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward-looking statements in this news release include statements regarding the Company’s continued progress in Phase I/IIa clinical trial of SPL026, the expected timing of the dataset for the Phase I clinical trial, 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.
The
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