Tag: DMT

Cybin Announces Publication of International PCT Patent Application for Inhalation Delivery of Multiple Psychedelic Molecules

TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (Cybin or the Company), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics™”, today announced that the World Intellectual Property Organization (WIPO) published an international patent application covering a range of inhalation delivery methods across multiple psychedelic molecules (Patent Cooperation Treaty (PCT) patent application no.PCT/EP2021/077057), further strengthening its long-term intellectual property (IP) position of psychedelic-based programs.

“The publication of this PCT patent application demonstrates our continued commitment to discovering and developing new psychedelic-based treatment options, in addition to identifying and combining potentially improved and well-controlled delivery systems with these clinical candidates,” said Doug Drysdale, Chief Executive Officer of Cybin. “In addition, our progress to secure IP for unique psychedelic delivery methods strongly aligns and supports our current CYB004 pipeline program of deuterated DMT via inhalation, which is aimed at overcoming some of the known challenges of oral and IV-administered DMT.”

The PCT application titled “Methods For Delivery Of Psychedelic Medications By Inhalation And Systems For Performing The Methods” allows Cybin to pursue patent applications and seek protection for multiple inhaled forms of psychedelic molecules that are currently being researched and developed, or may be developed by the Company in the future.

About Cybin

Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, United Kingdom and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

Cautionary Notes and Forward-Looking Statements

Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements regarding the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens to potentially treat psychiatric disorders.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company’s management’s discussion and analysis for the period ended December 31, 2021 and the Company’s listing statement dated November 9, 2020, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.

Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Investors & Media:
Leah Gibson
Vice President, Investor Relations & Strategic Communications
Cybin Inc.
leah@cybin.comSource: Cybin Inc.

PharmaDrug Advances DMT-Analogue Program for Glaucoma with Production of Medical Device Designed to Provide Sustained Control of Elevated Intraocular Pressure

• Prototype medical device engineered to deliver sustained, sub-psychedelic quantities of candidate DMT-analogues
• In vitro, time dependent drug elution profile evaluated for three candidate molecules
• Biocompatibility of drug-loaded medical device demonstrates cell-based safety at doses anticipated to be within therapeutic range
• Current results provide Company with refined focus for two candidate molecules

Toronto, Ontario -April 7, 2022 – PharmaDrug Inc. (CSE: PHRX) (OTCQB: LMLLF) (“PharmaDrug” or the “Company“), a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs, is pleased to announce that in collaboration with the Terasaki Institute for Biomedical Innovation (TIBI), it has successfully completed fabrication of a novel medical device capable of delivering sustained, low (sub-psychedelic) quantities of their undisclosed tryptamine-based pharmaceutical to the front of the eye; the intended purpose of which is to potentially lower intraocular pressure (IOP) in patients suffering from glaucoma. Additionally, a head-to-head drug elution study of the Company’s three undisclosed DMT-analogue candidates has now been completed and supportive cell-based biocompatibility has been examined for all three candidate molecules. Future in vivo efficacy testing in an accepted model of primary open angle glaucoma (POAG) is currently being planned with the goal of providing all necessary support to file an investigative new drug (IND) application with the United States Food and Drug Administration (the “FDA“) to conduct clinical studies.

Paul Van Slyke, CSO of PharmaDrug commented, “We are excited to announce that our recently fabricated proprietary medical device, designed to deliver controlled release of tryptamine-based pharmaceutical agents, has now progressed from the concept stage into a functioning prototype. Drug release rates were successfully characterized for each of the candidates under evaluation and as such, the current studies provide the Company with the critical data necessary to fine-tune fabrication efforts while also facilitating informed design for its future IND-enabling efficacy studies which will use a well accepted animal model of glaucoma”.

The aim of PharmaDrug’s DMT-analogue research program in ocular health is to develop suitable prototype medical devices capable of sustained ocular drug-delivery while also confirming efficacy, biocompatibility and stability of its candidate molecules in models of elevated IOP. Previous press releases (Feb 23, 2022, and Dec 13, Nov 5, Aug 5, 2021) have provided updates on in vitro potency, surrogate markers of efficacy and safety/toxicity. With today’s announcement the Company is pleased to deliver on several additional key objectives-namely, fabrication of its drug eluting medical device and in vitro biocompatibility test results. The research program scope currently underway includes full establishment and demonstration of candidate molecule loading capacity, release rate evaluations for conjugated materials as well as model organism testing to support an IND application with the FDA in the future.

