Latest news with #EMBRACE
Hypebeast
15 hours ago
- Entertainment
- Hypebeast
Saul Nash Explores Intimacy and Connection in SS26 'EMBRACE' Collection
Summary Saul Nash'sSpring/Summer 2026collection, 'EMBRACE,' presented atMilan Fashion Week, delves into themes of gesture, intimacy and physical connection. The London-based designer continues to expand his movement-centric approach, blending sportswear, tailoring and military wear with a spiritual and hedonistic touch. 'This season looks at movement but through the interaction of two people, playing with hard and soft fabrics in a way that echoes the subtle language of touch. It's a study of sensuality through movement,' Nash says of the collection. The designs are inspired by spaces where intimacy is present and men interact. Garments respond to the body in motion, blurring the lines between structure and softness, utility and expression. Key pieces include military-inspired flight jackets with Nash's signature kinetic cutting, paired with trousers featuring adjustable waist closures. In contrast, Bemberg boxy cupro shirts glide elegantly, while hooded sports jerseys incorporate draped tricot mesh made of recycled polyester, softening traditional masculine silhouettes. The collection features a sensitive palette of greys, gentle purples, and pale yellows. The title 'EMBRACE' is reflected in compression long-sleeve tops with a hand print across the chest, suggesting a held embrace. An interaction is also depicted in a heavyweight ISKO denim twinset, laser engraved with a hazy motif of two intertwined bodies. As the Saul Nash man embraces more formal attire, the brand expands its tailoring offerings. This includes hooded Oxford shirts made of water-resistant cotton Poplin and a Punta di Milano Marl half-lined suit, which nods to Nash's tracksuit origins while reflecting the brand's evolution. Another suit, in a light pinstripe tropical wool, features a hood and detachable sleeves. Pieces like transparent boxer shorts in workwear plaids and a matching cape encourage a more sensual everyday look. A stretch bamboo jersey Henley shirt with an asymmetric fastening can be unbuttoned to expose the nipple. Recycled nylon ripstop trousers can be completely unzipped to reveal a ventilated mesh lining, allowing the wearer to choose their level of exposure. Accessories include a sling bag made of recycled nylon that develops a crinkle finish , and Birkenstock footwear styles such as Reykjavik, Boston Nova, and London. Eyewear is provided by Cubits. The show itself highlighted the space between bodies, the quiet tension of proximity, and the emotional resonance of moving together. An eclectic cast of men performed a waltz in pairs, with the ambiguity of their shared movement presented as an act of liberation.
Business Wire
20-05-2025
- Health
- Business Wire
Cybin Applauds FDA Commissioner Dr. Martin Makary's Call to Accelerate and Prioritize Research on Psychedelic Therapeutics
TORONTO--(BUSINESS WIRE)-- Cybin Inc. (NYSE American: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, applauds recent comments made by Dr. Martin Makary, Commissioner of the U.S. FDA relating to the importance of accelerating and prioritizing research on the clinical benefits of psychedelic therapeutics. 'It is gratifying that the FDA Commissioner shares our belief in the potential therapeutic value of these innovative treatments – a long-held belief that stands at the core of Cybin's mission,' said Doug Drysdale, Chief Executive Officer of Cybin. 'We are doing the rigorous investigative clinical work to unlock the potential of this class of drugs to effectively treat a variety of disorders, including major depressive disorder and generalized anxiety disorder. We agree wholeheartedly that the time is now to address the mental health crisis, and we applaud Dr. Makary's commitment to expedite the regulatory review process for product candidates in development and to get them into the hands of providers and patients as soon as possible.' 'Cybin is committed to advancing its clinical-stage programs toward potential regulatory review and approval. Our CYB003 deuterated psilocin program, which is currently in Phase 3 development, has been granted FDA Breakthrough Therapy Designation for the adjunctive treatment of MDD which could expedite drug development timelines. We are encouraged by our ongoing positive interactions with the FDA and by the Agency's stated focus and openness to innovative treatments that show promise, even when they challenge traditional standards of care. This public endorsement that psychedelics are a 'frontier area' with compelling scientific evidence is welcome validation for the work we do every day,' concluded Drysdale. Clinical Program Summary CYB003: Deuterated Psilocin Program Status: Dosing continues in Phase 3 APPROACH study in MDD. APPROACH is the first pivotal study in Cybin's Phase 3 PARADIGM program, which includes two 12-week randomized, placebo-controlled studies (APPROACH and EMBRACE) and a long-term extension study (EXTEND). Summary of positive Phase 2 12-Month Efficacy Data in MDD Patients 100% of participants receiving two doses of 16 mg were responders. 71% of participants receiving two doses of 16 mg were in remission. Mean change from baseline in MADRS was approximately -23 points after two doses of 16 mg. Upcoming Milestones: Initiate second pivotal Phase 3 study, EMBRACE, around mid-2025. CYB004: Deuterated DMT Program Status: Dosing is ongoing in Phase 2 study in generalized anxiety disorder (GAD) Upcoming Milestones: Phase 2 GAD study is expected to complete mid-2025. To watch Dr. Makary's interview, click here. 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 industry leading 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 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', '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 advancing clinical-stage programs toward potential regulatory review and approval; the potential for FDA Breakthrough Therapy Designation to accelerate drug development timelines; initiating a second pivotal Phase 3 study, EMBRACE, around mid-2025; completing a Phase 2 GAD study in mid-2025; 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: 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 months 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 SEDAR+ at and with the U.S. Securities and Exchange Commission on EDGAR at 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.
