预约演示
更新于：2025-08-02
CYB-003
更新于：2025-08-02
概要
基本信息
药物类型 小分子化药 |
别名 Deuterated Psilocybin Analog、deuterated tryptamine、CYB 003 + [1] |
作用方式 激动剂 |
作用机制 5-HT2A receptor激动剂(5-羟色胺2A受体激动剂) |
非在研适应症- |
原研机构 |
非在研机构- |
权益机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评突破性疗法 (美国) |
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关联
5
项与 CYB-003 相关的临床试验NCT06820723
A Randomized, Double-Blind, Placebo-Controlled Mechanistic Study to Assess a Single Oral Dose of CYB003 in Participants With Major Depressive Disorder (MDD) and Moderate to Severe Anxiety
The goal of this study is to learn how psychedelics may help symptoms of depression and anxiety. Participants with major depressive disorder experiencing symptoms of depression and anxiety will receive one dose of either a drug related to psilocybin or a placebo. Assessments include interviews, self-report questionnaires, EEG and fMRI to measure symptoms and brain function.
开始日期2025-09-01 |
申办/合作机构 |
NCT06605105
A Phase III Long-Term Extension Trial With Optional Additional Doses of CYB003 to Assess the Safety and Long-term Efficacy in Participants With Major Depressive Disorder (EXTEND)
This is a long- term extension of the double-blind trials APPROACH (CYB003-002) and EMBRACE (CYB003-003). Its aim is to examine the safety and long-term efficacy of CYB003 in participants with MDD.
开始日期2025-07-15 |
申办/合作机构 Cybin IRL Ltd. [+1] |
NCT06793397
An Efficacy and Safety, Phase III, Multi-center, Double-Blind, Randomized Controlled Study Comparing 2 Active Doses of CYB003 and Placebo in Eligible Participants With Major Depressive Disorder
The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD.
开始日期2025-07-08 |
申办/合作机构 Cybin IRL Ltd. [+1] |
100 项与 CYB-003 相关的临床结果
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100 项与 CYB-003 相关的转化医学
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100 项与 CYB-003 相关的专利（医药）
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2
项与 CYB-003 相关的文献（医药）2010-02-05·The Journal of organic chemistry2区 · 化学
Unique Diastereoselectivity Trends in Aminyl Radical Cyclizations onto Silyl Enol Ethers
2区 · 化学
Article
作者: Zlotorzynska, Maria ; Sammis, Glenn M. ; Zhai, Huimin
The cyclization of nitrogen-centered radicals onto silyl enol ethers is an efficient method for the synthesis of polyhydroxylated alkaloids as the 2-hydroxymethylpyrrolidine core can be readily accessed from a linear precursor. During our studies on the synthesis of polyhydroxylated alkaloid CYB-3, we found that the diastereoselectivity of the cyclization was dependent on a complex combination of sterics and olefin geometry. A more thorough understanding of the factors that lead to high diastereoselectivites would greatly expand the utility of this methodology in complex natural product synthesis. We have found that cyclization diastereoselectivities of substrates with alkyl or aryl substitution were excellent regardless of olefin geometry or substitution pattern. When electronegative substituents were introduced adjacent to the silyl enol ether, only Z-silyl enol ethers provide high diastereoselectivites. Temperature, steric size of the silyl group, and sterics and electronics of the metal hydride affected the selectivity to a lesser extent.
