Small Pharma Releases Second Quarter Fiscal 2023 Highlights

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Last patient dosed in Phase IIa trial for lead product candidate, SPL026, with supportive therapy for treatment of major depressive disorder

Completion of 12-week follow-up planned by year-end with data shortly thereafter

Launch of an SSRI drug interaction study

MHRA approval for new SPL026 trial

LONDON, Oct. 14, 2022 (GLOBE NEWSWIRE) — Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” Where “small pharmacy”), a biotechnology company specializing in short-acting psychedelic-assisted therapies for mental health conditions, today released its financial results for the three and six months ended August 31, 2022. A full copy financial results can be found under the Company Profile on SEDAR at www.sedar.com. Unless otherwise stated, all currency references are in Canadian dollars.

Financial highlights (including subsequent events):

  • Cash at August 31, 2022 was $27.1 million. Cash is net of an unrealized loss of $3.4 million resulting from exchange rates incurred due to a strengthening of the Canadian dollar against the British pound (“GBP”) during the second trimester; however, as most of the Company’s operating costs are incurred in GBP, the loss has little impact on the Company’s underlying cash burn.
  • Cash flows used in operating activities were $6.0 million for the three months ended August 31, 2022.
  • Operating expenses for the three months ended August 31, 2022 were $7.5 million.
  • Normal course issuer bid permitting the repurchase by the Company of up to five million common shares in the capital of the Company, representing 1.55% of the issued and outstanding common shares, over a period of 12 months.

Operational highlights (including post-period events):

Ultra short acting psychedelic program

  • Dosing was completed in the Phase IIa clinical trial of SPL026 intravenously (“IV”) N,N-dimethyltryptamine (“DMT”) with supportive therapy for major depressive disorder (“private label”), as no serious drug-related adverse events have been reported to date. The trial requires patient follow-up for 12 weeks after their second dose, which is expected to be completed by the end of 2022. Data is expected shortly thereafter.
  • The preparation of the international multi-site phase IIb clinical trial SPL026 continues after further discussions with the European Medicines Agency (the “EMA“) and the United States Food and Drug Administration (the “FDA”).
  • Selective serotonin reuptake inhibitorSSRIs”) Drug interaction A phase Ib study in patients with MDD was initiated after approval from the UK Medicines and Healthcare Products Regulatory Agency (“MHRA”). This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPL026 with supportive treatment when administered with SSRIs.

Short-acting psychedelic programs

  • Clinical Trial Application (“call to action”) approval received from the MHRA for the phase I study evaluating SPL026 by the intramuscular route (“I AM”) to compare the treatment profile of IM and IV modes of administration.
  • CTA submission completed for Phase I study evaluating SPL028 deuterated DMT with supportive therapy.

Corporate activity

  • Leadership team established with George Tziras appointed CEO and Dr Alastair Riddell appointed COO. Peter Rands has assumed the role of Director of Innovation and Intellectual Property and Marie Layzell has been named Director of Manufacturing and Development.
  • Intellectual property (“IPs”) portfolio further strengthened with the grant of 3 new patents, bringing the total to 11 patents granted and 72 patent applications pending across the Company’s psychedelic and non-psychedelic portfolio.
    • First patent granted in the United States in the company’s psychedelic portfolio under patent no. 11,406,619 provides protection for new injectable formulations of DMT and deuterium-substituted DMT, including the active ingredients in SPL026 and SPL028. The patent also protects new injectable formulations of other known psychedelic compounds, including 5-methoxy-DMT and psilocybin.
    • Canadian patent no. 3104072 protects the composition of the material from certain deuterated analogues of DMT, including the active ingredient of SPL028. It adds to the company’s existing UK and European patents for SPL028, strengthening its protection in key international markets.
    • European patent no. 3902541 protects the use of a small group of deuterated DMT compounds in therapy, effectively covering all therapeutic uses of the specified compounds. The patent will provide broad protection for the company’s pipeline of deuterated compounds.
  • The company’s Director of Research and Development, Dr. Ellen James, will present data from the Phase I trial of SPL026 at the European College of Neuropsychopharmacology conference in Vienna on Sunday, October 16, 2022.