Yahoo
08-05-2025
- Business
- Yahoo
Cybin Announces Additional U.S. Patent Supporting its CYB003 Breakthrough Therapy Program in Phase 3 Development for Major Depressive Disorder
- Newly issued patent includes pharmaceutical compositions and oral dosage forms within the CYB003 program with expected exclusivity until 2041 - - Cybin's growing intellectual property portfolio comprises more than 80 granted patents and over 230 pending applications - - Patient dosing continues in APPROACH, Cybin's first pivotal Phase 3 study of CYB003 for the adjunctive treatment for Major Depressive Disorder ("MDD") - - Second Phase 3 study, EMBRACE, is expected to begin mid-2025 - TORONTO, May 08, 2025--(BUSINESS WIRE)--Cybin Inc. (NYSE American: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 the United States Patent and Trademark Office has granted U.S. patent 12,291,499 in support of its CYB003 program in MDD. The patent, which is expected to provide exclusivity until 2041, includes claims to pharmaceutical compositions and oral dosage forms within the Company's proprietary deuterated psilocin analog program, CYB003. "Securing an additional patent in support of CYB003 provides important validation of our program and reinforces the commercial potential of our pipeline," said Doug Drysdale, Chief Executive Officer of Cybin. "Robust patent protection is essential for drug development companies, and we are proud of our expanding intellectual property portfolio. As we continue to dose patients in our first Phase 3 study, we are focused on execution, delivering shareholder value, and ultimately, creating more effective treatments for those with mental health disorders." 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 industry leading 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 program, in Phase 3 development for the adjunctive treatment of major depressive disorder and CYB004, a proprietary deuterated N, N-dimethyltryptamine program 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 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 expectations respecting the patent exclusivity period; commencement of the second Phase 3 study, EMBRACE, in mid-2025; and the Company's plans to engineer 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 a pandemic 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, 2024 and the Company's annual information form for the year ended March 31, 2024, which are available under the Company's profile on SEDAR+ and with the U.S. Securities and Exchange Commission on EDGAR at 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. View source version on Contacts Investor & Media Contact: Gabriel FahelChief Legal OfficerCybin Inc.1-866-292-4601irteam@ – or – media@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
12-03-2025
- Health
- Associated Press
ViiV Healthcare's investigational broadly neutralising antibody - N6LS - successfully maintains viral suppression in long-acting treatment of HIV
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced positive findings from the company's EMBRACE phase IIb study. 1 The study found that N6LS (VH3810109 or VH109), given every four months in combination with monthly cabotegravir long-acting (CAB LA), successfully kept viral levels suppressed in adults living with HIV who were already stable on treatment. It was also well tolerated by participants. These results were presented today at the Conference on Retroviruses and Opportunistic Infections (CROI 2025) in San Francisco, U.S. Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: 'As leaders in long-acting injectable innovation, we are building on the positive patient and physician experience we have with Cabenuva and pioneering the next generation of long-acting treatment options. The EMBRACE study demonstrated that VH109, a CD4-binding broadly neutralising antibody, administered every four months with cabotegravir, achieved high efficacy and was well tolerated through six months. We're looking forward to continuing the development of VH109 as a component of our future ultra long-acting regimens.' Results from the EMBRACE study at the six-month primary endpoint showed that 96% of participants receiving VH109 60mg/kg intravenously (IV) and 88% receiving VH109 3000mg subcutaneously (SC) with rHuPH20 maintained HIV-1 RNA levels below 50 copies/mL, compared to 96% in the standard-of-care group. VH109 was administered in both arms every four months, combined with monthly CAB LA. Confirmed virologic failure was observed in two participants from each VH109 group. Overall, 4% of the IV group and 6% of the SC group had HIV-1 RNA levels of 50 copies/mL or higher, compared to none in the standard-of-care group when measured at month six. VH109 was generally well tolerated, though infusion site reactions were more frequent with SC administration, occurring in 14% compared to none with IV administration. Adverse events specific to the use of study medication were reported in 64% of the IV group and 65% of the SC group, with 16% of participants in the SC group experiencing grade 3-4 adverse events (erythema). No participants in the IV group experienced a grade 3-4 adverse event. Based on the favourable results seen in the trial, ViiV Healthcare will be progressing a six-month IV formulation of VH109 in combination with CAB LA for further evaluation in an EMBRACE part two trial. About Cabenuva (cabotegravir + rilpivirine) Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland Unlimited Company. Rilpivirine tablets are approved in the U.S. and when used with cabotegravir is indicated for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying. Please consult the full Prescribing Information. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. Shionogi became a ViiV shareholder in October 2012. The company's aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in GSK's Annual Report on Form 20-F for 2024. Registered in England & Wales: GSK plc GSK plc No. 3888792 ViiV Healthcare Limited No. 06876960 Registered Office: 79 New Oxford Street 79 New Oxford Street London WC1A 1DG ViiV Healthcare Limited GSK Medicines Research Centre Gunnels Wood Road, Stevenage SG1 2NY References ___________________________________ 1 Taiwo, B et al. VH3810109 (N6LS) Efficacy and Safety in Adults Who Are Virologically Suppressed: The EMBRACE Study. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA CONTACT: ViiV Healthcare enquiries: Media: Rachel Jaikaran +44 (0) 78 2352 3755 (London)Ken Inchausti +1 732 690 6938 (Philadelphia)GSK enquiries: Media: Tim Foley +44 (0) 20 8047 5502 (London)Sarah Clements +44 (0) 20 8047 5502 (London)Kathleen Quinn +1 202 603 5003 (Washington DC)Alison Hunt +1 540 742 3391 (Washington DC)Investor Relations: Annabel Brownrigg-Gleeson +44 (0) 7717 618834 (London)James Dodwell +44 (0) 20 8047 2406 (London)Mick Readey +44 (0) 7990 339653 (London)Camilla Campbell +44 (0) 7803 050238 (London)Steph Mountifield +44 (0) 7796 707505 (London)Jeff McLaughlin +1 215 751 7002 (Philadelphia)Frannie DeFranco +1 215 751 4855 (Philadelphia) INDUSTRY KEYWORD: AIDS HEALTH FDA GENETICS CLINICAL TRIALS PHARMACEUTICAL BIOTECHNOLOGY SOURCE: ViiV Healthcare Copyright Business Wire 2025. PUB: 03/12/2025 11:30 AM/DISC: 03/12/2025 11:32 AM
Yahoo
11-02-2025
- Business
- Yahoo
Cybin Reports Third Quarter Fiscal Year 2025 Financial Results and Recent Business Highlights
- Launched strategic clinical site partnerships to accelerate PARADIGM, a multinational pivotal Phase 3 program evaluating CYB003 for the adjunctive treatment of major depressive disorder ("MDD") - - PARADIGM 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 patients - - APPROACH has been initiated and will enroll 220 participants at more than 40 clinical sites in the United States and Europe - - Upcoming milestones include topline efficacy data readout from CYB004 Phase 2 study in general anxiety disorder and initiation of EXTEND and EMBRACE pivotal studies of CYB003 around mid-year 2025 - - CYB003 in development for MDD has a total addressable market of >300 million people worldwide2- - Cash totaled C$136.3 million as of December 31, 2024 - This news release constitutes a "designated news release" for the purposes of Cybin's prospectus supplement dated February 10, 2025, to its short form base shelf prospectus dated August 17, 2023, as amended December 22, 2023, April 8, 2024 and January 6, 2025. TORONTO, February 11, 2025--(BUSINESS WIRE)--Cybin Inc. (NYSE American:CYBN) (Cboe Canada 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, today reported unaudited financial results for its third quarter ended December 31, 2024, and recent business highlights. "As we advance our lead clinical programs, CYB003 and CYB004, our focus in 2025 remains on continued successful execution," said Doug Drysdale, Chief Executive Officer of Cybin. "With the initiation of PARADIGM, our multinational pivotal Phase 3 program evaluating CYB003 for the adjunctive treatment of MDD, we look forward to a rigorous investigation and to confirming the data from our Phase 2 study in a larger patient population. We anticipate total enrollment of roughly 550 patients across over 40 sites in the United States and Europe. In addition, given CYB003's Breakthrough Therapy Designation by the U.S. Food and Drug Administration, we see an opportunity to validate our results to-date and to potentially change the treatment landscape in depression away from daily dosing and toward more intermittent treatments". "Our expanded drug development team has decades of experience overseeing therapeutics through the regulatory process through to launch and are well-versed in the complexities of this type of research. Energized by the potential of these new treatments, we aim to carry forward the momentum from last year's clinical achievements as we plan for the next set of milestones," concluded Drysdale. Recent Business and Pipeline Highlights: Launched strategic clinical site partnerships to support PARADIGM. Strategic partnership agreements are expected to facilitate collaboration among sites, cultivate long-term partnerships, enhance efficiency in trial operations, and improve overall site performance. Segal Trials, a privately held company with a network of six research sites throughout South Florida, has been named as the first program member. Segal Trials has extensive experience conducting research trials with an emphasis on psychiatry, neurology, addiction and psychedelics research. Clinical Program Update CYB003: Summary of Phase 2 12-Month Efficacy Data in MDD Patients 100% of participants receiving two doses of 16 mg were responders. 