Adjustment disorders

The study, published in the journal Molecular Psychiatry, suggests that nature-derived psilocybin may be demonstrably more therapeutic than its synthetic analog Benefits are thought to include a more potent and prolonged effect on neuroplasticity NEW YORK, March 18, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq:PBM) ("Psyence Biomed" or the "Company") today issued a statement welcoming the results of a recent study finding evidence that nature-derived psilocybin may be demonstrably more therapeutic than synthetic psilocybin. Published on February 20, 2024, in the journal Molecular Psychiatry, the study was conducted by a research team from Hebrew University, and supervised by Professor Bernard Lerer, MD, Executive Director of the Hadassah Brain Labs and Center for Psychedelic Research. The study presents evidence that nature (mushroom)-derived psilocybin delivers a “more potent and prolonged effect” on “neuroplasticity” than its synthetic analog. “Neuroplasticity” is increasingly recognized as the gold standard by which the therapeutic efficacy of psychedelic pharmaceutical medicines can be measured. The study in mice also suggests that a potential combination of molecules that the study refers to as “the entourage effect” may provide “enhanced or prolonged therapeutic effects” not found in synthetic psilocybin. Dr. Neil Maresky, MD, Chief Executive Officer of Psyence Biomed, the first Nasdaq-traded botanical (non-synthetic) psilocybin biopharma company, stated, “This evidence-based and independent finding affirms Psyence Biomed’s pioneering commitment to nature-derived psilocybin and developing an FDA-approved, nature-derived psilocybin therapeutic for Palliative Care.” Palliative Care is a holistic and integrative medical specialty that provides patients who have received a life-limiting diagnosis with treatment for their emotional, physical, or spiritual distress or discomfort. Proprietary research suggests that the U.S. Palliative Care market is projected to grow to $28.6 billion in 2030. While most psychedelic companies research synthetic psilocybin, Psyence Biomed stands alone as the only Nasdaq traded biopharmaceutical company to research a nature-derived psilocybin candidate to treat Adjustment Disorder in the context of Palliative Care. Psyence Biomed has recently received ethics approval for the trial protocol for its Phase llb clinical trial to move forward. It is expected that the first patients will be randomized in the second quarter of 2024, with topline results available in 2025. The Psyence Biomed study will examine the use of nature-derived psilocybin as a treatment for Adjustment Disorder due to a recent cancer diagnosis in the Palliative Care context. Adjustment Disorder is a serious condition affecting approximately 19% of patients with a life-limiting diagnosis. It severely impacts the quality of life for patients, their families and caregivers, and regularly ranks among the top seven psychiatric diagnoses in the world, according to the World Health Organization (WHO). Dr. Maresky added, “Developing therapies such as psilocybin-assisted psychotherapy, which may reduce patients’ stress and anxiety and result in better quality of life as they navigate a cancer diagnosis, can be very impactful. With psilocybin-assisted psychotherapy, there is an opportunity to both improve patient quality of life while also reducing health care costs associated with Palliative Care.” Palliative Care is also increasingly recognized by the oncology community as a solution to stretching scarce health care resources. According to a separate report this month in the Journal of Clinical Oncology, the ASCO journal, “Randomized controlled trials have demonstrated that Palliative Care can improve quality of life and survival for outpatients with advanced cancer.” The JCO study found that with Palliative Care, hospitalizations decreased 18.7%. Neither Psyence Biomedical nor any of its investors or affiliates funded or in any way sponsored the Hebrew University study. The full text of the paper can be found here: https://link.springer.com/content/pdf/10.1038/s41380-024-02477-w.pdf The JCO paper can be found here: https://ascopubs.org/doi/10.1200/OP.23.00576 About Psyence Biomed:Psyence Biomedical Ltd. is a life science biotechnology company listed on Nasdaq (Nasdaq:PBM), with a focus on natural psychedelics. The Company is developing nature-derived psilocybin mushroom products for the healing of psychological trauma and its mental health consequences in the context of palliative care. Our name “Psyence” combines the words psychedelic and science to affirm our commitment to producing psychedelic medicines developed through evidence-based research. We work to develop advanced natural psilocybin products for clinical research and development. Learn more at www.psyencebiomed.com and on LinkedIn. Contact InformationEmail: ir@psyencebiomed.comMedia Inquiries: media@psyencebiomed.comGeneral Information: info@psyencebiomed.comPhone: +1 416-477-1708 Investor Contact:Jeremy FefferManaging DirectorLifeSci Advisorsjfeffer@lifesciadvisors.com Forward Looking Statements This communication contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, our plans, objectives, expectations and intentions with respect to future operations, products and services; and other statements identified by words such as "will likely result," "are expected to," "will continue," "is anticipated," "estimated," "believe," "intend," "plan," "projection," "outlook" or words of similar meaning. Forward-looking statements in this communication