1990-11-01·Journal of chemical ecology2区 · 环境科学与生态学
Behavioral and electrophysiological study of antifeedant mechanisms associated with polyhydroxy alkaloids
2区 · 环境科学与生态学
Article
作者: W. M. Blaney ; M. S. J. Simmonds ; L. E. Fellows
Eleven polyhydroxy alkaloids of plant origin were tested for anti-feedant effects against larvae of the lepidopteransSpodoptera littoralis, Spodoptera frugiperda, Heliothis virescens, andHelicoverpa armigera. Data from behavioral and electrophysiological investigations were correlated to reveal information on the mode of action of the antifeedants. The pyrrolidine DMDP was an effective antifeedant for all four species, whereas the piperidines fagomine and XZ-1 and the pyrrolizidine alexine were all ineffective as antifeedants. The activity of the pyrrolidines CYB-3 and DAB-1, the piperidines DNJ, DMJ, and BR1, and the bicyclic octahydroindolizine castanospermine varied among species. The investigation focuses on the structural similarities between some of the alkaloids and some common phagostimulatory sugars and illustrates a neural interaction involving the neurons that are differentially responsive to alkaloids and sugars. InS. littoralis, the neurons responding specifically to the alkaloids DMDP, DAB-1, and castanospermine and to the sugars fructose, sucrose, and glucose are more active when the compounds are applied singly than when an alkaloid and a sugar are applied together. The implications for the occurrence and functioning of different sugar receptor sites are discussed.
113
项与 CYB-003 相关的新闻（医药）2025-07-17
- EMBRACE, the second Phase 3 study within the PARADIGM program, expects to enroll 330 participants at approximately 60 clinical sites across the United States, Europe and Australia and will commence imminently -
- PARADIGMTM comprises two 12-week randomized, double-blind, placebo-controlled studies (APPROACH® and EMBRACE®) and a long-term extension study (EXTEND), with anticipated combined enrollment of approximately 550 participants –
- Dosing is currently underway in the first pivotal study, APPROACH, and patient rollover has begun into EXTEND -
TORONTO--(BUSINESS WIRE)-- Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage breakthrough neuropsychiatry company committed to advancing mental healthcare by developing new and innovative next-generation treatment options, today announced that it has received approval from the UK Medical and Healthcare Products Regulatory Agency (“MHRA”) to commence EMBRACE, the second pivotal study in PARADIGM, the Company’s Phase 3 multinational program evaluating CYB003, a proprietary deuterated psilocin analog. The Company previously received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (“FDA”) for CYB003 for the adjunctive treatment of Major Depressive Disorder (“MDD”).
“MHRA approval to initiate the EMBRACE component of our PARADIGM program in the UK marks an important step forward as we advance our lead program, CYB003, through the regulatory process,” said Doug Drysdale, Chief Executive Officer of Cybin. “The Agency’s decision serves as strong validation of both the quality of our data and the urgent need to develop new and effective therapeutics to treat depression. With expected enrollment of 330 participants suffering from moderate to severe MDD, the EMBRACE study aims to generate critical late-stage data that, ultimately, may lead to transforming the standard of care for patients in need.”
“There are encouraging signs of clinical and commercial success across this sector, along with increasing political and regulatory support. Health expert Dr. Martin Makary, Commissioner of the U.S Food and Drug Administration, has publicly recognized the potential value of these innovative therapeutics and has stated his intention to prioritize and expedite the review process. The commercial success of esketamine is also a positive signal for the entire sector. In the second quarter of 2025, esketamine sales totaled $366 million in the U.S. and $414 million worldwide, representing 61.1% growth year over year in the U.S., and an annual run rate of roughly $1.7 billion.1 These positive factors contribute to the credibility and opportunity of the work we are doing at Cybin,” concluded Drysdale.
EMBRACE™ Study Design:
EMBRACE will enroll 330 patients suffering from moderate to severe MDD (MADRS≥24) who are on a stable dose of antidepressant medication but are responding inadequately. Study participants will be randomized 1:1:1 to receive either CYB003 16 mg, CYB003 8 mg, or inactive placebo. Each study arm will evaluate two doses, administered three weeks apart. The primary endpoint will be change in depressive symptoms as measured by change in MADRS from baseline at six weeks after the first dose.
EMBRACE is the second Phase 3 randomized, double-blind clinical trial in the PARADIGM program, and is expected to enroll participants at approximately 60 clinical sites across the U.S., Europe, and Australia. The first Phase 3 trial, APPROACH, is taking place at approximately 45 clinical sites across the U.S. Participants from APPROACH and EMBRACE will have the opportunity to roll over into EXTEND after completing the 12-week, double-blind, placebo-controlled treatment periods.