The Company has now completed fabrication and initial testing of its novel medical device designed to deliver therapeutic quantities of its DMT-analogues to the front of the eye. Specifically, drug-loaded medical device prototypes were suspended in a biological solution meant to mimic the somewhat harsh environment of the eye. Samples, maintained at body temperature were removed at defined periods of time over sixteen days and were quantified to determine concentration and rate of drug elution for each of the Company’s three candidate molecules. The stability of one of the candidate molecules did not meet minimal necessary criteria and has now been eliminated from further consideration. The remaining two DMT-analogues displayed suitable 2-week provisional stability and elution characteristics that support further evaluation and optimization. One candidate molecule/medical device in particular, displayed a consistent drug elution profile from days 2-16 (end of study) suggesting that drug delivery of greater than two weeks may be possible. The biocompatibility of drug-loaded medical devices was examined by way of monitoring cell proliferation and live/dead staining on human ciliary muscle cells over time. Concentrations expected to be within the therapeutic range were found to not statistically impact cell viability for any of the drug-loaded medical devices.

Test article potency was previously evaluated using an in vitro calcium mobilization assay on trabecular meshwork cells; a cell type known to be critically important in the maintenance of healthy IOP. Calcium mobilization is understood to provoke cellular contraction, and specifically in the case of trabecular meshwork cells, is thought to contribute to the maintenance of healthy IOP by channeling aqueous humor away from the front of the eye. Test articles were found to activate calcium mobilization, to levels that were comparable or greater than the experimental positive control, ionomycin. The Company’s test articles were also examined for in vitro toxicity and were found to be non-toxic to trabecular meshwork cells at concentrations expected to be used in treatment for various eye diseases. Collectively the results of the above studies will be used to select a lead development candidate that will be taken forward into in vivo efficacy models for eye diseases, including glaucoma.

The Need for Improved Medications to Treat Primary Open Angle Glaucoma

Glaucoma is a disorder of the optic nerve that results in irreversible vision loss and is the second leading cause of blindness in the world, according to the World Health Organization. Glaucoma impacts more than 2.7 million people aged 40 or older in the United States and current treatments are known to have poor rates of compliance of up to 80% of patients. The global market for glaucoma was estimated by Market Scope at $4.8 billion in 2019 with the U.S. market representing $1.9 billion. Although the exact etiology of primary open angle glaucoma remains poorly understood, and may be variable across patient subsets, it is generally accepted that the observed increase in IOP correlates with progressive vision loss¹. Current treatments for POAG primarily consist of eye drops that can be grouped into three main categories: prostaglandin analogues, carbonic anhydrous inhibitors, and alpha-2 agonists. While these approaches usually provide partial improvement, they often result in side effects such as redness and stinging and require multiple daily applications; all of which diminish patient compliance. Tryptamines, including DMT-analogues are thought to work in a completely distinct way to lower IOP and as such potentially embody a new class of glaucoma medications that may be used alone, or in combination with already approved medications. The Company’s streamlined focus on two highly promising, undisclosed tryptamines as a potential therapeutic solution in treating glaucoma represents a potential paradigm shift.

Modulating the serotonin receptor pathway to improve glaucoma outcomes

Key regions of the eye that regulate fluid dynamics, including maintenance of healthy IOP, are known to be richly decorated with various serotonin receptor family members. Previous research has highlighted the role of serotonin receptor signaling in the regulation of IOP^2-5. Tryptamines, often hallucinogenic above certain threshold concentrations, constitute a large collection of molecules that selectively act on multiple different serotonin receptors including 5-HT1A and 5-HT2A. Topical application of several different tryptamines have shown early promise in preclinical models of elevated IOP, however formulation, delivery, the potential for undesirable hallucinogenic side effects, and the controlled substances act of 1970 have all contributed to a lack of development of tryptamines to treat this serious threat to vision.

About Terasaki Institute for Biomedical Innovation

The Terasaki Institute for Biomedical Innovation is a biotechnology institute which develops medical devices and cutting-edge protocols for a variety of diagnostic, monitoring and treatment applications. Their research platforms include work in biomaterials, cellular and tissue engineering, wearable biosensors and organs-on-a-chip, with specific expertise in novel polymer development.

About PharmaDrug Inc.

