SEC Form 6-K filed by Cybin Inc.

9/20/24 1:04:17 PM ET

Biotechnology: Pharmaceutical Preparations

Health Care

Get the next $CYBN alert in real time by email

6-K 1 cybininc-form6xk09x19x2024.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 September, 2024.

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:

September 20, 2024

By:

/s/ Doug Drysdale

Name:

Doug Drysdale

Title:

Chief Executive Officer

EXHIBIT INDEX


99.1			News Release dated September 19, 2024

Get the next $CYBN alert in real time by email

Chat with this insight

Save time and jump to the most important pieces.

Recent Analyst Ratings for
$CYBN

Date	Price Target	Rating	Analyst
11/22/2021	$8.00 → $10.00	Buy	HC Wainwright & Co.
11/19/2021		Buy → Hold	Maxim Group
10/5/2021	$7.00	Outperform	Oppenheimer
8/26/2021	$9.00	Overweight	Cantor Fitzgerald

More analyst ratings

$CYBN
Press Releases

Fastest customizable press release news feed in the world

Cybin Reports Positive Phase 2 Data for CYB003, Demonstrating Breakthrough 12-Month Efficacy in Treating Major Depressive Disorder
- 100% of participants were responsive to treatment and 71% of participants were in remission at 12 months after just two 16 mg doses of CYB003 - - Robust, long-term efficacy with ~23-point reduction in Montgomery-Asberg Depression Rating Scale ("MADRS") score compared to baseline at 12 months after two 16 mg doses of CYB003 - - Findings validate dosing regimen and confirm that CYB003's effects are highly durable and offer sustained relief for MDD patients - - CYB003 continues to be well-tolerated and demonstrates an excellent safety profile - - Cybin's Phase 3 PARADIGM TM multinational pivotal program evaluating the efficacy and safety of CYB003 has been initiated - - Company to
11/18/24 7:00:00 AM ET
$CYBN
Biotechnology: Pharmaceutical Preparations
Health Care
Cybin to Present 12-Month Phase 2 Data for CYB003 in Major Depressive Disorder on November 18, 2024
- Company to host conference call and webcast at 8:00 a.m. ET on Monday, November 18, 2024 - - Presentation will also include discussion of its recently initiated Phase 3 PARADIGM program for CYB003 - Cybin Inc. (NYSE:CYBN) (Cboe CA:CYBN) ("Cybin" or the "Company"), a clinical-stage breakthrough neuropsychiatry platform company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, today announced that it will host a conference call and webcast on Monday, November 18, 2024 at 8:00 a.m. ET. The event will be hosted by Cybin's Chief Executive Officer, Doug Drysdale, and Cybin's Chief Medical Officer, Amir Inamdar, and will incl
11/14/24 7:30:00 AM ET
$CYBN
Biotechnology: Pharmaceutical Preparations
Health Care
Cybin Initiates PARADIGM: A Multinational Pivotal Phase 3 Program Evaluating CYB003 for the Adjunctive Treatment of Major Depressive Disorder and Reports Second Quarter Financial Results
- PARADIGM ™ program comprises two 12-week randomized, placebo-controlled studies (APPROACH and EMBRACE) and a long-term extension study (EXTEND) - - APPROACH ™: A Phase III, Placebo-Controlled, Randomized, Double-Blind Trial of Oral Doses of CYB003 to Assess Combined Safety and Efficacy in Humans with Major Depressive Disorder has been initiated and will enroll 220 patients at 36 clinical sites across the U.S. and Europe; topline results expected in 2026 - - EMBRACE ™: An Efficacy and Safety, Phase III, Multi-center, Double-Blind, Randomized Controlled Study Comparing 2 Active and 1 Inactive Oral Doses of CYB003 in Eligible Participants with Major Depressive Disorder is expected to beg
11/13/24 7:30:00 AM ET
$CYBN
Biotechnology: Pharmaceutical Preparations
Health Care