include statements regarding the commencement of the clinical trial referred to in this news release and the anticipated timeframes for the execution of the clinical trial and receipt of trial results. These forward-looking statements are based on a number of assumptions, including the assumption that Psyence Australia will receive all such regulatory and other approvals as may be required to implement the clinical trial, and that patient recruitment will be successful in accordance with the expected timelines. There are numerous risks and uncertainties that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, among others: (i) the ability of iNGENū to execute its obligations in respect of the clinical trial; (ii) changes in applicable laws which may impact the clinical trial and/or the conducting thereof; (iii) Psyence Australia’s ability to achieve successful clinical results; (iv) Psyence Biomed’s ability to obtain regulatory approval for its product candidates, and any related restrictions or limitations of any approved products; (v) Psyence Biomed’s ability to obtain licensing of third-party intellectual property rights for future discovery and development of its product candidates; (vi) the ability of Psyence Biomed to maintain the listing of its common shares and warrants on Nasdaq; and (vii) volatility in the price of the securities of Psyence Biomed due to a variety of factors, including changes in the competitive and highly regulated industries in which Psyence Biomed operates, variations in performance across competitors, changes in laws and regulations affecting Psyence Biomed’s business and changes in Psyence Biomed’s capital structure. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of the Registration Statement on Form F-1, initially filed by the Company with the SEC on February 9, 2024 and other documents filed by the Company from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Actual results and future events could differ materially from those anticipated in such information. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Except as required by law, the Company does not intend to update these forward-looking statements. The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.

Geneva, Switzerland, March 14, 2024 – Addex Therapeutics (SIX: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, announced today that CEO, Tim Dyer, will present at the Bio-Europe Spring 2024 conference taking place March 18 - 20, 2024 in Barcelona, Spain. Dr. Robert Lütjens, Head of Discovery – Biology, will also be attending this event. In his presentation, Mr Dyer will provide a corporate update and discuss recent developments at Addex. Presentation Details: Date: Tuesday, March 19, 2024 Time: 11:00 - 11:15 CET Room: 133/134 Venue: International Barcelona Convention Center Mr Dyer and Dr Lütjens will be available for one-on-one meetings throughout the conference. For more information or to schedule a one-on-one meeting, please reach out through the conference online partnering system or contact IR@addexpharma.com. About Addex Therapeutics Addex Therapeutics is a clinical-stage pharmaceutical company focused on the development and commercialization of an emerging class of novel orally available, small molecule drugs known as allosteric modulators for neurological disorders. Allosteric modulators offer several potential advantages over conventional, non-allosteric molecules and may offer an improved therapeutic approach to conventional “orthosteric” small molecule or biological drugs. Addex’s allosteric modulator drug discovery platform targets receptors and other proteins that are recognized as essential for therapeutic intervention. Addex’s lead drug candidate, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with Janssen Pharmaceuticals, Inc., is in a Phase 2 clinical trial for the treatment of epilepsy. The company’s second clinical program, dipraglurant (mGlu5 negative allosteric modulator or NAM), is under evaluation for future development in post-stroke recovery. Indivior PLC has licensed Addex’s GABAB PAM program for the development of drug candidates, with a focus on substance use disorder. Addex is also advancing a broad preclinical pipeline, which includes development of a range of GABAB PAM for chronic cough, mGlu7 NAM for stress related disorders, M4 PAM for schizophrenia and other forms of psychosis and mGlu2 NAM for mild neurocognitive disorders and depression. Addex shares are listed on the SIX Swiss Exchange and American Depositary Shares representing its shares are listed on the NASDAQ Capital Market, and trade under the ticker symbol “ADXN” on each exchange. Contacts: Tim Dyer Chief Executive Officer Telephone: +41 22 884 15 55 PR@addextherapeutics.com Mike Sinclair Partner, Halsin Partners +44 7968 022075 msinclair@halsin.com Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements about the intended use of proceeds of the offering. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release, are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, uncertainties related to market conditions. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Addex Therapeutics’ Annual Report on Form 20-F for the year ended December 31, 2022, as filed with the SEC on March 30, 2023, the final prospectus supplement and accompanying prospectus and other filings that Addex Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release represent Addex Therapeutics’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Addex Therapeutics explicitly disclaims any obligation to update any forward-looking statements.