PharmaDrug is a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs. PharmaDrug owns 100% of Pharmadrug Production GmbH (“Pharmadrug Production”), a German medical cannabis distributor, with a Schedule I European Union narcotics license and German EuGMP certification allowing for the importation and distribution of medical cannabis to pharmacies in Germany and throughout the European Union. PharmaDrug owns 100% Sairiyo Therapeutics (“Sairiyo”), a biotech company that specializes in researching and reformulating established natural medicines with a goal of bringing them through clinical trials and the associated regulatory approval process in the US and Europe. Sairiyo is currently developing its patented reformulation of cepharanthine, a drug that has shown substantial third party validated potential for the treatment of infectious disease and rare cancers. Sairiyo is also conducting R&D in the psychedelics space for the treatment of non-neuropsychiatric conditions. The Company also owns 100% of Super Smart, a company building a vertically integrated retail business with the goal to elevate the use of functional mushrooms, and psilocybin mushrooms where federally legal, as natural based medicines.

For further information, please contact:

Daniel Cohen, Chairman and CEO
dcohen@pharmadrug.co
(647) 202-124

Caution Regarding Forward-Looking Information:

THE CANADIAN SECURITIES EXCHANGE HAS NOT REVIEWED NOR DOES IT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

This press release contains “forward-looking information” within the meaning of applicable securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. Generally, forward-looking information may be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “proposed”, “is expected”, “budgets”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. In particular, this press release contains forward-looking information in relation to: future in vivo efficacy testing in an accepted model of primary open angle glaucoma (POAG), the ability to complete the required studies and obtain regulatory approval, and the impact the Company’s potential products will have on treating glaucoma. This forward-looking information reflects the Company’s current beliefs and is based on information currently available to the Company and on assumptions the Company believes are reasonable. These assumptions include, but are not limited to the ability of the Company to successfully execute on its plans for the Company and its affiliated entities; the ability to obtain required regulatory approvals and the Company’s continued response and ability to navigate the COVID-19 pandemic being consistent with, or better than, its ability and response to date.

Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; the actual results of the Company’s future operations; competition; changes in legislation affecting the Company; the ability to obtain and maintain required permits and approvals, the timing and availability of external financing on acceptable terms; lack of qualified, skilled labour or loss of key individuals; risks related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures, service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, economic activity, financing, supply chains and sales channels, and a deterioration of general economic conditions; and a deterioration of financial markets that could limit the Company’s ability to obtain external financing.

A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in the Company’s disclosure documents on the SEDAR website at www.sedar.com. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Accordingly, readers should not place undue reliance on forward-looking information. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

The Company’s securities have not been registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or “U.S. Persons”, as such term is defined in Regulations under the U.S. Securities Act, absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in the United States or any jurisdiction in which such offer, solicitation or sale would be unlawful.

Forward-looking information contained in this press release is expressly qualified by this cautionary statement. The forward-looking information contained in this press release represents the expectations of the Company as of the date of this press release and, accordingly, are subject to change after such date. However, the Company expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.

References:

1. Weinreb RN, Leung CK, Crowston JG, Medeiros FA, Friedman DS, Wiggs JL, Martin KR. Primary open-angle glaucoma. Nat Rev Dis Primers. 2016 Sep 22;2:16067. doi: 10.1038/nrdp.2016.67. PMID: 27654570.
2. May JA, McLaughlin MA, Sharif NA, Hellberg MR, Dean TR. Evaluation of the ocular hypotensive response of serotonin 5-HT1A and 5-HT2 receptor ligands in conscious ocular hypertensive cynomolgus monkeys. J Pharmacol Exp Ther. 2003 Jul;306(1):301-9. doi: 10.1124/jpet.103.049528. Epub 2003 Apr 3. PMID: 12676887.
3. Sharif NA. Serotonin-2 receptor agonists as novel ocular hypotensive agents and their cellular and molecular mechanisms of action. Curr Drug Targets. 2010 Aug;11(8):978-93. doi: 10.2174/138945010791591278. PMID: 20426763.
4. Najam A Sharif & Jesse A May (2011) Potential for serotonergic agents to treat elevated intraocular pressure and glaucoma: focus on 5-HT2 receptor agonists, Expert Review of Ophthalmology, 6:1, 105-120, DOI: 10.1586/eop.10.69
5. Sharif NA, McLaughlin MA, Kelly CR. AL-34662: a potent, selective, and efficacious ocular hypotensive serotonin-2 receptor agonist. J Ocul Pharmacol Ther. 2007 Feb;23(1):1-13. doi: 10.1089/jop.2006.0093. PMID: 17341144.

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.