71% of participants receiving two doses of 16 mg were in remission. Mean change from baseline in MADRS was approximately -23 points after two doses of 16 mg. CYB004: Phase 2 proof-of-concept study in generalized anxiety disorder ("GAD") is underway The Phase 2 study is a randomized, double-blind study evaluating the safety and efficacy of CYB004 in participants with GAD, with concomitant antidepressant/anxiolytic treatment and co-morbid depression allowed. The Phase 2 study is being conducted at sites in the U.S., with topline safety and efficacy results expected in the first half of 2025. CYB005 Announced grant of first U.S. Composition of Matter patent in support of its CYB005 phenethylamines program. Cybin is investigating novel molecules within the CYB005 program at non-hallucinogenic doses for a range of Central Nervous System disorders and continues to explore non-hallucinogenic neuroplastogens within its broader discovery pipeline. Upcoming Clinical Milestones and Future Studies:1 CYB003 - Deuterated Psilocin Program Initiate second pivotal study, EMBRACE, around mid-2025. Initiate long-term extension study, EXTEND, which is expected to begin 12 weeks after commencement of APPROACH and EMBRACE, respectively. CYB004 – Deuterated DMT Program Dosing is underway and topline safety and efficacy readout from Phase 2 GAD study is expected in the first half of 2025. CYB004 is being developed as a novel intramuscular formulation expected to deliver an experience lasting approximately 90 minutes. Third-Quarter Financial Information Cash totaled C$136.3 million as of December 31, 2024. Cash balance excludes prepaid expenses totaling C$22.9 million as of December 31, 2024. With the previously completed public offerings of units of the Company (the "Units") and a combination of the Company's current cash position, and assuming the exercise in full of the warrants issued as part of the Units, the Company has access to over C$203.6 million. Net loss was C$10.5 million for the quarter ended December 31, 2024, compared to a net loss of C$30.3 million in the same period last year. Cash-based operating expenses consisting of research, general and administrative costs totaled C$28.0 million for the quarter ended December 31, 2024, compared to C$17.1 million in the same period last year. Cash flows used in operating activities were C$27.1 million for the quarter ended December 31, 2024, compared to C$26.0 million in the same period last year. New At-The-Market Equity Program of up to US$100 Million The Company also announced that it has launched a new at-the-market equity program (the "New ATM Program") to allow Cybin to issue and sell up to US$100,000,000 of common shares (the "Shares") in the capital of the Company from treasury to the public, from time to time, through the Agents (as defined below). All Shares sold under the New ATM Program will be sold in transactions that are deemed to be "at-the-market" distributions as defined in National Instrument 44-102 – Shelf Distributions, directly through Cboe Canada, the NYSE American LLC (the "NYSE American") or any other "marketplace" (as defined in National Instrument 21-101 – Marketplace Operation) upon which the Shares are listed, quoted or otherwise traded, at the prevailing market price at the time of sale. Cybin intends to use the net proceeds from sales of Shares under the New ATM Program, if any, for growth opportunities and working capital initiatives. Distributions of Shares under the New ATM Program, if any, will be made pursuant to the terms and conditions of an "at-the-market equity" distribution agreement (the "New Distribution Agreement") dated February 10, 2025 that the Company entered into with Cantor Fitzgerald Canada Corporation and Cantor Fitzgerald & Co. (collectively, the "Agents"). The New ATM Program will be effective until the earlier of the issuance and sale of all of the Shares issuable pursuant to the New ATM Program and September 17, 2025 unless earlier terminated in accordance with the terms of the New Distribution Agreement. The Company is not obligated to make any sales of Shares under the New ATM Program and there can be no assurance as to when such sales will be completed, if ever. The volume and timing of distributions under the New ATM Program, if any, will be determined in Cybin's sole discretion and in accordance with the New Distribution Agreement. As any Shares distributed under the New ATM Program will be issued and sold at the prevailing market price at the time of the applicable sale, prices may vary among purchasers through