Cybin Announces Grant of Additional U.S. Patent in Support of its CYB003 Breakthrough Therapy Program for Major Depressive Disorder

Rhea-AI Summary

Cybin Inc. announces the grant of an additional U.S. patent to support its CYB003 Breakthrough Therapy Program for Major Depressive Disorder. The patent is expected to provide exclusivity until at least 2041 and includes claims to pharmaceutical compositions within the Company's proprietary deuterated psilocybin analog program. Cybin's patent portfolio now consists of over 50 granted patents and 170 pending applications. The Company plans to begin enrollment for a multinational Phase 3 program evaluating CYB003 in Major Depressive Disorder by mid-year 2024.

Legal Expert

The grant of U.S. Patent 11,958,807 to Cybin for their deuterated psilocybin analog program, CYB003, is a key strategic advancement in the company's efforts to protect its intellectual property. This patent not only secures the company's exclusivity on these compounds until at least 2041 but also sends a positive signal to investors regarding the company's long-term market position. Patent protection is critical for biopharmaceutical companies as it can prevent competition and potentially lead to significant market share upon successful drug development and approval.

Medical Research Analyst

Cybin's expansion of its patent portfolio with the inclusion of CYB003 for Major Depressive Disorder offers a glimpse into the company's commitment to innovation in the mental healthcare space. With the breakthrough therapy designation from the FDA, the drug's development process could be expedited, potentially leading to faster commercialization. For investors, this could mean a quicker realization of returns on investment, although the inherent risks of clinical trials remain. It's important to watch the Phase 3 trials closely, as their outcomes will be pivotal in determining the drug's future and its financial impact on Cybin.

Pharmaceutical Market Analyst

The announcement of the Phase 3 program commencement for CYB003 in mid-year 2024 highlights Cybin's trajectory towards addressing a significant market: the treatment of Major Depressive Disorder. The successful development and approval of a breakthrough therapy could capture a sizeable portion of this market, given the growing demand for innovative treatments in mental health. The future looks promising if the therapy proves to be effective, but investors should be mindful of the timelines and the capital required to reach market readiness, as these factors can influence stock performance.

- Newly issued patent expected to provide exclusivity until at least 2041 and includes claims to pharmaceutical compositions within the Company’s proprietary deuterated psilocybin analog program -

- Cybin’s patent portfolio now includes more than 50 granted patents and over 170 pending applications -

- Company expects to commence enrollment for a multinational, multisite Phase 3 program evaluating CYB003 in Major Depressive Disorder around mid-year 2024 -

TORONTO--(BUSINESS WIRE)-- Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment options, today announced that the United States Patent and Trademark Office has granted U.S. patent 11,958,807 in support of its CYB003 program in Major Depressive Disorder (“MDD”).

The patent, which is expected to provide exclusivity until at least 2041, includes claims to pharmaceutical compositions within the Company’s proprietary deuterated psilocybin analog program, CYB003.

“As we continue to advance CYB003, our deuterated psilocybin analog program for the adjunctive treatment of MDD, further protecting our intellectual property through patent protection is an important achievement,” said Doug Drysdale, Chief Executive Officer of Cybin. “The strength of our patents supporting CYB003 underscore our commitment to developing innovative, next-generation, commercially scalable therapeutics to address the significant unmet medical need in MDD. With our robust patent portfolio, and the recent Breakthrough Therapy Designation by the U.S. Food and Drug Administration, we are encouraged by our regulatory pathway for CYB003 and are positioned to move quickly to progress the program,” concluded Drysdale.

About Cybin

Cybin is a clinical-stage biopharmaceutical company on a mission to create safe and effective psychedelic-based therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental health conditions.

Cybin’s goal of revolutionizing mental healthcare is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, and novel formulation approaches and treatment regimens. The Company is currently developing CYB003, a proprietary deuterated psilocybin analog for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated DMT molecule for generalized anxiety disorder and has a research pipeline of investigational psychedelic-based compounds.

Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. For company updates and to learn more about Cybin, visit www.cybin.com or follow the team on X, LinkedIn, YouTube and Instagram.

Cautionary Notes and Forward-Looking Statements

Certain statements in this news release relating to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the Company’s plan to commence enrollment for a multinational, multisite Phase 3 program around mid-year 2024; the potential reduction in drug development timeline afforded by Breakthrough Therapy Designation; and the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health 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 spread of COVID-19 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 each of the Company's management's discussion and analysis for the three and nine month periods ended December 31, 2023, and the Company’s annual information form for the year ended March 31, 2023, which are available under the Company's profile on www.sedarplus.ca 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 Cboe Canada 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240415766527/en/

Investor & Media:

Gabriel Fahel

Chief Legal Officer

Cybin Inc.

1-866-292-4601

irteam@cybin.com – or – media@cybin.com

Source: Cybin Inc.

FAQ

What is the significance of the newly granted U.S. patent for Cybin Inc.?

The newly granted U.S. patent supports Cybin's CYB003 Breakthrough Therapy Program for Major Depressive Disorder, providing exclusivity until at least 2041.

How many patents does Cybin's patent portfolio currently include?

Cybin's patent portfolio now comprises over 50 granted patents and 170 pending applications.

When does Cybin expect to commence enrollment for its Phase 3 program evaluating CYB003 in Major Depressive Disorder?

Cybin plans to begin enrollment for a multinational Phase 3 program evaluating CYB003 in Major Depressive Disorder by mid-year 2024.

What is the focus of Cybin's CYB003 program?

Cybin's CYB003 program is focused on the adjunctive treatment of Major Depressive Disorder using a deuterated psilocybin analog.