NEW YORK, March 06, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd (NASDAQ:PBM) ("Psyence Biomed" or the "Company") is pleased to announce that its wholly-owned subsidiary, Psyence Australia (Pty) Ltd ("Psyence Australia"), has received full approval from the Australian Health Research Ethics Committee (HREC) to initiate its planned Phase IIb study in Melbourne, Australia. The study will examine the use of nature-derived psilocybin as a treatment for Adjustment Disorder due to a recent cancer diagnosis in the palliative care context. Worldwide, an estimated 56.8 million people require palliative care annually, with a substantial number of these patients exhibiting a high burden of psychosocial distress after diagnosis. Adjustment Disorder is a serious condition affecting around 19% of patients with a life-limiting diagnosis. It severely impacts the quality of life for patients, their families and caregivers, and regularly ranks among the top seven psychiatric diagnoses in the world, according to the World Health Organization. Psyence Australia has partnered with a noted psychedelic Contract Research Organization (CRO), iNGENū Pty Ltd ("iNGENū"), to design and execute the clinical trial. iNGENū is an Australia-based, globally focused CRO with extensive experience working in psychedelic pharmaceutical drug research and development. “We are very pleased to have received HREC’s approval to initiate this clinical trial in the field of palliative care that, if successful, will enable us to seek a paradigm shift in the treatment of patients with life-limiting illnesses, improving quality life and elevating the standard of care,” said Dr. Neil Maresky, Psyence Chief Executive Officer. “It is a privilege to conduct this pioneering research with nature-derived psilocybin that may result in significant improvements in patients’ lives. HREC approval represents an important milestone for Psyence, and we can now proceed to initiate this important trial as expeditiously as possible.” The double-blind, placebo-controlled Phase IIb study will test three doses (25mg, 10mg and 1mg) of nature-derived psilocybin in 84 patients in conjunction with psychotherapy. The primary endpoint is change in HAM-A (Hamilton Anxiety Rating Scale), a widely used tool to measure anxiety severity, over time. “Developing therapies such as psilocybin assisted psychotherapy, which may reduce patients’ stress and anxiety and result in better quality of life as they navigate a cancer diagnosis, can be very impactful. The current management of Adjustment Disorder in palliative care has a low rate of success in addressing all symptoms, indicating that a significant unmet medical need persists. With psilocybin assisted psychotherapy, there is an opportunity to both improve patient quality of life while also reducing health care costs associated with palliative care,” Dr. Maresky added. "The Psyence clinical trial Is particularly important as it explores the potential benefits of psychedelic medicine for a vulnerable group of palliative care patients,” said Dr. Sud Agrawal, CEO of iNGENū. “The opportunity for global impact is substantial." Psyence anticipates enrolling the first patient in Q2 2024 and expects the primary endpoint results to be available in 2025. About Psyence Biomed: Psyence Biomedical Ltd is a life science biotechnology company listed on the NASDAQ (NASDAQ:PBM), with a focus on natural psychedelics. The Company is developing nature-derived psilocybin mushroom products for the healing of psychological trauma and its mental health consequences in the context of palliative care. Our name “Psyence” combines the words psychedelic and science to affirm our commitment to producing psychedelic medicines developed through evidence-based research. We work to develop advanced natural psilocybin products for clinical research and development. Learn more at www.psyence.com and on Twitter, Instagram and LinkedIn. Contact InformationEmail: ir@psyencebiomed.comMedia Inquiries: media@psyencebiomed.comGeneral Information: info@psyencebiomed.comPhone: +1 416-477-1708 Investor Contact:Jeremy FefferManaging DirectorLifeSci Advisorsjfeffer@lifesciadvisors.com Forward Looking Statements This communication contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, our plans, objectives, expectations and intentions with respect to future operations, products and services; and other statements identified by words such as "will likely result," "are expected to," "will continue," "is anticipated," "estimated," "believe," "intend," "plan," "projection," "outlook" or words of similar meaning. Forward-looking statements in this communication include statements regarding the commencement of the clinical trial referred to in this news release and the anticipated timeframes for the execution of the clinical trial and receipt of trial results. These forward-looking statements are based on a number of assumptions, including the assumption that Psyence Australia will receive all such regulatory and other approvals as may be required to implement the clinical trial, and that patient recruitment will be successful in accordance with the expected timelines. There are numerous risks and uncertainties that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, among others: (i) the ability of iNGENū to execute its obligations in respect of the clinical trial; (ii) changes in applicable laws which may impact the clinical trial and/or the conducting thereof; (iii) Psyence Australia’s ability to achieve successful clinical results; (iv) Psyence Biomed’s ability to obtain regulatory approval for its product candidates, and any related restrictions or limitations of any approved products; (v) Psyence Biomed’s ability to obtain licensing of third-party intellectual property rights for future discovery and development of its product candidates; (vi) the ability of Psyence Biomed to maintain the listing of its common shares and warrants on NASDAQ; and (vii) volatility in the price of the securities of Psyence Biomed due to a variety of factors, including changes in the competitive and highly regulated industries in which Psyence Biomed operates, variations in performance across competitors, changes in laws and regulations affecting Psyence Biomed’s business and changes in Psyence Biomed’s capital structure. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of the Registration Statement on Form F-1, initially filed by the Company with the SEC on February 9, 2024 and other documents filed by the Company from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Actual results and future events could differ materially from those anticipated in such information. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Except as required by law, the Company does not intend to update these forward-looking statements. The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.