the duration of the New ATM Program. The completion of sales of Shares under the New ATM Program will be subject to customary closing conditions, including the listing of such Shares on Cboe Canada and the NYSE American, and any required approvals of each exchange. The ATM Program is being established, and the sale of the Shares through the ATM Program will be made pursuant to, and qualified by way of a prospectus supplement dated February 10, 2025 (the "Prospectus Supplement") to the Company's short form base shelf prospectus dated August 17, 2023, as amended on December 22, 2023, April 8, 2024 and January 6, 2025 (the "Base Shelf Prospectus") filed with the securities commissions in each of the provinces and territories of Canada. The Base Shelf Prospectus allows Cybin to qualify offerings of Shares, warrants, subscription receipts, units or debt securities, or a combination thereof, up to an aggregate total of C$650,000,000 during the 25-month period, ending on September 17, 2025, that the Base Shelf Prospectus remains effective. The Prospectus Supplement will be filed with the United States Securities and Exchange Commission as a supplement to the Company's registration statement on Form F-10 (File No. 333-284173), which was declared effective on January 14, 2025, in accordance with the Multijurisdictional Disclosure System established between Canada and the United States. The Prospectus Supplement and accompanying Base Shelf Prospectus contain important detailed information about the New ATM Program. The Prospectus Supplement and accompanying Base Shelf Prospectus can be found under the Company's profile on SEDAR+ at and on EDGAR at Copies of the Prospectus Supplement and accompanying Base Shelf Prospectus may also be obtained from Cantor Fitzgerald Canada Corporation, Attn: Equity Capital Markets, 181 University Avenue, Suite 1500, Toronto, ON, M5H 3M7, Email: ecmcanada@ Cantor Fitzgerald & Co., Attn: Capital Markets, 110 East 59th Street, 6th floor, New York, New York 10022, Email: prospectus@ Prospective investors should read the Prospectus Supplement and accompanying Base Shelf Prospectus and the other documents the Company has filed before making an investment decision. In connection with the launch of the New ATM Program, the Company and the Agents have terminated the Company's existing "at-the market" equity program (the "2023 ATM Program"), which allowed the Company to issue and sell up to US$35,000,000 of Shares from treasury to the public pursuant to a distribution agreement, dated August 23, 2023, among the Company and the Agents. The Company sold a total of 1,653,320 Shares under the 2023 ATM Program at an average price of US$11.05 per Share for gross proceeds of approximately US$18,264,982. The 2023 ATM Program was qualified by way of a prospectus supplement dated August 23, 2023 (the "2023 ATM Supplement") to the Base Shelf Prospectus. The 2023 ATM Supplement was also filed with the SEC as part of a registration statement on Form F-10 (File No. 333-272706), as amended, which became effective on August 17, 2023 upon filing with the SEC. This news release does not constitute an offer to sell or the solicitation of an offer to buy the Shares, nor will there be any sale of the Shares, in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. 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 or follow the team on X, LinkedIn, YouTube and Instagram. Notes 1. There is no assurance that timelines will be met. Anticipated timelines regarding the initiation, advancement and results of clinical trials are based on reasonable assumptions informed by current knowledge and information available to the Company. See "Cautionary Notes and Forward-Looking Statements". 2. World Health Organization. (2017). Depression and other common mental disorders: global health estimates. World Health Organization. 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 report Phase 2 topline results for CYB004 in H1 2025; initiation of EMBRACE study around mid-year 2025; initiation of EXTEND study 12 weeks following commencement of APPROACH and EMBRACE studies, respectfully; timing of the initiation and ability of the Company to enroll participants for the PARADIGM program; the Company's ability to potentially transform the treatment landscape in depression; the exercise in full of the warrants issued as part of the Units, the sale of Shares from time to time under the New ATM Program; the Company's intended use of the net proceeds from sales of Shares, if any, under the New ATM Program; the receipt of applicable regulatory approvals, including the acceptance of Cboe Canada and authorization by NYSE American, 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: 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 SEDAR+ at and with the U.S. Securities and Exchange Commission on EDGAR at 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. View source version on Contacts Investors & Media: Gabriel FahelChief Legal OfficerCybin Inc.1-866-292-4601irteam@ – or – media@ Sign in to access your portfolio