Sources
About Cybin
Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions.
With promising proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder. The Company also has a research pipeline of investigational, 5-HT-receptor focused compounds.
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 or forward-looking information within the meaning of applicable securities laws (collectively, “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”, “potential”, “possible”, “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 plans to enroll participants and add additional clinical sites for the PARADIGM program; the timing of commencement of EMBRACE; the Company’s plan to enroll 330 participants at 60 clinical sites across the United States, Europe and Australia for the EMBRACE study; 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. APPROACH and EMBRACE are registered trademarks of Cybin IRL Limited, a subsidiary of Cybin.
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: 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; implications of disease outbreaks on the Company's operations; and the risk factors set out in each of the Company's management's discussion and analysis for the year ended March 31, 2025 and the Company’s annual information form for the year ended March 31, 2025, which are available under the Company's profile on SEDAR+ at www.sedarplus.ca and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov/edgar. 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 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 psilocin, 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 psilocin, 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. 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 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.
Investor & Media Contact: Gabriel Fahel Chief Legal Officer Cybin Inc. 1-866-292-4601 irteam@cybin.com – or – media@cybin.com
临床3期临床2期突破性疗法
2025-07-01
- Funding agreement contemplates a conversion formula with a potential 30% premium upon conversion and positions the Company for growth, and accelerated advancement of its clinical pipeline programs, CYB003 and CYB004 -
TORONTO--(BUSINESS WIRE)-- Cybin Inc. (NYSE American: CYBN) (Cboe Canada: 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 Company has entered into a securities purchase agreement (the “Securities Purchase Agreement”) with High Trail Special Situations LLC (“High Trail”), pursuant to which the Company agreed to sell and issue to High Trail up to US$500,000,000 in aggregate principal amount of unsecured convertible debentures (the “Convertible Debentures”). The sale and issue of US$50,000,000 principal amount of Convertible Debentures was completed on June 30, 2025 (the “Private Placement”). The sale and issue of US$450,000,000 of the principal amount of Convertible Debentures will be determined at a future date, upon mutual agreement of the parties.
“This financing represents a major inflection point for Cybin and supports our position as a leader within our sector,” said Doug Drysdale, Chief Executive Officer of Cybin. "High Trail Capital is an experienced investor, and its confidence and appreciation of our breakthrough clinical data and intellectual property portfolio recognize the potential of the Company. This financing comes at an opportune time for Cybin, as we advance our lead programs, CYB003 and CYB004, in Phase 3 and Phase 2, respectively. CYB003 demonstrated over 70% remission rates and continued durability over 12 months for patients with uncontrolled depression. We await the conclusion of our CYB004 Phase 2 proof-of-concept study, in patients with generalized anxiety disorder,” said Drysdale.
Joseph Gunnar & Co., LLC acted as the sole placement agent in connection with this transaction.
