0001628280-23-025685.txt : 20230726 0001628280-23-025685.hdr.sgml : 20230726 20230726143431 ACCESSION NUMBER: 0001628280-23-025685 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20230726 FILED AS OF DATE: 20230726 DATE AS OF CHANGE: 20230726 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CYBIN INC. CENTRAL INDEX KEY: 0001833141 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: A6 FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-40673 FILM NUMBER: 231112711 BUSINESS ADDRESS: STREET 1: 100 KING STREET WEST STREET 2: SUITE 5600 CITY: TORONTO STATE: A6 ZIP: M5X 1C9 BUSINESS PHONE: (908) 764-8385 MAIL ADDRESS: STREET 1: 100 KING STREET WEST STREET 2: SUITE 5600 CITY: TORONTO STATE: A6 ZIP: M5X 1C9 6-K 1 cybininc-form6xk07x26x2023.htm 6-K Document

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of July, 2023.
Commission File Number: 001-40673


Cybin Inc.
(Exact Name of Registrant as Specified in Charter)

100 King Street West, Suite 5600, Toronto, Ontario, M5X 1C9
(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F Form 40-F ⊠







SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
CYBIN INC.
(Registrant)
 
Date:July 26, 2023By:
/s/ Doug Drysdale    
Name:Doug Drysdale
Title:Chief Executive Officer





EXHIBIT INDEX



EX-99.1 2 a07-26x2023wctpressrelease.htm EX-99.1 Document


image_0a.jpg



Cybin Partners with Worldwide Clinical Trials to Support Future Clinical Development of CYB003 in Major Depressive Disorder

-Collaboration with Worldwide Clinical Trials provides Cybin with access to a contract research organization with substantial experience supporting multinational psychedelic clinical trials -

- Cybin expects to report Phase 2 topline efficacy data for CYB003 in major depressive disorder in Q3/Q4 2023 -

TORONTO – July 26, 2023 – Cybin Inc. (NYSE American:CYBN) (NEO:CYBN) (“Cybin”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative psychedelic-based treatment option, today announced that it has partnered with Worldwide Clinical Trials (“Worldwide”), a global, full-service contract research organization (“CRO”) with deep expertise managing clinical trials for mental health conditions, including major depressive disorder. To date, the partnership with Worldwide has been pivotal in the development of study designs, defining global regulatory strategy and navigation of regulatory pathways, and pharmacovigilance.

Worldwide has a track record of successful patient recruitment for psychedelic trials and global relationships with best-in-class investigative sites. Worldwide has recent experience managing 11 psychedelic studies in psychiatric populations, including Phase I and Phase II clinical trials conducted in the U.S., Canada, United Kingdom, and other European countries, across a range of psychedelic compounds and treatment models.

We are proud to align with Worldwide, a distinguished CRO with a proven track-record of supporting industry-sponsored psychedelic clinical trials,” said Doug Drysdale, Chief Executive Officer of Cybin. “Worldwide brings significant regulatory, logistical, and operational expertise as a leader in psychedelic clinical research, making Worldwide the ideal partner for navigating the regulatory landscape surrounding the development of psychedelic-based therapeutics.”

“At Worldwide, we share a passion for Cybin’s mission to revolutionize mental healthcare,” said Dr. Michael Murphy, Chief Medical and Scientific Officer of Worldwide Clinical Trials. “We are proud to partner with such a diverse and extraordinary group of experts to help create safe and



effective psychedelic-based therapies to transform potential treatment options for patients who live with mental health disorders.”

About Worldwide Clinical Trials

Worldwide Clinical Trials (Worldwide) is a leading full-service global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Worldwide’s capabilities include bioanalytical laboratory services, Phase I-IV clinical trials, and post-approval and real-world evidence studies – all powered by an accessible team of clinicians, scientists, and researchers who bring first-hand expertise and a collaborative, personalized approach to each clinical program.

Anchored in its scientific heritage, Worldwide is therapeutically focused on cardiovascular, metabolic, neuroscience, oncology, and rare diseases. The company’s deep therapeutic knowledge enables them to develop flexible plans and quickly solve problems for customers.

Worldwide’s team of 3,200+ professionals spans 60+ countries, and believes that through a culture that embraces diversity, equity, inclusion, and belonging (DEI&B), everyone plays a vital role in making a world of difference for patients and their caregivers. Worldwide is united in cause with its customers to improve the lives of patients through new, innovative therapies.

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 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 Twitter, 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 anticipated results and potential of CYB003; the Company’s plan to report top-line results from the complete CYB003 Phase 2 clinical trial; and the Company’s plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions.

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 year ended March 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.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.

Investor & Media Contact: 
Gabriel Fahel
Chief Legal Officer
Cybin Inc.
1-866-292-4601
irteam@cybin.com – or – media@cybin.com


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