George Tziras, Managing Director of Small Pharma, said, “Over the summer months, our team has made significant progress in our pipeline of short-acting psychedelic-assisted therapies, with a focus on advancing new trials into the clinic and expanding our IP portfolio. , including a key US patent grant. We continue to expand our SPL026 clinical program with the initiation of an SSRI drug interaction study and regulatory approval of another Phase I trial. We are also approaching a key milestone: the completion of our trial Phase IIa SPL026 clinical trial in patients with MDD. The assay is now complete and we eagerly await the results to learn more about the potential effectiveness of short-acting psychedelics in the treatment of MDD.

About Small Pharma

Small Pharma is a biotechnology company developing a pipeline of short-acting psychedelic-assisted therapies for the treatment of mental health conditions. The company is currently focused on exploring new therapeutic approaches for depression. Small Pharma’s lead candidate, SPL026, is a proprietary synthetic formulation of DMT. The Company is advancing a clinical program of intravenous SPL026 with supportive therapy for the treatment of MDD, which has received an Innovation Passport designation from the MHRA. In addition, Small Pharma has a pipeline of proprietary preclinical assets in development.

For more information, contact:

Petite Pharma Inc.
George Tziras, Managing Director
E-mail: [email protected]
Tel: +1 (646) 751-4363

Investor Relations:
Eric Ribner
LifeSci Advisors
E-mail: [email protected]
Such. : +1 (646) 889-1200

Media Relations:
Jaber Mohammad
MHP Communications
Email: [email protected]
Tel: +44 (0)7720 326 847

Caution Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information”) within the meaning of applicable Canadian securities laws. All statements, other than statements of historical facts, are forward-looking information and are based on expectations, estimates and projections as of the date of this press release. Any statement that discusses future predictions, expectations, beliefs, plans, projections, goals, assumptions, events or performance (often, but not always, using expressions such as “s’ expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “expected”, “expects”, “estimates”, “believes” or “intends” or variations of these words and phrases or indicating that certain actions, events or results “may” or “might”, “would”, “might” or “will” be assumed to occur or be realized) are not statements of historical fact and may be forward-looking information. Forward-looking statements in this press release include statements regarding the expected timeline for patient follow-up and data readout for the Company’s Phase IIa clinical trial; the planned start of the Company’s Phase IIb trial of SPL026; the Company’s SSRI drug interaction study with SPL026; the Company’s Phase I study evaluating SPL026 IM; the Company’s Phase I study evaluating deuterated DMT SPL028 with supportive therapy; the protections offered by European patent no. 3902541 and the company’s ability to advance short-acting psychedelic-assisted therapies for the treatment of mental health conditions

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 cannot guarantee that the expectations in such forward-looking information will prove to be correct. Known and unknown risks, uncertainties and other factors that may cause actual results and future events to differ materially from those expressed or implied by such forward-looking information. These factors include, but are not limited to: compliance with numerous 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 undertakes no obligation to update or revise forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting this forward-looking information. -search for information or other.

Small Pharma makes no medical, treatment or health benefit claims regarding the products it offers. The MHRA or other similar regulatory authorities have not evaluated claims regarding DMT-assisted therapies and other next-generation psychoactive compounds. The effectiveness of such therapies has not been confirmed by MHRA-approved research. There is no guarantee that these therapies assisted by DMT and other psychoactive compounds can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. Any reference to the quality, consistency, efficacy and safety of potential therapies does not imply that Small Pharma has verified it in clinical trials or that Small Pharma will complete such trials. Failure by Small Pharma to obtain the necessary approvals or research to commercialize its business could have a material adverse effect on Small Pharma’s performance and operations.

The TSX Venture Exchange (“TSXV”) has neither approved nor disapproved of the contents of this press 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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