Pipeline Acceleration Drives Multiple Value Creation Catalysts
The funding will accelerate Cybin’s clinical-stage programs across multiple high-value indications:
CYB003 Program Achievements:
Breakthrough Clinical Results: Unprecedented 71% remission rate in major depressive disorder at 12 months after two 16 mg doses in Phase 2 study Durability advantage: 12-month sustained efficacy demonstrating long-term therapeutic benefit FDA Recognition: Breakthrough Therapy Designation received, expediting regulatory pathway Multinational Phase 3 PARADIGM program underway
CYB004 Program Momentum:
Dual Indication Strategy: Expanding addressable market opportunity Phase 2 GAD study expected to complete around mid-year 2025 1
Commercialization Infrastructure:
Manufacturing Scale-Up: Finalizing production capabilities for market launch IP Portfolio Expansion: Strengthening competitive moat with more than 90 patents issued and over 230 applications pending Strategic Partnerships: Developing market access and pre-commercialization alliances
Value Catalysts Drive Sustained Momentum
Near-Term Catalysts:
CYB004 Phase 2 GAD study expected to complete around mid-2025 1 Initiation of second CYB003 pivotal study, EMBRACE, around mid-2025 1 EXTEND study initiation imminent 1
Medium-Term Catalysts (2025-2026):
Phase 3 top line readout for CYB003 2H 2026 1 Regulatory submission preparations Commercial manufacturing readiness International market expansion planning
Transaction Terms
The Convertible Debentures have a two-year term from the closing date (the “Term”). The Company shall pay guaranteed interest equal to 5.5% of the principal per annum for the Term. Such interest was pre-paid on closing. Upon the occurrence of an event of default, interest shall increase to a rate of 18% per annum on the outstanding principal balance. Pursuant to the terms of the Securities Purchase Agreement, the Company and High Trail may, upon mutual consent, enter into subsequent securities purchase agreements for the purchase and sale of up to an additional US$450,000,000 principal amount of Convertible Debentures, in tranches, in amounts on such dates as may be mutually agreed and each subsequent tranche shall include prepaid interest at a rate of 9.5%.
Subject to the terms of the Securities Purchase Agreement and the Convertible Debentures, High Trail will be entitled to convert the principal amount of, and accrued and unpaid interest, if any, on each Convertible Debenture, in whole or in part, from time to time, into common shares in the capital of the Company (the “Common Shares”) at a conversion price per Common Share equal to the lower of (a) 130% of the volume weighted average price (“VWAP”) of the Common Shares on the day prior to the initial issuance of the Convertible Debentures, or (b) the VWAP of the Common Shares during the five trading days immediately prior to the date of conversion.
The Company, in its sole discretion, may prepay any outstanding amount under the Convertible Debentures, in whole or in part, in cash by providing High Trail with advance written notice prior to such prepayment. The prepayment shall include, (i) if paid during the first year after closing, a 5% prepayment premium on the amount of the prepayment or (ii) if paid thereafter, a 3% prepayment premium on the amount of the prepayment.
The terms of the Convertible Debentures restrict the conversion of Convertible Debentures by High Trail if such a conversion or exercise would cause High Trail, together with any affiliate thereof, to beneficially own in excess of 4.99% of the number of Common Shares outstanding immediately after giving effect to such conversion.
The Company intends to use the net proceeds from the Private Placement for working capital and general corporate purposes.
The Convertible Debentures were offered on a private placement basis pursuant to prospectus exemptions in Canada and pursuant to exemptions and exclusions from the registration requirements of the United States Securities Act of 1933, as amended, and applicable state securities laws. The Company has agreed to use commercially reasonable efforts to: (a) file a prospectus supplement to the Company’s base shelf prospectus dated August 17, 2023, as amended on December 22, 2023, April 8, 2024 and January 6, 2025, with applicable Canadian securities regulators to qualify the secondary market sales of the Common Shares in the United States; and (b) either (i) prepare and file the Canadian prospectus supplement with the United States Securities and Exchange Commission, or (ii) file a prospectus supplement pursuant to General Instruction II.L of Form F-10 with the United States Securities and Exchange Commission to the Company’s registration statement on Form F-10 (File No. 333-284173), which was declared effective by the SEC on January 14, 2025, or on such other form as may be available to the Company, in either case qualifying the resale of the Common Shares underlying the Convertible Debentures.
No securities regulatory authority has either approved or disapproved of the contents of this news release. This news release is not an offer to sell or the solicitation of an offer to buy the securities in the United States or in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to qualification or registration under the securities laws of such jurisdiction. The securities being offered have not been registered under the U.S. Securities Act, and such securities may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from U.S. registration requirements and applicable U.S. state securities laws
About Cybin
Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions.
With promising proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder. The Company also has a research pipeline of investigational, 5-HT-receptor focused compounds.