Cybin Reports Positive Phase 2 Data for CYB003, Demonstrating Breakthrough 12-Month Efficacy in Treating Major Depressive Disorder
- 100% of participants were responsive to treatment and 71% of participants were in remission at 12 months after just two 16 mg doses of CYB003 - - Robust, long-term efficacy with ~23-point reduction in Montgomery-Asberg Depression Rating Scale ("MADRS") score compared to baseline at 12 months after two 16 mg doses of CYB003 - - Findings validate dosing regimen and confirm that CYB003's effects are highly durable and offer sustained relief for MDD patients - - CYB003 continues to be well-tolerated and demonstrates an excellent safety profile - - Cybin's Phase 3 PARADIGM TM multinational pivotal program evaluating the efficacy and safety of CYB003 has been initiated - - Company to
11/18/24 7:00:00 AM ET
$CYBN
Biotechnology: Pharmaceutical Preparations
Health Care
Cybin to Present 12-Month Phase 2 Data for CYB003 in Major Depressive Disorder on November 18, 2024
- Company to host conference call and webcast at 8:00 a.m. ET on Monday, November 18, 2024 - - Presentation will also include discussion of its recently initiated Phase 3 PARADIGM program for CYB003 - Cybin Inc. (NYSE:CYBN) (Cboe CA:CYBN) ("Cybin" or the "Company"), a clinical-stage breakthrough neuropsychiatry platform company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, today announced that it will host a conference call and webcast on Monday, November 18, 2024 at 8:00 a.m. ET. The event will be hosted by Cybin's Chief Executive Officer, Doug Drysdale, and Cybin's Chief Medical Officer, Amir Inamdar, and will incl
11/14/24 7:30:00 AM ET
$CYBN
Biotechnology: Pharmaceutical Preparations
Health Care
Cybin Receives FDA Breakthrough Therapy Designation for its Novel Psychedelic Molecule CYB003 and Announces Positive Four-Month Durability Data in Major Depressive Disorder
- Breakthrough Therapy Designation ("BTD") provides an expedited review pathway, as well as increased access to U.S. Food and Drug Administration ("FDA") guidance on trial design, with the potential to significantly reduce drug development timelines - - First known BTD granted by the FDA for an adjunctive psychedelic based therapy for the treatment of Major Depressive Disorder ("MDD") - - Robust, sustained and statistically significant improvement in depression symptoms at four months with 75% of patients in remission from depression after two doses (16mg) - - Impressive mean 22-point reduction in Montgomery-Asberg Depression Rating Scale ("MADRS") score from baseline at four months -
3/13/24 6:00:00 AM ET
$CYBN
Biotechnology: Pharmaceutical Preparations
Health Care

$CYBN
Leadership Updates

Live Leadership Updates

Cybin Expands Clinical Team to Support CYB003 Phase 3 Program
- Company is on track to initiate its global Phase 3 pivotal program for CYB003 in Major Depressive Disorder ("MDD") imminently - - Cybin welcomes Dr. Mirza Rahman as Senior Vice President, Patient Safety & Pharmacovigilance and Dr. Marcelo Gutierrez as Vice President, Clinical Pharmacology - - Other recent additions to the team include project directors. project managers, and clinical monitoring managers, as well as previously announced senior leadership team hires, and program lead for CYB003 - - Strengthened team in place to support CYB003 pivotal trials, which will consist of three studies spanning up to 12 countries - Cybin Inc. (NYSE:CYBN) (Cboe CA:CYBN) ("Cybin" or the "Company")
10/1/24 7:30:00 AM ET
$CYBN
Biotechnology: Pharmaceutical Preparations
Health Care
Cybin Announces Results of Annual and Special Meeting of Shareholders and Share Consolidation
Cybin Inc. (NYSE:CYBN) (Cboe CA:CYBN) (Cybin" or the "Company"), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options, is pleased to announce the voting results for each of the matters presented at the Company's annual and special meeting of shareholders held on August 27, 2024 (the "Meeting"). There were 87 shareholders represented in person or by proxy at the Meeting holding 453,195,063 common shares, representing 59.66% of Cybin's total issued and outstanding common shares as at the record date for the Meeting. The voting results for each matter presented at the Meeting are
8/27/24 7:01:00 PM ET
$CYBN
Biotechnology: Pharmaceutical Preparations
Health Care
Cybin Appoints Dr. Atul Mahableshwarkar M.D., as Senior Vice President, Clinical Development
- Dr. Mahableshwarkar, a Board-Certified Psychiatrist, is an experienced pharmaceutical industry leader with decades of expertise in drug development - Cybin Inc. (NYSE: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, is pleased to announce that Dr. Atul R. Mahableshwarkar M.D., DLFAPA, has joined the Company as Senior Vice President, Clinical Development. Dr. Mahableshwarkar will lead the development of the CYB003 program, Cybin's proprietary deuterated psilocybin analog which has received U.S. Food and Drug Admini
6/11/24 7:30:00 AM ET
$CYBN
Biotechnology: Pharmaceutical Preparations
Health Care