Permission enables company to conduct research with potentially patentable outcomes
Rare permission granted due to Company's commitment to knowledge transfer and species preservation
Research Partnership with Universidad Peruana Cayetano Heredia
Toronto, Ontario--(Newsfile Corp. - July 27, 2023) - Neural Therapeutics Inc. ("Neural" or the "Company") is pleased to announce that after nearly 11 months of a rigorous review process, the Company has received a key permission from Servicio Nacional Forestal y de Fauna Silvestre ("SERFOR"), the National Service for Forest and Wildlife, part of Peru's Ministry of Agriculture, which is in charge of regulating forest and wildlife. Due to the special nature of the Company's request, the application was further reviewed and approved by The Ministry of the Environment (MINAM). This permit provides the Company with access to genetic resources and their derivatives for the evaluation of the mescaline-containing cactus species of the Echinopsis genus (commonly known as San Pedro or Huachuma) for possible medicinal purposes.
Highlights
Neural receives a rare Peruvian permit to harvest and study San Pedro cacti;
The Company is planning to develop intellectual property that will lead to drug development;
The Company has previously partnered with Universidad Peruana Cayetano Heredia ("Cayetano University"), a recognised national institute which is permitted to carry out genetic and chemical studies; and
Neural commits to sustainable practices including replanting, donating samples for genetic preservation and publishing biomarker data to aid in wild stand preservation.
Management Commentary
Ian Campbell, Neural CEO, commented, "We are very pleased with the receipt of this crucial permit, which plays an important role in establishing legally compliant supply chain for the plant material that is required to commence our research towards the development of therapies for stress related disorders such as depression, substance use and anxiety. Furthermore, we anticipate certain outcomes related to products and processes to be potentially patentable."
The Research – Developing Intellectual Property
As part of its research, the Company intends to sequence the Echinopsis genome, information that to date has been unavailable in the scientific literature. This is of great importance towards obtaining future approvals of mescaline-based therapies by the various international medical regulators, such as the United States Food and Drug Administration and Health Canada.
In connection with the SERFOR permit, the Company has also entered into a contract with SERFOR ("SERFOR Contract"), which sets out the conditions under which the Company and its partners are permitted to carry out such research and development activities. Pursuant to the SERFOR Contract, the Company has been granted permission to file for patents related to derivatives of the genetics, as well as process related discoveries made during the research. In this way, the Company will retain all intellectual property related to its studies, apart from the plant's actual natural genome. The framework also helps to ensure that the Company's supply chain is established with the highest level of integrity and sustainability.
Mr. Campbell added, "We expect that the development of intellectual property will create significant value for the Company. We are also very aware of the cultural and historical importance of this plant for the indigenous and other communities within Peru and elsewhere, and do not intend to file for plant-genetic based patents. It is important to recognize that we owe a debt to these communities, and by conducting this research, we will also give back to these communities that have made this important research possible. We intend to publish the key genetic markers for species identification within this genus, thereby contributing to enhancing the longevity of this plant for future generations through organizations like SERFOR."
Mescaline – San Pedro
Mescaline is a chemical compound (and classified as a psychedelic with potential medicinal/therapeutic applications) derived from the Peyote and San Pedro cacti. Peyote, found in certain regions of North and Central America, is sacred to many indigenous populations. Furthermore, Peyote takes decades to mature and is considered endangered by various conventions including Convention on International Trade in Endangered Species of Wild Fauna and Flora ("CITES"). In comparison, the San Pedro cactus grows significantly faster with a greater biomass and is harvestable in a shorter time frame.
In 2022, the Peruvian Ministry of Culture declared the traditional use of San Pedro cactus in northern Peru as cultural heritage. According to various historic records, San Pedro has been used by humans for traditional and religious purposes for close to 6,000 years and has been exploited commercially for the past few hundred years, which is condoned by the Peruvian government. Given the documented historical use, the Company believes, that such evidence provides additional confidence in the potential positive outcome of Neural's planned pre-clinical studies (focusing on toxicity) and Phase I clinical studies (focusing on safety in healthy humans).
Neural will continue to work with various regulatory bodies to ensure a transfer of knowledge fostering environmental stewardship of the Echinopsis genus, starting with the genetic sequencing as a part of its partnership with Cayetano University.
Mr. Campbell continued, "To receive this kind of permission is rare due to the cultural and religious significance of these plants. We are committed to developing medicinal products that have the power to profoundly improve peoples' quality of lives. Our intended biological sampling plan provides for replanting to ensure that plant density is not compromised by our efforts. Additionally, we will donate specimens to a Peruvian sanctioned local herbarium for future scientific studies and species preservation."
About Neural Therapeutics
Neural is a drug-discovery company focusing on plant based active substances with the goal of delivering beneficial over-the-counter dietary-supplements and psychedelic-based therapeutic-medicines to treat serious mental ailments where no significant treatment is available today. Neural's key ingredient is mescaline derived from cacti. Neural has established a supply chain in Peru to source certain species of mescaline containing cacti, such as the San Pedro cactus, and has applied for and received the requisite permits with the National Service for Forest and Wildlife or Servicio Nacional Forestal y de Fauna Silvestre ("SERFOR"), to collect wild species of cacti within Peru for research purposes.
Neural Therapeutics is an unlisted reporting issuer in the Provinces of British Columbia, Alberta and Quebec.
For more information
Marc Lakmaaker
T: +1.647.289.6640
E: mlakmaaker@gmail.com
CAUTIONARY DISCLAIMER STATEMENT
No securities regulatory authority has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to the outlook for the psychedelic products and related industries; the achievement, and the timing of, certain development milestones and the successful execution of Neural's business strategy (including its business model and mission); anticipated capitalization, projected milestones and the go-forward management of Neural; timing and ability to complete any financings; timing and success of securing, obtaining or maintaining the permits required to carry out is research and development activities, including the genetic and chemical studies; timing and success of developing or securing intellectual property; timing and outcome of various studies, including pre-clinical and clinical studies; current and future compliance with applicable laws, regulations, statutes and conventions relevant to the Company's business in Peru and other jurisdictions; compliance with the regulations of SERFOR, CITES and other regulatory bodies and ability to continue to comply with the terms and conditions of the SERFOR Contract; permissibility of use of San Pedro and its extracts for the purpose of treating any ailments; anticipated timing and costs associated with the path to market; environmental, cultural and social impact as a result of the Company's activities and other expectations, beliefs, plans, objectives, assumptions, intentions or statements about future events or performance, expected regulatory filings, review and approval dates, and start-up timelines and schedules, and statements related to the continued overall advancement of Neural's business and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects", "plans" and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company's expectations include the inability to raise sufficient funds to conduct the Company's business plan; failure to satisfy the conditions of the relevant securities regulators(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. 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. Forward-looking statements contained in this news release are 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 such statements.
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 Regulation S 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.
Additionally, there are known and unknown risk factors which could cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information contained herein. 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.
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.
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