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.
Notes:
Cautionary Notes and Forward-Looking Statements
Certain statements in this news release constitute forward-looking information and forward-looking statements within the meaning of applicable securities laws (together, “forward-looking statements”). 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 use of Private Placement proceeds; the conversion of the Convertible Debentures into Common Shares; the sale and issue of US$450,000,000 principal amount of Convertible Debentures at a future date; CYB004 Phase 2 GAD study expected to complete around mid-2025; Initiation of second CYB003 pivotal study, EMBRACE, around mid-2025; the Company’s Medium-Term Catalysts for 2025-2026; Phase 3 PARADIGM program enrollment acceleration; the Company’s ability to achieve commercial success; and the Company’s ability to address the need for new and innovative treatment options for people who suffer from 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: 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; implications of disease outbreaks on the Company’s operations; 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, 2024 and the Company’s annual information form for the year ended March 31, 2024, which are available under the Company’s profile on www.sedarplus.ca and with the SEC on EDGAR at www.sec.gov/edgar. 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 psilocin, 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 psilocin, 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. 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.
Investor & Media Contact: Gabriel Fahel Chief Legal Officer Cybin Inc. 1-866-292-4601 irteam@cybin.com – or – media@cybin.com
临床2期临床3期突破性疗法临床结果
2025-06-30
- Funding agreement contemplates a conversion formula with a potential 30% premium upon conversion and positions the Company for growth, and accelerated advancement of its clinical pipeline programs, CYB003 and CYB004 -
TORONTO--(BUSINESS WIRE)-- Cybin Inc. (NYSE American: CYBN) (Cboe Canada: 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 Company has entered into a securities purchase agreement (the “Securities Purchase Agreement”) with High Trail Special Situations LLC (“High Trail”), pursuant to which the Company agreed to sell and issue to High Trail up to US$500,000,000 in aggregate principal amount of unsecured convertible debentures (the “Convertible Debentures”). The sale and issue of US$50,000,000 principal amount of Convertible Debentures was completed on June 30, 2025 (the “Private Placement”). The sale and issue of US$450,000,000 of the principal amount of Convertible Debentures will be determined at a future date, upon mutual agreement of the parties.
“This financing represents a major inflection point for Cybin and supports our position as a leader within our sector,” said Doug Drysdale, Chief Executive Officer of Cybin. "High Trail Capital is an experienced investor, and its confidence and appreciation of our breakthrough clinical data and intellectual property portfolio recognize the potential of the Company. This financing comes at an opportune time for Cybin, as we advance our lead programs, CYB003 and CYB004, in Phase 3 and Phase 2, respectively. CYB003 demonstrated over 70% remission rates and continued durability over 12 months for patients with uncontrolled depression. We await the conclusion of our CYB004 Phase 2 proof-of-concept study, in patients with generalized anxiety disorder,” said Drysdale.
Joseph Gunnar & Co., LLC acted as the sole placement agent in connection with this transaction.
Pipeline Acceleration Drives Multiple Value Creation Catalysts
The funding will accelerate Cybin’s clinical-stage programs across multiple high-value indications:
CYB003 Program Achievements:
Breakthrough Clinical Results: Unprecedented 71% remission rate in major depressive disorder at 12 months after two 16 mg doses in Phase 2 study Durability advantage: 12-month sustained efficacy demonstrating long-term therapeutic benefit FDA Recognition: Breakthrough Therapy Designation received, expediting regulatory pathway Multinational Phase 3 PARADIGM program underway
CYB004 Program Momentum:
Dual Indication Strategy: Expanding addressable market opportunity Phase 2 GAD study expected to complete around mid-year 2025 1
Commercialization Infrastructure:
Manufacturing Scale-Up: Finalizing production capabilities for market launch IP Portfolio Expansion: Strengthening competitive moat with more than 90 patents issued and over 230 applications pending Strategic Partnerships: Developing market access and pre-commercialization alliances
Value Catalysts Drive Sustained Momentum
Near-Term Catalysts:
CYB004 Phase 2 GAD study expected to complete around mid-2025 1 Initiation of second CYB003 pivotal study, EMBRACE, around mid-2025 1 EXTEND study initiation imminent 1
Medium-Term Catalysts (2025-2026):
Phase 3 top line readout for CYB003 2H 2026 1 Regulatory submission preparations Commercial manufacturing readiness International market expansion planning
Transaction Terms
The Convertible Debentures have a two-year term from the closing date (the “Term”). The Company shall pay guaranteed interest equal to 5.5% of the principal per annum for the Term. Such interest was pre-paid on closing. Upon the occurrence of an event of default, interest shall increase to a rate of 18% per annum on the outstanding principal balance. Pursuant to the terms of the Securities Purchase Agreement, the Company and High Trail may, upon mutual consent, enter into subsequent securities purchase agreements for the purchase and sale of up to an additional US$450,000,000 principal amount of Convertible Debentures, in tranches, in amounts on such dates as may be mutually agreed and each subsequent tranche shall include prepaid interest at a rate of 9.5%.
Subject to the terms of the Securities Purchase Agreement and the Convertible Debentures, High Trail will be entitled to convert the principal amount of, and accrued and unpaid interest, if any, on each Convertible Debenture, in whole or in part, from time to time, into common shares in the capital of the Company (the “Common Shares”) at a conversion price per Common Share equal to the lower of (a) 130% of the volume weighted average price (“VWAP”) of the Common Shares on the day prior to the initial issuance of the Convertible Debentures, or (b) the VWAP of the Common Shares during the five trading days immediately prior to the date of conversion.
The Company, in its sole discretion, may prepay any outstanding amount under the Convertible Debentures, in whole or in part, in cash by providing High Trail with advance written notice prior to such prepayment. The prepayment shall include, (i) if paid during the first year after closing, a 5% prepayment premium on the amount of the prepayment or (ii) if paid thereafter, a 3% prepayment premium on the amount of the prepayment.
The terms of the Convertible Debentures restrict the conversion of Convertible Debentures by High Trail if such a conversion or exercise would cause High Trail, together with any affiliate thereof, to beneficially own in excess of 4.99% of the number of Common Shares outstanding immediately after giving effect to such conversion.
The Company intends to use the net proceeds from the Private Placement for working capital and general corporate purposes.
The Convertible Debentures were offered on a private placement basis pursuant to prospectus exemptions in Canada and pursuant to exemptions and exclusions from the registration requirements of the United States Securities Act of 1933, as amended, and applicable state securities laws. The Company has agreed to use commercially reasonable efforts to: (a) file a prospectus supplement to the Company’s base shelf prospectus dated August 17, 2023, as amended on December 22, 2023, April 8, 2024 and January 6, 2025, with applicable Canadian securities regulators to qualify the secondary market sales of the Common Shares in the United States; and (b) either (i) prepare and file the Canadian prospectus supplement with the United States Securities and Exchange Commission, or (ii) file a prospectus supplement pursuant to General Instruction II.L of Form F-10 with the United States Securities and Exchange Commission to the Company’s registration statement on Form F-10 (File No. 333-284173), which was declared effective by the SEC on January 14, 2025, or on such other form as may be available to the Company, in either case qualifying the resale of the Common Shares underlying the Convertible Debentures.
No securities regulatory authority has either approved or disapproved of the contents of this news release. This news release is not an offer to sell or the solicitation of an offer to buy the securities in the United States or in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to qualification or registration under the securities laws of such jurisdiction. The securities being offered have not been registered under the U.S. Securities Act, and such securities may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from U.S. registration requirements and applicable U.S. state securities laws
About Cybin
Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions.
With promising proof-of-concept data, Cybin is working to change the mental health treatment landscape through the introduction of intermittent treatments that provide long lasting results. The Company is currently developing CYB003, a proprietary deuterated psilocin analog, in Phase 3 studies for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine molecule in a Phase 2 study for generalized anxiety disorder. The Company also has a research pipeline of investigational, 5-HT-receptor focused compounds.
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.
Notes:
Cautionary Notes and Forward-Looking Statements
Certain statements in this news release constitute forward-looking information and forward-looking statements within the meaning of applicable securities laws (together, “forward-looking statements”). 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 use of Private Placement proceeds; the conversion of the Convertible Debentures into Common Shares; the sale and issue of US$450,000,000 principal amount of Convertible Debentures at a future date; CYB004 Phase 2 GAD study expected to complete around mid-2025; Initiation of second CYB003 pivotal study, EMBRACE, around mid-2025; the Company’s Medium-Term Catalysts for 2025-2026; Phase 3 PARADIGM program enrollment acceleration; the Company’s ability to achieve commercial success; and the Company’s ability to address the need for new and innovative treatment options for people who suffer from 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: 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; implications of disease outbreaks on the Company’s operations; 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, 2024 and the Company’s annual information form for the year ended March 31, 2024, which are available under the Company’s profile on www.sedarplus.ca and with the SEC on EDGAR at www.sec.gov/edgar. 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 psilocin, 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 psilocin, 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. 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.
Investor & Media Contact: Gabriel Fahel Chief Legal Officer Cybin Inc. 1-866-292-4601 irteam@cybin.com – or – media@cybin.com
临床2期临床3期突破性疗法临床结果
100 项与 CYB-003 相关的药物交易
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 重度抑郁症 | 临床3期 | 美国 | 2024-11-15 | |
| 酒精使用障碍 | 临床前 | 加拿大 | 2023-09-18 |
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床2期 | - | CYB003 16 mg | 鬱艱艱遞觸鹹顧網觸構(齋網餘夢觸鏇選壓積憲) = 壓構齋醖糧窪糧淵簾鹹 膚簾憲夢顧積鏇簾願築 (構獵鑰醖繭憲窪鹽艱壓 ) 更多 | 积极 | 2024-11-18 | ||
CYB003 12 mg | 鬱艱艱遞觸鹹顧網觸構(齋網餘夢觸鏇選壓積憲) = 鏇艱繭願窪顧網糧積齋 膚簾憲夢顧積鏇簾願築 (構獵鑰醖繭憲窪鹽艱壓 ) 更多 | ||||||
临床1/2期 | - | 鏇鹹窪鹹膚簾齋鏇艱窪(構鑰憲構壓襯構鏇鑰醖) = 膚鹹壓鏇廠選築鹽蓋淵 襯範遞廠餘糧壓窪鹽壓 (夢淵製憲衊醖遞壓積醖 ) 更多 | 积极 | 2024-09-19 | |||
Placebo | - | ||||||
临床1/2期 | 36 | 鹽醖鹽網顧願憲獵鹹膚(積衊鹹糧鏇憲製襯襯願) = This resulted in a rapid statistically significant clinical improvement of large magnitude based on the MADRS scores on Day 21. 夢簾構製淵觸鏇範遞蓋 (鹹範選築廠鹹鏇鏇餘築 ) 更多 | 积极 | 2023-12-01 | |||
NEWS 人工标引  | 临床2期 | - | CYB003 12mg | 艱觸願鑰餘餘顧醖網膚(鹽壓夢壓鏇簾製齋遞繭) = 蓋壓夢範襯鏇獵齋鹽築 鑰膚鹹膚艱鏇願醖襯夢 (糧夢膚壓鬱糧膚築構顧 ) 更多 | 积极 | 2023-12-01 | |
CYB003 16mg | 壓鬱鹹壓鬱淵襯觸觸襯(淵壓鏇餘觸廠簾遞遞廠) = 簾觸積簾鏇襯簾襯憲憲 製膚齋壓繭選築積鹹淵 (壓鏇觸衊醖憲窪餘憲範 ) 更多 |
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